A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)

June 11, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease

The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (<150, US/FDA) or stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The protocol consists of 2 studies. Study 1 includes induction and maintenance treatment, and Study 2 includes only induction treatment. Each study has its own hypotheses and outcome measures that will be assessed independently.

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Recruiting
        • Concord Repatriation General Hospital-Gastroenterology and Liver Services ( Site 3202)
        • Contact:
          • Study Coordinator
          • Phone Number: +61 2 9767 5000
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Recruiting
        • Royal Brisbane and Women's Hospital ( Site 3200)
        • Contact:
          • Study Coordinator
          • Phone Number: +61736468401
      • Brisbane, Queensland, Australia, 4101
        • Recruiting
        • Mater Misericordiae Limited ( Site 3209)
        • Contact:
          • Study Coordinator
          • Phone Number: +61731638195
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hosp - GI Clinical Trials ( Site 3203)
        • Contact:
          • Study Coordinator
          • Phone Number: +61 8 7074 2200
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Health-Gastroenterology ( Site 3206)
        • Contact:
          • Study Coordinator
          • Phone Number: +61(0)395943577
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital-Gastroenterology ( Site 3201)
        • Contact:
          • Study Coordinator
          • Phone Number: +61(0)390760182
  • Austria
      • Salzburg, Austria, 5020
        • Recruiting
        • Uniklinikum Salzburg-Innere Medizin I ( Site 0201)
        • Contact:
          • Study Coordinator
          • Phone Number: 0043(0)572550
    • State of Vienna
      • Vienna, State of Vienna, Austria, 1090
        • Recruiting
        • Medizinische Universität Wien-Klinik für Innere Medizin III - Abteilung für Gastroenterologie und H ( Site 0202)
        • Contact:
          • Study Coordinator
          • Phone Number: +4314040062450
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Recruiting
        • Medizinische Universitaet Innsbruck-Innere Medizin 1 ( Site 0200)
        • Contact:
          • Study Coordinator
          • Phone Number: 0043504813111
  • Belgium
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • UZ Gent ( Site 0300)
        • Contact:
          • Study Coordinator
          • Phone Number: +32 9 332 51 66
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven-Gastroenterology - Inflammatory Bowel Disease ( Site 0301)
        • Contact:
          • Study Coordinator
          • Phone Number: 016 34 88 56
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgium, 8800
        • Recruiting
        • AZ Delta vzw-Gastroenterology ( Site 0304)
        • Contact:
          • Study Coordinator
          • Phone Number: 00 32 51 23 72 15
  • Brazil
      • São Paulo, Brazil, 01236-030
        • Recruiting
        • BR Trials - Ensaios Clinicos e Consultoria ( Site 6301)
        • Contact:
          • Study Coordinator
          • Phone Number: +5511915820176
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90160-093
        • Recruiting
        • Hospital Ernesto Dornelles ( Site 6312)
        • Contact:
          • Study Coordinator
          • Phone Number: +555132178584
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Recruiting
        • Hospital de Clinicas de Porto Alegre ( Site 6310)
        • Contact:
          • Study Coordinator
          • Phone Number: 55 11 99127 6767
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18618-686
        • Recruiting
        • Faculdade de Medicina da UNESP ( Site 6308)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 14 3880-1663
      • Campinas, São Paulo, Brazil, 13092-133
        • Recruiting
        • Loema Instituto de Pesquisa Clinica ( Site 6302)
        • Contact:
          • Study Coordinator
          • Phone Number: +551932353575
      • Jaú, São Paulo, Brazil, 17201-130
        • Recruiting
        • CECIP - Centro de Estudos do Interior Paulista ( Site 6316)
        • Contact:
          • Study Coordinator
          • Phone Number: +551436220500
      • Ribeirão Preto, São Paulo, Brazil, 14048-900
        • Recruiting
        • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) ( Site 6311)
        • Contact:
          • Study Coordinator
          • Phone Number: 55 16 3963 6484
      • Santo André, São Paulo, Brazil, 09080-110
        • Recruiting
        • Pesquisare Saude ( Site 6304)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 11 4432-2953
      • São José do Rio Preto, São Paulo, Brazil, 15015-110
        • Recruiting
        • Centro de Pesquisa Kaiser - CEPEK ( Site 6306)
        • Contact:
          • Study Coordinator
          • Phone Number: +551733024793
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Recruiting
        • Heritage Medical Research Clinic ( Site 0004)
        • Contact:
          • Study Coordinator
          • Phone Number: (403) 220-6014
      • Edmonton, Alberta, Canada, T5R 1W2
        • Recruiting
        • Gastroenterology and internal medicine research institute ( Site 0009)
        • Contact:
          • Study Coordinator
          • Phone Number: 780-499-1192
      • Lethbridge, Alberta, Canada, T1J 4G9
        • Recruiting
        • Prairie Institute of Liver and Luminal Advanced Research ( Site 0015)
        • Contact:
          • Study Coordinator
          • Phone Number: 403-852-7210
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
        • Recruiting
        • Fraser Clinical Trials Inc ( Site 0001)
        • Contact:
          • Study Coordinator
          • Phone Number: 604-521-4500
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Recruiting
        • G.I.R.I. GI Research Institute Foundation ( Site 0018)
        • Contact:
          • Study Coordinator
          • Phone Number: 604-688-6332
    • Nova Scotia
      • Kentville, Nova Scotia, Canada, B4N 0A3
        • Recruiting
        • Private Practice - Dr. Bruce Musgrave ( Site 0014)
        • Contact:
          • Study Coordinator
          • Phone Number: 902-681-9126
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Recruiting
        • Barrie GI Associates ( Site 0016)
        • Contact:
          • Study Coordinator
          • Phone Number: 705-721-3344
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • University Hospital - London Health Sciences Centre ( Site 0002)
        • Contact:
          • Study Coordinator
          • Phone Number: 5196858500x33655
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • London Health Sciences Centre ( Site 0007)
        • Contact:
          • Study Coordinator
          • Phone Number: 5196858500 Ex#75554
      • Mississauga, Ontario, Canada, L5M 2S4
        • Recruiting
        • West GTA Research Inc. ( Site 0020)
        • Contact:
          • Study Coordinator
          • Phone Number: 905-823-0223
      • Oakville, Ontario, Canada, L6L 5L7
        • Recruiting
        • ABP Research Services Corp. ( Site 0019)
        • Contact:
          • Study Coordinator
          • Phone Number: 2898631112
      • Toronto, Ontario, Canada, M6A 3B4
        • Recruiting
        • Toronto Immune & Digestive Health Institute ( Site 0005)
        • Contact:
          • Study Coordinator
          • Phone Number: 647-812-2113
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Active, not recruiting
        • TDDA Inc. ( Site 0006)
    • Quebec
      • Lévis, Quebec, Canada, G6V 3Z1
        • Recruiting
        • Centre de recherche du CISSS de Chaudière-Appalaches - Hôpital Hôtel Dieu de Levis ( Site 0011)
        • Contact:
          • Study Coordinator
          • Phone Number: 418-835-7121
      • Montreal, Quebec, Canada, H3G 1A4
        • Recruiting
        • Montreal General Hospital ( Site 0003)
        • Contact:
          • Study Coordinator
          • Phone Number: 514-934-1934 #36536
      • Montreal, Quebec, Canada, H2X 0C1
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal - Gastroenterology ( Site 0013)
        • Contact:
          • Study Coordinator
          • Phone Number: 514-890-8000 x11736
      • Québec, Quebec, Canada, G1V 4T3
        • Completed
        • Diex Recherche Quebec ( Site 0008)
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4781151
        • Recruiting
        • Hospital hernan henriquez aravena de temuco ( Site 2607)
        • Contact:
          • Study Coordinator
          • Phone Number: 56452556875
    • Biobio
      • Concepción, Biobio, Chile, 4070038
        • Recruiting
        • Hospital Clínico Regional Dr. Guillermo Grant Benavente ( Site 2604)
        • Contact:
          • Study Coordinator
          • Phone Number: +56412722500
    • Region M. de Santiago
      • Las Condes, Region M. de Santiago, Chile, 7620157
        • Recruiting
        • Clínica Universidad de Los Andes ( Site 2609)
        • Contact:
          • Study Coordinator
          • Phone Number: +56958373369
      • Santiago, Region M. de Santiago, Chile, 7500921
        • Recruiting
        • FALP-UIDO ( Site 2600)
        • Contact:
          • Study Coordinator
          • Phone Number: +56224205098
      • Santiago, Region M. de Santiago, Chile, 7650568
        • Recruiting
        • Clínica Alemana de Santiago-Unidad de Investigaciones ( Site 2602)
        • Contact:
          • Study Coordinator
          • Phone Number: 56222101111
      • Santiago, Region M. de Santiago, Chile, 7770086
        • Recruiting
        • Espacio Eme ( Site 2608)
        • Contact:
          • Study Coordinator
          • Phone Number: +56937137320
      • Santiago, Region M. de Santiago, Chile, 8320000
        • Recruiting
        • CECIM ( Site 2603)
        • Contact:
          • Study Coordinator
          • Phone Number: +56226965804
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2540488
        • Recruiting
        • Centro de Investigaciones Clinicas Vina del Mar ( Site 2606)
        • Contact:
          • Study Coordinator
          • Phone Number: +56323245375
  • China
    • Anhui
      • Hefei, Anhui, China, 230071
        • Recruiting
        • Anhui Provincial Hospital ( Site 3922)
        • Contact:
          • Study Coordinator
          • Phone Number: 0551-62283160
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100089
        • Recruiting
        • Peking University Third Hospital ( Site 3910)
        • Contact:
          • Study Coordinator
          • Phone Number: 010-82266699
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 401121
        • Recruiting
        • Chongqing General Hospital ( Site 3940)
        • Contact:
          • Study Coordinator
          • Phone Number: 023-63390710
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Recruiting
        • The First Affiliated Hospital Of Fujian Medical University ( Site 3916)
        • Contact:
          • Study Coordinator
          • Phone Number: 0591-87981262
      • Xiamen, Fujian, China, 361004
        • Recruiting
        • Zhongshan Hospital Affiliated to Xiamen University ( Site 3923)
        • Contact:
          • Study Coordinator
          • Phone Number: 0592 229 2201
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The First Affiliated hospital of Xiamen University ( Site 3924)
        • Contact:
          • Study Coordinator
          • Phone Number: 0592-2139767
    • Guangdong
      • Dongguan, Guangdong, China, 523059
        • Recruiting
        • Dongguan People's Hospital ( Site 3933)
        • Contact:
          • Study Coordinator
          • Phone Number: 0769-28636801
      • Guangzhou, Guangdong, China, 510655
        • Recruiting
        • The First Affiliated Hospital, Sun Yat-sen University ( Site 3901)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 20-87608185
      • Guangzhou, Guangdong, China, 526100
        • Recruiting
        • The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 3907)
        • Contact:
          • Study Coordinator
          • Phone Number: 020 3825 5347
      • Huizhou, Guangdong, China, 516001
        • Recruiting
        • Huizhou Municipal Central Hospital ( Site 3915)
        • Contact:
          • Study Coordinator
          • Phone Number: (0752)2288288
      • Shaoguan, Guangdong, China, 512026
        • Recruiting
        • Yuebei People's Hospital ( Site 3912)
        • Contact:
          • Study Coordinator
          • Phone Number: 0751-6913882
      • Shenzhen, Guangdong, China, 518110
        • Recruiting
        • Shenzhen Hospital of Southern Medical University ( Site 3932)
        • Contact:
          • Study Coordinator
          • Phone Number: (0755)23329999
      • Shenzhen, Guangdong, China, 518053
        • Recruiting
        • The University of Hong Kong-Shenzhen Hospital ( Site 3930)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 755-86913132
    • Hebei
      • Shijiazhuang, Hebei, China, 050200
        • Recruiting
        • The Second Afilliated Hospital of Hebei Medical University ( Site 3913)
        • Contact:
          • Study Coordinator
          • Phone Number: 031166002089
    • Henan
      • Zhengzhou, Henan, China, 450014
        • Recruiting
        • The Second Affiliated Hospital of Zhengzhou University ( Site 3909)
        • Contact:
          • Study Coordinator
          • Phone Number: 0371-63974128
    • Hubei
      • Shiyan, Hubei, China, 442099
        • Recruiting
        • Taihe Hospital ( Site 3944)
        • Contact:
          • Study Coordinator
          • Phone Number: 0719-8801880
      • Wuhan, Hubei, China, 430060
        • Recruiting
        • Renmin Hospital of Wuhan University ( Site 3921)
        • Contact:
          • Study Coordinator
          • Phone Number: 027-88999120
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University-gastroenterology department ( Site 3905)
        • Contact:
          • Study Coordinator
          • Phone Number: 0731-85295194
    • Jiangsu
      • Huaian, Jiangsu, China, 230000
        • Recruiting
        • Huai'an First People's Hospital ( Site 3948)
        • Contact:
          • Study Coordinator
          • Phone Number: 0517-84907287
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Zhongda Hospital Southeast University-Gastroenterology ( Site 3911)
        • Contact:
          • Study Coordinator
          • Phone Number: +8602583272114
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 3937)
        • Contact:
          • Study Coordinator
          • Phone Number: +8602583106666
      • Wuxi, Jiangsu, China, 214023
        • Recruiting
        • Wuxi People's Hospital ( Site 3925)
        • Contact:
          • Study Coordinator
          • Phone Number: 0510-85350351
      • Yangzhou, Jiangsu, China, 225000
        • Recruiting
        • Yangzhou University Affiliated Hospital ( Site 3947)
        • Contact:
          • Study Coordinator
          • Phone Number: +86051482099009
      • Zhenjiang, Jiangsu, China, 213000
        • Recruiting
        • Changzhou No.2 People's Hospital ( Site 3904)
        • Contact:
          • Study Coordinator
          • Phone Number: 0519-88104931
      • Zhenjiang, Jiangsu, China, 212001
        • Recruiting
        • Affiliated Hospital of Jiangsu University ( Site 3919)
        • Contact:
          • Study Coordinator
          • Phone Number: 0511-85023852
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Completed
        • Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army ( Site 3918)
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Recruiting
        • Ruijin Hospital Shanghai Jiaotong University School of Medicine ( Site 3931)
        • Contact:
          • Study Coordinator
          • Phone Number: 021-64370045
      • Shanghai, Shanghai Municipality, China, 200040
        • Recruiting
        • Huashan Hospital of Fudan University ( Site 3946)
        • Contact:
          • Study Coordinator
          • Phone Number: 021-52887120
      • Shanghai, Shanghai Municipality, China, 200120
        • Recruiting
        • Shanghai East Hospital ( Site 3914)
        • Contact:
          • Study Coordinator
          • Phone Number: 021-38804518
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University ( Site 3929)
        • Contact:
          • Study Coordinator
          • Phone Number: 028-85422114
      • Suining, Sichuan, China, 629000
        • Recruiting
        • Suining Central Hospital ( Site 3927)
        • Contact:
          • Study Coordinator
          • Phone Number: 0825-2292063
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Recruiting
        • First Affiliated Hospital of Kunming Medical University ( Site 3928)
        • Contact:
          • Study Coordinator
          • Phone Number: 0871-65324888
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-GI Medicine ( Site 3902)
        • Contact:
          • Study Coordinator
          • Phone Number: 0571777880
      • Taizhou, Zhejiang, China, 317000
        • Recruiting
        • Taizhou Hospital of Zhejiang Province ( Site 3936)
        • Contact:
          • Study Coordinator
          • Phone Number: 0576-89218961
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050030
        • Recruiting
        • Clinica Medellin S.A ( Site 2705)
        • Contact:
          • Study Coordinator
          • Phone Number: +57 3137694095
      • Medellín, Antioquia, Colombia, 05001
        • Recruiting
        • Salud SURA Industriales ( Site 2706)
        • Contact:
          • Study Coordinator
          • Phone Number: +573134673355
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia, 110111
        • Recruiting
        • Fundacion Santa Fe de Bogota ( Site 2703)
        • Contact:
          • Study Coordinator
          • Phone Number: +57 3212108418
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, Colombia, 23002
        • Recruiting
        • IMAT S.A.S ( Site 2700)
        • Contact:
          • Study Coordinator
          • Phone Number: +57 3135342052
    • Risaralda Department
      • Pereira, Risaralda Department, Colombia, 660001
        • Recruiting
        • Oncologos del Occidente ( Site 2702)
        • Contact:
          • Study Coordinator
          • Phone Number: +57 3002558656
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760032
        • Recruiting
        • Fundación Valle del Lili ( Site 2704)
        • Contact:
          • Study Coordinator
          • Phone Number: +573146824542
  • Croatia
    • City of Zagreb
      • Zagreb, City of Zagreb, Croatia, 10000
        • Recruiting
        • Klinička bolnica Merkur ( Site 0503)
        • Contact:
          • Study Coordinator
          • Phone Number: +38512431390
      • Zagreb, City of Zagreb, Croatia, 10000
        • Recruiting
        • Poliklinika Bates ( Site 0504)
        • Contact:
          • Study Coordinator
          • Phone Number: +38512338000
      • Zagreb, City of Zagreb, Croatia, 10000
        • Recruiting
        • Poliklinika Solmed ( Site 0502)
        • Contact:
          • Study Coordinator
          • Phone Number: +38515620921
      • Zagreb, City of Zagreb, Croatia, 10000
        • Recruiting
        • Klinički bolnički centar Zagreb ( Site 0501)
        • Contact:
          • Study Coordinator
          • Phone Number: +38512388888
    • County of Osijek-Baranja
      • Osijek, County of Osijek-Baranja, Croatia, 31000
        • Recruiting
        • Poliklinika Borzan ( Site 0500)
        • Contact:
          • Study Coordinator
          • Phone Number: +385914477723
  • Czechia
      • Hradec Králové, Czechia, 500 12
        • Recruiting
        • Hepato-Gastroenterologie HK ( Site 0652)
        • Contact:
          • Study Coordinator
          • Phone Number: +420 495 218 475
      • Prague, Czechia, 190 00
        • Recruiting
        • ISCARE klinické centrum ( Site 0656)
        • Contact:
          • Study Coordinator
          • Phone Number: +420234770800
    • Brno-mesto
      • Brno, Brno-mesto, Czechia, 602 00
        • Recruiting
        • KLINICKE CENTRUM Pratia Brno, Pratia Brno s.r.o. ( Site 0657)
        • Contact:
          • Study Coordinator
          • Phone Number: +420773762325
      • Brno, Brno-mesto, Czechia, 615 00
        • Recruiting
        • Vojenská Nemocnice Brno-Internal department ( Site 0655)
        • Contact:
          • Study Coordinator
          • Phone Number: +420973445520
    • Central Bohemia
      • Slaný, Central Bohemia, Czechia, 274 01
        • Recruiting
        • Nemocnice Slany-Gastroenterologicka a Endoskopicka ambulance ( Site 0651)
        • Contact:
          • Study Coordinator
          • Phone Number: +420312 575 111
    • Praha 4
      • Prague, Praha 4, Czechia, 140 21
        • Recruiting
        • Institut Klinicke a Experimentalni Mediciny-Klinika hepatogastroentrologie ( Site 0654)
        • Contact:
          • Study Coordinator
          • Phone Number: +420 236 052 139
  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2730
        • Recruiting
        • Herlev and Gentofte Hospital ( Site 5300)
        • Contact:
          • Study Coordinator
          • Phone Number: +45 38685609
    • Region Syddanmark
      • Odense, Region Syddanmark, Denmark, 5000
        • Recruiting
        • Odense Universitetshospital ( Site 5301)
        • Contact:
          • Study Coordinator
          • Phone Number: +4566113333
  • Dominican Republic
    • Nacional
      • Santo Domingo, Nacional, Dominican Republic, 10104
        • Recruiting
        • CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 2901)
        • Contact:
          • Study Coordinator
          • Phone Number: +18097410000
  • Finland
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Recruiting
        • Tampereen yliopistollinen sairaala ( Site 5401)
        • Contact:
          • Study Coordinator
          • Phone Number: +358331169448
    • Pohjois-Karjala
      • Joensuu, Pohjois-Karjala, Finland, 80210
        • Recruiting
        • Pohjois-Karjalan Keskussairaala ( Site 5403)
        • Contact:
          • Study Coordinator
          • Phone Number: +358133300
    • Southwest Finland
      • Turku, Southwest Finland, Finland, 20520
        • Recruiting
        • Turku University Hospital ( Site 5402)
        • Contact:
          • Study Coordinator
          • Phone Number: +358504448237
  • France
      • Paris, France, 75012
        • Recruiting
        • Hôpital Saint Antoine ( Site 0721)
        • Contact:
          • Study Coordinator
          • Phone Number: +33149283171
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06202
        • Recruiting
        • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0711)
        • Contact:
          • Study Coordinator
          • Phone Number: +33492039366
    • Aquitaine
      • Pessac, Aquitaine, France, 33600
        • Recruiting
        • CHU Bordeaux Haut-Leveque ( Site 0713)
        • Contact:
          • Study Coordinator
          • Phone Number: +33557623441
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13915
        • Recruiting
        • Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0722)
        • Contact:
          • Study Coordinator
          • Phone Number: +334913800
    • Bourgogne-Franche-Comté
      • Dijon, Bourgogne-Franche-Comté, France, 21000
        • Recruiting
        • Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 0708)
        • Contact:
          • Study Coordinator
          • Phone Number: 0380295653
    • Champagne-Ardenne
      • Reims, Champagne-Ardenne, France, 51092
        • Completed
        • Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré ( Site 0707)
    • Doubs
      • Besançon, Doubs, France, 25000
        • Recruiting
        • CHU Besançon ( Site 0724)
        • Contact:
          • Study Coordinator
          • Phone Number: +33 3 81 66 82 54
    • Drome
      • Valence, Drome, France, 26953
        • Completed
        • Centre Hospitalier de Valence ( Site 0725)
    • Gard
      • Nîmes, Gard, France, 30029
        • Recruiting
        • C.H.U. de Nimes. Hopital Caremeau ( Site 0731)
        • Contact:
          • Study Coordinator
          • Phone Number: +33 4 66 68 31 83
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Recruiting
        • CHU Rangueil ( Site 0710)
        • Contact:
          • Study Coordinator
          • Phone Number: +33 3 81 66 82 54
    • Hauts-de-Seine
      • Clichy, Hauts-de-Seine, France, 92110
        • Recruiting
        • Hopital Beaujon ( Site 0729)
        • Contact:
          • Study Coordinator
          • Phone Number: +33627203058
      • Neuilly-sur-Seine, Hauts-de-Seine, France, 92200
        • Recruiting
        • CMC Ambroise Paré Hartmann - Institut des MICI ( Site 0723)
        • Contact:
          • Study Coordinator
          • Phone Number: +33141430573
    • Isere
      • Échirolles, Isere, France, 38130
        • Recruiting
        • Clinique des Cèdres ( Site 0732)
        • Contact:
          • Study Coordinator
          • Phone Number: +33476852121
    • Languedoc-Roussillon
      • Montpellier, Languedoc-Roussillon, France, 34295
        • Active, not recruiting
        • CHU SAINT ELOI ( Site 0701)
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44093
        • Recruiting
        • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 0705)
        • Contact:
          • Study Coordinator
          • Phone Number: +33 2 40 08 31 52
    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54500
        • Recruiting
        • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 0717)
        • Contact:
          • Study Coordinator
          • Phone Number: 33383157450
    • Nord
      • Lille, Nord, France, 59037
        • Recruiting
        • Hopital Claude Huriez - CHU de Lille ( Site 0715)
        • Contact:
          • Study Coordinator
          • Phone Number: +33320445620
    • Rhone
      • Pierre-Bénite, Rhone, France, 69310
        • Recruiting
        • centre hospitalier lyon sud ( Site 0716)
        • Contact:
          • Study Coordinator
          • Phone Number: +33478861289
    • Somme
      • Amiens, Somme, France, 80000
        • Recruiting
        • CHU d'Amiens-Picardie - Hôpital Sud ( Site 0709)
        • Contact:
          • Study Coordinator
          • Phone Number: +33322088866
    • Val-de-Marne
      • Créteil, Val-de-Marne, France, 94010
        • Recruiting
        • Hopital Henri Mondor ( Site 0730)
        • Contact:
          • Study Coordinator
          • Phone Number: 0149812368
    • Île-de-France Region
      • Le Kremlin-Bicêtre, Île-de-France Region, France, 94275
        • Recruiting
        • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0702)
        • Contact:
          • Study Coordinator
          • Phone Number: +33145213726
  • Georgia
      • Tbilisi, Georgia, 0114
        • Recruiting
        • New Hospitals ( Site 0800)
        • Contact:
          • Study Coordinator
          • Phone Number: +995322190190
      • Tbilisi, Georgia, 0159
        • Recruiting
        • Caraps Medline ( Site 0803)
        • Contact:
          • Study Coordinator
          • Phone Number: +995 (32) 251-60-60
    • Adjara
      • Batumi, Adjara, Georgia, 6010
        • Recruiting
        • LTD High Technology Hospital Medcenter ( Site 0802)
        • Contact:
          • Study Coordinator
          • Phone Number: +995 577 65 27 66
      • Tbilisi, Adjara, Georgia, 0186
        • Recruiting
        • Caucasus Medical Centre ( Site 0801)
        • Contact:
          • Study Coordinator
          • Phone Number: +995599235553
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Charité Campus Virchow-Klinikum ( Site 0996)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 30 450 665318
      • Brandenburg, Germany, 14770
        • Recruiting
        • Universitätsklinikum Brandenburg an der Havel ( Site 0903)
        • Contact:
          • Study Coordinator
          • Phone Number: +49338141267
    • Baden-Wurttemberg
      • Pforzheim, Baden-Wurttemberg, Germany, 75179
        • Recruiting
        • Siloah St. Trudpert Klinikum-Zentrum für Innere Medizin ( Site 0992)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 72314983704
    • Bavaria
      • München, Bavaria, Germany, 81377
        • Recruiting
        • Klinikum der Universität München Großhadern ( Site 0990)
        • Contact:
          • Study Coordinator
          • Phone Number: +49-89-44000
      • München, Bavaria, Germany, 81675
        • Recruiting
        • klinikum rechts der isar der technischen universität münchen ( Site 0989)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 89 4140-2455
      • Ulm, Bavaria, Germany, 89081
        • Recruiting
        • Universitaetsklinikum Ulm. ( Site 0994)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 731 500 44727
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover ( Site 0999)
        • Contact:
          • Study Coordinator
          • Phone Number: +4905115328473
      • Lüneburg, Lower Saxony, Germany, 21339
        • Recruiting
        • Klinikum Lüneburg ( Site 0991)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 4131 772240
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany, 18057
        • Recruiting
        • Universitätsmedizin Rostock ( Site 0993)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 381494147483
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 51103
        • Recruiting
        • Evangelisches Krankenhaus Kalk gGmbH ( Site 0986)
        • Contact:
          • Study Coordinator
          • Phone Number: +49-221-82890
      • Duisburg, North Rhine-Westphalia, Germany, 47055
        • Recruiting
        • Stadtische Kliniken Duisburg, Abtlg. Innere Medizin ( Site 0985)
        • Contact:
          • Study Coordinator
          • Phone Number: +492037332390
      • Minden, North Rhine-Westphalia, Germany, 32423
        • Recruiting
        • Gastroenterologische Gemeinschaftspraxis Minden ( Site 0998)
        • Contact:
          • Study Coordinator
          • Phone Number: +4957195193703
      • Münster, North Rhine-Westphalia, Germany, 48155
        • Completed
        • Medizinisches Versorgungszentrum Portal 10 ( Site 0988)
      • Remscheid, North Rhine-Westphalia, Germany, 42859
        • Recruiting
        • Magen Darm Zentrum Remscheid ( Site 0984)
        • Contact:
          • Study Coordinator
          • Phone Number: +4921918901050
    • Rhineland-Palatinate
      • Ludwighafen Am Rhein, Rhineland-Palatinate, Germany, 67067
        • Recruiting
        • St. Marien und St. Annastift Krankenhaus ( Site 0987)
        • Contact:
          • Study Coordinator
          • Phone Number: +4962155012224
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Recruiting
        • Universitätsklinikum Leipzig ( Site 0997)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 341 97 12226
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Recruiting
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0995)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 431 500 22201
  • Greece
    • Attica
      • Athens, Attica, Greece, 106 76
        • Recruiting
        • Evangelismos General Hospital of Athens ( Site 1002)
        • Contact:
          • Study Coordinator
          • Phone Number: +306977617000
      • Athens, Attica, Greece, 115 27
        • Recruiting
        • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 1004)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2107763359
      • Nikaia Piraeus, Attica, Greece, 184 54
        • Recruiting
        • General Hospital of Nikaia-Piraeus "Agios Panteleimon" ( Site 1003)
        • Contact:
          • Study Coordinator
          • Phone Number: +302132077000
    • Central Macedonia
      • Thessaloniki, Central Macedonia, Greece, 54642
        • Recruiting
        • Ippokrateio General Hospital of Thessaloniki ( Site 1001)
        • Contact:
          • Study Coordinator
          • Phone Number: +302313312000
    • Crete
      • Heraklion, Crete, Greece, 711 10
        • Recruiting
        • University General Hospital of Heraklion-GASTROENTEROLOGY & HEPATOLOGY ( Site 1000)
        • Contact:
          • Study Coordinator
          • Phone Number: +302813402111
  • Hong Kong
      • Hksar, Hong Kong
        • Recruiting
        • Queen Mary Hospital ( Site 3300)
        • Contact:
          • Study Coordinator
          • Phone Number: +852 2255 3838
  • Hungary
      • Budapest, Hungary, 1033
        • Recruiting
        • Clinexpert Kft.-Clinexpert Budapest ( Site 1108)
        • Contact:
          • Study Coordinator
          • Phone Number: 0036 1 2108139
      • Budapest, Hungary, 1136
        • Recruiting
        • Pannónia Magánorvosi Centrum ( Site 1103)
        • Contact:
          • Study Coordinator
          • Phone Number: 36 30 347 9212
      • Budapest, Hungary, 1134
        • Recruiting
        • Eszak-Pesti Centrumkorhaz-Honvedkorhaz ( Site 1100)
        • Contact:
          • Study Coordinator
          • Phone Number: 36 30 201 7237
      • Budapest, Hungary, 1036
        • Completed
        • Synexus Magyarorszag Kft. (Budapest DRS) ( Site 1107)
      • Budapest, Hungary, 1082
        • Recruiting
        • Semmelweis Egyetem ( Site 1118)
        • Contact:
          • Study Coordinator
          • Phone Number: 36 1 459 1500 /52120
    • Bekescsaba
      • Békéscsaba, Bekescsaba, Hungary, 5600
        • Recruiting
        • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1105)
        • Contact:
          • Study Coordinator
          • Phone Number: +36304366675
    • Heves County
      • Eger, Heves County, Hungary, 3300
        • Completed
        • Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 1117)
      • Gyöngyös, Heves County, Hungary, 3200
        • Recruiting
        • Gyöngyösi Bugát Pál Kórház ( Site 1111)
        • Contact:
          • Study Coordinator
          • Phone Number: 36 37 312 491
    • Komárom-Esztergom
      • Tatabánya, Komárom-Esztergom, Hungary, 2800
        • Recruiting
        • Komarom-Esztergom Varmegyei Szent Borbala Korhaz ( Site 1115)
        • Contact:
          • Study Coordinator
          • Phone Number: +3634515488
    • Veszprém megye
      • Veszprém, Veszprém megye, Hungary, 8200
        • Recruiting
        • VeszLife Magánklinika ( Site 1102)
        • Contact:
          • Study Coordinator
          • Phone Number: +36309371646
  • Ireland
      • Dublin, Ireland, D09 V2NO
        • Completed
        • Beaumont Hospital, Dublin ( Site 5601)
  • Israel
      • Afula, Israel, 1834111
        • Recruiting
        • Emek Medical Center ( Site 1206)
        • Contact:
          • Study Coordinator
          • Phone Number: 972-46495766
      • Ashkelon, Israel, 7830604
        • Recruiting
        • Barzilai Medical Center ( Site 1209)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-54-5789300
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus ( Site 1201)
        • Contact:
          • Study Coordinator
          • Phone Number: 0502062249
      • Haifa, Israel, 3339419
        • Recruiting
        • Bnai Zion Medical Center ( Site 1203)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-50-6267321
      • Holon, Israel, 5810001
        • Recruiting
        • Edith Wolfson Medical Center ( Site 1204)
        • Contact:
          • Study Coordinator
          • Phone Number: +97235028482
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center ( Site 1208)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-50-7874311
      • Kfar Saba, Israel, 4428164
        • Recruiting
        • Meir Medical Center. ( Site 1202)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-58-5444887
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center ( Site 1207)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-54 5989299
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center ( Site 1200)
        • Contact:
          • Study Coordinator
          • Phone Number: 97235307072
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1308)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 0512144134
      • Messina, Italy, 98125
        • Recruiting
        • Azienda Ospedaliera Universitaria Di Messina G. Martino ( Site 1314)
        • Contact:
          • Study Coordinator
          • Phone Number: +39090 2212380
      • Milan, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele-Gastroenterology and Gastrointestinal Endoscopy ( Site 1300)
        • Contact:
          • Study Coordinator
          • Phone Number: +390226439415
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Dipartimento di Medicina Interna e Gas ( Site 1312)
        • Contact:
          • Study Coordinator
          • Phone Number: +390630153791
    • Apulia
      • Bari, Apulia, Italy, 70124
        • Recruiting
        • A.O.U.C. Policlinico di Bari ( Site 1306)
        • Contact:
          • Study Coordinator
          • Phone Number: +390805594035
    • Cagliari
      • Monserrato, Cagliari, Italy, 09042
        • Recruiting
        • Policlinico Universitario Monserrato-SC Gastroenterologia ( Site 1313)
        • Contact:
          • Study Coordinator
          • Phone Number: +390706754621
    • Lazio
      • Rome, Lazio, Italy, 00133
        • Active, not recruiting
        • Fondazione Policlinico Tor Vergata ( Site 1307)
    • Lombardy
      • Milan, Lombardy, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-Gastroenterology and Endoscopy Unit ( Site 1304)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 0255032141
      • Rozzano, Lombardy, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas-IBD center ( Site 1309)
        • Contact:
          • Study Coordinator
          • Phone Number: +390282248282
    • Napoli
      • Naples, Napoli, Italy, 80131
        • Recruiting
        • A.O.R.N. Ospedale dei Colli - Monaldi V. ( Site 1310)
        • Contact:
          • Study Coordinator
          • Phone Number: +390817062270
    • Piedmont
      • Turin, Piedmont, Italy, 10128
        • Recruiting
        • Ospedale Mauriziano - Gastroenterology Unit ( Site 9000)
        • Contact:
          • Study Coordinator
          • Phone Number: +390115082534
    • Pisa
      • Pontedera, Pisa, Italy, 56025
        • Recruiting
        • Ospedale "Felice Lotti" Di Pontedera ( Site 1311)
        • Contact:
          • Study Coordinator
          • Phone Number: 00390587273305
    • Sicily
      • Palermo, Sicily, Italy, 90146
        • Recruiting
        • Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO-U.O.S.D. Malattie Infiammatorie Croniche Intestinali ( Site 1302)
        • Contact:
          • Study Coordinator
          • Phone Number: +390916802022
    • Tuscany
      • Florence, Tuscany, Italy, 50134
        • Recruiting
        • Azienda Ospedaliera Universitaria Careggi-MICI ( Site 9002)
        • Contact:
          • Study Coordinator
          • Phone Number: +39055794111
    • Verona
      • Negrar, Verona, Italy, 37024
        • Recruiting
        • Ospedale Sacro Cuore Don G. Calabria-IBD Unit ( Site 1303)
        • Contact:
          • Study Coordinator
          • Phone Number: +390456013720
  • Japan
      • Fukuoka, Japan, 814-0180
        • Recruiting
        • Fukuoka University Hospital ( Site 3417)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-92-801-1011
      • Fukuoka, Japan, 815-8555
        • Recruiting
        • Japanese Red Cross Fukuoka Hospital ( Site 3462)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-92-521-1211
      • Hiroshima, Japan, 734-8551
        • Recruiting
        • Hiroshima University Hospital ( Site 3418)
        • Contact:
          • Study Coordinator
          • Phone Number: +81822575555
      • Kagoshima, Japan, 892-0843
        • Recruiting
        • Kagoshima IBD Gastroenterology Clinic ( Site 3428)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-99-813-7548
      • Kagoshima, Japan, 890-8520
        • Recruiting
        • Kagoshima University Hospital ( Site 3425)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-99-275-5111
      • Kumamoto, Japan, 862-0971
        • Recruiting
        • Coloproctology Center Takano Hospital ( Site 3466)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-96-320-6500
      • Kyoto, Japan, 602-8566
        • Recruiting
        • University Hospital,Kyoto Prefectural University of Medicine ( Site 3406)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-75-251-5111
      • Kyoto, Japan, 612-8555
        • Recruiting
        • National Hospital Organization Kyoto Medical Center ( Site 3411)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-75-641-9161
      • Okayama, Japan, 700-8558
        • Recruiting
        • Okayama University Hospital ( Site 3454)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-86-223-7151
      • Osaka, Japan, 530-0011
        • Recruiting
        • Infusion Clinic ( Site 3408)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-6-6359-2123
      • Osaka, Japan, 540-0006
        • Recruiting
        • National Hospital Organization Osaka National Hospital ( Site 3453)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-6-6942-1331
      • Saga, Japan, 849-8501
        • Active, not recruiting
        • Saga University Hospital ( Site 3424)
      • Tokyo, Japan, 169-0073
        • Recruiting
        • Tokyo Yamate Medical Center ( Site 3415)
        • Contact:
          • Study Coordinator
          • Phone Number: 0333640251
      • Toyama, Japan, 930-0975
        • Recruiting
        • Toyama Prefectural Central Hospital ( Site 3410)
        • Contact:
          • Study Coordinator
          • Phone Number: +81764241531
      • Yamagata, Japan, 990-9585
        • Recruiting
        • Yamagata University Hospital ( Site 3426)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-23-633-1122
    • Aichi-ken
      • Nagakute, Aichi-ken, Japan, 480-1195
        • Recruiting
        • Aichi Medical University Hospital ( Site 3429)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-561-62-3311
      • Nagoya, Aichi-ken, Japan, 466-8560
        • Recruiting
        • Nagoya University Hospital ( Site 3445)
        • Contact:
          • Study Coordinator
          • Phone Number: +81527412111
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Recruiting
        • Nagoya City University Hospital ( Site 3446)
        • Contact:
          • Study Coordinator
          • Phone Number: +81528515511
    • Chiba
      • Abiko, Chiba, Japan, 270-1168
        • Recruiting
        • Tokatsu Tsujinaka Hospital ( Site 3403)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-4-7184-9000
      • Kashiwa, Chiba, Japan, 277-0871
        • Recruiting
        • Tsujinaka Hospital - Kashiwanoha ( Site 3402)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-4-7137-3737
      • Sakura, Chiba, Japan, 285-8741
        • Recruiting
        • Toho University Sakura Medical Center ( Site 3413)
        • Contact:
          • Study Coordinator
          • Phone Number: 81434628811
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Recruiting
        • Kurume University Hospital ( Site 3419)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-942-35-3311
    • Gunma
      • Maebashi, Gunma, Japan, 371-8511
        • Recruiting
        • Gunma University Hospital ( Site 3432)
        • Contact:
          • Study Coordinator
          • Phone Number: +81272207111
    • Hiroshima
      • Fukuyama, Hiroshima, Japan, 720-8520
        • Recruiting
        • National Hospital Organization Fukuyama Medical Center ( Site 3442)
        • Contact:
          • Study Coordinator
          • Phone Number: +81849220001
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 064-0919
        • Recruiting
        • Medical Corporation Sapporo IBD Clinic ( Site 3420)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-11-213-0397
      • Sapporo, Hokkaido, Japan, 004-0041
        • Recruiting
        • Sapporo Tokushukai Hospital ( Site 3427)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-11-890-1110
      • Sapporo, Hokkaido, Japan, 065-0033
        • Recruiting
        • Sapporohigashi Tokushukai Hospital ( Site 3441)
        • Contact:
          • Study Coordinator
          • Phone Number: +81117221110
      • Sapporo, Hokkaido, Japan, 060-8543
        • Recruiting
        • Sapporo Medical University Hospital ( Site 3460)
        • Contact:
          • Study Coordinator
          • Phone Number: +81116112111
    • Hyōgo
      • Nishinomiya, Hyōgo, Japan, 663-8501
        • Recruiting
        • Hyogo Medical University Hospital ( Site 3430)
        • Contact:
          • Study Coordinator
          • Phone Number: +81798456111
    • Ibaraki
      • Hitachi, Ibaraki, Japan, 317-0077
        • Recruiting
        • Hitachi General Hospital ( Site 3438)
        • Contact:
          • Study Coordinator
          • Phone Number: +81294231111
      • Tsuchiura, Ibaraki, Japan, 300-0028
        • Recruiting
        • Tsuchiura Kyodo General Hospital ( Site 3463)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-29-830-3711
      • Tsukuba, Ibaraki, Japan, 300-2622
        • Recruiting
        • Tsukuba Memorial Hospital ( Site 3461)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-29-864-1212
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Recruiting
        • Kanazawa University Hospital ( Site 3436)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-76-265-2000
    • Iwate
      • Shiwa-gun, Iwate, Japan, 028-3695
        • Recruiting
        • Iwate Medical University Hospital ( Site 3457)
        • Contact:
          • Study Coordinator
          • Phone Number: ＋81196136111
    • Kanagawa
      • Kamakura, Kanagawa, Japan, 247-0056
        • Recruiting
        • Gokeikai Ofuna Chuo Hospital ( Site 3412)
        • Contact:
          • Study Coordinator
          • Phone Number: +81467452111
      • Kawasaki, Kanagawa, Japan, 216-8511
        • Recruiting
        • St. Marianna University Hospital ( Site 3440)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-44-977-8111
      • Yokohama, Kanagawa, Japan, 232-0024
        • Recruiting
        • Yokohama City University Medical Center ( Site 3439)
        • Contact:
          • Study Coordinator
          • Phone Number: +81452615656
      • Yokohama, Kanagawa, Japan, 220-0041
        • Recruiting
        • Matsushima Hospital ( Site 3450)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-45-321-7311
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
        • Recruiting
        • Mie University Hospital ( Site 3405)
        • Contact:
          • Study Coordinator
          • Phone Number: +81- 59-232-1111
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital ( Site 3447)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-22-717-7000
    • Okinawa
      • Ginowan, Okinawa, Japan, 901-2725
        • Recruiting
        • University of the Ryukyus Hospital ( Site 3459)
        • Contact:
          • Study Coordinator
          • Phone Number: +81988953331
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital ( Site 3409)
        • Contact:
          • Study Coordinator
          • Phone Number: +81728040101
    • Saitama
      • Kawagoe, Saitama, Japan, 350-8550
        • Recruiting
        • Saitama Medical Center ( Site 3452)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-49-228-3807
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 432-8061
        • Recruiting
        • Matsuda Hospital ( Site 3404)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-53-448-5121
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Recruiting
        • Hamamatsu University Hospital ( Site 3449)
        • Contact:
          • Study Coordinator
          • Phone Number: +81534352111
      • Shimizu, Shizuoka, Japan, 411-8611
        • Recruiting
        • National Hospital Organization Shizuoka Medical Center ( Site 3401)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-55-975-2000
    • Tokyo
      • Bunkyō, Tokyo, Japan, 113-8519
        • Recruiting
        • Institute of Science Tokyo Hospital ( Site 3437)
        • Contact:
          • Study Coordinator
          • Phone Number: +81338136111
      • Chūō, Tokyo, Japan, 104-0061
        • Recruiting
        • Ginza Central Clinic ( Site 3407)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-5579-5995
      • Minato, Tokyo, Japan, 108-8642
        • Recruiting
        • Kitasato University Kitasato Institute Hospital ( Site 3458)
        • Contact:
          • Study Coordinator
          • Phone Number: +81334446161
      • Minato-ku, Tokyo, Japan, 105-8470
        • Recruiting
        • Toranomon Hospital ( Site 3433)
        • Contact:
          • Study Coordinator
          • Phone Number: +81335881111
      • Mitaka, Tokyo, Japan, 181-8611
        • Recruiting
        • Kyorin University Hospital ( Site 3443)
        • Contact:
          • Study Coordinator
          • Phone Number: 81422475511
      • Mitato, Tokyo, Japan, 105-8471
        • Recruiting
        • The Jikei University Hospital ( Site 3414)
        • Contact:
          • Study Coordinator
          • Phone Number: +81334331111
      • Shinjuku, Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital ( Site 3456)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3342-6111
      • Shinjuku, Tokyo, Japan, 162-8655
        • Recruiting
        • National Center for Global Health and Medicine ( Site 3423)
        • Contact:
          • Study Coordinator
          • Phone Number: +81332027181
    • Yamanashi
      • Kofu, Yamanashi, Japan, 400-8506
        • Recruiting
        • Yamanashi Prefectural Central Hospital ( Site 3435)
        • Contact:
          • Study Coordinator
          • Phone Number: +81552537111
  • Latvia
      • Riga, Latvia, LV1002
        • Recruiting
        • Pauls Stradins Clinical University Hospital ( Site 5903)
        • Contact:
          • Study Coordinator
          • Phone Number: +37167069210
    • Ādaži
      • Adazi, Ādaži, Latvia, 2164
        • Recruiting
        • SIA M & M Centrs ( Site 5902)
        • Contact:
          • Study Coordinator
          • Phone Number: +37126164281
  • Lithuania
      • Vilnius, Lithuania, LT-08661
        • Recruiting
        • VILNIUS UNIVERSITY HOSPITAL SANTAROS KLINIKOS-Department of Clinical Trials and Pharmacology ( Site 6001)
        • Contact:
          • Study Coordinator
          • Phone Number: +37052365000
    • Kaunas County
      • Kaunas, Kaunas County, Lithuania, 50161
        • Recruiting
        • Hospital of Lithuanian University of Health Sciences Kauno klinikos-Gastroenterology ( Site 6000)
        • Contact:
          • Study Coordinator
          • Phone Number: +37037326379
  • Malaysia
    • Johor
      • Johor Bahru, Johor, Malaysia, 80100
        • Recruiting
        • Hospital Sultanah Aminah ( Site 6104)
        • Contact:
          • Study Coordinator
          • Phone Number: +6072257000
    • Kelantan
      • Kubang Kerian, Kelantan, Malaysia, 16150
        • Recruiting
        • Hospital Universiti Sains Malaysia ( Site 6103)
        • Contact:
          • Study Coordinator
          • Phone Number: +6097673000
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University Malaya Medical Centre ( Site 6101)
        • Contact:
          • Study Coordinator
          • Phone Number: +60479492351
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Recruiting
        • Sarawak General Hospital ( Site 6102)
        • Contact:
          • Study Coordinator
          • Phone Number: +6082276820
    • Selangor
      • Ampang, Selangor, Malaysia, 68000
        • Recruiting
        • Hospital Ampang ( Site 6106)
        • Contact:
          • Study Coordinator
          • Phone Number: +60342896559
  • Mexico
      • Chihuahua City, Mexico, 31207
        • Recruiting
        • Scientia Investigacion Clinica S.C. ( Site 3114)
        • Contact:
          • Study Coordinator
          • Phone Number: 6142783902
    • Guanajuato
      • León, Guanajuato, Mexico, 37000
        • Recruiting
        • Morales Vargas Centro de Investigacion ( Site 3101)
        • Contact:
          • Study Coordinator
          • Phone Number: 4775580244
    • Jalisco
      • Tlajomulco de Zúñiga, Jalisco, Mexico, 45640
        • Recruiting
        • Centro Medico Clinico Quirurgico Especializado en Investigación ( Site 3106)
        • Contact:
          • Study Coordinator
          • Phone Number: +523311491351
    • Mexico City
      • Mexico City, Mexico City, Mexico, 03330
        • Recruiting
        • Centro de Investigación y Gastroenterología - S.C. ( Site 3102)
        • Contact:
          • Study Coordinator
          • Phone Number: +52 55 9314 4340
      • Mexico City, Mexico City, Mexico, 14050
        • Recruiting
        • Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 3104)
        • Contact:
          • Study Coordinator
          • Phone Number: +525544472849
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62290
        • Recruiting
        • JM Research SC ( Site 3109)
        • Contact:
          • Study Coordinator
          • Phone Number: +527773333178
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Recruiting
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Gastroenterología ( Site 3100)
        • Contact:
          • Study Coordinator
          • Phone Number: 8111855955
      • San Pedro Garza García, Nuevo León, Mexico, 66220
        • Recruiting
        • Servicios de Oncología Médica Integral, S.A de C.V. ( Site 3108)
        • Contact:
          • Study Coordinator
          • Phone Number: 8110674829
    • Oaxaca
      • Oaxaca City, Oaxaca, Mexico, 68020
        • Recruiting
        • Centro de Investigacion Clinica de Oaxaca ( Site 3105)
        • Contact:
          • Study Coordinator
          • Phone Number: +529512570569
    • Yucatán
      • Mérida, Yucatán, Mexico, 97070
        • Recruiting
        • Medical Care and Research SA de CV-GASTROENTEROLOGY ( Site 3110)
        • Contact:
          • Study Coordinator
          • Phone Number: +529999203879
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • University Medical Center Groningen ( Site 1506)
        • Contact:
          • Study Coordinator
          • Phone Number: 0031503612620
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • Universitair Medisch Centrum Utrecht ( Site 1502)
        • Contact:
          • Study Coordinator
          • Phone Number: 003188-7573618
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Recruiting
        • Radboudumc ( Site 1505)
        • Contact:
          • Study Coordinator
          • Phone Number: 0031243619190
    • North Brabant
      • Tilburg, North Brabant, Netherlands, 5022GC
        • Recruiting
        • ETZ Elisabeth ( Site 1501)
        • Contact:
          • Study Coordinator
          • Phone Number: 0031(0)13-2218466
      • Uden, North Brabant, Netherlands, 5406 PT
        • Recruiting
        • Ziekenhuis Bernhoven ( Site 1508)
        • Contact:
          • Study Coordinator
          • Phone Number: +3141-3402933
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1081 HV
        • Recruiting
        • Amsterdam UMC, locatie VUmc-IBD Trial Unit ( Site 1500)
        • Contact:
          • Study Coordinator
          • Phone Number: +31205666545
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015 GD
        • Recruiting
        • Erasmus Medisch Centrum ( Site 1504)
        • Contact:
          • Study Coordinator
          • Phone Number: +3110-7030792
      • Rotterdam, South Holland, Netherlands, 3045 PM
        • Recruiting
        • Franciscus Gasthuis & Vlietland, Locatie Gasthuis ( Site 1503)
        • Contact:
          • Study Coordinator
          • Phone Number: 0031104617430
  • New Zealand
      • Auckland, New Zealand, 2025
        • Recruiting
        • Aotearoa Clinical Trials ( Site 3501)
        • Contact:
          • Study Coordinator
          • Phone Number: +64212070632
    • Otago
      • Dunedin, Otago, New Zealand, 9016
        • Recruiting
        • Dunedin Hospital ( Site 3505)
        • Contact:
          • Study Coordinator
          • Phone Number: +6434740999
    • Wellington Region
      • Lower Hutt, Wellington Region, New Zealand, 5010
        • Recruiting
        • Hutt Valley District Health board HVDHB ( Site 3500)
        • Contact:
          • Study Coordinator
          • Phone Number: +64 4 587 2519
  • Peru
      • Lima, Peru, Lima 31
        • Recruiting
        • Hospital Cayetano Heredia ( Site 3003)
        • Contact:
          • Study Coordinator
          • Phone Number: +51932016758
      • Lima, Peru, Lima11
        • Recruiting
        • Hospital Nacional Edgardo Rebagliati Martins-Aparato Digestivo ( Site 0154)
        • Contact:
          • Study Coordinator
          • Phone Number: +51999856018
      • Lima, Peru, 15023
        • Recruiting
        • Investigaciones Clínicas / Instituto de Ginecología y Reproducción ( Site 3002)
        • Contact:
          • Study Coordinator
          • Phone Number: +51 01 4694064
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-324
        • Recruiting
        • Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.,Twoja Przychodnia PCM ( Site 1632)
        • Contact:
          • Study Coordinator
          • Phone Number: +48 605 654 590
      • Poznan, Greater Poland Voivodeship, Poland, 60-309
        • Recruiting
        • EMC Instytut Medyczny S.A,Prywatna Lecznica Certus Ambulatoria,Prywatna Lecznica Certus Szpital Nr1 ( Site 1605)
        • Contact:
          • Study Coordinator
          • Phone Number: +48734217034
      • Poznan, Greater Poland Voivodeship, Poland, 60-192
        • Recruiting
        • Pratia S.A. Pratia Poznan ( Site 1603)
        • Contact:
          • Study Coordinator
          • Phone Number: +48 512 491 461
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-231
        • Recruiting
        • NZOZ Centrum Medyczne KERmed ( Site 1641)
        • Contact:
          • Study Coordinator
          • Phone Number: +48533550245
      • Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
        • Recruiting
        • Gastromed Sp. z o. o. ( Site 1619)
        • Contact:
          • Study Coordinator
          • Phone Number: +48 665 954 004
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-363
        • Recruiting
        • Centrum Medyczne Plejady ( Site 1627)
        • Contact:
          • Study Coordinator
          • Phone Number: +48664007799
      • Krakow, Lesser Poland Voivodeship, Poland, 31-501
        • Recruiting
        • FutureMeds Krakow ( Site 1628)
        • Contact:
          • Study Coordinator
          • Phone Number: +48124231722
      • Krakow, Lesser Poland Voivodeship, Poland, 31-513
        • Recruiting
        • PROMED P. LACH R. GLOWACKI SP. J. ( Site 1636)
        • Contact:
          • Study Coordinator
          • Phone Number: +48124111398
      • Nowy Targ, Lesser Poland Voivodeship, Poland, 34-400
        • Recruiting
        • Allmedica ( Site 1602)
        • Contact:
          • Study Coordinator
          • Phone Number: +48600616769
      • Oświęcim, Lesser Poland Voivodeship, Poland, 32-600
        • Recruiting
        • Medicome Sp. z o.o ( Site 1635)
        • Contact:
          • Study Coordinator
          • Phone Number: 48698901491
    • Lower Silesian Voivodeship
      • Jelenia Góra, Lower Silesian Voivodeship, Poland, 58-500
        • Active, not recruiting
        • Amicare ( Site 1620)
      • Wroclaw, Lower Silesian Voivodeship, Poland, 52-210
        • Recruiting
        • Planetmed ( Site 1600)
        • Contact:
          • Study Coordinator
          • Phone Number: +48601749801
      • Wroclaw, Lower Silesian Voivodeship, Poland, 53-149
        • Recruiting
        • Vistamed & Vertigo Sp. z o.o. ( Site 1621)
        • Contact:
          • Study Coordinator
          • Phone Number: +48600411536
      • Wroclaw, Lower Silesian Voivodeship, Poland, 54-239
        • Recruiting
        • Penta Hospitals Przychodnie Wrocław Wejherowska ( Site 1601)
        • Contact:
          • Study Coordinator
          • Phone Number: +48666873220
      • Wroclaw, Lower Silesian Voivodeship, Poland, 53-611
        • Recruiting
        • Melita Medical Sp. z o.o. ( Site 1607)
        • Contact:
          • Study Coordinator
          • Phone Number: 717072111
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-582
        • Recruiting
        • Medrise Sp. z o.o. ( Site 1626)
        • Contact:
          • Study Coordinator
          • Phone Number: +48795404502
      • Lublin, Lublin Voivodeship, Poland, 20-954
        • Recruiting
        • Uniwersytecki Szpital Kliniczny nr 4 w Lublinie, Kliniczny Oddział Gastroenterologii, Hepatologii i ( Site 1615)
        • Contact:
          • Study Coordinator
          • Phone Number: +48814485180
      • Zamość, Lublin Voivodeship, Poland, 22-400
        • Recruiting
        • ETG Zamosc ( Site 1631)
        • Contact:
          • Study Coordinator
          • Phone Number: +48537858147
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Gastroenterologii Onkologiczne ( Site 1624)
        • Contact:
          • Study Coordinator
          • Phone Number: 48 22 546 2328
      • Warsaw, Masovian Voivodeship, Poland, 03-580
        • Recruiting
        • Vivamed Sp. z o.o. ( Site 1623)
        • Contact:
          • Study Coordinator
          • Phone Number: +48226792883
      • Warsaw, Masovian Voivodeship, Poland, 04-501
        • Recruiting
        • WIP Warsaw IBD Point Profesor Kierkuś ( Site 1622)
        • Contact:
          • Study Coordinator
          • Phone Number: +48 535 553 560
      • Warsaw, Masovian Voivodeship, Poland, 02-677
        • Recruiting
        • ETG Warszawa ( Site 1629)
        • Contact:
          • Study Coordinator
          • Phone Number: +48575000243
      • Warsaw, Masovian Voivodeship, Poland, 00-189
        • Recruiting
        • EB Group Sp. Z o.o. Centrum Zdrowia MDM ( Site 1618)
        • Contact:
          • Study Coordinator
          • Phone Number: +48663097750
    • Opole Voivodeship
      • Opole, Opole Voivodeship, Poland, 45-819
        • Recruiting
        • Twoja Przychodnia Opolskie Centrum Medyczne ( Site 1633)
        • Contact:
          • Study Coordinator
          • Phone Number: +48690548825
    • Pomeranian Voivodeship
      • Sopot, Pomeranian Voivodeship, Poland, 81-756
        • Recruiting
        • Endoskopia Sp. z.o.o. ( Site 1637)
        • Contact:
          • Study Coordinator
          • Phone Number: +48585552631
    • Silesian Voivodeship
      • Chorzów, Silesian Voivodeship, Poland, 41-500
        • Recruiting
        • M2M ( Site 1630)
        • Contact:
          • Study Coordinator
          • Phone Number: +48518424470
      • Tychy, Silesian Voivodeship, Poland, 43-100
        • Recruiting
        • H-T Centrum Medyczne Endoterapia ( Site 1610)
        • Contact:
          • Study Coordinator
          • Phone Number: +48515342221
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Poland, 71-434
        • Recruiting
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne ( Site 1612)
        • Contact:
          • Study Coordinator
          • Phone Number: +48914332919
      • Szczecin, West Pomeranian Voivodeship, Poland, 71-685
        • Recruiting
        • Sonomed Sp. z o. o. ( Site 1617)
        • Contact:
          • Study Coordinator
          • Phone Number: +48918201110
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 91-034
        • Recruiting
        • Centrum Medyczne Med-Gastr Sp. z o.o. ( Site 1616)
        • Contact:
          • Study Coordinator
          • Phone Number: +48 42 258 22 33
      • Lodz, Łódź Voivodeship, Poland, 91-495
        • Recruiting
        • AmiCare Sp. z o.o. Sp. k. ( Site 1608)
        • Contact:
          • Study Coordinator
          • Phone Number: +48 42 639 49 44
      • Lodz, Łódź Voivodeship, Poland, 90-752
        • Recruiting
        • IP Clinic ( Site 1638)
        • Contact:
          • Study Coordinator
          • Phone Number: +422089798
  • Portugal
      • Leiria, Portugal, 2410-197
        • Recruiting
        • Unidade Local de Saude da Região de Leiria - Hospital Santo André ( Site 1706)
        • Contact:
          • Study Coordinator
          • Phone Number: 00351244817000
      • Lisbon, Portugal, 1500-650
        • Recruiting
        • Hospital da Luz Lisboa ( Site 1707)
        • Contact:
          • Study Coordinator
          • Phone Number: 00351217104400
      • Lisbon, Portugal
        • Recruiting
        • Hospital dos Lusíadas Lisboa ( Site 1701)
        • Contact:
          • Study Coordinator
          • Phone Number: 00351217704040
      • Viana do Castelo, Portugal, 4900-858
        • Recruiting
        • ULSAM - Hospital de Santa Luzia ( Site 1703)
        • Contact:
          • Study Coordinator
          • Phone Number: +351258802100
      • Viseu, Portugal, 3504-509
        • Recruiting
        • Unidade Local de Saude Dão-Lafões - Hospital de São Teotónio ( Site 1702)
        • Contact:
          • Study Coordinator
          • Phone Number: +351232420500
    • Braga District
      • Guimarães, Braga District, Portugal, 4835-044
        • Recruiting
        • Unidade Local de Saúde do Alto Ave - Hospital Senhora da Oliveira ( Site 1704)
        • Contact:
          • Study Coordinator
          • Phone Number: 00351253540330
    • Faro District
      • Portimão, Faro District, Portugal, 8500-338
        • Recruiting
        • Unidade Local de Saude do Algarve - Hospital de Portimão ( Site 1700)
        • Contact:
          • Study Coordinator
          • Phone Number: 00351289891100
  • Romania
      • Bucharest, Romania, 012015
        • Recruiting
        • Monza Ares SRL ( Site 1804)
        • Contact:
          • Study Coordinator
          • Phone Number: 0040219178
    • Bucharest
      • Bucharest, Bucharest, Romania, 013823
        • Recruiting
        • MEMORIAL HEALTHCARE INTERNATIONAL S.R.L ( Site 1806)
        • Contact:
          • Study Coordinator
          • Phone Number: 0040319393
      • Bucharest, Bucharest, Romania, 022328
        • Recruiting
        • Fundeni Clinical Institute-Gastroenterology and Hepatology Center ( Site 1808)
        • Contact:
          • Study Coordinator
          • Phone Number: 0040212750500
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400394
        • Recruiting
        • GastroMed ( Site 1809)
        • Contact:
          • Study Coordinator
          • Phone Number: 0744332107
    • Mureș County
      • Târgu Mureş, Mureș County, Romania, 540205
        • Recruiting
        • Spitalul Clinic Judetean Mures-Gastroenterology ( Site 1807)
        • Contact:
          • Study Coordinator
          • Phone Number: 0040265217235
    • Timiș County
      • Timișoara, Timiș County, Romania, 300239
        • Recruiting
        • ASOCIATIA ONCOHELP ( Site 1805)
        • Contact:
          • Study Coordinator
          • Phone Number: 0040256495403
  • Saudi Arabia
    • Makkah Al Mukarramah
      • Mecca, Makkah Al Mukarramah, Saudi Arabia, 24246
        • Recruiting
        • King Abdullah Medical City Specialist Hospital ( Site 5230)
        • Contact:
          • Study Coordinator
          • Phone Number: +966533853299
    • Riyadh Region
      • Riyadh, Riyadh Region, Saudi Arabia, 11426
        • Recruiting
        • King Abdul Aziz Medical City - AlRiyadh ( Site 5210)
        • Contact:
          • Study Coordinator
          • Phone Number: +966112520088
      • Riyadh, Riyadh Region, Saudi Arabia, 12713
        • Recruiting
        • King Faisal Specialist Hospital and Research Center ( Site 5200)
        • Contact:
          • Study Coordinator
          • Phone Number: +966114647272
      • Riyadh, Riyadh Region, Saudi Arabia, 11472
        • Recruiting
        • King Saud University Medical City ( Site 5220)
        • Contact:
          • Study Coordinator
          • Phone Number: +966502191786
  • Serbia
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Recruiting
        • Clinical Hospital Center Zvezdara-Gastroenterology and hepatology Department ( Site 1903)
        • Contact:
          • Study Coordinator
          • Phone Number: +381608838001
      • Belgrade, Beograd, Serbia, 11080
        • Recruiting
        • University Medical Center "Bezanijska kosa"-Gastroenterology and hepatology ( Site 1900)
        • Contact:
          • Study Coordinator
          • Phone Number: +381641608353
      • Belgrade, Beograd, Serbia, 11 000
        • Recruiting
        • Clinical Hospital Center Dragisa Misovic ( Site 1906)
        • Contact:
          • Study Coordinator
          • Phone Number: +381643509133
      • Zemun, Beograd, Serbia, 11080
        • Recruiting
        • Zemun Medical Centre ( Site 1910)
        • Contact:
          • Study Coordinator
          • Phone Number: +38163282082
    • Srednjebanatski Okrug
      • Zrenjanin, Srednjebanatski Okrug, Serbia, 23000
        • Recruiting
        • General Hospital "Djordje Joanovic" ( Site 1905)
        • Contact:
          • Study Coordinator
          • Phone Number: +381606076527
    • Sumadijski Okrug
      • Kragujevac, Sumadijski Okrug, Serbia, 34000
        • Recruiting
        • Clinical Center Kragujevac ( Site 1904)
        • Contact:
          • Study Coordinator
          • Phone Number: +381604401776
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 169608
        • Recruiting
        • Singapore General Hospital ( Site 6202)
        • Contact:
          • Study Coordinator
          • Phone Number: +6563213652
      • Singapore, Central Singapore, Singapore, 308433
        • Recruiting
        • Tan Tock Seng Hospital-Gastroenterology and Hepatology ( Site 6201)
        • Contact:
          • Study Coordinator
          • Phone Number: +6597235084
    • South East
      • Singapore, South East, Singapore, 529889
        • Completed
        • Changi General Hospital ( Site 6203)
  • Slovakia
    • Banská Bystrica Region
      • Banská Bystrica, Banská Bystrica Region, Slovakia, 974 01
        • Recruiting
        • Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica-Gastroenterologicke oddelenie ( Site 2002)
        • Contact:
          • Study Coordinator
          • Phone Number: +421905838606
    • Bratislava Region
      • Bratislava, Bratislava Region, Slovakia, 81109
        • Recruiting
        • Cliniq s.r.o. ( Site 2001)
        • Contact:
          • Study Coordinator
          • Phone Number: +421917752297
    • Nitra Region
      • Nitra, Nitra Region, Slovakia, 949 01
        • Recruiting
        • KM Management ( Site 2000)
        • Contact:
          • Study Coordinator
          • Phone Number: +421377415408
    • Presov
      • Prešov, Presov, Slovakia, 080 01
        • Recruiting
        • GASTRO I ( Site 2004)
        • Contact:
          • Study Coordinator
          • Phone Number: +421903607349
      • Prešov, Presov, Slovakia, 080 01
        • Recruiting
        • Gastro LM ( Site 2005)
        • Contact:
          • Study Coordinator
          • Phone Number: +421905794001
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Recruiting
        • Wits Clinical Research ( Site 4004)
        • Contact:
          • Study Coordinator
          • Phone Number: +27110812179
      • Soweto, Gauteng, South Africa, 2013
        • Recruiting
        • Wits Clinical Research-Chris Hani Baragwanath Hospital ( Site 4005)
        • Contact:
          • Study Coordinator
          • Phone Number: +27119836501
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7700
        • Recruiting
        • Spoke Research ( Site 4003)
        • Contact:
          • Study Coordinator
          • Phone Number: +2783284462
      • Cape Town, Western Cape, South Africa, 7708
        • Recruiting
        • Life Kingsbury Hospital ( Site 4000)
        • Contact:
          • Study Coordinator
          • Phone Number: +27837033097
      • Cape Town, Western Cape, South Africa, 7500
        • Recruiting
        • Panorama Medical Centre ( Site 4001)
        • Contact:
          • Study Coordinator
          • Phone Number: +27219300923
      • Plumstead, Western Cape, South Africa, 7800
        • Recruiting
        • Private Practice - Dr. M.N. Rajabally ( Site 4007)
        • Contact:
          • Study Coordinator
          • Phone Number: +27217973550
  • South Korea
      • Seoul, South Korea, 02447
        • Recruiting
        • Kyung Hee University Hospital ( Site 3611)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-2-952-8238
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital ( Site 3607)
        • Contact:
          • Study Coordinator
          • Phone Number: +8227408112
      • Seoul, South Korea, 03181
        • Recruiting
        • Kangbuk Samsung Hospital-Internal Medicine ( Site 3612)
        • Contact:
          • Study Coordinator
          • Phone Number: +82220018555
      • Seoul, South Korea, 03312
        • Recruiting
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3602)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-2-2030-4737
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System-Department of Internal Medicine ( Site 3603)
        • Contact:
          • Study Coordinator
          • Phone Number: +82222281990
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center ( Site 3609)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-2-3010-3181
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center ( Site 3613)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-2-3410-1927
    • Kang-won-do
      • Wŏnju, Kang-won-do, South Korea, 26426
        • Recruiting
        • Wonju Severance Christian Hospital-Internal Medicine ( Site 3600)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-33-741-0114
    • Kyonggi-do
      • Ansan-si, Kyonggi-do, South Korea, 15355
        • Recruiting
        • Korea University Ansan Hospital ( Site 3617)
        • Contact:
          • Study Coordinator
          • Phone Number: +82314127674
      • Suwon, Kyonggi-do, South Korea, 16247
        • Recruiting
        • The Catholic University Of Korea St. Vincent's Hospital-Gastroenterology ( Site 3608)
        • Contact:
          • Study Coordinator
          • Phone Number: +82318818912
    • Pusan-Kwangyokshi
      • Busan, Pusan-Kwangyokshi, South Korea, 49201
        • Recruiting
        • Dong-A University Hospital ( Site 3601)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-51-240-5677
      • Haeundae-gu, Pusan-Kwangyokshi, South Korea, 48108
        • Recruiting
        • Inje University Haeundae Paik Hospital ( Site 3605)
        • Contact:
          • Study Coordinator
          • Phone Number: +82517970475
    • Seoul
      • Dongjak-gu, Seoul, South Korea, 06973
        • Recruiting
        • Chung-Ang University Hospital ( Site 3606)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-2-6299-1355
    • Taegu-Kwangyokshi
      • Daegu, Taegu-Kwangyokshi, South Korea, 42415
        • Recruiting
        • Yeungnam Univeristy Medical Center ( Site 3610)
        • Contact:
          • Study Coordinator
          • Phone Number: +82536203897
      • Daegu, Taegu-Kwangyokshi, South Korea, 41944
        • Recruiting
        • Kyungpook National Univ.Hospital ( Site 3616)
        • Contact:
          • Study Coordinator
          • Phone Number: +82532508096
      • Daegu, Taegu-Kwangyokshi, South Korea, 42601
        • Recruiting
        • Keimyung University Dongsan Medical Center ( Site 3614)
        • Contact:
          • Study Coordinator
          • Phone Number: +82532507088
    • Taejon-Kwangyokshi
      • Daejeon, Taejon-Kwangyokshi, South Korea, 34943
        • Recruiting
        • The Catholic University of Korea, Daejeon St. Mary's Hospital ( Site 3604)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-42-220-9501
  • Spain
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz ( Site 2100)
        • Contact:
          • Study Coordinator
          • Phone Number: 912071350
      • Pontevedra, Spain, 36071
        • Recruiting
        • Hospital Montecelo. Complexo Hospitalario de Pontevedra ( Site 2107)
        • Contact:
          • Study Coordinator
          • Phone Number: 0034986800000
      • Santa Cruz de Tenerife, Spain, 38010
        • Recruiting
        • Hospital Universitario Nuestra Senora de la Candelaria ( Site 2105)
        • Contact:
          • Study Coordinator
          • Phone Number: 922602345
      • Valencia, Spain, 46010
        • Recruiting
        • HOSPITAL CLINICO DE VALENCIA-MEDICINA DIGESTIVA ( Site 2103)
        • Contact:
          • Study Coordinator
          • Phone Number: +34961973820
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe ( Site 2111)
        • Contact:
          • Study Coordinator
          • Phone Number: +34669754974
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Universitario Miguel Servet ( Site 2104)
        • Contact:
          • Study Coordinator
          • Phone Number: 34976765526
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Hospital Germans Trias i Pujol ( Site 2101)
        • Contact:
          • Study Coordinator
          • Phone Number: 34934978909
    • Catalonia
      • Barcelona, Catalonia, Spain, 08036
        • Recruiting
        • HOSPITAL CLÍNIC DE BARCELONA-ICMDM - Clinical Institute of Digestive and Metabolic Diseases ( Site 2112)
        • Contact:
          • Study Coordinator
          • Phone Number: 34932275418
    • La Coruna
      • A Coruña, La Coruna, Spain, 15405
        • Recruiting
        • Complejo Hospitalario Universitario de Ferrol ( Site 2114)
        • Contact:
          • Study Coordinator
          • Phone Number: 0034981334000
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro ( Site 2102)
        • Contact:
          • Study Coordinator
          • Phone Number: 911916480
      • Torrejón de Ardoz, Madrid, Spain, 28850
        • Recruiting
        • Hospital Universitario de Torrejón ( Site 2108)
        • Contact:
          • Study Coordinator
          • Phone Number: 34916262600
  • Sweden
    • Stockholm County
      • Danderyd, Stockholm County, Sweden, 182 88
        • Recruiting
        • Danderyds Sjukhus ( Site 5501)
        • Contact:
          • Study Coordinator
          • Phone Number: +46812355000
      • Stockholm, Stockholm County, Sweden, 171 64
        • Recruiting
        • Karolinska Universitetssjukhuset Solna ( Site 5500)
        • Contact:
          • Study Coordinator
          • Phone Number: 46812370000
    • Östergötland County
      • Linköping, Östergötland County, Sweden, 581 85
        • Recruiting
        • Universitetssjukhuset i Linköping ( Site 5502)
        • Contact:
          • Study Coordinator
          • Phone Number: +46101030000
  • Switzerland
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Switzerland, 4031
        • Recruiting
        • University Hospital Basel-Gastroenterology and Hepatology ( Site 2204)
        • Contact:
          • Study Coordinator
          • Phone Number: +41617777575
    • Canton of Bern
      • Bern, Canton of Bern, Switzerland, 3012
        • Recruiting
        • INTESTO-Gastroenterologische Praxis / Crohn-Colitis Zentrum Bern ( Site 2202)
        • Contact:
          • Study Coordinator
          • Phone Number: +41313023234
    • Canton of St. Gallen
      • Sankt Gallen, Canton of St. Gallen, Switzerland, 9000
        • Recruiting
        • Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 2201)
        • Contact:
          • Study Coordinator
          • Phone Number: 0041714946264
    • Canton of Zurich
      • Zurich, Canton of Zurich, Switzerland, 8091
        • Recruiting
        • UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 2200)
        • Contact:
          • Study Coordinator
          • Phone Number: 0041442551111
  • Taiwan
      • Taipei, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital-Internal Medicine ( Site 3700)
        • Contact:
          • Study Coordinator
          • Phone Number: +886223123456
      • Taoyuan, Taiwan, 33305
        • Recruiting
        • Chang Gung Medical Foundation-Linkou Branch ( Site 3701)
        • Contact:
          • Study Coordinator
          • Phone Number: +886975366024
    • Hsinchu
      • Zhubei, Hsinchu, Taiwan, 302058
        • Recruiting
        • National Taiwan University BioMedical Park Hospital ( Site 3702)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-930-169320
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06100
        • Recruiting
        • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2300)
        • Contact:
          • Study Coordinator
          • Phone Number: +905322249998
      • Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Ankara Bilkent Şehir Hastanesi-Gastroenterology ( Site 2301)
        • Contact:
          • Study Coordinator
          • Phone Number: +905327848568
      • Ankara, Turkey (Türkiye), 06230
        • Completed
        • ANKARA UNIVERSITY IBNI SINA HOSPITAL-Gastroenterology ( Site 2303)
      • Antalya, Turkey (Türkiye), 07100
        • Recruiting
        • Antalya Egitim ve Arastırma Hastanesi ( Site 2304)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 242 249 44 00
      • Eskişehir, Turkey (Türkiye), 26040
        • Recruiting
        • Eskisehir Osmangazi University Faculty of Medicine ( Site 2308)
        • Contact:
          • Study Coordinator
          • Phone Number: +9005069692590
      • Istanbul, Turkey (Türkiye), 34899
        • Recruiting
        • Marmara Univetsitesi Pendik Egitim ve Arastirma Hastanesi ( Site 2305)
        • Contact:
          • Study Coordinator
          • Phone Number: +905052914056
      • Istanbul, Turkey (Türkiye), 34098
        • Completed
        • Istanbul Universitesi Cerrahpasa Tip Fakultesi Hastanesi ( Site 2306)
      • Kocaeli, Turkey (Türkiye), 41380
        • Recruiting
        • Kocaeli University Medical Faculty Hospital ( Site 2309)
        • Contact:
          • Study Coordinator
          • Phone Number: +905378767651
    • İzmir
      • Bornova, İzmir, Turkey (Türkiye), 35100
        • Recruiting
        • Ege Universitesi Hastanesi ( Site 2302)
        • Contact:
          • Study Coordinator
          • Phone Number: +905057823808
  • Ukraine
      • Kyiv, Ukraine, 03057
        • Recruiting
        • Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 5800)
        • Contact:
          • Study Coordinator
          • Phone Number: +380445213003
      • Kyiv, Ukraine, 03151
        • Recruiting
        • Dobrobut Medical Center ( Site 5801)
        • Contact:
          • Study Coordinator
          • Phone Number: +380671502987
      • Kyiv, Ukraine, 04116
        • Recruiting
        • Medical Center of Private Enterprise "Sygma" ( Site 5808)
        • Contact:
          • Study Coordinator
          • Phone Number: +380503538207
    • Ivano-Frankivsk Oblast
      • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76008
        • Recruiting
        • Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council" ( Site 5815)
        • Contact:
          • Study Coordinator
          • Phone Number: +380342528765
    • Kyivska Oblast
      • Kyiv, Kyivska Oblast, Ukraine, 04210
        • Recruiting
        • Center of Family Medicine Plus ( Site 5803)
        • Contact:
          • Study Coordinator
          • Phone Number: +380972094524
      • Kyiv, Kyivska Oblast, Ukraine, 04050
        • Recruiting
        • Medical Center of Limited ( Site 5806)
        • Contact:
          • Study Coordinator
          • Phone Number: +380979132763
    • Lviv Oblast
      • Lviv, Lviv Oblast, Ukraine, 79010
        • Recruiting
        • Communal Non-profit Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"-proctology ( Site 5809)
        • Contact:
          • Study Coordinator
          • Phone Number: +380632380055
    • Vinnytsia Oblast
      • Vinnytsia, Vinnytsia Oblast, Ukraine, 21009
        • Recruiting
        • Limited liability company "Medical center Health Clinic" ( Site 5807)
        • Contact:
          • Study Coordinator
          • Phone Number: +380960992929
      • Vinnytsia, Vinnytsia Oblast, Ukraine, 21018
        • Recruiting
        • Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of Vinnytsia ( Site 5814)
        • Contact:
          • Study Coordinator
          • Phone Number: +380432570572
      • Vinnytsia, Vinnytsia Oblast, Ukraine, 21029
        • Recruiting
        • Clinic of Scientific and Research Institute of Invalid Rehabilitation of VNMU n.a. M.I.Pyrohov ( Site 5812)
        • Contact:
          • Study Coordinator
          • Phone Number: +380673978046
      • Vinnytsia, Vinnytsia Oblast, Ukraine, 21029
        • Recruiting
        • Communal Non-Commercial Enterprise "Vinnytsia City Clinical -Clinical Therapeutic Department #1 ( Site 5811)
        • Contact:
          • Study Coordinator
          • Phone Number: +380678775448
    • Volyn Oblast
      • Lutsk, Volyn Oblast, Ukraine, 43005
        • Recruiting
        • Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council ( Site 5813)
        • Contact:
          • Study Coordinator
          • Phone Number: +38 0332 77 31 35
  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Recruiting
        • Addenbrooke's Hospital ( Site 2400)
        • Contact:
          • Study Coordinator
          • Phone Number: +441223331130
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • Recruiting
        • Royal Devon & Exeter Hospital ... ( Site 2407)
        • Contact:
          • Study Coordinator
          • Phone Number: 01392 408937
    • England
      • Doncaster, England, United Kingdom, DN2 5LT
        • Recruiting
        • Doncaster Royal Infirmary ( Site 2401)
        • Contact:
          • Study Coordinator
          • Phone Number: 01302643331
      • Huddersfield, England, United Kingdom, HD3 3EA
        • Recruiting
        • Huddersfield Royal Infirmary ( Site 2409)
        • Contact:
          • Study Coordinator
          • Phone Number: 01484342905
      • London, England, United Kingdom, E11 1NR
        • Recruiting
        • Whipps Cross University Hospital-Clinical Research Unit ( Site 2404)
        • Contact:
          • Study Coordinator
          • Phone Number: 020 8539 5522
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Recruiting
        • Southampton General Hospital ( Site 2402)
        • Contact:
          • Study Coordinator
          • Phone Number: 023 8077 7222
    • London, City of
      • London, London, City of, United Kingdom, NW1 2PG
        • Recruiting
        • University College London Hospital-Clinical Research Facility ( Site 2405)
        • Contact:
          • Study Coordinator
          • Phone Number: +442034477618
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Recruiting
        • The John Radcliffe Hospital ( Site 2406)
        • Contact:
          • Study Coordinator
          • Phone Number: 01865 231618
    • South Gloucestershire
      • Bristol, South Gloucestershire, United Kingdom, BS10 5NB
        • Recruiting
        • Southmead Hospital ( Site 2403)
        • Contact:
          • Study Coordinator
          • Phone Number: 0117 414 8133
    • Walsall
      • West Midlands, Walsall, United Kingdom, WS2 9PS
        • Active, not recruiting
        • Walsall Manor Hospital ( Site 2410)
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36301
        • Completed
        • Digestive Health Specialists ( Site 5064)
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Completed
        • Arizona Arthritis & Rheumatology Research, PC ( Site 5094)
      • Sun City, Arizona, United States, 85351
        • Recruiting
        • GI Alliance - Sun City ( Site 5118)
        • Contact:
          • Study Coordinator
          • Phone Number: 623-972-2116
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • University of Arizona Clinical and Translational Sciences Research Center ( Site 5111)
        • Contact:
          • Study Coordinator
          • Phone Number: 520-626-8000
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas for Medical Sciences ( Site 5147)
        • Contact:
          • Study Coordinator
          • Phone Number: 501-398-8622
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Clinnova Research ( Site 5110)
        • Contact:
          • Study Coordinator
          • Phone Number: 949-889-0249
      • Coronado, California, United States, 92118
        • Recruiting
        • Southern California Research Center ( Site 5044)
        • Contact:
          • Study Coordinator
          • Phone Number: 619-522-0330
      • Lancaster, California, United States, 93534
        • Recruiting
        • Om Research LLC ( Site 5038)
        • Contact:
          • Study Coordinator
          • Phone Number: 661-388-2239
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Clinical & Translational Research Center (CTRC) ( Site 5116)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-206-3778
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai Medical Center ( Site 5080)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-423-0035
      • Orange, California, United States, 92868
        • Recruiting
        • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 5128)
        • Contact:
          • Study Coordinator
          • Phone Number: 714-456-7890
      • Oxnard, California, United States, 93030
        • Recruiting
        • Om Research LLC ( Site 5045)
        • Contact:
          • Study Coordinator
          • Phone Number: 661-388-2239
      • San Diego, California, United States, 92103
        • Recruiting
        • Clinical Applications Laboratories ( Site 5123)
        • Contact:
          • Study Coordinator
          • Phone Number: 619-260-1012
      • Valencia, California, United States, 91355
        • Active, not recruiting
        • Amicis Research Center ( Site 5055)
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 5026)
        • Contact:
          • Study Coordinator
          • Phone Number: 720-848-2777
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Peak Gastroenterology Associates ( Site 5023)
        • Contact:
          • Study Coordinator
          • Phone Number: 719-310-6719
      • Englewood, Colorado, United States, 80113
        • Recruiting
        • South Denver Gastroenterology, PC ( Site 5132)
        • Contact:
          • Study Coordinator
          • Phone Number: 303-406-4288
      • Lakewood, Colorado, United States, 80228
        • Recruiting
        • Rocky Mountain Gastroenterology ( Site 5082)
        • Contact:
          • Study Coordinator
          • Phone Number: 303-463-3900
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Completed
        • Medical Research Center of Connecticut ( Site 5005)
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University School of Medicine-Digestive Disease ( Site 5019)
        • Contact:
          • Study Coordinator
          • Phone Number: 203-785-4138
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20009
        • Recruiting
        • Emerson Clinical Research Institute ( Site 5051)
        • Contact:
          • Study Coordinator
          • Phone Number: 202-239-0777
    • Florida
      • Clearwater, Florida, United States, 33756
        • Active, not recruiting
        • Gastroenterology Consultants of Clearwater ( Site 5052)
      • Fort Myers, Florida, United States, 33912
        • Recruiting
        • Covenant Metabolic Specialists, LLC ( Site 5150)
        • Contact:
          • Study Coordinator
          • Phone Number: 941-500-3200
      • Inverness, Florida, United States, 34452
        • Recruiting
        • Nature Coast Clinical Research - Inverness ( Site 5042)
        • Contact:
          • Study Coordinator
          • Phone Number: 352-341-2100
      • Margate, Florida, United States, 33063
        • Active, not recruiting
        • Atlantic Medical Research ( Site 5073)
      • Miami, Florida, United States, 33157
        • Recruiting
        • Sanchez Clinical Research ( Site 5144)
        • Contact:
          • Study Coordinator
          • Phone Number: 305-590-8555
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Endoscopic Research Inc ( Site 5061)
        • Contact:
          • Study Coordinator
          • Phone Number: 407-896-1726 ext 314
      • Orlando, Florida, United States, 32806
        • Completed
        • Orlando Health-Digestive Health Institute ( Site 5010)
      • Orlando, Florida, United States, 32803
        • Recruiting
        • AdventHealth Orlando ( Site 5131)
        • Contact:
          • Study Coordinator
          • Phone Number: 407-303-5503
      • Tampa, Florida, United States, 33612
        • Recruiting
        • USF Health Carol and Frank Morsani Center for Advanced Healthcare ( Site 5039)
        • Contact:
          • Study Coordinator
          • Phone Number: 813-396-2254
      • University Park, Florida, United States, 34201
        • Recruiting
        • Covenant Metabolic Specialists, LLC ( Site 5143)
        • Contact:
          • Study Coordinator
          • Phone Number: 941-500-3200
    • Georgia
      • Atlanta, Georgia, United States, 30310
        • Recruiting
        • Morehouse School Of Medicine ( Site 5071)
        • Contact:
          • Study Coordinator
          • Phone Number: 404-616-1000
      • Decatur, Georgia, United States, 30033
        • Completed
        • Atlanta Center for Gastroenterology ( Site 5035)
      • Macon, Georgia, United States, 31201
        • Recruiting
        • Gastroenterology Associates of Central Georgia ( Site 5048)
        • Contact:
          • Study Coordinator
          • Phone Number: 478-464-2600
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center ( Site 5066)
        • Contact:
          • Study Coordinator
          • Phone Number: 773-834-2193
      • Chicago, Illinois, United States, 60621
        • Completed
        • Eagle Clinical Research ( Site 5089)
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • Endeavor Health ( Site 5018)
        • Contact:
          • Study Coordinator
          • Phone Number: 847-971-9992
      • Gurnee, Illinois, United States, 60031
        • Recruiting
        • GI ALLIANCE - GURNEE ( Site 5003)
        • Contact:
          • Study Coordinator
          • Phone Number: 224-441-2217
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health University Hospital ( Site 5022)
        • Contact:
          • Study Coordinator
          • Phone Number: 317-944-3332
    • Iowa
      • Clive, Iowa, United States, 50325
        • Recruiting
        • Iowa Digestive Disease Center ( Site 5007)
        • Contact:
          • Study Coordinator
          • Phone Number: 515-225-6050
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center ( Site 5091)
        • Contact:
          • Study Coordinator
          • Phone Number: 913-588-6158
      • Topeka, Kansas, United States, 66606
        • Recruiting
        • Cotton O'Neil Digestive Health Center ( Site 5033)
        • Contact:
          • Study Coordinator
          • Phone Number: 785-270-4386
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville Hospital ( Site 5120)
        • Contact:
          • Study Coordinator
          • Phone Number: 502-852-1958
    • Louisiana
      • Zachary, Louisiana, United States, 70791
        • Completed
        • Southern Clinical Research ( Site 5095)
    • Maryland
      • Bethesda, Maryland, United States, 20889
        • Recruiting
        • Walter Reed National Military Medical Center ( Site 5006)
        • Contact:
          • Study Coordinator
          • Phone Number: 301-295-6814
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital-Crohn's and Colitis Center ( Site 5037)
        • Contact:
          • Study Coordinator
          • Phone Number: 334-836-3341
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan ( Site 5060)
        • Contact:
          • Study Coordinator
          • Phone Number: 734-615-4843
      • Clinton Township, Michigan, United States, 48038
        • Recruiting
        • Clinical Research Institute of Michigan, LLC ( Site 5002)
        • Contact:
          • Study Coordinator
          • Phone Number: 586-598-3329
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester, Minnesota ( Site 5024)
        • Contact:
          • Study Coordinator
          • Phone Number: 507-284-2511
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Mid-America GI Clinical Research ( Site 5130)
        • Contact:
          • Study Coordinator
          • Phone Number: 816-561-2000
      • Liberty, Missouri, United States, 64068
        • Recruiting
        • BVL Research - Kansas ( Site 5099)
        • Contact:
          • Study Coordinator
          • Phone Number: 785-217-6559
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine ( Site 5058)
        • Contact:
          • Study Coordinator
          • Phone Number: 314-273-0301
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • HMH Justice Marie Garibaldi Medical Plaza ( Site 5072)
        • Contact:
          • Study Coordinator
          • Phone Number: 551-996-1115
    • New York
      • Great Neck, New York, United States, 11021
        • Recruiting
        • Northwell Health Physician Partners Center for Advanced IBD Care ( Site 5017)
        • Contact:
          • Study Coordinator
          • Phone Number: 516-504-3955
      • Middletown, New York, United States, 12589
        • Completed
        • Circuit Clinical /Crystal Run Healthcare LLP ( Site 5050)
      • New York, New York, United States, 10075
        • Recruiting
        • New York Gastroenterology Associates ( Site 5013)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-369-2490
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 5078)
        • Contact:
          • Study Coordinator
          • Phone Number: 646-754-3433
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medical College, New-York Presbyterian Hospital ( Site 5079)
        • Contact:
          • Study Coordinator
          • Phone Number: 646-697-0985
      • Port Jefferson, New York, United States, 11777
        • Recruiting
        • Northwell Mather Hospital ( Site 5138)
        • Contact:
          • Study Coordinator
          • Phone Number: 631-686-1409
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • University of North Carolina Medical Center ( Site 5034)
        • Contact:
          • Study Coordinator
          • Phone Number: 984-974-3777
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Atrium Health Gastroenterology MMP ( Site 5105)
        • Contact:
          • Study Coordinator
          • Phone Number: 704-355-0282
      • Charlotte, North Carolina, United States, 28210
        • Completed
        • Javara - Tryon Medical Partners ( Site 5046)
    • Ohio
      • Mentor, Ohio, United States, 44060
        • Recruiting
        • Great Lakes Gastroenterology Research, LLC ( Site 5016)
        • Contact:
          • Study Coordinator
          • Phone Number: 440-205-1225
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73114
        • Recruiting
        • Digestive Disease Specialists Inc. ( Site 5117)
        • Contact:
          • Study Coordinator
          • Phone Number: 405-702-1300
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State University Milton S. Hershey Medical Center ( Site 5102)
        • Contact:
          • Study Coordinator
          • Phone Number: 800-243-1455
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital ( Site 5133)
        • Contact:
          • Study Coordinator
          • Phone Number: 609-472-1549
      • Uniontown, Pennsylvania, United States, 15401
        • Recruiting
        • Frontier Clinical Research, LLC ( Site 5098)
        • Contact:
          • Study Coordinator
          • Phone Number: 724-550-4099
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Recruiting
        • University Gastroenterology - Providence - West River Street ( Site 5057)
        • Contact:
          • Study Coordinator
          • Phone Number: 401-821-6306
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Sanford USD Medical Center ( Site 5129)
        • Contact:
          • Study Coordinator
          • Phone Number: 605-333-1000
    • Tennessee
      • Nashville, Tennessee, United States, 37204
        • Recruiting
        • Vanderbilt Inflammatory Bowel Disease Clinic ( Site 5049)
        • Contact:
          • Study Coordinator
          • Phone Number: 615-322-2312
      • Nashville, Tennessee, United States, 37211
        • Recruiting
        • Quality Medical Research ( Site 5114)
        • Contact:
          • Study Coordinator
          • Phone Number: 615-835-4750
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor University Medical Center ( Site 5031)
        • Contact:
          • Study Coordinator
          • Phone Number: 214-820-2687
      • Dallas, Texas, United States, 75246
        • Completed
        • GI Alliance - Dallas - Gaston Avenue ( Site 5054)
      • Denton, Texas, United States, 76201
        • Recruiting
        • Epic Medical Research - Mesquite ( Site 5153)
        • Contact:
          • Study Coordinator
          • Phone Number: 940-252-0504
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine Medical Center ( Site 5020)
        • Contact:
          • Study Coordinator
          • Phone Number: 713-798-5765
      • Houston, Texas, United States, 77030
        • Recruiting
        • Michael E. DeBakey VA Medical Center ( Site 5086)
        • Contact:
          • Study Coordinator
          • Phone Number: 713-798-5765
      • Lubbock, Texas, United States, 79424
        • Recruiting
        • Caprock Gastro Research ( Site 5077)
        • Contact:
          • Study Coordinator
          • Phone Number: 808-239-1823
      • Lubbock, Texas, United States, 79410
        • Completed
        • GI Alliance - Lubbock ( Site 5012)
      • Mansfield, Texas, United States, 76063
        • Recruiting
        • GI Alliance: Mansfield ( Site 5015)
        • Contact:
          • Study Coordinator
          • Phone Number: 817-415-9664
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Southern Star Research Institute ( Site 5000)
        • Contact:
          • Study Coordinator
          • Phone Number: 210-581-2812
      • Southlake, Texas, United States, 76092-9167
        • Recruiting
        • GI Alliance - Southlake ( Site 5109)
        • Contact:
          • Study Coordinator
          • Phone Number: 817-424-1525
      • Tyler, Texas, United States, 75701
        • Recruiting
        • Tyler Research Institute ( Site 5001)
        • Contact:
          • Study Coordinator
          • Phone Number: 903-630-6211
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Recruiting
        • Richmond VA Medical Center ( Site 5021)
        • Contact:
          • Study Coordinator
          • Phone Number: 804-675-5000
    • Washington
      • Bellevue, Washington, United States, 98004
        • Active, not recruiting
        • Washington Gastroenterology - Bellevue ( Site 5040)
      • Seattle, Washington, United States, 98104
        • Completed
        • Swedish Medical Center ( Site 5112)
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington ( Site 5115)
        • Contact:
          • Study Coordinator
          • Phone Number: 414-805-3000
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Washington Gastroenterology - Tacoma ( Site 5004)
        • Contact:
          • Study Coordinator
          • Phone Number: 253-272-5127

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

  • Has had a diagnosis of CD at least 3 months before study.
  • Has moderately to severely active CD.
  • Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.
  • Adolescent participants ≥16 and <18 years of age can participate if approved by the country or regulatory/health authority.

Exclusion Criteria:

  • Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.
  • Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
  • Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
  • Has current stoma or need for colostomy or ileostomy.
  • Is missing >2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
  • Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides Crohn's disease.
  • Has surgical bowel resection within 3 months of study.
  • Has prior or current gastrointestinal dysplasia.
  • Has chronic infection requiring ongoing antimicrobial treatment.
  • Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years.
  • Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
  • Has active tuberculosis.
  • Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.
  • Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-TL1A antibody.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Study 1: Placebo
Participants receive IV placebo, followed by an SC placebo regimen.
Drug: IV Tulisokibart
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
Other Names:
  • PRA023
  • MK-7240
Other: SC Placebo
Placebo matching SC tulisokibart
Other: IV Placebo
Placebo matching IV tulisokibart
Experimental: Study 1: High Dose Induction, High Dose Maintenance
Participants receive high dose intravenous (IV) tulisokibart, followed by a high dose subcutaneous (SC) tulisokibart regimen.
Drug: IV Tulisokibart
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
Other Names:
  • PRA023
  • MK-7240
Drug: SC Tulisokibart
Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
Other Names:
  • PRA023
  • MK-7240
Experimental: Study 1: High Dose Induction, Low Dose Maintenance
Participants receive high dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
Drug: IV Tulisokibart
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
Other Names:
  • PRA023
  • MK-7240
Drug: SC Tulisokibart
Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
Other Names:
  • PRA023
  • MK-7240
Other: SC Placebo
Placebo matching SC tulisokibart
Experimental: Study 1: Low Dose Induction, Low Dose Maintenance
Participants receive low dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
Drug: IV Tulisokibart
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
Other Names:
  • PRA023
  • MK-7240
Drug: SC Tulisokibart
Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
Other Names:
  • PRA023
  • MK-7240
Other: SC Placebo
Placebo matching SC tulisokibart
Experimental: Study 2: High Dose Induction
Participants receive high dose IV tulisokibart.
Drug: IV Tulisokibart
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
Other Names:
  • PRA023
  • MK-7240
Experimental: Study 2: Low Dose Induction
Participants receive low dose IV tulisokibart.
Drug: IV Tulisokibart
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
Other Names:
  • PRA023
  • MK-7240
Other: SC Placebo
Placebo matching SC tulisokibart
Placebo Comparator: Study 2: Placebo
Participants receive IV placebo.
Drug: IV Tulisokibart
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
Other Names:
  • PRA023
  • MK-7240
Other: SC Placebo
Placebo matching SC tulisokibart
Other: IV Placebo
Placebo matching IV tulisokibart
Experimental: Study 1: High Dose Extension
Participants receive a high dose SC tulisokibart regimen. Participants may continue in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.
Drug: SC Tulisokibart
Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
Other Names:
  • PRA023
  • MK-7240
Experimental: Study 1: Low Dose Extension
Participants receive a low dose SC tulisokibart and placebo regimen. Participants may continue in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.
Drug: SC Tulisokibart
Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
Other Names:
  • PRA023
  • MK-7240
Other: SC Placebo
Placebo matching SC tulisokibart
Experimental: Study 2: High Dose Extension
Participants receive a high dose SC tulisokibart regimen. Participants may continue in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.
Drug: SC Tulisokibart
Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
Other Names:
  • PRA023
  • MK-7240
Experimental: Study 2: Low Dose Extension
Participants receive a low dose SC tulisokibart regimen. Participants may continue in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.
Drug: SC Tulisokibart
Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
Other Names:
  • PRA023
  • MK-7240

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score at Week 52
Time Frame: Week 52
The percentage of participants achieving clinical remission, as defined by CDAI score <150 for study 1 will be presented.
Week 52
Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52
Time Frame: Week 52
The percentage of participants achieving clinical remission per stool frequency/abdominal pain score (SF/APS), as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 1 will be presented.
Week 52
Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
Time Frame: Week 12
The percentage of participants achieving clinical remission, as defined by CDAI score <150 for study 1 will be presented.
Week 12
Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
Time Frame: Week 12
The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 1 will be presented.
Week 12
Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
Time Frame: Week 12
The percentage of participants achieving clinical remission, as defined by CDAI score <150 for study 2 will be presented.
Week 12
Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
Time Frame: Week 12
The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 2 will be presented.
Week 12
Study 1: Percentage of Participants Achieving Endoscopic Response at Week 52
Time Frame: Week 52
The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in Simplified endoscopic score for Crohn's disease (SES-CD) from baseline for study 1 will be presented.
Week 52
Study 1: Percentage of Participants Achieving Endoscopic Response at Week 12
Time Frame: Week 12
The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in SES-CD from baseline for study 1 will be presented.
Week 12
Study 2: Percentage of Participants Achieving Endoscopic Response at Week 12
Time Frame: Week 12
The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in SES-CD from baseline for study 2 will be presented.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
Time Frame: Week 12
The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 1 will be presented.
Week 12
Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
Time Frame: Week 12
The percentage of participants achieving clinical remission, as defined by CDAI score <150 for study 1 will be presented.
Week 12
Study 1: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 12
Time Frame: Week 12
The percentage of participants achieving a reduction in CDAI ≥100 points from baseline for study 1 will be presented.
Week 12
Study 1: Mean Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12
Time Frame: Baseline and Week 12
The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0 to 52-point scale, with lower scores indicating greater fatigue. The mean change from baseline in FACIT-Fatigue score for study 1 will be presented.
Baseline and Week 12
Study 1 and 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Clinical Remission per CDAI at Week 12
Time Frame: Week 12
Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The percentage of Dx+ participants achieving clinical remission, as defined by CDAI score <150 for study 1 and study 2 will be presented.
Week 12
Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52
Time Frame: Week 52
The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 1 will be presented.
Week 52
Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 52
Time Frame: Week 52
The percentage of participants achieving clinical remission, as defined by CDAI score <150 for study 1 will be presented.
Week 52
Study 1: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 52
Time Frame: Week 52
The percentage of participants achieving a reduction in CDAI ≥ 100 points from baseline for study 1 will be presented.
Week 52
Study 1: Percentage of Participants Achieving Sustained Clinical Remission per CDAI at Both Week 12 and Week 52
Time Frame: Week 12 and Week 52
The percentage of participants achieving sustained clinical remission, as defined by CDAI score <150 for study 1 will be presented.
Week 12 and Week 52
Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per CDAI Score at Week 52
Time Frame: Week 52
The percentage of participants who are in clinical remission as defined by CDAI score <150 and without corticosteroid use for CD at least 90 days prior to that assessment for study 1 will be presented.
Week 52
Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52
Time Frame: Week 52
The percentage of participants who are in clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline and without corticosteroid use for CD at least 90 days prior to that assessment for study 1 will be presented.
Week 52
Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency, Abdominal Pain Score, and Endoscopic Remission at Week 52
Time Frame: Week 52
The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline and achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore >1 in any individual variable for study 1 will be presented.
Week 52
Study 1: Percentage of Participants Achieving Clinical Remission per CDAI and Endoscopic Remission at Week 52
Time Frame: Week 52
The percentage of participants achieving clinical remission as defined by CDAI score <150 and achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore >1 in any individual variable for study 1 will be presented.
Week 52
Study 1: Mean Change from Baseline in FACIT-Fatigue Score at Week 52
Time Frame: Baseline and Week 52
The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0 to 52-point scale, with lower scores indicating greater. The mean change from baseline in FACIT-Fatigue score for study 1 will be presented.
Baseline and Week 52
Study 1: Mean Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 52
Time Frame: Baseline and Week 52
The IBDQ measures health related quality of life in participants with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges between 32 to 224 with higher scores indicating a better quality of life. The mean change from baseline in IBDQ score for study 1 will be presented.
Baseline and Week 52
Study 1: Percentage of Participants with Ulcer-Free Endoscopy at Week 52
Time Frame: Week 52
The percentage of participants achieving ulcer-free endoscopy (mucosal healing), as defined by SES-CD ulcerated surface subscore of 0 in participants with SES-CD ulcerated surface subscore ≥1 at baseline for study 1 will be presented.
Week 52
Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
Time Frame: Week 12
The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 2 will be presented.
Week 12
Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
Time Frame: Week 12
The percentage of participants achieving clinical remission, as defined by CDAI score <150 for study 2 will be presented.
Week 12
Study 2: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 12
Time Frame: Week 12
The percentage of participants achieving a reduction in CDAI ≥ 100 points from baseline for study 2 will be presented.
Week 12
Study 2: Mean Change from Baseline in FACIT-Fatigue Score at Week 12
Time Frame: Baseline and Week 12
The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0 to 52-point scale, with lower scores indicating greater. The mean change from baseline in FACIT-Fatigue score for study 2 will be presented.
Baseline and Week 12
Study 2: Mean Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12
Time Frame: Baseline and Week 12
The IBDQ measures health related quality of life in participants with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges between 32 to 224 with higher scores indicating a better quality of life. The mean change from baseline in IBDQ score for study 2 will be presented.
Baseline and Week 12
Study 2: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 6
Time Frame: Week 6
The percentage of participants achieving a reduction in CDAI ≥ 100 points from baseline for study 2 will be presented.
Week 6
Study 2: The percentage of Participants with Ulcer-Free Endoscopy at Week 12
Time Frame: Week 12
The percentage of participants achieving ulcer-free endoscopy (mucosal healing), as defined by SES-CD ulcerated surface subscore of 0 in participants with SES-CD ulcerated surface subscore ≥1 at baseline for study 1 will be presented.
Week 12
Study 1: Percentage of Participants Who Experienced an Adverse Event (AE)
Time Frame: Up to approximately 52 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE for study 1 will be presented.
Up to approximately 52 weeks
Study 1: Percentage of Participants who Discontinue Study Intervention due to an AE
Time Frame: Up to approximately 52 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study intervention due to an AE for study 1 will be presented.
Up to approximately 52 weeks
Study 2: Percentage of Participants Who Experienced an AE
Time Frame: Up to approximately 12 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE for study 2 will be presented.
Up to approximately 12 weeks
Study 2: Percentage of Participants who Discontinue Study Intervention due to an AE
Time Frame: Up to approximately 12 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study intervention due to an AE for study 2 will be presented.
Up to approximately 12 weeks
Study 1 and 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Endoscopic Response at Week 12
Time Frame: Week 12
Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The percentage of Dx+ participants achieving endoscopic response, as defined by a ≥50% decrease in simplified endoscopic score for Crohn's disease (CD) from baseline for study 1 and study 2 will be presented.
Week 12
Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 12
Time Frame: Week 12
The percentage of participants achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore >1 in any individual variable for study 1 will be presented. SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing), each on a scale from 0 to 3, in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, left colon/sigmoid, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
Week 12
Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 52
Time Frame: Week 52
The percentage of participants achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore >1 in any individual variable for study 1 will be presented. SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing), each on a scale from 0 to 3, in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, left colon/sigmoid, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
Week 52
Study 2: Percentage of Participants Achieving Endoscopic Remission at Week 12
Time Frame: Week 12
The percentage of participants achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore >1 in any individual variable for study 2 will be presented. SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing), each on a scale from 0 to 3, in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, left colon/sigmoid, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2024

Primary Completion (Estimated)

October 30, 2028

Study Completion (Estimated)

November 12, 2029

Study Registration Dates

First Submitted

May 21, 2024

First Submitted That Met QC Criteria

May 21, 2024

First Posted (Actual)

May 28, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7240-008
  • MK-7240-008 (Other Identifier: MSD)
  • U1111-1298-6080 (Registry Identifier: UTN)
  • jRCT2031240196 (Registry Identifier: jRCT)
  • 2023-508636-61-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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