A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of MK-7240 in Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this protocol is to evaluate the efficacy of tulisokibart in participants with moderately to severely active ulcerative colitis. 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 according to the Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at week 52. 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 according to the Modified Mayo Score at Week 12.

Study Overview

Status

Active, not 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)

1020

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 Locations

  • Argentina
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Centro de Investigaciones Médicas Mar del Plata ( Site 2101)
    • Buenos Aires F.D.
      • Quilmes, Buenos Aires F.D., Argentina, B1878DVB
        • CER medical Institute-Gastroenterology ( Site 2110)
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2002KDT
        • Hospital Provincial del Centenario ( Site 2108)
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000IKO
        • C.I.C.E. 9 de Julio-CICE 9 DE JULIO ( Site 2103)
  • Australia
    • New South Wales
      • Kingswood, New South Wales, Australia, 2747
        • Nepean Hospital-Gastroenterology/Hepatology ( Site 2501)
      • Sydney, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital-Gastroenterology and Liver Services ( Site 2508)
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital ( Site 2500)
      • Brisbane, Queensland, Australia, 4101
        • Mater Misericordiae Limited-Gastroenterology ( Site 2506)
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital-Gastroenterology/Hepatology ( Site 2504)
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Health-Gastroenterology ( Site 2505)
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital-Gastroenterology ( Site 2503)
      • Melbourne, Victoria, Australia, 3065
        • St Vincent's Hospital ( Site 2510)
  • Austria
      • Salzburg, Austria, 5020
        • Uniklinikum Salzburg-Innere Medizin I ( Site 0201)
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Universitaetsklinik fuer Innere Medizin I Innsbruck ( Site 0200)
    • Vienna
      • Vienna, Vienna, Austria, 1090
        • Medizinische Universität Wien-Klinik für Innere Medizin III - Abteilung für Gastroenterologie und H ( Site 0202)
  • Belgium
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent ( Site 0300)
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven-Gastroenterology - Inflammatory Bowel Disease ( Site 0301)
  • Brazil
    • Federal District
      • Brasília, Federal District, Brazil, 70200-730
        • L2IP - Instituto de Pesquisas Clínicas ( Site 5104)
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36025-290
        • Endogastro Clínica de Gastroenterologia e Endoscopia Digestiva Lida - Galileo Pesquisa Clínica ( Site 5100)
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
        • Hospital Moinhos de Vento ( Site 5108)
    • São Paulo
      • Santo André, São Paulo, Brazil, 09080-110
        • Pesquisare Saude ( Site 5112)
      • São José do Rio Preto, São Paulo, Brazil, 15015-110
        • Centro de Pesquisa Kaiser - CEPEK ( Site 5103)
      • São José do Rio Preto, São Paulo, Brazil, 15090-160
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 5107)
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Medconsult Pleven ( Site 0410)
      • Plovdiv, Bulgaria, 4023
        • DKC V - Plovdiv ( Site 0402)
      • Rousse, Bulgaria, 7013
        • MC Rusemed ( Site 0408)
      • Sliven, Bulgaria, 8800
        • MHAT Hadzhi Dimitar-Gastroenterology ( Site 0403)
      • Sofia, Bulgaria, 1113
        • Diagnostic Consultative Center 22 - Sofia ( Site 0401)
      • Sofia, Bulgaria, 1606
        • 4th MHAT ( Site 0409)
      • Veliko Tarnovo, Bulgaria, 5000
        • Medica Plus Medical Center ( Site 0404)
    • Pazardzhik
      • Velingrad, Pazardzhik, Bulgaria, 4600
        • MC Velingrad 2017 EOOD ( Site 0406)
    • Sofia (stolitsa)
      • Sofia, Sofia (stolitsa), Bulgaria, 1618
        • "Diagnostic - Consultative Center XX - Sofia" EOOD ( Site 0407)
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Heritage Medical Research Clinic ( Site 0004)
      • Edmonton, Alberta, Canada, T5R 1W2
        • Gastroenterology and internal medicine research institute ( Site 0010)
      • Lethbridge, Alberta, Canada, T1J 4G9
        • Prairie Institute of Liver and Luminal Advanced Research ( Site 0013)
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
        • Fraser Clinical Trials Inc. ( Site 0019)
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • G.I.R.I. GI Research Institute Foundation ( Site 0001)
    • Nova Scotia
      • Kentville, Nova Scotia, Canada, B4N 0A3
        • Private Practice - Dr. Bruce Musgrave ( Site 0011)
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Barrie GI Associates ( Site 0012)
      • London, Ontario, Canada, N6A 5A5
        • University Hospital - London Health Sciences Centre ( Site 0002)
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre ( Site 0007)
      • Mississauga, Ontario, Canada, L5M 2S4
        • West GTA Research Inc. ( Site 0017)
      • Ontario, Ontario, Canada, L6L 5L7
        • ABP Research Services Corp. ( Site 0016)
      • Toronto, Ontario, Canada, M6A 3B4
        • Toronto Immune & Digestive Health Institute ( Site 0005)
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Toronto Digestive Disease Associates ( Site 0006)
    • Quebec
      • Lévis, Quebec, Canada, G6V 3Z1
        • Centre Intégré de Santé et Service Sociaux de Chaudière-Appalaches ( Site 0015)
      • Montreal, Quebec, Canada, H2X 0C1
        • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0018)
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital ( Site 0003)
      • Québec, Quebec, Canada, G1V 4T3
        • Diex Recherche Quebec ( Site 0008)
  • Chile
    • Los Ríos Region
      • Valdivia, Los Ríos Region, Chile, 5110683
        • Clinical Research Chile SpA ( Site 2201)
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500653
        • Centro de Estudios Clínicos SAGA-CECSAGA ( Site 2203)
      • Santiago, Region M. de Santiago, Chile, 7500921
        • FALP-UIDO ( Site 2208)
      • Santiago, Region M. de Santiago, Chile, 7620157
        • Clínica Universidad de Los Andes ( Site 2202)
      • Santiago, Region M. de Santiago, Chile, 7650568
        • Clínica Alemana de Santiago ( Site 2209)
      • Santiago, Region M. de Santiago, Chile, 7691236
        • Clínica MEDS La Dehesa ( Site 2207)
      • Santiago, Region M. de Santiago, Chile, 8320000
        • CECIM ( Site 2200)
      • Santiago, Region M. de Santiago, Chile, 8330034
        • Pontificia Universidad Catolica de Chile-CICUC ( Site 2205)
  • China
    • Anhui
      • Hefei, Anhui, China, 230022
        • The First Affiliated Hospital of Anhui Medical University ( Site 3957)
      • Hefei, Anhui, China, 230036
        • Anhui Provincial Hospital ( Site 3947)
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100050
        • Beijing Friendship Hospital Affiliate of Capital University ( Site 3923)
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital ( Site 3909)
      • Beijing, Beijing Municipality, China, 101199
        • Beijing Luhe Hospital Capital Medical University ( Site 3911)
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 404000
        • Chongqing University Three Gorges Hospital ( Site 3928)
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • The First Affiliated Hospital Of Fujian Medical University ( Site 3904)
      • Xiamen, Fujian, China, 361003
        • The First Affiliated hospital of Xiamen University-Gastroenterology ( Site 3954)
    • Guangdong
      • Dongguan, Guangdong, China, 523059
        • Dongguan People's Hospital-Gastroenterology department ( Site 3944)
      • Guangzhou, Guangdong, China, 510260
        • Guangzhou Medical University 2nd Hospital ( Site 3908)
      • Guangzhou, Guangdong, China, 510515
        • Southern Medical University Nanfang Hospital-Gastroenterology ( Site 3914)
      • Guangzhou, Guangdong, China, 510655
        • The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 3906)
      • Huizhou, Guangdong, China, 516001
        • Huizhou Municipal Central Hospital ( Site 3917)
      • Shaoguan, Guangdong, China, 512026
        • Yuebei People's Hospital Guangdong ( Site 3948)
      • Shenzhen, Guangdong, China, 518053
        • The University of Hong Kong-Shenzhen Hospital ( Site 3955)
      • Shenzhen, Guangdong, China, 518110
        • Shenzhen Hospital of Southern Medical University ( Site 3905)
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • The Second Hospital of Hebei Medical University ( Site 3934)
    • Henan
      • Zhengzhou, Henan, China, 450014
        • The Second Affiliated Hospital of Zhengzhou University ( Site 3935)
    • Hubei
      • Shiyan, Hubei, China, 442099
        • Taihe Hospital ( Site 3941)
      • Wuhan, Hubei, China, 430014
        • The Central Hospital of Wuhan ( Site 3939)
      • Wuhan, Hubei, China, 430060
        • Renmin Hospital of Wuhan University ( Site 3912)
    • Hunan
      • Changsha, Hunan, China, 410011
        • The Second Xiangya Hospital of Central South University ( Site 3930)
    • Jiangsu
      • Changzhou, Jiangsu, China, 213100
        • Changzhou No.2 People's Hospital ( Site 3950)
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 3900)
      • Nanjing, Jiangsu, China, 210009
        • Zhongda Hospital Southeast University ( Site 3919)
      • Wuxi, Jiangsu, China, 214023
        • Wuxi People's Hospital ( Site 3920)
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University ( Site 3926)
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army ( Site 3929)
    • Shandong
      • Binzhou, Shandong, China, 256603
        • Binzhou Medical University Hospital ( Site 3953)
      • Taian, Shandong, China, 271000
        • Taian City Central Hospital-gastroenterology department ( Site 3946)
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Ruijin Hospital Shanghai Jiaotong University School of Medicine-Gastroneterology ( Site 3903)
      • Shanghai, Shanghai Municipality, China, 200120
        • Shanghai East Hospital ( Site 3922)
      • Shanghai, Shanghai Municipality, China
        • Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 3915)
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University ( Site 3951)
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300052
        • Tianjin Medical University General Hospital ( Site 3945)
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830054
        • The First Teaching Hospital of Xinjiang Medical University. ( Site 3937)
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • First Affiliated Hospital of Kunming Medical University ( Site 3925)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-GI Medicine ( Site 3916)
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050034
        • Clínica las Américas ( Site 2318)
      • Medellín, Antioquia, Colombia
        • Clinica Medellin S.A ( Site 2317)
      • Rionegro, Antioquia, Colombia, 054040
        • Clinica Somer-Unidad de Investigacion y Docencia ( Site 2303)
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080020
        • Clinica de la Costa S.A.S. ( Site 2305)
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 110111
        • Fundacion Santa Fe de Bogota ( Site 2316)
    • Risaralda Department
      • Pereira, Risaralda Department, Colombia, 660001
        • Oncologos del Occidente ( Site 2310)
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760032
        • Fundación Valle del Lili ( Site 2307)
  • Croatia
    • City of Zagreb
      • Zagreb, City of Zagreb, Croatia, 10000
        • Klinička bolnica Merkur ( Site 0505)
      • Zagreb, City of Zagreb, Croatia, 10000
        • Klinički bolnički centar Zagreb ( Site 0501)
      • Zagreb, City of Zagreb, Croatia, 10000
        • Poliklinika Bates ( Site 0504)
      • Zagreb, City of Zagreb, Croatia, 10000
        • Poliklinika Solmed ( Site 0502)
    • County of Osijek-Baranja
      • Osijek, County of Osijek-Baranja, Croatia, 31000
        • Poliklinika Borzan ( Site 0500)
    • Split-Dalmatia County
      • Split, Split-Dalmatia County, Croatia, 21000
        • Klinički Bolnički Centar Split ( Site 0503)
  • Czechia
      • Hradec Králové, Czechia, 500 12
        • Hepato-Gastroenterologie HK ( Site 0602)
    • Brno-mesto
      • Brno, Brno-mesto, Czechia, 615 00
        • Vojenská Nemocnice Brno-Internal department ( Site 0605)
    • Central Bohemia
      • Slaný, Central Bohemia, Czechia, 274 01
        • Nemocnice Slany ( Site 0601)
    • Praha 4
      • Prague, Praha 4, Czechia, 140 21
        • Institut Klinicke a Experimentalni Mediciny-Klinika hepatogastroentrologie ( Site 0604)
  • Dominican Republic
    • Nacional
      • Santo Domingo, Nacional, Dominican Republic, 10104
        • CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 3601)
  • Finland
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Tampereen yliopistollinen sairaala ( Site 4300)
    • Pohjois-Karjala
      • Joensuu, Pohjois-Karjala, Finland, 80210
        • Pohjois-Karjalan keskussairaala ( Site 4302)
    • Southwest Finland
      • Turku, Southwest Finland, Finland, 20520
        • Turku University Hospital ( Site 4301)
  • France
      • Paris, France, 75012
        • Hôpital Saint Antoine ( Site 0703)
      • Paris, France, 75475
        • Hôpital Saint-Louis ( Site 0702)
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06202
        • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0706)
    • Aquitaine
      • Pessac, Aquitaine, France, 33600
        • CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0700)
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13915
        • Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0714)
    • Champagne-Ardenne
      • Reims, Champagne-Ardenne, France, 51092
        • Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré ( Site 0705)
    • Doubs
      • Besançon, Doubs, France, 25000
        • CHU Besançon ( Site 0710)
    • Gard
      • Nîmes, Gard, France, 30029
        • C.H.U. de Nimes. Hopital Caremeau ( Site 0718)
    • Hauts-de-Seine
      • Clichy, Hauts-de-Seine, France, 92110
        • Hopital Beaujon ( Site 0716)
      • Neuilly-sur-Seine, Hauts-de-Seine, France, 92200
        • CMC Ambroise Paré Hartmann - Institut des MICI ( Site 0709)
    • Isere
      • Échirolles, Isere, France, 38130
        • Clinique des Cèdres ( Site 0719)
    • Languedoc-Roussillon
      • Montpellier, Languedoc-Roussillon, France, 34295
        • CHU SAINT ELOI ( Site 0711)
    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54511
        • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 0708)
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, France, 44093
        • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 0701)
    • Rhone
      • Pierre-Bénite, Rhone, France, 69310
        • centre hospitalier lyon sud ( Site 0707)
    • Somme
      • Amiens, Somme, France, 80054
        • CHU d'Amiens-Picardie - Hôpital Sud-Hepato-gastroentérology ( Site 0712)
    • Val-de-Marne
      • Créteil, Val-de-Marne, France, 94010
        • Hopital Henri Mondor ( Site 0717)
      • Le Kremlin-Bicêtre, Val-de-Marne, France, 94270
        • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0715)
  • Georgia
      • Tbilisi, Georgia, 0159
        • Caraps Medline ( Site 0803)
      • Tbilisi, Georgia, 0162
        • New Hospitals ( Site 0800)
    • Adjara
      • Batumi, Adjara, Georgia, 6010
        • LTD High Technology Hospital Medcenter ( Site 0802)
      • Tbilisi, Adjara, Georgia, 0186
        • Caucasus Medical Centre ( Site 0801)
  • Germany
      • Berlin, Germany, 13353
        • Charité Campus Virchow-Klinikum ( Site 0906)
      • Brandenburg, Germany, 14770
        • Universitätsklinikum Brandenburg an der Havel ( Site 0905)
    • Baden-Wurttemberg
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Universitaetsklinikum Ulm. ( Site 0902)
    • Bavaria
      • Dachau, Bavaria, Germany, 85221
        • MVZ Dachau ( Site 0918)
      • Munich, Bavaria, Germany, 81337
        • Klinikum der Universität München Großhadern-Medizinische Klinik und Poliklinik II ( Site 0907)
    • Hesse
      • Frankfurt am Main, Hesse, Germany
        • Agaplesion Markus Krankenhaus ( Site 0904)
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • Medizinische Hochschule Hannover ( Site 0913)
      • Lüneburg, Lower Saxony, Germany, 21339
        • Klinikum Lüneburg ( Site 0908)
    • North Rhine-Westphalia
      • Duisburg, North Rhine-Westphalia, Germany, 47055
        • Stadtische Kliniken Duisburg, Abtlg. Innere Medizin ( Site 0916)
      • Minden, North Rhine-Westphalia, Germany, 32423
        • Gastroenterologische Gemeinschaftspraxis Minden ( Site 0911)
      • Münster, North Rhine-Westphalia, Germany, 48155
        • Medizinisches Versorgungszentrum Portal 10 ( Site 0914)
    • Rhineland-Palatinate
      • Ludwighafen Am Rhein, Rhineland-Palatinate, Germany, 67067
        • St. Marien und St. Annastift Krankenhaus ( Site 0901)
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Universitätsklinikum Leipzig ( Site 0909)
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0903)
  • Greece
    • Attica
      • Athens, Attica, Greece, 106 76
        • Evangelismos General Hospital of Athens ( Site 4001)
      • Athens, Attica, Greece, 115 27
        • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 4000)
      • Nikaia Piraeus, Attica, Greece, 184 54
        • General Hospital of Nikaia-Piraeus "Agios Panteleimon" ( Site 4006)
    • Central Macedonia
      • Thessaloniki, Central Macedonia, Greece, 54642
        • Ippokrateio General Hospital of Thessaloniki ( Site 4004)
    • Crete
      • Heraklion, Crete, Greece, 711 10
        • University General Hospital of Heraklion-GASTROENTEROLOGY & HEPATOLOGY ( Site 4003)
  • Hungary
      • Budapest, Hungary, 1036
        • Synexus Magyarorszag Kft. (Budapest DRS) ( Site 1009)
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem ( Site 1006)
      • Budapest, Hungary, 1136
        • Pannónia Magánorvosi Centrum ( Site 1004)
    • Baranya
      • Mohács, Baranya, Hungary, 7700
        • Mohácsi Kórház ( Site 1008)
    • Bekescsaba
      • Békéscsaba, Bekescsaba, Hungary, 5600
        • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1007)
    • Bács-Kiskun county
      • Kecskemét, Bács-Kiskun county, Hungary, 6000
        • Csőszi Endoszkópos KFT ( Site 1001)
    • Heves County
      • Eger, Heves County, Hungary, 3300
        • Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 1012)
      • Gyöngyös, Heves County, Hungary, 3200
        • Gyöngyösi Bugát Pál Kórház ( Site 1011)
    • Komárom-Esztergom
      • Tatabánya, Komárom-Esztergom, Hungary, 2800
        • Komarom-Esztergom Varmegyei Szent Borbala Korhaz ( Site 1010)
    • Veszprém megye
      • Veszprém, Veszprém megye, Hungary, 8200
        • VeszLife Magánklinika ( Site 1002)
  • Israel
      • Afula, Israel, 1834111
        • Emek Medical Center ( Site 1106)
      • Ashkelon, Israel, 7830604
        • Barzilai Medical Center ( Site 1109)
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus ( Site 1101)
      • Haifa, Israel, 3339419
        • Bnai Zion Medical Center ( Site 1103)
      • Holon, Israel, 5810001
        • Edith Wolfson Medical Center ( Site 1104)
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center ( Site 1108)
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center. ( Site 1102)
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center ( Site 1107)
      • Ramat Gan, Israel, 5265601
        • Sheba Medical Center ( Site 1100)
  • Italy
      • Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1208)
      • Milan, Italy, 20100
        • ASST Fatebenefratelli Sacco-UOC Gastroenterologia ( Site 1200)
      • Milan, Italy, 20132
        • Ospedale San Raffaele-Gastroenterology and Gastrointestinal Endoscopy ( Site 1205)
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo-General Medicine ( Site 1206)
    • Cagliari
      • Monserrato, Cagliari, Italy, 09042
        • Policlinico Universitario Monserrato-SC Gastroenterologia ( Site 1207)
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy, 71013
        • IRCCS Casa Sollievo della Sofferenza ( Site 1213)
    • Lazio
      • Rome, Lazio, Italy, 00133
        • Fondazione Policlinico Tor Vergata ( Site 1209)
    • Lombardy
      • Milan, Lombardy, Italy, 20122
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-Gastroenterology and Endoscopy Unit ( Site 1202)
      • Rozzano, Lombardy, Italy, 20089
        • Istituto Clinico Humanitas-IBD center ( Site 1201)
    • Milano
      • Rho, Milano, Italy, 20017
        • Ospedale Di Circolo-U.O.C. di Gastroenterologia ed Endoscopia Digestiva ( Site 1216)
    • Napoli
      • Naples, Napoli, Italy, 80131
        • A.O.R.N. Ospedale dei Colli - Monaldi V. ( Site 1217)
    • Roma
      • Rome, Roma, Italy, 00149
        • Azienda Ospedaliera San Camillo Forlanini ( Site 1204)
      • Rome, Roma, Italy, 00186
        • Fatebenefratelli Isola Tiberina - Gemelli Isola ( Site 1214)
    • Sicily
      • Palermo, Sicily, Italy, 90146
        • Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO-U.O.S.D. Malattie Infiammatorie Croniche Intestinali ( Site 1210)
    • Veneto
      • Padua, Veneto, Italy, 35128
        • Azienda Ospedale - Università Padova-Surgery Oncology and Gastroenterology ( Site 1211)
    • Verona
      • Negrar, Verona, Italy, 37024
        • Ospedale Sacro Cuore Don G. Calabria ( Site 1212)
  • Japan
      • Fukui, Japan, 910-0846
        • Fukui Prefectural Hospital ( Site 2844)
      • Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital ( Site 2818)
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital ( Site 2845)
      • Kagoshima, Japan, 890-8520
        • Kagoshima University Hospital ( Site 2848)
      • Kagoshima, Japan, 892-0843
        • Kagoshima IBD Gastroenterology Clinic ( Site 2821)
      • Kyoto, Japan, 602-8566
        • University Hospital,Kyoto Prefectural University of Medicine ( Site 2819)
      • Kyoto, Japan, 612-8555
        • National Hospital Organization Kyoto Medical Center ( Site 2813)
      • Okayama, Japan, 700-8558
        • Okayama University Hospital ( Site 2870)
      • Osaka, Japan, 530-0011
        • Infusion Clinic ( Site 2806)
      • Osaka, Japan, 540-0006
        • National Hospital Organization Osaka National Hospital ( Site 2869)
      • Saga, Japan, 849-8501
        • Saga University Hospital ( Site 2812)
      • Saitama, Japan, 336-0963
        • Tokitokai Tokito Clinic Coloproctology Center ( Site 2811)
      • Tokyo, Japan, 169-0073
        • Tokyo Yamate Medical Center ( Site 2803)
      • Toyama, Japan, 930-0975
        • Toyama Prefectural Central Hospital ( Site 2807)
      • Yamagata, Japan, 990-9585
        • Yamagata University Hospital ( Site 2849)
      • Ōita, Japan, 870-0823
        • Ishida Clinic of IBD and Gastroenterology ( Site 2820)
    • Aichi-ken
      • Nagakute, Aichi-ken, Japan, 480-1195
        • Aichi Medical University Hospital ( Site 2841)
    • Chiba
      • Abiko, Chiba, Japan, 270-1168
        • Tokatsu Tsujinaka Hospital ( Site 2832)
      • Kashiwa, Chiba, Japan, 277-0871
        • Tsujinaka Hospital - Kashiwanoha ( Site 2802)
      • Sakura, Chiba, Japan, 285-8741
        • Toho University Sakura Medical Center ( Site 2805)
    • Ehime
      • Matsuyama, Ehime, Japan, 790-0024
        • Ehime Prefectural Central Hospital ( Site 2868)
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 802-8561
        • Kitakyushu Municipal Medical Center ( Site 2873)
      • Kurume, Fukuoka, Japan, 830-0011
        • Kurume University Hospital ( Site 2846)
    • Gunma
      • Maebashi, Gunma, Japan, 371-8511
        • Gunma University Hospital ( Site 2850)
    • Hiroshima
      • Fukuyama, Hiroshima, Japan, 720-0825
        • National Hospital Organization Fukuyama Medical Center ( Site 2831)
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 070-8610
        • Asahikawa City Hospital ( Site 2840)
      • Asahikawa, Hokkaido, Japan, 078-8510
        • Asahikawa Medical University Hospital ( Site 2815)
      • Sapporo, Hokkaido, Japan, 004-0041
        • Sapporo Tokushukai Hospital ( Site 2808)
      • Sapporo, Hokkaido, Japan, 060-8543
        • Sapporo Medical University Hospital ( Site 2829)
      • Sapporo, Hokkaido, Japan, 064-0919
        • Medical Corporation Sapporo IBD Clinic ( Site 2842)
      • Sapporo, Hokkaido, Japan, 065-0033
        • Sapporohigashi Tokushukai Hospital ( Site 2860)
    • Hyōgo
      • Nishinomiya, Hyōgo, Japan, 663-8501
        • Hyogo Medical University Hospital ( Site 2830)
    • Ibaraki
      • Hitachi, Ibaraki, Japan, 317-0077
        • Hitachi General Hospital ( Site 2856)
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8530
        • Ishikawa Prefectural Central Hospital ( Site 2835)
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Kanazawa University Hospital ( Site 2839)
    • Iwate
      • Morioka, Iwate, Japan, 020-8505
        • Iwate Medical University Uchimaru Medical Center ( Site 2833)
    • Kanagawa
      • Kamakura, Kanagawa, Japan, 247-0056
        • Gokeikai Ofuna Chuo Hospital ( Site 2801)
      • Kawasaki, Kanagawa, Japan, 216-8511
        • St. Marianna University Hospital ( Site 2852)
      • Yokohama, Kanagawa, Japan, 220-0041
        • Matsushima Hospital ( Site 2822)
      • Yokohama, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center ( Site 2865)
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
        • Mie University Hospital ( Site 2838)
    • Osaka
      • Fujiidera, Osaka, Japan, 583-0027
        • Sai Gastroenterology/Proctology Clinic ( Site 2814)
      • Hirakata, Osaka, Japan, 573-1191
        • Kansai Medical University Hospital ( Site 2823)
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Hamamatsu University Hospital ( Site 2874)
      • Hamamatsu, Shizuoka, Japan, 432-8061
        • Matsuda Hospital ( Site 2826)
      • Shimizu, Shizuoka, Japan, 411-8611
        • National Hospital Organization Shizuoka Medical Center ( Site 2837)
    • Tokyo
      • Bunkyō, Tokyo, Japan, 113-8519
        • Institute of Science Tokyo Hospital ( Site 2827)
      • Chūō, Tokyo, Japan, 104-0061
        • Ginza Central Clinic ( Site 2824)
      • Minato, Tokyo, Japan, 105-8471
        • The Jikei University Hospital ( Site 2843)
      • Minato-ku, Tokyo, Japan, 105-8470
        • Toranomon Hospital ( Site 2828)
      • Minato-ku, Tokyo, Japan, 108-8642
        • Kitasato University Kitasato Institute Hospital ( Site 2817)
      • Mitaka-shi, Tokyo, Japan, 181-8611
        • Kyorin University Hospital ( Site 2804)
      • Shinagawa-ku, Tokyo, Japan, 141-0022
        • NTT Medical Center Tokyo ( Site 2834)
    • Yamanashi
      • Kofu, Yamanashi, Japan, 400-8506
        • Yamanashi Prefectural Central Hospital ( Site 2836)
  • Latvia
      • Liepāja, Latvia, 3414
        • Liepaja Regional Hospital ( Site 4501)
      • Riga, Latvia, LV1002
        • P.Stradins Clinical University Hospital Center of Gastroenterology Hepatology and Nutrition ( Site 4503)
    • Ādaži
      • Ādaži, Ādaži, Latvia, 2164
        • SIA M & M Centrs ( Site 4502)
  • Lithuania
    • Kaunas County
      • Kaunas, Kaunas County, Lithuania, 50161
        • Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 4600)
    • Vilniaus Miestas
      • Vilnius, Vilniaus Miestas, Lithuania, 08406
        • VUL SANTAROS KLINIKOS ( Site 4601)
  • Malaysia
    • Johor
      • Johor Bahru, Johor, Malaysia, 80100
        • Hospital Sultanah Aminah ( Site 4702)
    • Kelantan
      • Kubang Kerian, Kelantan, Malaysia, 16150
        • Hospital Universiti Sains Malaysia ( Site 4704)
    • Negeri Sembilan
      • Seremban, Negeri Sembilan, Malaysia, 70300
        • Hospital Tuanku Jaafar Seremban ( Site 4705)
    • Selangor
      • Ampang, Selangor, Malaysia, 68000
        • Hospital Ampang ( Site 4703)
  • Mexico
      • Chihuahua City, Mexico, 31000
        • ICARO Investigaciones en Medicina ( Site 2405)
      • Mexico City, Mexico, 03330
        • Centro de Investigación y Gastroenterología - S.C. ( Site 2410)
      • Oaxaca City, Mexico, 68000
        • Oaxaca Site Management Organization S.C. ( Site 2404)
    • Guanajuato
      • León, Guanajuato, Mexico, 37000
        • Morales Vargas Centro de Investigacion ( Site 2411)
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • PanAmerican Clinical Research - Guadalajara ( Site 2400)
      • Tlajumulco de Zuniga, Jalisco, Mexico, 45640
        • Centro Medico Clinico Quirurgico Especializado en Investigación ( Site 2403)
    • Mexico City
      • Mexico City, Mexico City, Mexico, 14050
        • Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 2406)
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 2409)
    • Yucatán
      • Mérida, Yucatán, Mexico, 97130
        • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan ( Site 2407)
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum Utrecht ( Site 1404)
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Radboudumc ( Site 1402)
    • North Brabant
      • Tilburg, North Brabant, Netherlands, 5022 GC
        • ETZ Elisabeth-Department of Gastroenterology and Hepatology ( Site 1403)
      • Uden, North Brabant, Netherlands, 5406 PT
        • Ziekenhuis Bernhoven-Researchbureau ( Site 1401)
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1051 AC
        • Onze Lieve Vrouwe Gasthuis ( Site 1405)
      • Amsterdam, North Holland, Netherlands, 1081 HZ
        • Amsterdam UMC, locatie VUmc-IBD Trial Unit ( Site 1400)
    • Overijssel
      • Deventer, Overijssel, Netherlands, 7416 SE
        • Deventer Ziekenhuis ( Site 1411)
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015 GD
        • Erasmus Medisch Centrum ( Site 1410)
      • Rotterdam, South Holland, Netherlands, 3045 PM
        • Franciscus Gasthuis & Vlietland, Locatie Gasthuis ( Site 1406)
  • New Zealand
      • Auckland, New Zealand, 2025
        • Aotearoa Clinical Trials ( Site 2900)
    • Waikato Region
      • Hamilton, Waikato Region, New Zealand, 3204
        • Waikato Hospital ( Site 2903)
    • Wellington Region
      • Lower Hutt, Wellington Region, New Zealand, 5010
        • Hutt Valley District Health board HVDHB ( Site 2902)
  • Norway
      • Oslo, Norway, 0450
        • Oslo Universitetssykehus Ullevål ( Site 4201)
    • Akershus
      • Lørenskog, Akershus, Norway, 1478
        • Akershus Universitetssykehus ( Site 4200)
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-192
        • Pratia Poznan ( Site 1530)
      • Poznan, Greater Poland Voivodeship, Poland, 60-324
        • Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.,Twoja Przychodnia PCM ( Site 1523)
    • Kuyavian-Pomeranian Voivodeship
      • Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
        • Gastromed Sp. z o. o. ( Site 1513)
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 31-506
        • Topolowa Medicenter Ryszawa & Wspolnicy sp.j. ( Site 1500)
      • Krakow, Lesser Poland Voivodeship, Poland, 31-513
        • PROMED P. LACH R. GLOWACKI SP. J. ( Site 1529)
      • Nowy Targ, Lesser Poland Voivodeship, Poland, 34-400
        • Allmedica ( Site 1508)
      • Wadowice, Lesser Poland Voivodeship, Poland, 34-100
        • NZOZ FOR MED sp. z o.o. ( Site 1511)
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 52-210
        • Planetmed ( Site 1506)
      • Wroclaw, Lower Silesian Voivodeship, Poland, 53-149
        • Vistamed & Vertigo Sp. z o.o. ( Site 1528)
      • Wroclaw, Lower Silesian Voivodeship, Poland, 53-611
        • Melita Medical ( Site 1519)
      • Wroclaw, Lower Silesian Voivodeship, Poland, 54-239
        • Penta Hospitals Przychodnie Wrocław Wejherowska ( Site 1505)
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 00-189
        • Centrum Zdrowia MDM ( Site 1512)
      • Warsaw, Masovian Voivodeship, Poland, 02-677
        • ETG Warszawa ( Site 1525)
      • Warsaw, Masovian Voivodeship, Poland, 03-580
        • Vivamed Sp. z o.o. ( Site 1510)
      • Warsaw, Masovian Voivodeship, Poland, 04-501
        • WIP Warsaw IBD Point Profesor Kierkuś ( Site 1503)
    • Silesian Voivodeship
      • Chorzów, Silesian Voivodeship, Poland, 41-500
        • M2M Med ( Site 1526)
      • Katowice, Silesian Voivodeship, Poland, 40-748
        • Vita Longa Sp. Zoo ( Site 1527)
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Poland, 71-434
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne ( Site 1502)
      • Szczecin, West Pomeranian Voivodeship, Poland, 71-685
        • Sonomed Sp. z o. o. ( Site 1516)
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 91-034
        • Med-Gastr Sp. z o.o., sp.k ( Site 1515)
      • Lodz, Łódź Voivodeship, Poland, 91-495
        • AmiCare Centrum Medyczne - Zgierska ( Site 1517)
  • Portugal
      • Braga, Portugal, 4710-243
        • Unidade Local de Saude de Braga - Hospital de Braga ( Site 3300)
      • Lisbon, Portugal, 1500-458
        • Hospital dos Lusíadas Lisboa ( Site 3303)
      • Lisbon, Portugal, 1649-035
        • Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3305)
      • Viana do Castelo, Portugal, 4904 - 858
        • ULSAM - Hospital de Santa Luzia ( Site 3302)
      • Viseu, Portugal, 3504-509
        • Unidade Local de Saude Dão-Lafões - Hospital de São Teotónio ( Site 3308)
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1349-019
        • Unidade Local de Saude Lisboa Ocidental - Hospital Egas Moniz ( Site 3306)
  • Romania
    • București
      • Bucharest, București, Romania, 013823
        • MEMORIAL HEALTHCARE INTERNATIONAL S.R.L ( Site 1606)
      • Bucharest, București, Romania, 022328
        • Fundeni Clinical Institute-Gastroenterology and Hepatology Center ( Site 1608)
      • Bucharest, București, Romania, 021967
        • Monza Ares SRL ( Site 1604)
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400006
        • Spitalul Clinic Judetean de Urgenta Cluj Napoca-Gastroenterology ( Site 1605)
      • Cluj-Napoca, Cluj, Romania, 400394
        • GastroMed ( Site 1609)
    • Mureș County
      • Târgu Mureş, Mureș County, Romania, 540205
        • Spitalul Clinic Judetean Mures-Gastroenterology ( Site 1607)
    • Timiș County
      • Timișoara, Timiș County, Romania, 300002
        • S.C Centrul de Gastroenterologie Dr. Goldis S.R.L-Gastroenterology ( Site 1601)
      • Timișoara, Timiș County, Romania, 300239
        • Asociatia Oncohelp ( Site 1610)
  • Serbia
    • Beograd
      • Belgrade, Beograd, Serbia, 11 000
        • Clinical Hospital Center Dragisa Misovic ( Site 1708)
      • Belgrade, Beograd, Serbia, 11000
        • Clinical Hospital Center Zvezdara-Gastroenterology and hepatology Department ( Site 1705)
      • Belgrade, Beograd, Serbia, 11080
        • University Medical Center "Bezanijska kosa"-Gastroenterology and hepatology ( Site 1704)
      • Kragujevac, Beograd, Serbia, 34000
        • Clinical Center Kragujevac ( Site 1703)
    • Srednjebanatski Okrug
      • Zrenjanin, Srednjebanatski Okrug, Serbia, 23000
        • General Hospital "Djordje Joanovic" ( Site 1707)
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 169608
        • Singapore General Hospital ( Site 4801)
      • Singapore, Central Singapore, Singapore, 308433
        • Tan Tock Seng Hospital-Gastroenterology and Hepatology ( Site 4800)
  • Slovakia
    • Banská Bystrica Region
      • Brezno, Banská Bystrica Region, Slovakia, 977 01
        • Breznianske centrum gastroenterologie ( Site 1806)
      • Slovakia, Banská Bystrica Region, Slovakia, 974 01
        • Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica ( Site 1802)
    • Bratislava Region
      • Bratislava, Bratislava Region, Slovakia, 811 09
        • Cliniq s.r.o. ( Site 1800)
    • Košice Region
      • Košice, Košice Region, Slovakia, 040 13
        • ENDOMED ( Site 1801)
    • Nitra Region
      • Nitra, Nitra Region, Slovakia, 949 01
        • KM Management ( Site 1804)
      • Šahy, Nitra Region, Slovakia, 936 01
        • Accout Center ( Site 1805)
    • Presov
      • Prešov, Presov, Slovakia, 080 01
        • GASTRO I ( Site 1807)
      • Prešov, Presov, Slovakia, 080 01
        • Gastro LM ( Site 1808)
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Wits Clinical Research-Research ( Site 3208)
      • Soweto, Gauteng, South Africa, 2013
        • Wits Clinical Research-Wits Clinical Research Bara ( Site 3206)
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7506
        • Panorama Medical Centre ( Site 3209)
      • Cape Town, Western Cape, South Africa, 7700
        • Spoke Research ( Site 3210)
      • Cape Town, Western Cape, South Africa, 7708
        • Life Kingsbury Hospital ( Site 3203)
      • Cape Town, Western Cape, South Africa, 7800
        • Private Practice - Dr. M.N. Rajabally ( Site 3213)
  • South Korea
      • Seoul, South Korea, 02447
        • Kyung Hee University Hospital ( Site 3013)
      • Seoul, South Korea, 03080
        • Seoul National University Hospital ( Site 3005)
      • Seoul, South Korea, 03181
        • Kangbuk Samsung Hospital-Internal Medicine ( Site 3002)
      • Seoul, South Korea, 03312
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3012)
      • Seoul, South Korea, 03722
        • Severance Hospital, Yonsei University Health System-Department of Internal Medicine ( Site 3000)
      • Seoul, South Korea, 05505
        • Asan Medical Center ( Site 3007)
      • Seoul, South Korea, 06351
        • Samsung Medical Center ( Site 3001)
    • Kang-won-do
      • Wŏnju, Kang-won-do, South Korea, 26426
        • Wonju Severance Christian Hospital-Internal Medicine ( Site 3003)
    • Kyonggi-do
      • Suwon, Kyonggi-do, South Korea, 16247
        • The Catholic University Of Korea St. Vincent's Hospital-Gastroenterology ( Site 3006)
    • Pusan-Kwangyokshi
      • Busan, Pusan-Kwangyokshi, South Korea, 49201
        • Dong-A University Hospital ( Site 3010)
      • Haeundae-gu, Pusan-Kwangyokshi, South Korea, 48108
        • Inje University Haeundae Paik Hospital ( Site 3009)
    • Seoul
      • Dongjak-gu, Seoul, South Korea, 06973
        • Chung-Ang University Hospital ( Site 3008)
    • Taegu-Kwangyokshi
      • Daegu, Taegu-Kwangyokshi, South Korea, 42415
        • Yeungnam University Medical Center ( Site 3004)
    • Taejon-Kwangyokshi
      • Daejeon, Taejon-Kwangyokshi, South Korea, 34943
        • The Catholic University of Korea, Daejeon St. Mary's Hospital ( Site 3011)
  • Spain
      • Madrid, Spain, 28028
        • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Aparato Digestivo ( Site 3403)
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz-Unidad de Enfermedad Inflamatoria Intestinal ( Site 3402)
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol ( Site 3413)
      • Terrassa, Barcelona, Spain, 08221
        • Hospital Universitari Mutua Terrassa ( Site 3416)
    • Bizkaia
      • Galdakao-Usansolo, Bizkaia, Spain, 48960
        • Hospital Galdakao-Usansolo ( Site 3409)
    • Madrid
      • Fuenlabrada, Madrid, Spain, 28942
        • Hospital Universitario de Fuenlabrada-Digestive ( Site 3415)
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28006
        • Hospital La Princesa-Gastroenterology ( Site 3411)
      • Madrid, Madrid, Comunidad de, Spain, 28040
        • Fundación Jimenez Diaz ( Site 3420)
      • Torrejón de Ardoz, Madrid, Comunidad de, Spain, 28850
        • Hospital Universitario de Torrejon ( Site 3417)
    • Valencia
      • Valencia, Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe-Enfermedad Inflamatoria Intestinal ( Site 3405)
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46010
        • HOSPITAL CLINICO DE VALENCIA ( Site 3406)
  • Sweden
    • Stockholm County
      • Danderyd, Stockholm County, Sweden, 182 88
        • Danderyds Sjukhus ( Site 4401)
      • Stockholm, Stockholm County, Sweden, 171 64
        • Karolinska Universitetssjukhuset Solna ( Site 4400)
    • Uppsala County
      • Uppsala, Uppsala County, Sweden, 75185
        • Akademiska Sjukhuset ( Site 4403)
    • Östergötland County
      • Linköping, Östergötland County, Sweden, 581 85
        • Universitetssjukhuset i Linköping ( Site 4402)
  • Switzerland
    • Canton of Bern
      • Bern, Canton of Bern, Switzerland, 3012
        • INTESTO-Gastroenterologische Praxis / Crohn-Colitis Zentrum Bern ( Site 1902)
    • Canton of St. Gallen
      • Sankt Gallen, Canton of St. Gallen, Switzerland, 9000
        • Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 1901)
    • Canton of Zurich
      • Zurich, Canton of Zurich, Switzerland, 8091
        • UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 1900)
  • Taiwan
      • Taichung, Taiwan, 404332
        • China Medical University Hospital ( Site 3100)
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital ( Site 3102)
      • Taoyuan District, Taiwan, 333
        • Chang Gung Medical Foundation-Linkou Branch ( Site 3101)
    • Changhua
      • Changhua County, Changhua, Taiwan, 50006
        • Changhua Christian Hospital ( Site 3104)
    • Hsinchu
      • Zhubei, Hsinchu, Taiwan, 302058
        • National Taiwan University BioMedical Park Hospital ( Site 3103)
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 3507)
      • Ankara, Turkey (Türkiye), 06230
        • Hacettepe Universite Hastaneleri ( Site 3500)
      • Ankara, Turkey (Türkiye), 06800
        • Ankara Bilkent Şehir Hastanesi-Gastroenterology ( Site 3501)
      • Antalya, Turkey (Türkiye), 07100
        • Antalya Egitim ve Arastirma Hastanesi ( Site 3508)
      • Edirne, Turkey (Türkiye), 22030
        • Trakya University Medical Faculty Hospital ( Site 3510)
      • Eskişehir, Turkey (Türkiye), 26040
        • Eskisehir Osmangazi University Faculty of Medicine ( Site 3512)
      • Istanbul, Turkey (Türkiye), 34899
        • Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 3505)
      • Kocaeli, Turkey (Türkiye), 41380
        • Kocaeli University Medical Faculty Hospital ( Site 3509)
    • Istanbul
      • Istanbul- Fatih, Istanbul, Turkey (Türkiye), 34098
        • Istanbul Universitesi Cerrahpasa-Internal Diseases ( Site 3503)
  • Ukraine
      • Kyiv, Ukraine, 03057
        • Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 4100)
      • Kyiv, Ukraine, 03151
        • Dobrobut Medical Center ( Site 4101)
      • Kyiv, Ukraine, 04116
        • Medical Center of Private Enterprise "Sygma" ( Site 4108)
    • Ivano-Frankivsk Oblast
      • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76008
        • Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council" ( Site 4115)
    • Kyivska Oblast
      • Kyiv, Kyivska Oblast, Ukraine, 04210
        • Center of Family Medicine Plus-Treatment Prevention Unit ( Site 4103)
    • Lviv Oblast
      • Lviv, Lviv Oblast, Ukraine, 79010
        • Communal Non-profit Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"-proctology ( Site 4109)
    • Vinnytsia Oblast
      • Vinnytsia, Vinnytsia Oblast, Ukraine, 21009
        • Limited liability company "Medical center Health Clinic"-Gastroenterology, Hepatology and Endocrino ( Site 4107)
      • Vinnytsia, Vinnytsia Oblast, Ukraine, 21018
        • Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical -Gastroenterology department ( Site 4114)
      • Vinnytsia, Vinnytsia Oblast, Ukraine, 21029
        • Communal Non-Commercial Enterprise "Vinnytsia City Clinical -Clinical Therapeutic Department #1 ( Site 4111)
    • Volyn Oblast
      • Lutsk, Volyn Oblast, Ukraine, 43005
        • Municipal Enterprise "Volyn Regional Clinical Hospital" of V-surgery department (abdominal, colopro ( Site 4113)
  • United Kingdom
    • Bristol, City of
      • Bristol, Bristol, City of, United Kingdom, BS10 5NB
        • Southmead Hospital ( Site 2004)
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Addenbrooke's Hospital ( Site 2005)
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • Royal Devon & Exeter Hospital-IBD Research Group ( Site 2001)
    • England
      • Doncaster, England, United Kingdom, DN2 5LT
        • Doncaster Royal Infirmary ( Site 2006)
      • Huddersfield, England, United Kingdom, HD3 3EA
        • Huddersfield Royal Infirmary ( Site 2010)
      • London, England, United Kingdom, E11 1NR
        • Whipps Cross University Hospital-Clinical Research Unit ( Site 2000)
      • London, England, United Kingdom, SW17 0QT
        • St. George's Hospital ( Site 2007)
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 0YD
        • Southampton General Hospital-Gastroenterology ( Site 2003)
    • London, City of
      • London, London, City of, United Kingdom, NW1 2PG
        • University College London Hospital-Clinical Research Facility ( Site 2002)
    • Walsall
      • West Midlands, Walsall, United Kingdom, WS2 9PS
        • Walsall Manor Hospital ( Site 2009)
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36301
        • Digestive Health Specialists ( Site 0135)
      • Fairhope, Alabama, United States, 36532
        • IMC-Gulf Coast Gastroenterology ( Site 0157)
    • Arizona
      • Litchfield Park, Arizona, United States, 85340
        • Research Solutions of Arizona ( Site 3816)
      • Scottsdale, Arizona, United States, 85258
        • One of a Kind Clinical Research Center ( Site 3852)
      • Sun City, Arizona, United States, 85351
        • GI Alliance - Sun City ( Site 0103)
    • California
      • Anaheim, California, United States, 92805
        • Clinnova Research ( Site 3803)
      • Coronado, California, United States, 92118
        • Southern California Research Center ( Site 3828)
      • La Jolla, California, United States, 92037
        • UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0113)
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center ( Site 0119)
      • Orange, California, United States, 92868
        • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3851)
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 0172)
      • Colorado Springs, Colorado, United States, 80907
        • Peak Gastroenterology Associates ( Site 0116)
      • Englewood, Colorado, United States, 80113
        • South Denver Gastroenterology, PC ( Site 3849)
      • Littleton, Colorado, United States, 80120
        • Rocky Mountain Gastroenterology/Topography Health ( Site 3838)
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Connecticut Clinical Research Institute ( Site 0126)
      • Hamden, Connecticut, United States, 06518
        • Medical Research Center of Connecticut ( Site 0151)
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine-Digestive Disease ( Site 0163)
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20009
        • Emerson Clinical Research Institute ( Site 3820)
    • Florida
      • Clearwater, Florida, United States, 33756
        • Gastroenterology Consultants of Clearwater ( Site 0152)
      • Gainesville, Florida, United States, 32610
        • University of Florida College of Medicine-Gastroenterology ( Site 3821)
      • Inverness, Florida, United States, 34452
        • Nature Coast Clinical Research - Inverness ( Site 3806)
      • Kissimmee, Florida, United States, 34741
        • Central Florida Gastro Research ( Site 0124)
      • Miami, Florida, United States, 33134
        • Research Associates of South Florida - Miami - Southwest 8th Street ( Site 3810)
      • Orlando, Florida, United States, 32806
        • Orlando Health ( Site 0145)
      • Tampa, Florida, United States, 33612
        • USF Health ( Site 0169)
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine ( Site 3818)
      • Atlanta, Georgia, United States, 30342
        • Atlanta Gastroenterology Associates - Peachtree Dunwoody ( Site 0115)
      • Decatur, Georgia, United States, 30033
        • Atlanta Center for Gastroenterology ( Site 0155)
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center ( Site 0134)
      • Glenview, Illinois, United States, 60026
        • GI Alliance - Glenview ( Site 0168)
      • Gurnee, Illinois, United States, 60031
        • GI ALLIANCE - GURNEE ( Site 0107)
    • Iowa
      • Clive, Iowa, United States, 50325
        • Iowa Digestive Disease Center ( Site 0123)
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Hospital-Clinical Trials Unit ( Site 0165)
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Baton Rouge General Medical Center - Bluebonnet ( Site 0112)
      • New Orleans, Louisiana, United States, 70112
        • Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 0154)
    • Maryland
      • Bethesda, Maryland, United States, 20889
        • Walter Reed National Military Medical Center ( Site 0121)
      • Glen Burnie, Maryland, United States, 21061
        • Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 3835)
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital-Crohn's and Colitis Center ( Site 0132)
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan ( Site 0143)
      • Clinton Township, Michigan, United States, 48038
        • Clinical Research Institute of Michigan, LLC ( Site 0108)
      • Farmington Hills, Michigan, United States, 48334
        • Michigan Center of Medical Research (MICHMER) ( Site 3850)
      • Troy, Michigan, United States, 48098
        • Clinical Research Institute of Michigan, LLC ( Site 0150)
      • Ypsilanti, Michigan, United States, 48197
        • Huron Gastroenterology ( Site 3836)
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester, Minnesota ( Site 0147)
    • Missouri
      • Liberty, Missouri, United States, 64068
        • BVL Research - Kansas ( Site 3847)
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine ( Site 0129)
    • New York
      • Middletown, New York, United States, 10940
        • Circuit Clinical /Middletown Medical PC ( Site 3831)
      • New York, New York, United States, 10016
        • NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 3846)
      • New York, New York, United States, 10075
        • Lenox Hill Hospital ( Site 0128)
      • New York, New York, United States, 10128
        • New York Gastroenterology Associates ( Site 0159)
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina Medical Center ( Site 0140)
      • Greenville, North Carolina, United States, 27834
        • Carolina Digestive Diseases and Endoscopy Center ( Site 3809)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania ( Site 0170)
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • University Gastroenterology ( Site 0164)
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • Gastroenterology Associates of Orangeburg ( Site 0149)
    • Tennessee
      • Nashville, Tennessee, United States, 37204
        • Vanderbilt Inflammatory Bowel Disease Clinic ( Site 0131)
      • Nashville, Tennessee, United States, 37211
        • Quality Medical Research ( Site 3807)
    • Texas
      • Garland, Texas, United States, 75044
        • GI Alliance - Garland ( Site 0109)
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine Medical Center ( Site 3812)
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston-Internal Medicine-Division of Gastroentero ( Site 0144)
      • Houston, Texas, United States, 77074
        • Clinical Trial Network ( Site 3819)
      • Lubbock, Texas, United States, 79410
        • GI Alliance - Lubbock ( Site 0167)
      • Lubbock, Texas, United States, 79424
        • Caprock Gastro Research ( Site 0101)
      • Mansfield, Texas, United States, 76063
        • GI Alliance: Mansfield ( Site 0161)
      • San Antonio, Texas, United States, 78212
        • CARTA - Clinical Associates In Research Therapeutics Of America ( Site 0122)
      • San Antonio, Texas, United States, 78229
        • Southern Star Research Institute ( Site 0106)
      • San Marcos, Texas, United States, 78666
        • GI Alliance - San Marcos ( Site 0130)
      • Southlake, Texas, United States, 76092-9167
        • GI Alliance - Southlake ( Site 0104)
      • Tyler, Texas, United States, 75701
        • Tyler Research Institute ( Site 0105)
      • Webster, Texas, United States, 77598
        • Texas Digestive Disease Consultants ( Site 0136)
    • Utah
      • West Jordan, Utah, United States, 84088
        • Velocity Clinical Research, Salt Lake City ( Site 3801)
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Richmond VA Medical Center ( Site 3845)
    • Washington
      • Bellevue, Washington, United States, 98004-4631
        • Washington Gastroenterology - Bellevue ( Site 3844)
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center - Montlake ( Site 0137)
      • Tacoma, Washington, United States, 98405
        • Washington Gastroenterology - Tacoma ( Site 0102)
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin ( Site 0141)

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

Inclusion Criteria:

  • Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before randomization
  • Has moderately to severely active UC
  • Weight ≥40 kg

  • Satisfies at least 1 of the following criteria:

    • Has had an inadequate response or loss of response to 1 or more protocol-specified UC treatments
    • Protocol specified corticosteroid dependence
    • Has been intolerant to 1 or more protocol-specified UC treatments
  • Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable
  • Adolescent participants ≥16 and <18 years of age can participate if approved by the country or regulatory/health authority
  • A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding and Is not a participant of childbearing potential (POCBP); or is a POCBP and uses an acceptable contraceptive method, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention, medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy

Exclusion Criteria:

  • Has a diagnosis of Crohn's Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis that may confound efficacy assessment.
  • Has a current diagnosis of fulminant colitis and/or toxic megacolon
  • Has UC limited to the rectum (i.e, must have evidence of UC extending beyond the rectosigmoid junction, which is ~10 cm from the anal margin)
  • Has a current or impending need for colostomy or ileostomy
  • Has had a total proctocolectomy or partial colectomy
  • Has received fecal microbial transplantation within 4 weeks before randomization
  • Has had UC exacerbation requiring hospitalization within 2 weeks before screening
  • Has prior or current evidence of definite colonic dysplasia except for low-grade dysplasia that has been completely removed
  • Has any active or serious infections without resolution after adequate treatment
  • Has had cytomegalovirus infection that resolved less than 4 weeks before screening
  • Has a transplanted organ which requires continued immunosuppression
  • Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years
  • Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
  • Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidelines), or inadequately treated TB (for participants with history of TB)
  • Has confirmed or suspected COVID-19
  • Has a history of drug or alcohol abuse within 6 months prior to screening
  • Has had major surgery within 3 months before screening or has a major surgery planned during the study
  • Is currently receiving or is planning to receive total parenteral nutrition at any time during study treatment
  • Has received UC-related antibiotics and has not been on stable doses for at least 14 days before randomization or has discontinued these medications within 14 days of randomization
  • Requires treatment with a therapy that does not adhere to the protocol-specified guidance parameters
  • Has received protocol-specified prohibited medications
  • Has had prior exposure to tulisokibart or another anti-tumor necrosis factor-like cytokine 1A (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
Drug: SC Placebo
Placebo matching SC tulisokibart
Drug: 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 tumor necrosis factor-like cytokine 1A (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 tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously
Other Names:
  • PRA023
  • MK-7240
Drug: 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 tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously
Other Names:
  • PRA023
  • MK-7240
Drug: SC Placebo
Placebo matching SC tulisokibart
Experimental: Study 1: High Dose Extension
Participants receive a high dose SC tulisokibart regimen. Participants may be enrolled 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 tumor necrosis factor-like cytokine 1A (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 be enrolled 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 tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously
Other Names:
  • PRA023
  • MK-7240
Drug: 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
Experimental: Study 2: High Dose Extension
Participants receive a high dose SC tulisokibart regimen. Participants may be enrolled 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 tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously
Other Names:
  • PRA023
  • MK-7240
Experimental: Study 2: Low Dose Extension
Participants receive a low dose SC tulisokibart regimen. Participants may be enrolled 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 tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously
Other Names:
  • PRA023
  • MK-7240
Drug: 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
Drug: SC Placebo
Placebo matching SC tulisokibart
Drug: IV Placebo
Placebo matching IV tulisokibart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study 1: Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12
Time Frame: Week 12
The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Week 12
Study 1: Percentage of Participants Achieving Clinical Remission Per MMS at Week 52
Time Frame: Week 52
The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Week 52
Study 2: Percentage of Participants Achieving Clinical Remission Per MMS at Week 12
Time Frame: Week 12
The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study 1: Percentage of Participants With One or More Adverse Events (AEs)
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 will be reported.
Up to approximately 52 weeks
Study 1: Percentage of Participants Who Discontinued 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 number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 52 weeks
Study 1: Percentage of Participants Achieving Clinical Response Per Partial Modified Mayo Score (pMMS) at Week 2
Time Frame: Week 2
The partial Modified Mayo Score (pMMS) is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as pMMS reduction of 1 or more points and 30% or more, plus a reduction of 1 or more points in RBS or an absolute RBS of 0 or 1.
Week 2
Study 1: Percentage of Participants With Endoscopic Improvement at Week 12
Time Frame: Week 12
Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Week 12
Study 1: Percentage of Participants Achieving a Clinical Response Per MMS at Week 12
Time Frame: Week 12
The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as an MMS reduction of 2 or more points and 30% or more, plus a reduction of more than 1 point in RBS or an absolute RBS of 0 or 1.
Week 12
Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement (HEMI) at Week 12
Time Frame: Week 12
HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
Week 12
Study 1: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 12
Time Frame: Week 12
pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical remission per pMMS is defined as an RBS of 0 and SFS of ≤1.
Week 12
Study 1: Percentage of Participants With Endoscopic Remission at Week 12
Time Frame: Week 12
ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). Endoscopic remission is defined as an ES of 0.
Week 12
Study 1: Percentage of Participants Reporting No Bowel Urgency at Week 12
Time Frame: Week 12
Bowel urgency is measured using an NRS, which rates bowel urgency on a 0-11 scale of increasing severity. Resolution is defined as a score of 0 or 1 in participants who had a baseline score of 3 or more.
Week 12
Study 1: Percentage of Participants Reporting No Abdominal Pain at Week 12
Time Frame: Week 12
Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0.
Week 12
Study 1: Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12
Time Frame: Week 12
The IBDQ measures health related quality of life in subjects with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges from 32 to 224. IBDQ remission is defined as a score of at least 170.
Week 12
Study 1: 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 0-52 point scale, with greater scores indicating a better fatigue-related quality of life. The change from baseline in FACIT-Fatigue score will be presented.
Baseline and Week 12
Percentage of Diagnostic Assay Positive (Dx+) Participants Achieving Clinical Remission Per MMS at Week 12
Time Frame: Week 12
Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Week 12
Percentage of Dx+ Participants With Endoscopic Improvement at Week 12
Time Frame: Week 12
Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. Endoscopic improvement is defined as ES of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Week 12
Study 1: Percentage of Participants Achieving Histologic-Endoscopic Remission (HER) at Week 12
Time Frame: Week 12
HER is defined as a Geboes score of less than 2 and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
Week 12
Study 1: Percentage of Participants with Endoscopic Improvement at Week 52
Time Frame: Week 52
Endoscopic improvement is defined as ES of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Week 52
Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission Per MMS at Week 52
Time Frame: Week 52
The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Corticosteroid-free clinical remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS, and no corticosteroid use for ≥90 days before Week 52.
Week 52
Study 1: Percentage of Participants Achieving HEMI at Week 52
Time Frame: Week 52
HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
Week 52
Study 1: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 52
Time Frame: Week 52
pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical remission per pMMS is defined as an RBS of 0 and SFS of ≤1.
Week 52
Study 1: Percentage of Participants Achieving Sustained Clinical Remission Per MMS at Both Week 12 and Week 52
Time Frame: Week 12 and Week 52
The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Sustained clinical remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS, at both Week 12 and Week 52.
Week 12 and Week 52
Study 1: Percentage of Participants Reporting No Bowel Urgency at Week 52
Time Frame: Week 52
Bowel urgency is measured using an NRS, which rates bowel urgency on a 0-11 scale of increasing severity. Resolution is defined as a score of 0 or 1 in participants who had a baseline score of 3 or more.
Week 52
Study 1: Percentage of Participants Reporting No Abdominal Pain at Week 52
Time Frame: Week 52
Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0.
Week 52
Study 1: Percentage of Participants With Endoscopic Remission at Week 52
Time Frame: Week 52
ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). Endoscopic remission is defined as an ES of 0.
Week 52
Study 1: Percentage of Participants with Sustained Endoscopic Improvement at Both Week 12 and Week 52
Time Frame: Week 12 and Week 52
Sustained endoscopic improvement is defined as an ES of 0 or 1 at both Week 12 and Week 52. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Week 12 and Week 52
Study 1: Percentage of Participants Achieving HER at Week 52
Time Frame: Week 52
HER is defined as a Geboes score of less than 2 and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
Week 52
Study 1: Percentage of Participants Achieving IBDQ Remission at Week 52
Time Frame: Week 52
The IBDQ measures health related quality of life in subjects with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges from 32 to 224. IBDQ remission is defined as a score of at least 170.
Week 52
Study 1: 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 0-52 point scale, with greater scores indicating a better fatigue-related quality of life. The change from baseline in FACIT-Fatigue score will be presented.
Baseline and Week 52
Study 2: Percentage of Participants with Clinical Response Per pMMS at Week 2
Time Frame: Week 2
pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as pMMS reduction of 1 or more points and 30% or more, plus a reduction of 1 or more points in RBS or an absolute RBS of 0 or 1.
Week 2
Study 2: Percentage of Participants With Endoscopic Improvement at Week 12
Time Frame: Week 12
Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Week 12
Study 2: Percentage of Participants Achieving a Clinical Response Per MMS at Week 12
Time Frame: Week 12
The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as an MMS reduction of 2 or more points and 30% or more, plus a reduction of more than 1 point in RBS or an absolute RBS of 0 or 1.
Week 12
Study 2: Percentage of Participants Achieving HEMI at Week 12
Time Frame: Week 12
HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
Week 12
Study 2: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 12
Time Frame: Week 12
pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical remission per pMMS is defined as an RBS of 0 and SFS of ≤1.
Week 12
Study 2: Percentage of Participants With Endoscopic Remission at Week 12
Time Frame: Week 12
ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). Endoscopic remission is defined as an ES of 0.
Week 12
Study 2: Percentage of Participants Reporting No Bowel Urgency at Week 12
Time Frame: Week 12
Bowel urgency is measured using a numeric rating scale (NRS), which rates bowel urgency on a 0-11 scale of increasing severity.
Week 12
Study 2: Percentage of Participants Reporting No Abdominal Pain at Week 12
Time Frame: Week 12
Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0.
Week 12
Study 2: Percentage of Participants Achieving IBDQ Remission at Week 12
Time Frame: Week 12
The IBDQ measures health related quality of life in subjects with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges from 32 to 224. IBDQ remission is defined as a score of at least 170.
Week 12
Study 2: 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 0-52 point scale, with greater scores indicating a better fatigue-related quality of life. The change from baseline in FACIT-Fatigue score will be presented.
Baseline and Week 12
Study 2: Percentage of Participants Achieving HER at Week 12
Time Frame: Week 12
HER is defined as a Geboes score of less than 2 and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation.
Week 12
Study 2: Percentage of Participants With One or More AEs
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 number of participants who experience an AE will be reported.
Up to approximately 12 weeks
Study 2: Percentage of Participants Who Discontinued 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 number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 12 weeks
Study 1: Percentage of Dx+ Participants Achieving Clinical Remission Per MMS at Week 52
Time Frame: Week 52
Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Week 52
Study 1: Percentage of Dx+ Participants With Endoscopic Improvement at Week 52
Time Frame: Week 52
Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. Endoscopic improvement is defined as ES of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Week 52

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

Collaborators

PPD, Part of Thermo Fisher Scientific

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)

October 25, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

September 18, 2023

First Submitted That Met QC Criteria

September 18, 2023

First Posted (Actual)

September 25, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7240-001
  • PR200-301 (Other Identifier: PrometheusBio)
  • jRCT2031230563 (Registry Identifier: jRCT)
  • U1111-1296-0203 (Registry Identifier: UTN)
  • U1111-1314-0050 (Registry Identifier: UTN)
  • 2023-507473-17-00 (Registry Identifier: EU CT)
  • 2024-518603-22-00 (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

product manufactured in and exported from the U.S.

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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