A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease (GALAXI)

May 7, 2026 updated by: Janssen Research & Development, LLC

A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.

Study Overview

Status

Active, not recruiting

Conditions

Crohn's Disease

Intervention / Treatment

Detailed Description

This program consists of 3 separate studies: a 48-week Phase 2 dose-ranging study (GALAXI 1) and two 48-week Phase 3 confirmatory studies (GALAXI 2 and GALAXI 3). In Phase 2, safety and efficacy of guselkumab dose regimens will be evaluated to support the selection of induction and maintenance dose regimens for confirmatory evaluation in Phase 3. Participants who complete the 48-week Phase 2 or Phase 3 studies may be eligible to enter the long term extension (LTE). Throughout the 3 studies, efficacy, pharmacokinetic, biomarkers, and safety will be assessed.

Study Type

Interventional

Enrollment (Actual)

1409

Phase

Phase 2
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

Australia
- - Adelaide, Australia, 5011
    - The Queen Elizabeth Hospital
  - Clayton, Australia, 3168
    - Monash Health, Monash Medical Centre
  - Concord, Australia, 2139
    - Concord Hospital
  - Heidelberg, Australia, 3084
    - Austin Hospital
  - Nedlands, Australia, 6009
    - Sir Charles Gairdner Hospital
  - North Terrace, Australia, 5000
    - Royal Adelaide Hospital
  - Parkville, Australia, 3050
    - Royal Melbourne Hospital
  - Penrith, Australia, 2751
    - Nepean Hospital
  - Prahran, Australia, 3004
    - The Alfred Hospital
  - South Brisbane, Australia, 4101
    - Mater Hospital Brisbane
  - Woolloongabba, Australia, 4102
    - Princess Alexandra Hospital
Austria
- - Salzburg, Austria, 5020
    - Universitaetsklinikum Salzburg Landeskrankenhaus
  - Vienna, Austria, 1090
    - AKH Wien
Belarus
- - Grodno, Belarus, 230017
    - Grodno University Hospital
  - Homyel, Belarus, 246029
    - Gomel Regional Clinical Hospital
  - Homyel, Belarus, 246040
    - Republican Research Centre of Radiation Medicine and Human E
  - Minsk, Belarus, 220116
    - Healthcare Institution,Minsk Scientific center for surgery,
  - Vitebsk, Belarus, 210037
    - Vitebsk Regional Clinical Hospital
Belgium
- - Brasschaat, Belgium, 2930
    - AZ Klina
  - Brussels, Belgium, 1070
    - Hôpital Erasme
  - Brussels, Belgium, 1000
    - CHU Saint-Pierre
  - Ghent, Belgium, 9000
    - UZ Gent
  - Kortrijk, Belgium, 8500
    - AZ Groeninge
  - Roeselare, Belgium, 8800
    - Algemeen Ziekenhuis Delta
  - Tournai, Belgium, 7500
    - CHWAPI
Bosnia and Herzegovina
- - Banja Luka, Bosnia and Herzegovina, 78000
    - University Clinical Centre of the Republic of Srpska
  - Mostar, Bosnia and Herzegovina, 88000
    - Clinical Hospital Mostar
  - Sarajevo, Bosnia and Herzegovina, 71000
    - Clinical Center University of Sarajevo
  - Sarajevo, Bosnia and Herzegovina, 71000
    - Polyclinic Dr. Al-Tawil
  - Zenica, Bosnia and Herzegovina, 72000
    - Cantonal Hospital Zenica
Brazil
- - Blumenau, Brazil, 89010-506
    - MK Blumenau Pesquisa Clínica
  - Botucatu, Brazil, 18618-970
    - Universidade Estadual Paulista 'Julio De Mesquita Filho'
  - Brasília, Brazil, 70200 730
    - L2IP Instituto de Pesquisas Clinicas
  - Campinas, Brazil, 13060-904
    - Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
  - Curitiba, Brazil, 80810-040
    - Hospital Nossa Senhora das Graças
  - Goiânia, Brazil, 74535-170
    - Inst Goiano Gastroenterologia e Endoscopia Digest Ltda - Clinica de Gastro
  - Jaú, Brazil, 17201-130
    - Centro de Estudos Clínicos do Interior Paulista - CECIP
  - Juiz de Fora, Brazil, 36010 570
    - CMIP - Centro Mineiro de Pesquisa Ltda
  - Niterói, Brazil, 24020-096
    - Complexo Hospitalar de Niteroi
  - Passo Fundo, Brazil, 99010-120
    - Instituto Méderi de Pesquisa e Saúde
  - Porto Alegre, Brazil, 90035-903
    - Hospital das Clinicas de Porto Alegre
  - Porto Alegre, Brazil, 90560-002
    - Instituto do Aparelho Digestivo
  - Rio de Janeiro, Brazil, 21941-913
    - Universidade Federal do Rio de Janeiro - Faculdade de Medicina
  - Salvador, Brazil, 40050-410
    - Hospital Santa Izabel
  - Santo André, Brazil, 09090-790
    - Praxis Pesquisa Medica
  - Santo André, Brazil, 09190-510
    - CEMEC - Centro Multidisciplinar de Estudos Clínicos
  - Santo André, Brazil, 09080-110
    - Pesquisare Saude
  - Santos São Paulo, Brazil, 11075-101
    - Irmandade da Santa Casa da Misericórdia de Santos
  - São José do Rio Preto, Brazil, 15015-110
    - Kaiser Hospta
  - São José do Rio Preto, Brazil, 15090-000
    - Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
  - São Paulo, Brazil, 01228-200
    - CPCLIN - Centro de Pesquisas Clínicas
  - São Paulo, Brazil, 03325-050
    - BR Trials
  - São Paulo, Brazil, 01236-030
    - Hemomed
  - Teresina, Brazil, 64049-550
    - Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N4Z6
    - University of Calgary
  - Edmonton, Alberta, Canada, T5R 1W2
    - Gastroenterology and Internal Medicine Research Institute (GIRI)
  - Edmonton, Alberta, Canada, T6G 2X8
    - University of Alberta- Ziedler Ledcor Centre
- British Columbia
  - New Westminster, British Columbia, Canada
    - Columbia Gastroenterology
- Manitoba
  - Winnipeg, Manitoba, Canada, R3A1R9
    - Health Sciences Centre
- Ontario
  - Barrie, Ontario, Canada, L4M 7G1
    - Barrie GI Associates
  - London, Ontario, Canada, N6A 5A5
    - London Health Sciences Centre
  - Toronto, Ontario, Canada, M5G 1X5
    - Mount Sinai Hospital-Toronto
  - Waterloo, Ontario, Canada, N2J 1C4
    - Pharmaceutical Integrated Research Company
- Quebec
  - Montreal, Quebec, Canada, H3H2R9
    - MUHC Montreal General Hospital
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7N 0W8
    - Royal University Hospital
China
- - Beijing, China, 100191
    - Peking University Third Hospital
  - Beijing, China, 100050
    - Beijing Friendship Hospital
  - Beijing, China, 100034
    - Peking University First Hospital
  - Beijing, China, 100700
    - The Military General Hospital of Beijing PLA
  - Changsha, China, 200120
    - The Second Xiangya Hospital of Central South University
  - Changzhou, China, 213004
    - Changzhou No 2 Peoples Hospital
  - Chengdu, China, 610041
    - West China Hospital Sichuan University
  - Chongqing, China, 400010
    - The Second Affiliated Hospital of Chongqing Medical University
  - Ganzhou, China, 341000
    - First Affiliated Hospital of Gannan Medical University
  - Guangzhou, China, 510610
    - Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital
  - Guangzhou, China, 510080
    - The First Affiliated Hospital Sun Yat-sen University
  - Guangzhou, China, 510235
    - Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  - Guangzhou, China, 510280
    - Zhujiang Hospital of Southern Medical University
  - Hangzhou, China, 310003
    - The Second Affiliated Hospital of Zhejiang University
  - Hangzhou, China, 310016
    - Sir Run Run Shaw Hospital Zhejiang University School of Medicine
  - Hefei, China, 230022
    - The First Affiliated Hospital of Anhui Medical University
  - Huai'an, China
    - Huai'an 1st Hospital
  - Nanchang, China, 330006
    - The First Affiliated Hospital of Nanchang University
  - Nanjing, China, 210008
    - Nanjing Drum Tower Hospital
  - Nanjing, China, 210009
    - Zhongda Hospital Southeast University
  - Shanghai, China, 200040
    - Huashan Hospital Fudan University
  - Shanghai, China, 200433
    - Second Military Medical University (SMMU)
  - Shanghai, China, 430030
    - Tongji Hospital of Tongji University
  - Shanghai, China, 200011
    - Shanghai Ninth Peoples Hospital
  - Shanghai, China
    - Ruijin Hospital Shanghai Jiao Tong University
  - Shenyang, China, 110004
    - Shengjing Hospital Of China Medical University
  - Shenzhen, China, 518036
    - Peking University Shenzhen Hospital
  - Suzhou, China
    - The first affiliated hospital of suzhou University
  - Wenzhou, China, 325003
    - The First Affiliated Hospital of Wenzhou Medical University
  - Wuhan, China, 430060
    - Renmin Hospital of Wuhan University
  - Wuhan, China, 430022
    - Wuhan Union Hospital
  - Wuxi, China, 214023
    - Wuxi People s Hospital
  - Xiamen, China, 361004
    - Zhongshan Hospital, Xiamen University
  - Yangzhou, China, 225001
    - Yangzhou First People's Hospital
  - Zhangzhou, China, 363000
    - Zhangzhou Municipal Hospital of Fujian Province
Colombia
- - Bogotá, Colombia, 110111
    - Medplus Medicina Prepagada S.A.
  - Bogotá, Colombia, 110221
    - Clinica de la Mujer
  - Bogotá, Colombia, 111111
    - Endocare Ltda.
  - Cali, Colombia, 760042
    - Centro Médico Imbanaco
  - Medellín, Colombia, 50012
    - Corporacion para Estudios en Salud Clinica CES - Gastroenterology
Croatia
- - Bjelovar, Croatia, 43000
    - Opca bolnica Bjelovar
  - Zadar, Croatia, 23000
    - Opca bolnica Zadar
  - Zagreb, Croatia, 10000
    - University Hospital Center Zagreb
  - Zagreb, Croatia, 10000
    - University Hospital Dubrava
  - Zagreb, Croatia, 10000
    - CH Sestre Milosrdnice
  - Zagreb, Croatia, 10000
    - Poliklinika Solmed
Czechia
- - Hořovice, Czechia, 268 31
    - NH Hospital, a.s.
  - Hradec Králové, Czechia, 500 12
    - Hepato-Gastroenterologie HK, s.r.o.
  - Prague, Czechia, 120 00
    - Synexus Czech s.r.o.
  - Prague, Czechia, 100 34
    - Fakultní Nemocnice Královské Vinohrady
  - Prague, Czechia, 190 00
    - ISCARE a.s.
  - České Budějovice, Czechia, 370 01
    - Nemocnice Ceske Budejovice
France
- - Amiens, France, 80054
    - CHU Amiens
  - Bayonne, France, 64100
    - Centre Hospitalier de la Cote Basque
  - Besançon, France, 25000
    - CHRU Besancon Hopital Jean Minjoz
  - Caen, France, 14033
    - Centre Hospitalier Universitaire (CHU) de Caen
  - Chambray Les Tours Centre, France, 37170
    - CHRU de Tours - Hôpital Trousseau
  - Créteil, France, 94010
    - Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor
  - Grenoble, France, 38700
    - CHU Grenoble
  - Lille, France, 59037
    - CHRU de Lille Hopital Claude Huriez
  - Marseille, France, 13915
    - Hôpital Nord Marseille
  - Montpellier, France, 34295
    - CHRU Montpellier - Hopital Saint-Eloi
  - Nantes, France, 44093
    - CHU de Nantes hotel Dieu
  - Nice, France, 06202
    - CHU de Nice Hopital de l Archet
  - Nîmes, France, 30029
    - CHU Nimes Hopital Caremeau
  - Paris, France, 75877
    - Hôpital Bichat
  - Paris, France, 75908
    - Groupement Hospitalier Universitaire Ouest
  - Pierre-Bénite, France, 69495
    - Centre Hospitalier Lyon Sud
  - Reims, France, 51092
    - Centre Hospitalier Universitaire de Reims, Hôpital Robert Debré
  - Saint-Etienne, France, 42270
    - CHU Saint Etienne
  - Saint-Mandé, France, 94160
    - Hopital D'Instruction Des Armees
  - Strasbourg, France, 67098
    - CHRU de Strasbourg - Hopital de Hautepierre
  - Toulouse, France, 31059
    - CHU Toulouse - Hopital de Rangueil
  - Toulouse, France, 50032
    - Hôpital Rangueil
  - Vandœuvre-lès-Nancy, France, 54511
    - CHU de Nancy_ Hopital Brabois
Georgia
- - Tbilisi, Georgia, 0141
    - TSMU The First University Clinic
  - Tbilisi, Georgia, 0159
    - Institute of Clinical Cardiology, Ltd.
  - Tbilisi, Georgia, 0159
    - LTD 'Georgia Archangel St. Michael Multiprofile Clinical Hospital'
  - Tbilisi, Georgia, 112
    - LTD Helsicore
  - Tbilisi, Georgia, 0160
    - LTD 'Aversi Clinic'
  - Telavi, Georgia, 2200
    - LTD Unimed Kakheti- Telavi Referral Hospital
Germany
- - Augsburg, Germany, D-86158
    - Klinikum Augsburg
  - Berlin, Germany, 13353
    - Universitaetsklinikum Charite, Campus Virchow Klinikum
  - Berlin, Germany, 10117
    - Charite - Campus Mitte
  - Berlin, Germany, 12627
    - Synexus Berlin Research Center
  - Berlin, Germany, 14163
    - Krankenhaus Waldfriede Mitte
  - Dresden, Germany, 1307
    - Klinikum Dresden
  - Frankfurt, Germany, 60313
    - Synexus Clinical Research GmbH
  - Frankfurt, Germany, 69590
    - JWG-University Hospital
  - Frankfurt am Main, Germany, 60431
    - Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
  - Hamburg, Germany, 20246
    - Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie
  - Hamburg, Germany, 22559
    - Asklepios Westklinikum
  - Hanover, Germany, 30625
    - Medizinische Hochschule Hannover
  - Heidelberg, Germany, 69120
    - Universitaetsklinikum Heidelberg
  - Karlshorst, Germany, 10318
    - Gastroenterologische Spezialpraxis - Berlin-Karlshorst
  - Kiel, Germany, 24105
    - Universitatsklinikum Schleswig Holstein Kiel
  - Leipzig, Germany, 04103
    - Eugastro GmbH
  - Leipzig, Germany, 04103
    - Gastroenterologie und Hepatologie am Johannisplatz
  - Lüneburg, Germany, 21339
    - Staedtisches Klinikum Lueneburg
  - Mannheim, Germany, 68167
    - Universitaetsklinikum Mannheim
  - Münster, Germany, 48159
    - Gemeinschaftspraxis Germania-Campus
  - Regensburg, Germany, 93053
    - Praxiszentrum Alte Mälzerei
  - Saarbrücken, Germany, 66111
    - Zentrum für Gastroenterologie Saar MVZ GmbH
  - Ulm, Germany, 89081
    - Universitatsklinikum Ulm
Greece
- - Athens, Greece, 11527
    - Laiko General Hospital of Athens
  - Heraklion, Greece, 71110
    - University Hospital of Heraklion
Hungary
- - Budapest, Hungary, 1036
    - Synexus Magyarorszag Kft
  - Budapest, Hungary, 1076
    - Péterfy Sándor utcai Kórház
  - Budapest, Hungary, H-1062
    - Meddica Centre Hungarian Defence Froces
  - Budapest, Hungary, H-1088
    - Semmelweis Egyetem
  - Békéscsaba, Hungary, 5600
    - Réthy Pál Kórház - Rendelőintézet
  - Gyula, Hungary, 5700
    - Synexus Magyarorszag Kft
  - Szekszárd, Hungary, 7100
    - Tolna Megyei Balassa János Kórház
India
- - Jaipur, India, 302017
    - Apex Hospitals Ltd
  - New Delhi, India, 110088
    - Fortis Hospital 1
  - Noida, India, 201301
    - Fortis Hospital
  - Rajkot, India, 360005
    - Shree Giriraj Multispeciality Hospital
  - Surat, India, 395009
    - BAPS Pramukhswami Hospital
  - Surat, India, 395002
    - Nirmal Hospital Pvt. Ltd.
  - Surat, India, 395002
    - Surat Institute of Digestive Sciences Hospitals
  - Surat, India, 395010
    - Unity Hospital
Israel
- - Afula, Israel, 1834111
    - Ha'Emek Medical Center
  - Ashkelon, Israel, 78278
    - Barzilai Medical Center
  - Bear Sheva, Israel, 84100
    - Soroka Medical Center
  - Haifa, Israel, 31096
    - Rambam Medical Center
  - Haifa, Israel, 3339419
    - Bnai Zion Medical Center
  - Jerusalem, Israel, 9103102
    - Shaare Zedek Medical Center
  - Jerusalem, Israel, 91120
    - Hadassah Hebrew University Medical Center
  - Kfar Saba, Israel, 4428164
    - Meir Medical Center
  - Petah Tikva, Israel, 4941492
    - Rabin Med Ctr Beilinson Hosp
  - Ramat Gan, Israel, 5262000
    - Chaim Sheba Medical Center
  - Tel Aviv, Israel, 6423906
    - Tel Aviv Sourasky Medical Center
  - Tzrifin, Israel, 70300
    - Assaf Harofeh Medical Center
Italy
- - Bologna, Italy, 40138
    - Policlinico S.Orsola Malpighi, AOU di Bologna
  - Cagliari, Italy, 09042
    - Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato
  - Cento, Italy, 44042
    - Ospedale Santissima Annunziata
  - Messina, Italy, 98125
    - AOU Policlinico G.Martino
  - Milan, Italy, 20097
    - Gruppo Ospedaliero San Donato - Istituto di Ricovero e Cura
  - Padova, Italy, 35128
    - Universita degli Studi di Padova - Azienda Ospedaliera di Padova
  - Roma, Italy, 00168
    - Policlinico Universitario Agostino Gemelli
  - Roma, Italy, 00128
    - Università Campus Biomedico di Roma
  - Rome, Italy, 00168
    - Complesso Integrato Columbus
  - Rozzano, Italy, 20089
    - IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali
  - San Giovanni Rotondo, Italy, 71013
    - Casa Sollievo della Sofferenza
  - Torino, Italy, 10128
    - S.C. Gastroenterologia
  - Udine, Italy, 33100
    - Azienda Ospedaliero Universitaria S.Maria Della Misericordia
  - Verona, Italy, 37134
    - Policlinico G.B.Rossi
Japan
- - Asahikawa, Japan, 087-8686
    - Asahikawa City Hospital
  - Bunkyō City, Japan, 113-8431
    - Juntendo University Hospital
  - Bunkyō City, Japan, 113 8519
    - Tokyo Medical and Dental University Hospital
  - Bunkyō City, Japan, 279-0021
    - Juntendo University Hospital 1
  - Chiba, Japan, 260-8677
    - Chiba University Hospital
  - Chikushino-shi, Japan, 818-8502
    - Fukuoka University Chikushi Hospital
  - Fukuoka, Japan, 814-0180
    - Fukuoka University Hospital
  - Fukuoka, Japan, 810-0001
    - Saiseikai Fukuoka General Hospital
  - Gifu, Japan, 501-1194
    - Gifu University Hospital
  - Hachiōji, Japan, 192-0032
    - Tokai University Hachioji Hospital
  - Hamamatsu, Japan, 432-8061
    - Matsuda Hospital
  - Higashiibaraki-gun, Japan, 311-3193
    - Mito Medical Center - Digestive Organs
  - Hirosaki, Japan, 036-8174
    - National Hospital Organization Hirosaki General Medical Center
  - Hiroshima, Japan, 734-8551
    - Hiroshima University Hospital
  - Ishikawa, Japan, 920 8650
    - National Hospital Organization Kanazawa Medical Center
  - Izumiōtsu, Japan, 595-0027
    - Izumiotsu Municipal Hospital
  - Izumo, Japan, 693-8501
    - Shimane University Hospital
  - Kagoshima, Japan, 892-0846
    - Sameshima Hospital
  - Kagoshima, Japan, 892-0843
    - Kagoshima IBD Gastroenterology Clinic
  - Kagoshima, Japan, 892-8512
    - Nanpuh Hospital
  - Kanazawa, Japan, 9208651
    - Kanazawa University Hospital
  - Kashihara, Japan, 634-8522
    - Nara Medical University Hospital
  - Kashiwa, Japan, 277-0871
    - Tsujinaka Hospital Kashiwanoha
  - Kashiwa, Japan, 277-8567
    - The Jikei University Hospital 1
  - Kobe, Japan, 650-0017
    - Kobe University Hospital
  - Kobe, Japan, 650-0015
    - Aoyama Naika Clinic
  - Kochi, Japan, 780-8077
    - National Hospital Organization Kochi National Hospital
  - Kofu, Japan, 400-8506
    - Yamanashi Prefectural Central Hospital
  - Kure, Japan, 736-0023
    - National Hospital Organization Kure Medical Center and Chugoku Cancer Center
  - Kurume, Japan, 830-0011
    - Kurume University Hospital
  - Kyoto, Japan, 606-8507
    - Kyoto University Hospital
  - Kyoto, Japan, 612-8555
    - National Hospital Organization Kyoto Medical Center
  - Kyoto, Japan, 602-8566
    - University Hospital Kyoto Prefectural University of Medicine
  - Kyoto, Japan, 605-0981
    - JRC Kyoto Daiichi Hospital
  - Minatoku, Japan, 108-8642
    - Kitasato University Kitasato Institute Hospital
  - Mitaka, Japan, 181-8611
    - Kyorin University Hospital
  - Morioka, Japan, 020-8505
    - Iwate Medical University Hospital
  - Nagakute, Japan, 480-1195
    - Aichi Medical University Hospital
  - Nagaoka, Japan, 940-2085
    - Nagaoka Red Cross Hospital
  - Nagasaki, Japan, 852-8501
    - Nagasaki University Hospital
  - Nagoya, Japan, 466-8560
    - Nagoya University Hospital
  - Nagoya, Japan, 467-8602
    - Nagoya City University Hospital
  - Nishinomiya, Japan, 663-8501
    - The Hospital of Hyogo College of Medicine
  - Obihiro, Japan, 080-0024
    - JA Obihiro Kosei Hospital
  - Okayama, Japan, 700-8511
    - Okayama Saiseikai General Hospital
  - Okinawa, Japan, 904-2195
    - Nakagami Hospital
  - Osaka, Japan, 540-0006
    - National Hospital Organization Osaka National Hospital
  - Osaka, Japan, 545-8586
    - Osaka City University Hospital
  - Osaka, Japan, 530-8480
    - Kitano Hospital
  - Osaka, Japan, 530-0011
    - Kinshukai Infusion Clinic
  - Osaka, Japan, 543 8555
    - Japanese Red Cross Osaka Hospital
  - Saitama, Japan, 350-0495
    - Saitama Medical University Hospital
  - Saitama, Japan, 330-0074
    - Japan Community Health Care Organization Saitama Medical Center
  - Saitama, Japan, 336-0963
    - Tokitokai Tokito Clinic Coloproctology Center
  - Sakura, Japan, 285-8741
    - Toho University Sakura Medical Center
  - Sapporo, Japan, 060-8648
    - Hokkaido University Hospital
  - Sapporo, Japan, 065-0033
    - Sapporo Higashi Tokushukai Hospital
  - Sapporo, Japan, 060-0033
    - JA Sapporo-Kosei General Hospital - 1st Digestive Organs
  - Sapporo Chuo-ku, Japan, 064-0919
    - Sapporo IBD Clinic
  - Shinjuku-ku, Japan, 169-0073
    - Tokyo Yamate Medical Center
  - Suita-shi, Japan, 565-0871
    - Osaka University Hospital
  - Takamatsu, Japan, 760-0017
    - Takamatsu Red Cross Hospital
  - Takamatsu, Japan, 760-85557
    - Kagawa Prefectural Central Hospital
  - Tokushima, Japan, 770-8503
    - Tokushima University Hospital
  - Tokyo, Japan, 105 8471
    - The Jikei University Hospital
  - Tomishiro, Japan, 901-0243
    - Yuaikai Tomishiro Central Hospital
  - Toyama, Japan, 939 8511
    - Toyama City Hospital
  - Toyoake, Japan, 470-1192
    - Fujita Health University Hospital
  - Tsu, Japan, 514-8507
    - Mie University Hospital
  - Tōon, Japan, 791-0295
    - Ehime University Hospital
  - Wakayama, Japan, 641-8509
    - Wakayama Medical University Hospital
  - Yokohama, Japan, 232 0024
    - Yokohama City University Medical Center
  - Ōita, Japan, 870-0033
    - Oita Red Cross Hospital
  - Ōsaka-sayama, Japan, 589-8511
    - Kindai University Hospital
  - Ōsaki, Japan, 989-6183
    - Osaki Citizen Hospital
  - Ōtsu, Japan, 520-2192
    - Shiga University of Medical Science Hospital
  - Ōtsu, Japan, 527-8505
    - National Hospital Organization Higashi Ohmi General Medical Center
Jordan
- - Amman, Jordan, 11942
    - Jordan University Hospital
  - Amman, Jordan, 11183
    - Khalidi Hospital and Medical Center
  - Irbid, Jordan, 22110
    - King Abdullah University Hospital
  - Irbid, Jordan, 21110
    - Irbid Specialty Hospital
Latvia
- - Riga, Latvia, LV-1002
    - Pauls Stradins Clinical University Hospital
  - Riga, Latvia, LV-1046
    - Alda Pukisa arsta prakse
Lebanon
- - Ain Wazein, Lebanon
    - Ain Wazein Hospital
  - Beirut, Lebanon
    - Rafik Hariri University Hospital
  - Beirut, Lebanon, 166830
    - Hotel Dieu de France Hospital
  - Beirut, Lebanon
    - Bellevue Medical Center
  - Beirut, Lebanon
    - Mount Lebanon Hospital
  - Beirut, Lebanon, 110 72020
    - American Universitty of Beirut Medical Center
  - Beirut, Lebanon, 166378
    - St Georges Hospital university medical centre
  - Tripoli, Lebanon, NAP
    - Nini Hospital
Lithuania
- - Kaunas, Lithuania, LT-50161
    - Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik
  - Vilnius, Lithuania, LT-08661
    - Vilnius University Hospital Santaros Klinikos, Public Institution
Malaysia
- - Ampang, Malaysia, 68000
    - Hospital Ampang
  - Ipoh, Malaysia, 30990
    - Hospital Raja Permaisuri Bainun
  - Johor Bharu, Malaysia, 80100
    - Hospital Sultanah Aminah
  - Kota Bharu, Malaysia, 15160
    - Hospital Raja Perempuan Zainab Ii
  - Kuala Lumpur, Malaysia, 59100
    - University Malaya Medical Centre
  - Kuantan, Malaysia, 25100
    - Hospital Tengku Ampuan Afzan
Netherlands
- - Amsterdam, Netherlands, 7057-1007 MB
    - Amsterdam UMC Locatie VUMC
  - Maastricht, Netherlands, 6229 HX
    - Academisch Ziekenhuis Maastricht
  - Sittard-Geleen, Netherlands, 6130 MB
    - Stichting Zuyderland Medisch Centrum
New Zealand
- - Auckland, New Zealand, 1142
    - Auckland City Hospital
  - Christchurch, New Zealand, 8140
    - Christchurch Hospital
  - Dunedin, New Zealand, 9016
    - Dunedin Hospital
  - Hamilton, New Zealand, 3204
    - Waikato Hospital
North Macedonia
- - Skopje, North Macedonia, 1000
    - General City Hospital 8mi Septemvri
  - Skopje, North Macedonia, 1000
    - University Clinic of Gastroenterohepatology
  - Skopje, North Macedonia, 1000
    - University Clinic of Gastroenterohepatology 1
Poland
- - Bydgoszcz, Poland, 85 681
    - NZOZ Centrum Medyczne KERmed
  - Chojnice, Poland, 89-600
    - Centrum Medyczne Lukamed
  - Częstochowa, Poland, 42-202
    - Synexus Polska Sp. z o.o. Oddzial w Czestochowie
  - Gdansk, Poland, 80 382
    - Synexus Polska Sp. z o.o. Oddzial w Gdansku
  - Gdynia, Poland, 81 537
    - Synexus Scm Sp Z o o Oddzial Gdynia
  - Jelenia Góra, Poland, 8 500
    - Prywatna Praktyka Lekarska
  - Katowice, Poland, 40 040
    - Synexus Polska Sp z o o Oddzial w Katowicach
  - Krakow, Poland, 31-411
    - Centrum Medyczne Promed
  - Krakow, Poland, 30 149
    - Malopolskie Centrum Kliniczne
  - Krakow, Poland, 30 363
    - Centrum Medyczne Plejady
  - Ksawerów, Poland, 95-054
    - Centrum Opieki Zdrowotnej Orkan Med Stec Michalska sj
  - Lodz, Poland, 90-644
    - AmiCare Centrum Medyczne
  - Lodz, Poland, 90 127
    - Synexus Polska Sp z o o
  - Lublin, Poland, 20-582
    - Gastromed Spotka Z Ograniczona Odpowiedzialnoscia Sp. K.
  - Lublin, Poland, 20 049
    - 1 Wojskowy Szpital Kliniczny Z Poliklinika SPZOZ W Lublinie
  - Olsztyn, Poland, 10 561
    - Wojewodzki Szpital Specjalistyczny w Olsztynie
  - Opole, Poland, 45-819
    - Twoja Przychodnia 1
  - Oświęcim, Poland, 32 600
    - Oswiecimskie Centrum Badan Klinicznych
  - Poznan, Poland, 60-702
    - Synexus Polska Sp. z.o.o. Oddzial w Poznaniu
  - Poznan, Poland, 61-293
    - Twoja Przychodnia
  - Poznan, Poland, 60 309
    - EMC Instytut Medyczny SA
  - Poznan, Poland, 60 529
    - Solumed S C
  - Rzeszów, Poland, 35-055
    - Centrum Medyczne 'Medyk' Sp. z o.o. K.
  - Sopot, Poland, 81-756
    - Endoskopia Sp z o.o.
  - Sosnowiec, Poland, 41-209
    - Kiepury Clinic
  - Szczecin, Poland, 71-434
    - Twoja Przychodnia - Szczecinskie Centrum Medyczne
  - Szczecin, Poland, 71-685
    - Niepubliczny Zaklad Opieki Zdrowotnej
  - Torun, Poland, 87 100
    - GASTROMED Specjalistyczne Centrum Gastrologii i Endoskopii Specjalistyczne Gabinety Lekarskie
  - Tychy, Poland, 43-100
    - H-T Centrum Medyczne Endoterapia
  - Warsaw, Poland, 02-507
    - Centralny Szpital Kliniczny MSWiA w Warszawie
  - Warsaw, Poland, 03-580
    - NZOZ Vivamed Zespol Lekarzy Specjalistow
  - Warsaw, Poland, 04-730
    - Szpital Pomnik Centrum Zdrowia Dziecka
  - Warsaw, Poland, 00 141
    - Wojskowy Instytut Medyczny
  - Warsaw, Poland, 02 676
    - Centrum Medyczne
  - Warsaw, Poland, 02-679
    - Centrum Badawcze Wspolczesnej Terapii
  - Warsaw, Poland, 623832
    - Synexus Polska Sp z o o Oddzial w Warszawie
  - Wierzchosławice, Poland, 33-122
    - Centrum Zdrowia Tuchow
  - Wroclaw, Poland, 50-088
    - FutureMeds Sp. z o.o.
  - Wroclaw, Poland, 50-449
    - Melita Medical Sp. z o.o.
  - Wroclaw, Poland, 53-333
    - ARS MEDICA Rybak Maria, Rybak Zbigniew, s.c.
  - Wroclaw, Poland, 54 144
    - EuroMediCare Szpital Specjalistyczny z Przychodnia
  - Wroclaw, Poland, 50 381
    - Synexus Polska Sp z o o Oddzial we Wroclawiu
  - Wroclaw, Poland, 50 449
    - Przychodnia VISTAMED
  - Włocławek, Poland, 87-800
    - Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska
  - Zamość, Poland, 22-400
    - ETG Zamosc
Portugal
- - Braga, Portugal, 4710-243
    - Hospital de Braga
  - Coimbra, Portugal, 3000-075
    - Centro Hospitalar e Universitário de Coimbra, EPE
  - Guimarães, Portugal, 4835-044
    - Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes
  - Portimão, Portugal, 8500-338
    - Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio
  - Porto, Portugal, 4099-001
    - H. Santo António - Centro Hospitalar do Porto
  - Santa Maria da Feira, Portugal, 4520-211
    - Centro Hospitalar de Entre o Douro e Vouga, E.P.E
Puerto Rico
- - Caguas, Puerto Rico, 00726
    - San Juan Bautista School of Medicine
Russia
- - Kazan', Russia, 420012
    - Kazan State Medical University
  - Krasnoyarsk, Russia, 660022
    - KGBUZ 'Regional Clinical Hospital'
  - Moscow, Russia, 123423
    - State Scientific Centre of Coloproctology
  - Nizhny Novgorod, Russia, 603126
    - Novgorod Regional Clinical Hospital n.a. N.A. Semashko
  - Novosibirsk, Russia, 630091
    - City Clinical Hospital #12
  - Novosibirsk, Russia, 630117
    - FSBI 'Scientific Research Institute of Clinical and Experimental Lymphology' of Siberian Branch
  - Omsk, Russia, 644024
    - Clinical Diagnostic Center 'Ultramed'
  - Podolsk, Russia, 142105
    - GBUZ of Moscow Region City Clinical Hospital #3
  - Rostov-on-Don, Russia, 344022
    - GBOU VPO Rostov State Medical University
  - Rostov-on-Don, Russia, 344091
    - City Hospital #20
  - Saint Petersburg, Russia, 194291
    - Clinical Hospital #122 n.a. after L.G. Sokolov
  - Saint Petersburg, Russia, 195257
    - City Hospital named after St. Martyr Elizabeth
  - Saint Petersburg, Russia, 196143
    - The Limited Liability Company Research center Eco-safety
  - Saint Petersburg, Russia, 197022
    - St.Petersburg State Medical University n.a.Pavlov
  - Saint Petersburg, Russia, 197110
    - City Clinical Hospital #31
  - Samara, Russia, 443001
    - Medical University Reaviz
  - Samara, Russia, 443041
    - NUZ 'Railway Clinical Hospital on Samara station of LLC 'Russian Railways'
  - Saratov, Russia, 410071
    - Saratov City Hospital #5
  - Tomsk, Russia, 634063
    - Tomsk Regional Clinical Hospital
  - Ulyanovsk, Russia, 432063
    - Ulyanovsk Regional Clinical Hospital
  - Veliky Novgorod, Russia, 173008
    - GUZ Novgorod Regional Clinical Hospital
Saudi Arabia
- - Mecca, Saudi Arabia, 21955
    - King Abdullah Medical City in Holy Capital
  - Riyadh, Saudi Arabia, 11426
    - King Abdul Aziz Medical City for National Guard Health Affairs
Serbia
- - Belgrade, Serbia, 11080
    - Clinical Hospital Center Bezanijska Kosa
  - Belgrade, Serbia, 11000
    - University Clinical Center of Serbia
  - Belgrade, Serbia, 11000
    - Zvezdara University Medical Center
  - Belgrade, Serbia, 11000
    - Special hospital for Internal diseases, Oncomed system
  - Kragujevac, Serbia, 34000
    - University Clinical Center Kragujevac
  - Zrenjanin, Serbia, 23000
    - General Hospital 'Djordje Joanovic'
Slovakia
- - Banská Bystrica, Slovakia, 975 17
    - FNsP F.D.R. Banska Bystrica
  - Košice, Slovakia, 040 13
    - ENDOMED s.r.o
  - Prešov, Slovakia, 080 01
    - GASTRO I. s.r.o.
South Korea
- - Ansan-si, South Korea, 15355
    - Korea University Ansan Hospital
  - Busan, South Korea, 49201
    - Dong-A University Hospital
  - Busan, South Korea, 48108
    - Inje University Haeundae Paik Hospital
  - Daegu, South Korea, 41944
    - Kyungpook National University Hospital
  - Daegu, South Korea, 41404
    - Kyongpook national university Medical center
  - Gyeonggi-do, South Korea, 16247
    - The Catholic University of Korea, St. Vincent'S Hospital
  - Hwaseong-si, South Korea, 18450
    - Hallym University Dongtan Sacred Heart Hospital
  - Seongnam, South Korea, 13496
    - Cha Bundang Medical Center, Cha University
  - Seongnam, South Korea, 13620
    - The Catholic Univ of Korea DaeJeon St Mary s Hospital
  - Seongnam-si, South Korea, 13620
    - Seoul National University Bundang Hospital
  - Seoul, South Korea, 05505
    - Asan Medical Center
  - Seoul, South Korea, 06351
    - Samsung Medical Center
  - Seoul, South Korea, 03181
    - Kangbuk Samsung Hospital
  - Seoul, South Korea, 03722
    - Yonsei University College of Medicine
  - Seoul, South Korea, 06973
    - Chung-Ang University Hospital
  - Seoul, South Korea, 135-720
    - Gangnam Severance Hospital
  - Wŏnju, South Korea, 26426
    - Wonju Christian Hospital
  - Yangch’ŏn-gu, South Korea, 07985
    - Ewha Womans University Mokdong Hospital
Spain
- - Córdoba, Spain, 14004
    - Hosp Reina Sofia
  - Ferrol, Spain, 15405
    - Complejo Hosp Univ. de Ferrol
  - Girona, Spain, 17007
    - Hosp. Univ. Dr. Josep Trueta
  - Huelva, Spain, 21005
    - Hosp. Gral. Juan Ramon Jimenez
  - Madrid, Spain, 28040
    - Hosp. Clinico San Carlos
  - Madrid, Spain, 28046
    - Hosp. Univ. La Paz
  - Oviedo, Spain, 33011
    - Hosp. Univ. Central de Asturias
  - Pontevedra, Spain, 36071
    - Hosp. Provincial de Pontevedra
  - Seville, Spain, 41013
    - Hosp. Virgen Del Rocio
  - Torrejón de Ardoz, Spain, 28850
    - Hosp. Univ. de Torrejon
  - Vigo, Spain, 36312
    - Hosp. Alvaro Cunqueiro
  - Zaragoza, Spain, 50009
    - Hosp. Univ. Miguel Servet
Taiwan
- - Changhua, Taiwan, 500
    - Chang-Hua Christian Hospital
  - Taichung, Taiwan, 40447
    - China Medical University Hospital
  - Taipei, Taiwan, 10002
    - National Taiwan University Hospital
  - Taoyuan, Taiwan, 33305
    - Chang-Gung Memorial Hospital-Linkou
Tunisia
- - Nabeul, Tunisia, 8000
    - Hopital Regional Mohamed Tahar El Maamouri
  - Sousse, Tunisia, 4051
    - Hopital Universitaire Sahloul
  - Tunis, Tunisia, 1008
    - Hopital Habib Thameur
  - Tunis, Tunisia
    - Military Hospital of Instruction of Tunis
  - Tunis Jebbari, Tunisia, 1007
    - Hospital La Rabta
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06230
    - Hacettepe University Medical Faculty
  - Ankara, Turkey (Türkiye), 6010
    - Gulhane Egitim ve Arastirma Hastanesi
  - Elâzığ, Turkey (Türkiye), 23200
    - Firat University Hospital
  - Hatay, Turkey (Türkiye), 31001
    - Mustafa Kemal University Research and Practise Hospital
  - Istanbul, Turkey (Türkiye), 34349
    - Acibadem Fulya Hospital
  - Istanbul, Turkey (Türkiye), 34899
    - Marmara University Medical Faculty
  - Istanbul, Turkey (Türkiye), 34732
    - BAU Medical Park Goztepe Hospital
  - Istanbul, Turkey (Türkiye), 34360
    - Sisli Etfal Egitim ve Arastirma Hospital
  - Izmir, Turkey (Türkiye), 35340
    - Dokuz Eylul University Medical Faculty
Ukraine
- - Kharkiv, Ukraine, 61039
    - SE 'National institute therapy named L.T. Maloi NAMS of Ukraine'
  - Kharkiv, Ukraine, 61037
    - MNCE City Clinical Hospital No 2 named after prof O O Shalimov of the Kharkiv City Council
  - Kherson, Ukraine, 73000
    - KZ Khersonska Miska Klinichna Likarnia Im. Ye.Ie.Karabelesha
  - Kyiv, Ukraine, 03049
    - Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
  - Kyiv, Ukraine, 4107
    - Kyiv Regional Clinical Hospital
  - Kyiv, Ukraine, 01030
    - KNP Kyivska miska klinichna likarnia №18 vykonavchoho orhanu KMR (KMDA)
  - Kyiv, Ukraine, 02002
    - LLC Treatment and Diagnostic Center Adonis Plus
  - Kyiv, Ukraine, 03037
    - Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud
  - Odesa, Ukraine, 65025
    - Odeska oblasna klinichna likarnia
  - Ternopil, Ukraine, 46000
    - Ternopil municipal hospital #1
  - Uzhhorod, Ukraine, 88018
    - MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council
  - Vinnytsia, Ukraine, 21009
    - Health Clinic Limited Liability Company
  - Zaporizhzhya, Ukraine, 69035
    - KU 6 miska klinichna likarnia ZMR
United Kingdom
- - Barnsley, United Kingdom, S75 2EP
    - Barnsley District General Hospital
  - Cambridge, United Kingdom, CB2 0QQ
    - Addenbrooke's Hospital
  - London, United Kingdom, SW17 0QT
    - St Georges Healthcare NHS Trust
United States
- Alabama
  - Dothan, Alabama, United States, 36305
    - Digestive Health Specialists Of The Southeast
  - Mobile, Alabama, United States, 36693
    - Internal Medicine Center
- Arizona
  - Tucson, Arizona, United States, 85724
    - University of Arizona
- California
  - Anaheim, California, United States, 92805
    - Advanced Research Center Inc
  - Beverly Hills, California, United States, 90211
    - Paul Wallace MD
  - La Jolla, California, United States, 92093
    - University of California San Diego
  - Lancaster, California, United States, 93534
    - Om Research LLC
  - Mission Viejo, California, United States, 92691
    - Allameh Medical Corp
  - Murrieta, California, United States, 92563
    - United Gastroenterologists
  - Orange, California, United States, 92868
    - Clinnova Research
  - Rialto, California, United States, 91106
    - Inland Empire Liver Foundation
  - Sacramento, California, United States, 95817
    - UC Davis Medical Center
  - San Diego, California, United States, 91941
    - Clinical Applications Laboratories, Inc
- Colorado
  - Colorado Springs, Colorado, United States, 80920
    - Peak Gastroenterology Associates
- Florida
  - Coconut Creek, Florida, United States, 33066
    - Pioneer Research Solutions Inc.
  - Fort Lauderdale, Florida, United States, 33308
    - InvesClinic, LLC
  - Hialeah, Florida, United States, 33016
    - Harmony Medical Research Institute, Inc.
  - Inverness, Florida, United States, 34452
    - Elite Research Network - Nature Coast Clinical Research, LLC
  - Kissimmee, Florida, United States, 34759
    - SIH Research
  - Lakeland, Florida, United States, 33813
    - Auzmer Research
  - Lakewood Rch, Florida, United States, 34211
    - Florida Research Center Inc.
  - Miami, Florida, United States, 33180
    - Visionary Investigators Network
  - Miami, Florida, United States, 33155
    - Community Research Foundation, Inc.
  - Miami, Florida, United States, 33157-6575
    - Sanchez Clinical Research, Inc
  - Miami, Florida, United States, 33032
    - Homestead Associates in Research Inc
  - Naples, Florida, United States, 34102
    - Gastroenterology Group Of Naples
  - Orlando, Florida, United States, 32803
    - Florida Hospital
  - Orlando, Florida, United States, 32825
    - Care Access Research, Orlando
  - Orlando, Florida, United States, 32808
    - Omega Research Consultants
  - Pinellas Park, Florida, United States, 33781
    - Synexus Clinical Research US Inc 1
  - Saint Cloud, Florida, United States, 34769
    - Central Florida Internists
  - St. Petersburg, Florida, United States, 33705
    - Synergy Clinical Research
  - St. Petersburg, Florida, United States, 33709
    - Theia Clincial Research, LLC
  - Tampa, Florida, United States, 33603
    - Clinical Research of West Florida
  - Tampa, Florida, United States, 33613
    - Florida Hospital Tampa
  - Tampa, Florida, United States, 33615
    - Alliance Clinical Research
  - Tampa, Florida, United States, 33609
    - GCP Clinical Research
  - Weston, Florida, United States, 33331
    - Cleveland Clinic Florida
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Emory University
  - Atlanta, Georgia, United States, 30310
    - Morehouse School of Medicine
  - Atlanta, Georgia, United States, 30224
    - Atlanta Gastroenterology Associates
  - Decatur, Georgia, United States, 30033
    - Atlanta Center For Gastroenterology
  - Roswell, Georgia, United States, 30076
    - Gastroenterology Consultants
  - Suwanee, Georgia, United States, 30024
    - Atlanta Gastroenterology Specialists PC
- Illinois
  - Urbana, Illinois, United States, 61801
    - Carle Foundation Hospital
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - IU Health University Hospital
- Kansas
  - Leawood, Kansas, United States, 66211
    - BVL Clinical Research
  - Pratt, Kansas, United States, 67124
    - Health Science Research Center
  - Topeka, Kansas, United States, 66606
    - Cotton O'Neil Digestive Health Center
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Gastroenterology Associates
  - Lafayette, Louisiana, United States, 70503
    - Gastroenterology Clinic of Acadiana
  - Marrero, Louisiana, United States, 70072
    - Tandem Clinical Research
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Clinic Foundation
  - New Orleans, Louisiana, United States, 70124
    - DelRicht Research
  - Shreveport, Louisiana, United States, 71105
    - Louisiana Research Center, LLC
  - Shreveport, Louisiana, United States, 71103
    - LSUHSC Shreveport Feist-Weiller Cancer Center
- Maryland
  - Baltimore, Maryland, United States, 21208
    - Woodholme Gastroenterology Associates
- Massachusetts
  - Chelmsford, Massachusetts, United States, 01824
    - Digestive Health Specialists PC
- Michigan
  - Chesterfield, Michigan, United States, 48047
    - Clinical Research Institute of Michigan, LLC
  - Ypsilanti, Michigan, United States, 48197
    - Huron Gastroenterology Associates Center for Digestive Care
- Nevada
  - Las Vegas, Nevada, United States, 89113
    - Las Vegas Medical Research
- New Jersey
  - Morristown, New Jersey, United States, 07960
    - Atlantic Digestive Health Institute/ Atlantic IBD Center
- New York
  - Jackson Heights, New York, United States, 11372
    - A1 Clinical Research
  - New York, New York, United States, 10021
    - Weill Cornell Medical College
  - New York, New York, United States, 10028
    - New York Gastroenterology Associates
  - New York, New York, United States, 10065
    - Care Access Research
  - New York, New York, United States, 11021
    - NYU Langone Medical Center
  - Rochester, New York, United States, 14642
    - University of Rochester Medical Center
  - Syracuse, New York, United States, 13210
    - Syracuse VA Medical Center
- North Carolina
  - Asheville, North Carolina, United States, 28801
    - Asheville Gastroenterology Associates
  - Chapel Hill, North Carolina, United States, 27599
    - University North Carolina at Chapel Hill
  - Charlotte, North Carolina, United States, 28277
    - Onsite Clinical Solutions
  - Charlotte, North Carolina, United States, 28207
    - Charlotte Gastroenterology and Hepatology, PLLC
  - Fayetteville, North Carolina, United States, 28304
    - Cumberland Research Associates
  - Kinston, North Carolina, United States, 28501
    - Care Access Research, Kinston
  - Mount Airy, North Carolina, United States, 27030
    - Clinical Trials of America
  - Winston-Salem, North Carolina, United States, 27103
    - PMG Research of Winston-Salem
- Ohio
  - Beavercreek, Ohio, United States, 45432
    - Clinical Inquest Center, LTD
  - Columbus, Ohio, United States, 43210
    - Ohio State University
  - Columbus, Ohio, United States, 43212
    - Synexus Clinical Research US Inc 2
  - Mentor, Ohio, United States, 44060
    - Great Lakes Gastroenterology Research, LLC
  - Poland, Ohio, United States, 44514
    - Southwoods Health
  - Westlake, Ohio, United States, 44145
    - NorthShore Gastroenterology Research, LLC
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73112
    - Integris Baptist Office
- Pennsylvania
  - Wyomissing, Pennsylvania, United States, 19610
    - US Digestive Health
- South Carolina
  - Anderson, South Carolina, United States, 29621-2062
    - Synexus Clinical Research US Inc
  - Greenville, South Carolina, United States, 29615
    - Gastroenterology Associates P.A.
- Tennessee
  - Chattanooga, Tennessee, United States, 37404
    - Memorial Health Care System
  - Germantown, Tennessee, United States, 38138
    - Gastro One
  - Johnson, Tennessee, United States, 37614-1700
    - Tennessee State University
  - Nashville, Tennessee, United States, 37212-1610
    - Vanderbilt University Medical Center
- Texas
  - Garland, Texas, United States, 75044
    - DHAT Research Institute
  - Houston, Texas, United States, 77030
    - Baylor College of Medicine
  - Houston, Texas, United States, 77030
    - Houston Methodist Hospital
  - Houston, Texas, United States, 77074
    - Houston Digestive Diseases Consultants
  - Houston, Texas, United States, 77079
    - CliniCore Houston
  - Lubbock, Texas, United States, 79424
    - Caprock Gastro Research
  - San Antonio, Texas, United States, 78229
    - Gastroenterology Research of America, LLC
  - San Antonio, Texas, United States, 78229
    - Gastroenterology Clinic Of San Antonio P A
  - San Antonio, Texas, United States, 78229
    - UT Health Science Center at San Antonio
  - Southlake, Texas, United States, 76092
    - Texas Digestive Disease Consultants
  - Spring, Texas, United States, 77386
    - Texas Gastroenterology Associates - Research
  - Temple, Texas, United States, 76508
    - Baylor Scott and White Research Institute
  - Tyler, Texas, United States, 75701
    - Tyler Research Institute, LLC
- Virginia
  - Chesapeake, Virginia, United States, 23320
    - Gastroenterology Associates of Tidewater
  - Petersburg, Virginia, United States, 23805
    - Center for Gastrointestinal Health
  - Roanoke, Virginia, United States, 24014-1372
    - Gastroenterology Consultants of Southwest Virginia
- Washington
  - Bellevue, Washington, United States, 98004
    - Northwest Gastroenterology Associates - USA
  - Tacoma, Washington, United States, 98405
    - Washington Gastroenterology, PLLC

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Have Crohn's disease (CD) or fistulizing Crohn's disease of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
Have moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for Crohn's Disease (SES-CD)
Have screening laboratory test results within the protocol specified parameters
A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD

Exclusion Criteria:

Current diagnosis of ulcerative colitis or indeterminate colitis
Has complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation
Unstable doses of concomitant Crohn's disease therapy
Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocol
Any medical contraindications preventing study participation

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: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 2 (GALAXI 1): Group 1 (Guselkumab) Participants will receive guselkumab (Dose 1) by intravenous (IV) infusion, followed by guselkumab (Dose 2) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the Long-Term Extension (LTE) phase and continue to receive guselkumab.	Drug: Guselkumab Dose 1 Guselkumab will be administered by IV infusion. Drug: Guselkumab Dose 2 Guselkumab will be administered by SC injection.
Experimental: Phase 2 (GALAXI 1): Group 2 (Guselkumab) Participants will receive guselkumab (Dose 3) by intravenous (IV) infusion, followed by guselkumab (Dose 2) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.	Drug: Guselkumab Dose 2 Guselkumab will be administered by SC injection. Drug: Guselkumab Dose 3 Guselkumab will be administered by IV infusion.
Experimental: Phase 2 (GALAXI 1): Group 3 (Guselkumab) Participants will receive guselkumab (Dose 4) by intravenous (IV) infusion, followed by guselkumab (Dose 5) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.	Drug: Guselkumab Dose 4 Guselkumab will be administered by IV infusion. Drug: Guselkumab Dose 5 Guselkumab will be by SC injection.
Active Comparator: Phase 2 (GALAXI 1): Group 4 (Ustekinumab) Participants will receive ustekinumab by intravenous (IV) infusion, followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue ustekinumab may enter the LTE and continue to receive ustekinumab.	Drug: Ustekinumab Ustekinumab will be administered by IV infusion and SC injection.
Experimental: Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab) Participants will receive placebo administered by intravenous (IV) infusion. At Week 12, non-responders will receive active treatment (Ustekinumab) administered by intravenous (IV) infusion followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue placebo/ustekinumab may enter the LTE and continue to receive placebo/ustekinumab.	Drug: Ustekinumab Ustekinumab will be administered by IV infusion and SC injection. Drug: Placebo Placebo will be administered as IV infusion.
Experimental: Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab) Participants will receive guselkumab by intravenous (IV) infusion, followed by guselkumab by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.	Drug: Guselkumab Guselkumab will be administered by IV infusion and SC injection.
Active Comparator: Phase 3 (GALAXI 2 and 3): Group 3 (Ustekinumab) Participants will receive ustekinumab by intravenous (IV) infusion, followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue ustekinumab may enter the LTE phase and continue to receive ustekinumab.	Drug: Ustekinumab Ustekinumab will be administered by IV infusion and SC injection.
Experimental: Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab) Participants will receive placebo administered by intravenous (IV) infusion. At Week 12, non-responders will receive active treatment (ustekinumab) administered by intravenous (IV) infusion followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue placebo/ustekinumab may enter the LTE and continue to receive placebo/ustekinumab.	Drug: Ustekinumab Ustekinumab will be administered by IV infusion and SC injection. Drug: Placebo Placebo will be administered as IV infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12 Time Frame: Baseline and Week 12	The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity. Baseline was defined as the last observation prior to or at the date of the first study intervention.	Baseline and Week 12
Global: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48 Time Frame: Weeks 48	Clinical response was defined as a decrease from baseline (BL) in CDAI score greater than or equal to (>=) 100 points or CDAI score <150. Clinical remission was defined as a CDAI score <150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.	Weeks 48
Global: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48 Time Frame: Weeks 48	CR: decrease from BL in CDAI score >=100/<150. ER: >=50% improvement from BL in SES-CD score/SES-CD score <=2. CDAI(8 variables):extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid/soft stools, abdominal pain/cramps, general well-being. Last 3 variables scored over 7 eligible days by participant on diary. Total CDAI score ranged:0-600(in general):higher score=higher disease activities. Decrease in total CDAI score over time=improvement in disease. SES-CD evaluated 4 endoscopic components (presence & size of ulcer, extent of ulcerated surface, extent of affected surface, presence & type of narrowing) across 5 ileocolonic segments (ileum; right, left & transverse colon; rectum) each scored 0(best) to 3(worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. SES-CD score: sum of all component scores(all segments) ranged:0-56, higher scores=more severe disease.	Weeks 48
Global: GALAXI 3: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48 Time Frame: Weeks 48	Clinical response was defined as a decrease from baseline in CDAI score >= 100 points or CDAI score <150. Clinical remission was defined as a CDAI score <150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.	Weeks 48
Global: GALAXI 3: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48 Time Frame: Weeks 48	CR: decrease from BL in CDAI score >=100/<150. ER: >=50% improvement from BL in SES-CD score/SES-CD score <=2. CDAI(8 variables):extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid/soft stools, abdominal pain/cramps, general well-being. Last 3 variables scored over 7 eligible days by participant on diary. Total CDAI score ranged:0-600(in general):higher score=higher disease activities. Decrease in total CDAI score over time=improvement in disease. SES-CD evaluated 4 endoscopic components (presence & size of ulcer, extent of ulcerated surface, extent of affected surface, presence & type of narrowing) across 5 ileocolonic segments (ileum; right, left & transverse colon; rectum) each scored 0(best) to 3(worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. SES-CD score: sum of all component scores(all segments) ranged:0-56, higher scores=more severe disease.	Weeks 48
Regional: GALAXI 2: Percentage of Participants With Clinical Remission at Week 12 Time Frame: Week 12	Clinical remission was defined as a CDAI score <150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.	Week 12
Regional: GALAXI 2: Percentage of Participants With Endoscopic Response at Week 12 Time Frame: Week 12	Endoscopic response was defined as >=50% improvement from baseline in SES-CD score or SES-CD score <=2. SES-CD evaluated 4 endoscopic components (presence and size of ulcer, extent of ulcerated surface, extent of affected surface, presence and type of narrowing) across 5 ileocolonic segments (ileum, right colon, transverse colon, left colon, rectum), each scored 0 (best) to 3 (worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. Total SES-CD score: sum of all component scores across all segments, ranged: 0 to 56, higher scores = more severe disease.	Week 12
Regional: GALAXI 3: Percentage of Participants With Clinical Remission at Week 12 Time Frame: Week 12	Clinical remission was defined as a CDAI score <150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.	Week 12
Regional: GALAXI 3: Percentage of Participants With Endoscopic Response at Week 12 Time Frame: Week 12	Endoscopic response was defined as >=50% improvement from baseline in SES-CD score or SES-CD score <=2. SES-CD evaluated 4 endoscopic components (presence and size of ulcer, extent of ulcerated surface, extent of affected surface, presence and type of narrowing) across 5 ileocolonic segments (ileum, right colon, transverse colon, left colon, rectum), each scored 0 (best) to 3 (worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. Total SES-CD score: sum of all component scores across all segments, ranged: 0 to 56, higher scores = more severe disease.	Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
GALAXI 1: Percentage of Participants With Clinical Remission at Week 12 Time Frame: At Week 12	At Week 12
GALAXI 1: Percentage of Participants With Clinical Response at Week 12 Time Frame: At Week 12	At Week 12
GALAXI 1: Percentage of Participants With Patient-Reported Outcome (PRO) 2 Remission at Week 12 Time Frame: At Week 12	At Week 12
GALAXI 1: Percentage of Participants With Clinical-Biomarker Response at Week 12 Time Frame: At Week 12	At Week 12
GALAXI 1: Percentage of Participants With Endoscopic Response at Week 12 Time Frame: At Week 12	At Week 12
Global: GALAXI 2 and 3: Percentage of Participants With Clinical Response at Week 4 Time Frame: At Week 4	At Week 4
Global: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 12 Time Frame: At Week 12	At Week 12
Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 12 Time Frame: At Week 12	At Week 12
Global: GALAXI 2 and 3: Percentage of Participants With Fatigue Response at Week 12 Time Frame: At Week 12	At Week 12
Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission and Endoscopic Response at Week 12 Time Frame: At Week 12	At Week 12
Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 12 Time Frame: At Week 12	At Week 12
Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Response at Week 12 and Corticosteroid-Free Clinical Remission at Week 48 Time Frame: At Week 48	At Week 48
Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Response at Week 12 and Endoscopic Remission at Week 48 Time Frame: At Week 48	At Week 48
Global: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 48 Time Frame: At Week 48	At Week 48
Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 48 Time Frame: At Week 48	At Week 48
Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission and Endoscopic Response at Week 48 Time Frame: At Week 48	At Week 48
Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 48 Time Frame: At Week 48	At Week 48
Global: GALAXI 2 and 3: Percentage of Participants With Deep Remission at Week 48 Time Frame: At Week 48	At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With PRO-2 Remission at Week 12 Time Frame: At Week 12	At Week 12
Regional: GALAXI 2 and 3: Percentage of Participants With Fatigue Response at Week 12 Time Frame: At Week 12	At Week 12
Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 12 Time Frame: At Week 12	At Week 12
Regional: GALAXI 2 and 3: Percentage of Participants With Corticosteroid-free Clinical Remission at Week 48 Time Frame: At Week 48	At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 48 Time Frame: At Week 48	At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 48 Time Frame: At Week 48	At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 48 Time Frame: At Week 48	At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With Durable Clinical Remission at Week 48 Time Frame: At Week 48	At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With PRO-2 Remission at Week 48 Time Frame: At Week 48	At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission at Week 48 and Endoscopic Response at Week 48 Time Frame: At Week 48	At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With Corticosteroid-free Remission at Week 48 Time Frame: At Week 48	At Week 48

Collaborators and Investigators

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

Sponsor

Janssen Research & Development, LLC

Investigators

Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, 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.

General Publications

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)

April 13, 2018

Primary Completion (Actual)

October 20, 2023

Study Completion (Estimated)

January 28, 2028

Study Registration Dates

First Submitted

March 8, 2018

First Submitted That Met QC Criteria

March 8, 2018

First Posted (Actual)

March 15, 2018

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

CR108387
2017-002195-13 (EudraCT Number)
CNTO1959CRD3001 (Other Identifier: Janssen Research & Development, LLC)
2023-504736-18-00 (Registry Identifier: EUCT number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease (GALAXI)

A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Crohn's Disease

Clinical Trials on Guselkumab Dose 1

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