A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)
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
7 other identifiers
interventional
1,020
43 countries
463
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2023
Longer than P75 for phase_3
463 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2023
CompletedFirst Posted
Study publicly available on registry
September 25, 2023
CompletedStudy Start
First participant enrolled
October 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2029
March 13, 2026
March 1, 2026
2.8 years
September 18, 2023
March 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Study 1: Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at 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
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
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 Outcomes (42)
Study 1: Percentage of Participants With One or More Adverse Events (AEs)
Up to approximately 52 weeks
Study 1: Percentage of Participants Who Discontinued Study Intervention Due to an AE
Up to approximately 52 weeks
Study 1: Percentage of Participants Achieving Clinical Response Per Partial Modified Mayo Score (pMMS) at Week 2
Week 2
Study 1: Percentage of Participants With Endoscopic Improvement at Week 12
Week 12
Study 1: Percentage of Participants Achieving a Clinical Response Per MMS at Week 12
Week 12
- +37 more secondary outcomes
Study Arms (11)
Study 1: High Dose Induction, High Dose Maintenance
EXPERIMENTALParticipants receive high dose intravenous (IV) tulisokibart, followed by a high dose subcutaneous (SC) tulisokibart regimen.
Study 1: High Dose Induction, Low Dose Maintenance
EXPERIMENTALParticipants receive high dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
Study 1: Low Dose Induction, Low Dose Maintenance
EXPERIMENTALParticipants receive low dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
Study 1: Placebo
PLACEBO COMPARATORParticipants receive IV placebo, followed by an SC placebo regimen.
Study 1: High Dose Extension
EXPERIMENTALParticipants 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.
Study 1: Low Dose Extension
EXPERIMENTALParticipants 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.
Study 2: High Dose Induction
EXPERIMENTALParticipants receive high dose IV tulisokibart.
Study 2: Low Dose Induction
EXPERIMENTALParticipants receive low dose IV tulisokibart.
Study 2: Placebo
PLACEBO COMPARATORParticipants receive IV placebo.
Study 2: High Dose Extension
EXPERIMENTALParticipants 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.
Study 2: Low Dose Extension
EXPERIMENTALParticipants 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.
Interventions
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously
Placebo matching SC tulisokibart
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merck Sharp & Dohme LLClead
- PPD, Part of Thermo Fisher Scientificcollaborator
Study Sites (476)
Digestive Health Specialists ( Site 0135)
Dothan, Alabama, 36301, United States
IMC-Gulf Coast Gastroenterology ( Site 0157)
Fairhope, Alabama, 36532, United States
Research Solutions of Arizona ( Site 3816)
Litchfield Park, Arizona, 85340, United States
One of a Kind Clinical Research Center ( Site 3852)
Scottsdale, Arizona, 85258, United States
GI Alliance - Sun City ( Site 0103)
Sun City, Arizona, 85351, United States
Clinnova Research ( Site 3803)
Anaheim, California, 92805, United States
Southern California Research Center ( Site 3828)
Coronado, California, 92118, United States
UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0113)
La Jolla, California, 92037, United States
Cedars-Sinai Medical Center ( Site 0119)
Los Angeles, California, 90048, United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3851)
Orange, California, 92868, United States
University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 0172)
Aurora, Colorado, 80045, United States
Peak Gastroenterology Associates ( Site 0116)
Colorado Springs, Colorado, 80907, United States
South Denver Gastroenterology, PC ( Site 3849)
Englewood, Colorado, 80113, United States
Rocky Mountain Gastroenterology/Topography Health ( Site 3838)
Littleton, Colorado, 80120, United States
Connecticut Clinical Research Institute ( Site 0126)
Bristol, Connecticut, 06010, United States
Medical Research Center of Connecticut ( Site 0151)
Hamden, Connecticut, 06518, United States
Yale University School of Medicine-Digestive Disease ( Site 0163)
New Haven, Connecticut, 06510, United States
Emerson Clinical Research Institute ( Site 3820)
Washington D.C., District of Columbia, 20009, United States
Gastroenterology Consultants of Clearwater ( Site 0152)
Clearwater, Florida, 33756, United States
University of Florida College of Medicine-Gastroenterology ( Site 3821)
Gainesville, Florida, 32610, United States
Nature Coast Clinical Research - Inverness ( Site 3806)
Inverness, Florida, 34452, United States
Central Florida Gastro Research ( Site 0124)
Kissimmee, Florida, 34741, United States
Research Associates of South Florida - Miami - Southwest 8th Street ( Site 3810)
Miami, Florida, 33134, United States
Orlando Health ( Site 0145)
Orlando, Florida, 32806, United States
USF Health ( Site 0169)
Tampa, Florida, 33612, United States
Emory University School of Medicine ( Site 3818)
Atlanta, Georgia, 30322, United States
Atlanta Gastroenterology Associates - Peachtree Dunwoody ( Site 0115)
Atlanta, Georgia, 30342, United States
Atlanta Center for Gastroenterology ( Site 0155)
Decatur, Georgia, 30033, United States
University of Chicago Medical Center ( Site 0134)
Chicago, Illinois, 60637, United States
GI Alliance - Glenview ( Site 0168)
Glenview, Illinois, 60026, United States
GI ALLIANCE - GURNEE ( Site 0107)
Gurnee, Illinois, 60031, United States
Iowa Digestive Disease Center ( Site 0123)
Clive, Iowa, 50325, United States
University of Louisville Hospital-Clinical Trials Unit ( Site 0165)
Louisville, Kentucky, 40202, United States
Baton Rouge General Medical Center - Bluebonnet ( Site 0112)
Baton Rouge, Louisiana, 70809, United States
Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 0154)
New Orleans, Louisiana, 70112, United States
Walter Reed National Military Medical Center ( Site 0121)
Bethesda, Maryland, 20889, United States
Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 3835)
Glen Burnie, Maryland, 21061, United States
Massachusetts General Hospital-Crohn's and Colitis Center ( Site 0132)
Boston, Massachusetts, 02114, United States
University of Michigan ( Site 0143)
Ann Arbor, Michigan, 48109, United States
Clinical Research Institute of Michigan, LLC ( Site 0108)
Clinton Township, Michigan, 48038, United States
Michigan Center of Medical Research (MICHMER) ( Site 3850)
Farmington Hills, Michigan, 48334, United States
Clinical Research Institute of Michigan, LLC ( Site 0150)
Troy, Michigan, 48098, United States
Huron Gastroenterology ( Site 3836)
Ypsilanti, Michigan, 48197, United States
Mayo Clinic in Rochester, Minnesota ( Site 0147)
Rochester, Minnesota, 55905, United States
BVL Research - Kansas ( Site 3847)
Liberty, Missouri, 64068, United States
Washington University School of Medicine ( Site 0129)
St Louis, Missouri, 63110, United States
Circuit Clinical /Middletown Medical PC ( Site 3831)
Middletown, New York, 10940, United States
NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 3846)
New York, New York, 10016, United States
Lenox Hill Hospital ( Site 0128)
New York, New York, 10075, United States
New York Gastroenterology Associates ( Site 0159)
New York, New York, 10128, United States
University of North Carolina Medical Center ( Site 0140)
Chapel Hill, North Carolina, 27514, United States
Carolina Digestive Diseases and Endoscopy Center ( Site 3809)
Greenville, North Carolina, 27834, United States
Hospital of the University of Pennsylvania ( Site 0170)
Philadelphia, Pennsylvania, 19104, United States
University Gastroenterology ( Site 0164)
Providence, Rhode Island, 02904, United States
Gastroenterology Associates of Orangeburg ( Site 0149)
Orangeburg, South Carolina, 29118, United States
Vanderbilt Inflammatory Bowel Disease Clinic ( Site 0131)
Nashville, Tennessee, 37204, United States
Quality Medical Research ( Site 3807)
Nashville, Tennessee, 37211, United States
GI Alliance - Garland ( Site 0109)
Garland, Texas, 75044, United States
Baylor College of Medicine Medical Center ( Site 3812)
Houston, Texas, 77030, United States
The University of Texas Health Science Center at Houston-Internal Medicine-Division of Gastroentero ( Site 0144)
Houston, Texas, 77030, United States
Clinical Trial Network ( Site 3819)
Houston, Texas, 77074, United States
GI Alliance - Lubbock ( Site 0167)
Lubbock, Texas, 79410, United States
Caprock Gastro Research ( Site 0101)
Lubbock, Texas, 79424, United States
GI Alliance: Mansfield ( Site 0161)
Mansfield, Texas, 76063, United States
CARTA - Clinical Associates In Research Therapeutics Of America ( Site 0122)
San Antonio, Texas, 78212, United States
Southern Star Research Institute ( Site 0106)
San Antonio, Texas, 78229, United States
GI Alliance - San Marcos ( Site 0130)
San Marcos, Texas, 78666, United States
GI Alliance - Southlake ( Site 0104)
Southlake, Texas, 76092-9167, United States
Tyler Research Institute ( Site 0105)
Tyler, Texas, 75701, United States
Texas Digestive Disease Consultants ( Site 0136)
Webster, Texas, 77598, United States
Velocity Clinical Research, Salt Lake City ( Site 3801)
West Jordan, Utah, 84088, United States
Richmond VA Medical Center ( Site 3845)
Richmond, Virginia, 23249, United States
Washington Gastroenterology - Bellevue ( Site 3844)
Bellevue, Washington, 98004-4631, United States
University of Washington Medical Center - Montlake ( Site 0137)
Seattle, Washington, 98195, United States
Washington Gastroenterology - Tacoma ( Site 0102)
Tacoma, Washington, 98405, United States
Medical College of Wisconsin ( Site 0141)
Milwaukee, Wisconsin, 53226, United States
Centro de Investigaciones Médicas Mar del Plata ( Site 2101)
Mar del Plata, Buenos Aires, 7600, Argentina
CER medical Institute-Gastroenterology ( Site 2110)
Quilmes, Buenos Aires F.D., B1878DVB, Argentina
Hospital Provincial del Centenario ( Site 2108)
Rosario, Santa Fe Province, S2002KDT, Argentina
C.I.C.E. 9 de Julio-CICE 9 DE JULIO ( Site 2103)
San Miguel de Tucumán, Tucumán Province, T4000IKO, Argentina
Nepean Hospital-Gastroenterology/Hepatology ( Site 2501)
Kingswood, New South Wales, 2747, Australia
Concord Repatriation General Hospital-Gastroenterology and Liver Services ( Site 2508)
Sydney, New South Wales, 2139, Australia
Royal Brisbane and Women's Hospital ( Site 2500)
Brisbane, Queensland, 4029, Australia
Mater Misericordiae Limited-Gastroenterology ( Site 2506)
Brisbane, Queensland, 4101, Australia
Royal Adelaide Hospital-Gastroenterology/Hepatology ( Site 2504)
Adelaide, South Australia, 5000, Australia
Monash Health-Gastroenterology ( Site 2505)
Clayton, Victoria, 3168, Australia
The Alfred Hospital-Gastroenterology ( Site 2503)
Melbourne, Victoria, 3004, Australia
St Vincent's Hospital ( Site 2510)
Melbourne, Victoria, 3065, Australia
Universitaetsklinik fuer Innere Medizin I Innsbruck ( Site 0200)
Innsbruck, Tyrol, 6020, Austria
Medizinische Universität Wien-Klinik für Innere Medizin III - Abteilung für Gastroenterologie und H ( Site 0202)
Vienna, Vienna, 1090, Austria
Uniklinikum Salzburg-Innere Medizin I ( Site 0201)
Salzburg, 5020, Austria
UZ Gent ( Site 0300)
Ghent, Oost-Vlaanderen, 9000, Belgium
UZ Leuven-Gastroenterology - Inflammatory Bowel Disease ( Site 0301)
Leuven, Vlaams-Brabant, 3000, Belgium
L2IP - Instituto de Pesquisas Clínicas ( Site 5104)
Brasília, Federal District, 70200-730, Brazil
Endogastro Clínica de Gastroenterologia e Endoscopia Digestiva Lida - Galileo Pesquisa Clínica ( Site 5100)
Juiz de Fora, Minas Gerais, 36025-290, Brazil
Hospital Moinhos de Vento ( Site 5108)
Porto Alegre, Rio Grande do Sul, 90035-001, Brazil
Pesquisare Saude ( Site 5112)
Santo André, São Paulo, 09080-110, Brazil
Centro de Pesquisa Kaiser - CEPEK ( Site 5103)
São José do Rio Preto, São Paulo, 15015-110, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 5107)
São José do Rio Preto, São Paulo, 15090-160, Brazil
MC Velingrad 2017 EOOD ( Site 0406)
Velingrad, Pazardzhik, 4600, Bulgaria
"Diagnostic - Consultative Center XX - Sofia" EOOD ( Site 0407)
Sofia, Sofia (stolitsa), 1618, Bulgaria
Medconsult Pleven ( Site 0410)
Pleven, 5800, Bulgaria
DKC V - Plovdiv ( Site 0402)
Plovdiv, 4023, Bulgaria
MC Rusemed ( Site 0408)
Rousse, 7013, Bulgaria
MHAT Hadzhi Dimitar-Gastroenterology ( Site 0403)
Sliven, 8800, Bulgaria
Diagnostic Consultative Center 22 - Sofia ( Site 0401)
Sofia, 1113, Bulgaria
4th MHAT ( Site 0409)
Sofia, 1606, Bulgaria
Medica Plus Medical Center ( Site 0404)
Veliko Tarnovo, 5000, Bulgaria
Heritage Medical Research Clinic ( Site 0004)
Calgary, Alberta, T2N 4Z6, Canada
Gastroenterology and internal medicine research institute ( Site 0010)
Edmonton, Alberta, T5R 1W2, Canada
Prairie Institute of Liver and Luminal Advanced Research ( Site 0013)
Lethbridge, Alberta, T1J 4G9, Canada
Fraser Clinical Trials Inc. ( Site 0019)
New Westminster, British Columbia, V3L 3W4, Canada
G.I.R.I. GI Research Institute Foundation ( Site 0001)
Vancouver, British Columbia, V6Z 2K5, Canada
Private Practice - Dr. Bruce Musgrave ( Site 0011)
Kentville, Nova Scotia, B4N 0A3, Canada
Barrie GI Associates ( Site 0012)
Barrie, Ontario, L4M 7G1, Canada
University Hospital - London Health Sciences Centre ( Site 0002)
London, Ontario, N6A 5A5, Canada
London Health Sciences Centre ( Site 0007)
London, Ontario, N6A 5W9, Canada
West GTA Research Inc. ( Site 0017)
Mississauga, Ontario, L5M 2S4, Canada
ABP Research Services Corp. ( Site 0016)
Ontario, Ontario, L6L 5L7, Canada
Toronto Immune & Digestive Health Institute ( Site 0005)
Toronto, Ontario, M6A 3B4, Canada
Toronto Digestive Disease Associates ( Site 0006)
Vaughan, Ontario, L4L 4Y7, Canada
Centre Intégré de Santé et Service Sociaux de Chaudière-Appalaches ( Site 0015)
Lévis, Quebec, G6V 3Z1, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0018)
Montreal, Quebec, H2X 0C1, Canada
Montreal General Hospital ( Site 0003)
Montreal, Quebec, H3G 1A4, Canada
Diex Recherche Quebec ( Site 0008)
Québec, Quebec, G1V 4T3, Canada
Clinical Research Chile SpA ( Site 2201)
Valdivia, Los Ríos Region, 5110683, Chile
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 2203)
Santiago, Region M. de Santiago, 7500653, Chile
FALP-UIDO ( Site 2208)
Santiago, Region M. de Santiago, 7500921, Chile
Clínica Universidad de Los Andes ( Site 2202)
Santiago, Region M. de Santiago, 7620157, Chile
Clínica Alemana de Santiago ( Site 2209)
Santiago, Region M. de Santiago, 7650568, Chile
Clínica MEDS La Dehesa ( Site 2207)
Santiago, Region M. de Santiago, 7691236, Chile
CECIM ( Site 2200)
Santiago, Region M. de Santiago, 8320000, Chile
Pontificia Universidad Catolica de Chile-CICUC ( Site 2205)
Santiago, Region M. de Santiago, 8330034, Chile
The First Affiliated Hospital of Anhui Medical University ( Site 3957)
Hefei, Anhui, 230022, China
Anhui Provincial Hospital ( Site 3947)
Hefei, Anhui, 230036, China
Beijing Friendship Hospital Affiliate of Capital University ( Site 3923)
Beijing, Beijing Municipality, 100050, China
Peking University Third Hospital ( Site 3909)
Beijing, Beijing Municipality, 100191, China
Beijing Luhe Hospital Capital Medical University ( Site 3911)
Beijing, Beijing Municipality, 101199, China
Chongqing University Three Gorges Hospital ( Site 3928)
Chongqing, Chongqing Municipality, 404000, China
The First Affiliated Hospital Of Fujian Medical University ( Site 3904)
Fuzhou, Fujian, 350005, China
The First Affiliated hospital of Xiamen University-Gastroenterology ( Site 3954)
Xiamen, Fujian, 361003, China
Dongguan People's Hospital-Gastroenterology department ( Site 3944)
Dongguan, Guangdong, 523059, China
Guangzhou Medical University 2nd Hospital ( Site 3908)
Guangzhou, Guangdong, 510260, China
Southern Medical University Nanfang Hospital-Gastroenterology ( Site 3914)
Guangzhou, Guangdong, 510515, China
The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 3906)
Guangzhou, Guangdong, 510655, China
Huizhou Municipal Central Hospital ( Site 3917)
Huizhou, Guangdong, 516001, China
Yuebei People's Hospital Guangdong ( Site 3948)
Shaoguan, Guangdong, 512026, China
The University of Hong Kong-Shenzhen Hospital ( Site 3955)
Shenzhen, Guangdong, 518053, China
Shenzhen Hospital of Southern Medical University ( Site 3905)
Shenzhen, Guangdong, 518110, China
The Second Hospital of Hebei Medical University ( Site 3934)
Shijiazhuang, Hebei, 050000, China
The Second Affiliated Hospital of Zhengzhou University ( Site 3935)
Zhengzhou, Henan, 450014, China
Taihe Hospital ( Site 3941)
Shiyan, Hubei, 442099, China
The Central Hospital of Wuhan ( Site 3939)
Wuhan, Hubei, 430014, China
Renmin Hospital of Wuhan University ( Site 3912)
Wuhan, Hubei, 430060, China
The Second Xiangya Hospital of Central South University ( Site 3930)
Changsha, Hunan, 410011, China
Changzhou No.2 People's Hospital ( Site 3950)
Changzhou, Jiangsu, 213100, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 3900)
Nanjing, Jiangsu, 210008, China
Zhongda Hospital Southeast University ( Site 3919)
Nanjing, Jiangsu, 210009, China
Wuxi People's Hospital ( Site 3920)
Wuxi, Jiangsu, 214023, China
The First Affiliated Hospital of Nanchang University ( Site 3926)
Nanchang, Jiangxi, 330006, China
Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army ( Site 3929)
Xi'an, Shaanxi, 710038, China
Binzhou Medical University Hospital ( Site 3953)
Binzhou, Shandong, 256603, China
Taian City Central Hospital-gastroenterology department ( Site 3946)
Taian, Shandong, 271000, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine-Gastroneterology ( Site 3903)
Shanghai, Shanghai Municipality, 200025, China
Shanghai East Hospital ( Site 3922)
Shanghai, Shanghai Municipality, 200120, China
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 3915)
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University ( Site 3951)
Chengdu, Sichuan, 610041, China
Tianjin Medical University General Hospital ( Site 3945)
Tianjin, Tianjin Municipality, 300052, China
The First Teaching Hospital of Xinjiang Medical University. ( Site 3937)
Ürümqi, Xinjiang, 830054, China
First Affiliated Hospital of Kunming Medical University ( Site 3925)
Kunming, Yunnan, 650032, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-GI Medicine ( Site 3916)
Hangzhou, Zhejiang, 310000, China
Clínica las Américas ( Site 2318)
Medellín, Antioquia, 050034, Colombia
Clinica Medellin S.A ( Site 2317)
Medellín, Antioquia, Colombia
Clinica Somer-Unidad de Investigacion y Docencia ( Site 2303)
Rionegro, Antioquia, 054040, Colombia
Clinica de la Costa S.A.S. ( Site 2305)
Barranquilla, Atlántico, 080020, Colombia
Fundacion Santa Fe de Bogota ( Site 2316)
Bogota, Cundinamarca, 110111, Colombia
Oncologos del Occidente ( Site 2310)
Pereira, Risaralda Department, 660001, Colombia
Fundación Valle del Lili ( Site 2307)
Cali, Valle del Cauca Department, 760032, Colombia
Klinička bolnica Merkur ( Site 0505)
Zagreb, City of Zagreb, 10000, Croatia
Klinički bolnički centar Zagreb ( Site 0501)
Zagreb, City of Zagreb, 10000, Croatia
Poliklinika Bates ( Site 0504)
Zagreb, City of Zagreb, 10000, Croatia
Poliklinika Solmed ( Site 0502)
Zagreb, City of Zagreb, 10000, Croatia
Poliklinika Borzan ( Site 0500)
Osijek, County of Osijek-Baranja, 31000, Croatia
Klinički Bolnički Centar Split ( Site 0503)
Split, Split-Dalmatia County, 21000, Croatia
Vojenská Nemocnice Brno-Internal department ( Site 0605)
Brno, Brno-mesto, 615 00, Czechia
Nemocnice Slany ( Site 0601)
Slaný, Central Bohemia, 274 01, Czechia
Institut Klinicke a Experimentalni Mediciny-Klinika hepatogastroentrologie ( Site 0604)
Prague, Praha 4, 140 21, Czechia
Hepato-Gastroenterologie HK ( Site 0602)
Hradec Králové, 500 12, Czechia
CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 3601)
Santo Domingo, Nacional, 10104, Dominican Republic
Tampereen yliopistollinen sairaala ( Site 4300)
Tampere, Pirkanmaa, 33520, Finland
Pohjois-Karjalan keskussairaala ( Site 4302)
Joensuu, Pohjois-Karjala, 80210, Finland
Turku University Hospital ( Site 4301)
Turku, Southwest Finland, 20520, Finland
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0706)
Nice, Alpes-Maritimes, 06202, France
CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0700)
Pessac, Aquitaine, 33600, France
Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0714)
Marseille, Bouches-du-Rhone, 13915, France
Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré ( Site 0705)
Reims, Champagne-Ardenne, 51092, France
CHU Besançon ( Site 0710)
Besançon, Doubs, 25000, France
C.H.U. de Nimes. Hopital Caremeau ( Site 0718)
Nîmes, Gard, 30029, France
Hopital Beaujon ( Site 0716)
Clichy, Hauts-de-Seine, 92110, France
CMC Ambroise Paré Hartmann - Institut des MICI ( Site 0709)
Neuilly-sur-Seine, Hauts-de-Seine, 92200, France
Clinique des Cèdres ( Site 0719)
Échirolles, Isere, 38130, France
CHU SAINT ELOI ( Site 0711)
Montpellier, Languedoc-Roussillon, 34295, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 0708)
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 0701)
Nantes, Pays de la Loire Region, 44093, France
centre hospitalier lyon sud ( Site 0707)
Pierre-Bénite, Rhone, 69310, France
CHU d'Amiens-Picardie - Hôpital Sud-Hepato-gastroentérology ( Site 0712)
Amiens, Somme, 80054, France
Hopital Henri Mondor ( Site 0717)
Créteil, Val-de-Marne, 94010, France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0715)
Le Kremlin-Bicêtre, Val-de-Marne, 94270, France
Hôpital Saint Antoine ( Site 0703)
Paris, 75012, France
Hôpital Saint-Louis ( Site 0702)
Paris, 75475, France
LTD High Technology Hospital Medcenter ( Site 0802)
Batumi, Adjara, 6010, Georgia
Caucasus Medical Centre ( Site 0801)
Tbilisi, Adjara, 0186, Georgia
Caraps Medline ( Site 0803)
Tbilisi, 0159, Georgia
New Hospitals ( Site 0800)
Tbilisi, 0162, Georgia
Universitaetsklinikum Ulm. ( Site 0902)
Ulm, Baden-Wurttemberg, 89081, Germany
MVZ Dachau ( Site 0918)
Dachau, Bavaria, 85221, Germany
Klinikum der Universität München Großhadern-Medizinische Klinik und Poliklinik II ( Site 0907)
Munich, Bavaria, 81337, Germany
Agaplesion Markus Krankenhaus ( Site 0904)
Frankfurt am Main, Hesse, Germany
Medizinische Hochschule Hannover ( Site 0913)
Hanover, Lower Saxony, 30625, Germany
Klinikum Lüneburg ( Site 0908)
Lüneburg, Lower Saxony, 21339, Germany
Stadtische Kliniken Duisburg, Abtlg. Innere Medizin ( Site 0916)
Duisburg, North Rhine-Westphalia, 47055, Germany
Gastroenterologische Gemeinschaftspraxis Minden ( Site 0911)
Minden, North Rhine-Westphalia, 32423, Germany
Medizinisches Versorgungszentrum Portal 10 ( Site 0914)
Münster, North Rhine-Westphalia, 48155, Germany
St. Marien und St. Annastift Krankenhaus ( Site 0901)
Ludwighafen Am Rhein, Rhineland-Palatinate, 67067, Germany
Universitätsklinikum Leipzig ( Site 0909)
Leipzig, Saxony, 04103, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0903)
Kiel, Schleswig-Holstein, 24105, Germany
Charité Campus Virchow-Klinikum ( Site 0906)
Berlin, 13353, Germany
Universitätsklinikum Brandenburg an der Havel ( Site 0905)
Brandenburg, 14770, Germany
Evangelismos General Hospital of Athens ( Site 4001)
Athens, Attica, 106 76, Greece
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 4000)
Athens, Attica, 115 27, Greece
General Hospital of Nikaia-Piraeus "Agios Panteleimon" ( Site 4006)
Nikaia Piraeus, Attica, 184 54, Greece
Ippokrateio General Hospital of Thessaloniki ( Site 4004)
Thessaloniki, Central Macedonia, 54642, Greece
University General Hospital of Heraklion-GASTROENTEROLOGY & HEPATOLOGY ( Site 4003)
Heraklion, Crete, 711 10, Greece
Mohácsi Kórház ( Site 1008)
Mohács, Baranya, 7700, Hungary
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1007)
Békéscsaba, Bekescsaba, 5600, Hungary
Csőszi Endoszkópos KFT ( Site 1001)
Kecskemét, Bács-Kiskun county, 6000, Hungary
Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 1012)
Eger, Heves County, 3300, Hungary
Gyöngyösi Bugát Pál Kórház ( Site 1011)
Gyöngyös, Heves County, 3200, Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz ( Site 1010)
Tatabánya, Komárom-Esztergom, 2800, Hungary
VeszLife Magánklinika ( Site 1002)
Veszprém, Veszprém megye, 8200, Hungary
Synexus Magyarorszag Kft. (Budapest DRS) ( Site 1009)
Budapest, 1036, Hungary
Semmelweis Egyetem ( Site 1006)
Budapest, 1085, Hungary
Pannónia Magánorvosi Centrum ( Site 1004)
Budapest, 1136, Hungary
Emek Medical Center ( Site 1106)
Afula, 1834111, Israel
Barzilai Medical Center ( Site 1109)
Ashkelon, 7830604, Israel
Rambam Health Care Campus ( Site 1101)
Haifa, 3109601, Israel
Bnai Zion Medical Center ( Site 1103)
Haifa, 3339419, Israel
Edith Wolfson Medical Center ( Site 1104)
Holon, 5810001, Israel
Shaare Zedek Medical Center ( Site 1108)
Jerusalem, 9103102, Israel
Meir Medical Center. ( Site 1102)
Kfar Saba, 4428164, Israel
Rabin Medical Center ( Site 1107)
Petah Tikva, 4941492, Israel
Sheba Medical Center ( Site 1100)
Ramat Gan, 5265601, Israel
Policlinico Universitario Monserrato-SC Gastroenterologia ( Site 1207)
Monserrato, Cagliari, 09042, Italy
IRCCS Casa Sollievo della Sofferenza ( Site 1213)
San Giovanni Rotondo, Foggia, 71013, Italy
Fondazione Policlinico Tor Vergata ( Site 1209)
Rome, Lazio, 00133, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-Gastroenterology and Endoscopy Unit ( Site 1202)
Milan, Lombardy, 20122, Italy
Istituto Clinico Humanitas-IBD center ( Site 1201)
Rozzano, Lombardy, 20089, Italy
Ospedale Di Circolo-U.O.C. di Gastroenterologia ed Endoscopia Digestiva ( Site 1216)
Rho, Milano, 20017, Italy
A.O.R.N. Ospedale dei Colli - Monaldi V. ( Site 1217)
Naples, Napoli, 80131, Italy
Azienda Ospedaliera San Camillo Forlanini ( Site 1204)
Rome, Roma, 00149, Italy
Fatebenefratelli Isola Tiberina - Gemelli Isola ( Site 1214)
Rome, Roma, 00186, Italy
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO-U.O.S.D. Malattie Infiammatorie Croniche Intestinali ( Site 1210)
Palermo, Sicily, 90146, Italy
Azienda Ospedale - Università Padova-Surgery Oncology and Gastroenterology ( Site 1211)
Padua, Veneto, 35128, Italy
Ospedale Sacro Cuore Don G. Calabria ( Site 1212)
Negrar, Verona, 37024, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1208)
Bologna, 40138, Italy
ASST Fatebenefratelli Sacco-UOC Gastroenterologia ( Site 1200)
Milan, 20100, Italy
Ospedale San Raffaele-Gastroenterology and Gastrointestinal Endoscopy ( Site 1205)
Milan, 20132, Italy
Fondazione IRCCS Policlinico San Matteo-General Medicine ( Site 1206)
Pavia, 27100, Italy
Aichi Medical University Hospital ( Site 2841)
Nagakute, Aichi-ken, 480-1195, Japan
Tokatsu Tsujinaka Hospital ( Site 2832)
Abiko, Chiba, 270-1168, Japan
Tsujinaka Hospital - Kashiwanoha ( Site 2802)
Kashiwa, Chiba, 277-0871, Japan
Toho University Sakura Medical Center ( Site 2805)
Sakura, Chiba, 285-8741, Japan
Ehime Prefectural Central Hospital ( Site 2868)
Matsuyama, Ehime, 790-0024, Japan
Kitakyushu Municipal Medical Center ( Site 2873)
Kitakyushu, Fukuoka, 802-8561, Japan
Kurume University Hospital ( Site 2846)
Kurume, Fukuoka, 830-0011, Japan
Gunma University Hospital ( Site 2850)
Maebashi, Gunma, 371-8511, Japan
National Hospital Organization Fukuyama Medical Center ( Site 2831)
Fukuyama, Hiroshima, 720-0825, Japan
Asahikawa City Hospital ( Site 2840)
Asahikawa, Hokkaido, 070-8610, Japan
Asahikawa Medical University Hospital ( Site 2815)
Asahikawa, Hokkaido, 078-8510, Japan
Sapporo Tokushukai Hospital ( Site 2808)
Sapporo, Hokkaido, 004-0041, Japan
Sapporo Medical University Hospital ( Site 2829)
Sapporo, Hokkaido, 060-8543, Japan
Medical Corporation Sapporo IBD Clinic ( Site 2842)
Sapporo, Hokkaido, 064-0919, Japan
Sapporohigashi Tokushukai Hospital ( Site 2860)
Sapporo, Hokkaido, 065-0033, Japan
Hyogo Medical University Hospital ( Site 2830)
Nishinomiya, Hyōgo, 663-8501, Japan
Hitachi General Hospital ( Site 2856)
Hitachi, Ibaraki, 317-0077, Japan
Ishikawa Prefectural Central Hospital ( Site 2835)
Kanazawa, Ishikawa-ken, 920-8530, Japan
Kanazawa University Hospital ( Site 2839)
Kanazawa, Ishikawa-ken, 920-8641, Japan
Iwate Medical University Uchimaru Medical Center ( Site 2833)
Morioka, Iwate, 020-8505, Japan
Gokeikai Ofuna Chuo Hospital ( Site 2801)
Kamakura, Kanagawa, 247-0056, Japan
St. Marianna University Hospital ( Site 2852)
Kawasaki, Kanagawa, 216-8511, Japan
Matsushima Hospital ( Site 2822)
Yokohama, Kanagawa, 220-0041, Japan
Yokohama City University Medical Center ( Site 2865)
Yokohama, Kanagawa, 232-0024, Japan
Mie University Hospital ( Site 2838)
Tsu, Mie-ken, 514-8507, Japan
Sai Gastroenterology/Proctology Clinic ( Site 2814)
Fujiidera, Osaka, 583-0027, Japan
Kansai Medical University Hospital ( Site 2823)
Hirakata, Osaka, 573-1191, Japan
Hamamatsu University Hospital ( Site 2874)
Hamamatsu, Shizuoka, 431-3192, Japan
Matsuda Hospital ( Site 2826)
Hamamatsu, Shizuoka, 432-8061, Japan
National Hospital Organization Shizuoka Medical Center ( Site 2837)
Shimizu, Shizuoka, 411-8611, Japan
Institute of Science Tokyo Hospital ( Site 2827)
Bunkyō, Tokyo, 113-8519, Japan
Ginza Central Clinic ( Site 2824)
Chūō, Tokyo, 104-0061, Japan
The Jikei University Hospital ( Site 2843)
Minato, Tokyo, 105-8471, Japan
Toranomon Hospital ( Site 2828)
Minato-ku, Tokyo, 105-8470, Japan
Kitasato University Kitasato Institute Hospital ( Site 2817)
Minato-ku, Tokyo, 108-8642, Japan
Kyorin University Hospital ( Site 2804)
Mitaka-shi, Tokyo, 181-8611, Japan
NTT Medical Center Tokyo ( Site 2834)
Shinagawa-ku, Tokyo, 141-0022, Japan
Yamanashi Prefectural Central Hospital ( Site 2836)
Kofu, Yamanashi, 400-8506, Japan
Fukui Prefectural Hospital ( Site 2844)
Fukui, 910-0846, Japan
Fukuoka University Hospital ( Site 2818)
Fukuoka, 814-0180, Japan
Hiroshima University Hospital ( Site 2845)
Hiroshima, 734-8551, Japan
Kagoshima University Hospital ( Site 2848)
Kagoshima, 890-8520, Japan
Kagoshima IBD Gastroenterology Clinic ( Site 2821)
Kagoshima, 892-0843, Japan
University Hospital,Kyoto Prefectural University of Medicine ( Site 2819)
Kyoto, 602-8566, Japan
National Hospital Organization Kyoto Medical Center ( Site 2813)
Kyoto, 612-8555, Japan
Okayama University Hospital ( Site 2870)
Okayama, 700-8558, Japan
Infusion Clinic ( Site 2806)
Osaka, 530-0011, Japan
National Hospital Organization Osaka National Hospital ( Site 2869)
Osaka, 540-0006, Japan
Ishida Clinic of IBD and Gastroenterology ( Site 2820)
Ōita, 870-0823, Japan
Saga University Hospital ( Site 2812)
Saga, 849-8501, Japan
Tokitokai Tokito Clinic Coloproctology Center ( Site 2811)
Saitama, 336-0963, Japan
Tokyo Yamate Medical Center ( Site 2803)
Tokyo, 169-0073, Japan
Toyama Prefectural Central Hospital ( Site 2807)
Toyama, 930-0975, Japan
Yamagata University Hospital ( Site 2849)
Yamagata, 990-9585, Japan
Liepaja Regional Hospital ( Site 4501)
Liepāja, 3414, Latvia
P.Stradins Clinical University Hospital Center of Gastroenterology Hepatology and Nutrition ( Site 4503)
Riga, LV1002, Latvia
SIA M & M Centrs ( Site 4502)
Ādaži, Ādaži, 2164, Latvia
Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 4600)
Kaunas, Kaunas County, 50161, Lithuania
VUL SANTAROS KLINIKOS ( Site 4601)
Vilnius, Vilniaus Miestas, 08406, Lithuania
Hospital Sultanah Aminah ( Site 4702)
Johor Bahru, Johor, 80100, Malaysia
Hospital Universiti Sains Malaysia ( Site 4704)
Kubang Kerian, Kelantan, 16150, Malaysia
Hospital Tuanku Jaafar Seremban ( Site 4705)
Seremban, Negeri Sembilan, 70300, Malaysia
Hospital Ampang ( Site 4703)
Ampang, Selangor, 68000, Malaysia
Morales Vargas Centro de Investigacion ( Site 2411)
León, Guanajuato, 37000, Mexico
PanAmerican Clinical Research - Guadalajara ( Site 2400)
Guadalajara, Jalisco, 44670, Mexico
Centro Medico Clinico Quirurgico Especializado en Investigación ( Site 2403)
Tlajumulco de Zuniga, Jalisco, 45640, Mexico
Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 2406)
Mexico City, Mexico City, 14050, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 2409)
Monterrey, Nuevo León, 64460, Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan ( Site 2407)
Mérida, Yucatán, 97130, Mexico
ICARO Investigaciones en Medicina ( Site 2405)
Chihuahua City, 31000, Mexico
Centro de Investigación y Gastroenterología - S.C. ( Site 2410)
Mexico City, 03330, Mexico
Oaxaca Site Management Organization S.C. ( Site 2404)
Oaxaca City, 68000, Mexico
Radboudumc ( Site 1402)
Nijmegen, Gelderland, 6525 GA, Netherlands
ETZ Elisabeth-Department of Gastroenterology and Hepatology ( Site 1403)
Tilburg, North Brabant, 5022 GC, Netherlands
Ziekenhuis Bernhoven-Researchbureau ( Site 1401)
Uden, North Brabant, 5406 PT, Netherlands
Onze Lieve Vrouwe Gasthuis ( Site 1405)
Amsterdam, North Holland, 1051 AC, Netherlands
Amsterdam UMC, locatie VUmc-IBD Trial Unit ( Site 1400)
Amsterdam, North Holland, 1081 HZ, Netherlands
Deventer Ziekenhuis ( Site 1411)
Deventer, Overijssel, 7416 SE, Netherlands
Erasmus Medisch Centrum ( Site 1410)
Rotterdam, South Holland, 3015 GD, Netherlands
Franciscus Gasthuis & Vlietland, Locatie Gasthuis ( Site 1406)
Rotterdam, South Holland, 3045 PM, Netherlands
Universitair Medisch Centrum Utrecht ( Site 1404)
Utrecht, 3584 CX, Netherlands
Waikato Hospital ( Site 2903)
Hamilton, Waikato Region, 3204, New Zealand
Hutt Valley District Health board HVDHB ( Site 2902)
Lower Hutt, Wellington Region, 5010, New Zealand
Aotearoa Clinical Trials ( Site 2900)
Auckland, 2025, New Zealand
Akershus Universitetssykehus ( Site 4200)
Lørenskog, Akershus, 1478, Norway
Oslo Universitetssykehus Ullevål ( Site 4201)
Oslo, 0450, Norway
Pratia Poznan ( Site 1530)
Poznan, Greater Poland Voivodeship, 60-192, Poland
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.,Twoja Przychodnia PCM ( Site 1523)
Poznan, Greater Poland Voivodeship, 60-324, Poland
Gastromed Sp. z o. o. ( Site 1513)
Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
Topolowa Medicenter Ryszawa & Wspolnicy sp.j. ( Site 1500)
Krakow, Lesser Poland Voivodeship, 31-506, Poland
PROMED P. LACH R. GLOWACKI SP. J. ( Site 1529)
Krakow, Lesser Poland Voivodeship, 31-513, Poland
Allmedica ( Site 1508)
Nowy Targ, Lesser Poland Voivodeship, 34-400, Poland
NZOZ FOR MED sp. z o.o. ( Site 1511)
Wadowice, Lesser Poland Voivodeship, 34-100, Poland
Planetmed ( Site 1506)
Wroclaw, Lower Silesian Voivodeship, 52-210, Poland
Vistamed & Vertigo Sp. z o.o. ( Site 1528)
Wroclaw, Lower Silesian Voivodeship, 53-149, Poland
Melita Medical ( Site 1519)
Wroclaw, Lower Silesian Voivodeship, 53-611, Poland
Penta Hospitals Przychodnie Wrocław Wejherowska ( Site 1505)
Wroclaw, Lower Silesian Voivodeship, 54-239, Poland
Centrum Zdrowia MDM ( Site 1512)
Warsaw, Masovian Voivodeship, 00-189, Poland
ETG Warszawa ( Site 1525)
Warsaw, Masovian Voivodeship, 02-677, Poland
Vivamed Sp. z o.o. ( Site 1510)
Warsaw, Masovian Voivodeship, 03-580, Poland
WIP Warsaw IBD Point Profesor Kierkuś ( Site 1503)
Warsaw, Masovian Voivodeship, 04-501, Poland
M2M Med ( Site 1526)
Chorzów, Silesian Voivodeship, 41-500, Poland
Vita Longa Sp. Zoo ( Site 1527)
Katowice, Silesian Voivodeship, 40-748, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne ( Site 1502)
Szczecin, West Pomeranian Voivodeship, 71-434, Poland
Sonomed Sp. z o. o. ( Site 1516)
Szczecin, West Pomeranian Voivodeship, 71-685, Poland
Med-Gastr Sp. z o.o., sp.k ( Site 1515)
Lodz, Łódź Voivodeship, 91-034, Poland
AmiCare Centrum Medyczne - Zgierska ( Site 1517)
Lodz, Łódź Voivodeship, 91-495, Poland
Unidade Local de Saude Lisboa Ocidental - Hospital Egas Moniz ( Site 3306)
Lisbon, Lisbon District, 1349-019, Portugal
Unidade Local de Saude de Braga - Hospital de Braga ( Site 3300)
Braga, 4710-243, Portugal
Hospital dos Lusíadas Lisboa ( Site 3303)
Lisbon, 1500-458, Portugal
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3305)
Lisbon, 1649-035, Portugal
ULSAM - Hospital de Santa Luzia ( Site 3302)
Viana do Castelo, 4904 - 858, Portugal
Unidade Local de Saude Dão-Lafões - Hospital de São Teotónio ( Site 3308)
Viseu, 3504-509, Portugal
MEMORIAL HEALTHCARE INTERNATIONAL S.R.L ( Site 1606)
Bucharest, București, 013823, Romania
Monza Ares SRL ( Site 1604)
Bucharest, București, 021967, Romania
Fundeni Clinical Institute-Gastroenterology and Hepatology Center ( Site 1608)
Bucharest, București, 022328, Romania
Spitalul Clinic Judetean de Urgenta Cluj Napoca-Gastroenterology ( Site 1605)
Cluj-Napoca, Cluj, 400006, Romania
GastroMed ( Site 1609)
Cluj-Napoca, Cluj, 400394, Romania
Spitalul Clinic Judetean Mures-Gastroenterology ( Site 1607)
Târgu Mureş, Mureș County, 540205, Romania
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L-Gastroenterology ( Site 1601)
Timișoara, Timiș County, 300002, Romania
Asociatia Oncohelp ( Site 1610)
Timișoara, Timiș County, 300239, Romania
Clinical Hospital Center Dragisa Misovic ( Site 1708)
Belgrade, Beograd, 11 000, Serbia
Clinical Hospital Center Zvezdara-Gastroenterology and hepatology Department ( Site 1705)
Belgrade, Beograd, 11000, Serbia
University Medical Center "Bezanijska kosa"-Gastroenterology and hepatology ( Site 1704)
Belgrade, Beograd, 11080, Serbia
Clinical Center Kragujevac ( Site 1703)
Kragujevac, Beograd, 34000, Serbia
General Hospital "Djordje Joanovic" ( Site 1707)
Zrenjanin, Srednjebanatski Okrug, 23000, Serbia
Singapore General Hospital ( Site 4801)
Singapore, Central Singapore, 169608, Singapore
Tan Tock Seng Hospital-Gastroenterology and Hepatology ( Site 4800)
Singapore, Central Singapore, 308433, Singapore
Breznianske centrum gastroenterologie ( Site 1806)
Brezno, Banská Bystrica Region, 977 01, Slovakia
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica ( Site 1802)
Slovakia, Banská Bystrica Region, 974 01, Slovakia
Cliniq s.r.o. ( Site 1800)
Bratislava, Bratislava Region, 811 09, Slovakia
ENDOMED ( Site 1801)
Košice, Košice Region, 040 13, Slovakia
KM Management ( Site 1804)
Nitra, Nitra Region, 949 01, Slovakia
Accout Center ( Site 1805)
Šahy, Nitra Region, 936 01, Slovakia
GASTRO I ( Site 1807)
Prešov, Presov, 080 01, Slovakia
Gastro LM ( Site 1808)
Prešov, Presov, 080 01, Slovakia
Wits Clinical Research-Research ( Site 3208)
Johannesburg, Gauteng, 2193, South Africa
Wits Clinical Research-Wits Clinical Research Bara ( Site 3206)
Soweto, Gauteng, 2013, South Africa
Panorama Medical Centre ( Site 3209)
Cape Town, Western Cape, 7506, South Africa
Spoke Research ( Site 3210)
Cape Town, Western Cape, 7700, South Africa
Life Kingsbury Hospital ( Site 3203)
Cape Town, Western Cape, 7708, South Africa
Private Practice - Dr. M.N. Rajabally ( Site 3213)
Cape Town, Western Cape, 7800, South Africa
Wonju Severance Christian Hospital-Internal Medicine ( Site 3003)
Wŏnju, Kang-won-do, 26426, South Korea
The Catholic University Of Korea St. Vincent's Hospital-Gastroenterology ( Site 3006)
Suwon, Kyonggi-do, 16247, South Korea
Dong-A University Hospital ( Site 3010)
Busan, Pusan-Kwangyokshi, 49201, South Korea
Inje University Haeundae Paik Hospital ( Site 3009)
Haeundae-gu, Pusan-Kwangyokshi, 48108, South Korea
Chung-Ang University Hospital ( Site 3008)
Dongjak-gu, Seoul, 06973, South Korea
Yeungnam University Medical Center ( Site 3004)
Daegu, Taegu-Kwangyokshi, 42415, South Korea
The Catholic University of Korea, Daejeon St. Mary's Hospital ( Site 3011)
Daejeon, Taejon-Kwangyokshi, 34943, South Korea
Kyung Hee University Hospital ( Site 3013)
Seoul, 02447, South Korea
Seoul National University Hospital ( Site 3005)
Seoul, 03080, South Korea
Kangbuk Samsung Hospital-Internal Medicine ( Site 3002)
Seoul, 03181, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3012)
Seoul, 03312, South Korea
Severance Hospital, Yonsei University Health System-Department of Internal Medicine ( Site 3000)
Seoul, 03722, South Korea
Asan Medical Center ( Site 3007)
Seoul, 05505, South Korea
Samsung Medical Center ( Site 3001)
Seoul, 06351, South Korea
Hospital Germans Trias i Pujol ( Site 3413)
Badalona, Barcelona, 08916, Spain
Hospital Universitari Mutua Terrassa ( Site 3416)
Terrassa, Barcelona, 08221, Spain
Hospital Galdakao-Usansolo ( Site 3409)
Galdakao-Usansolo, Bizkaia, 48960, Spain
Hospital Universitario de Fuenlabrada-Digestive ( Site 3415)
Fuenlabrada, Madrid, 28942, Spain
Hospital La Princesa-Gastroenterology ( Site 3411)
Madrid, Madrid, Comunidad de, 28006, Spain
Fundación Jimenez Diaz ( Site 3420)
Madrid, Madrid, Comunidad de, 28040, Spain
Hospital Universitario de Torrejon ( Site 3417)
Torrejón de Ardoz, Madrid, Comunidad de, 28850, Spain
Hospital Universitari i Politecnic La Fe-Enfermedad Inflamatoria Intestinal ( Site 3405)
Valencia, Valencia, 46026, Spain
HOSPITAL CLINICO DE VALENCIA ( Site 3406)
Valencia, Valenciana, Comunitat, 46010, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Aparato Digestivo ( Site 3403)
Madrid, 28028, Spain
Hospital Universitario La Paz-Unidad de Enfermedad Inflamatoria Intestinal ( Site 3402)
Madrid, 28046, Spain
Danderyds Sjukhus ( Site 4401)
Danderyd, Stockholm County, 182 88, Sweden
Karolinska Universitetssjukhuset Solna ( Site 4400)
Stockholm, Stockholm County, 171 64, Sweden
Akademiska Sjukhuset ( Site 4403)
Uppsala, Uppsala County, 75185, Sweden
Universitetssjukhuset i Linköping ( Site 4402)
Linköping, Östergötland County, 581 85, Sweden
INTESTO-Gastroenterologische Praxis / Crohn-Colitis Zentrum Bern ( Site 1902)
Bern, Canton of Bern, 3012, Switzerland
Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 1901)
Sankt Gallen, Canton of St. Gallen, 9000, Switzerland
UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 1900)
Zurich, Canton of Zurich, 8091, Switzerland
Changhua Christian Hospital ( Site 3104)
Changhua County, Changhua, 50006, Taiwan
National Taiwan University BioMedical Park Hospital ( Site 3103)
Zhubei, Hsinchu, 302058, Taiwan
China Medical University Hospital ( Site 3100)
Taichung, 404332, Taiwan
National Taiwan University Hospital ( Site 3102)
Taipei, 10002, Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 3101)
Taoyuan District, 333, Taiwan
Istanbul Universitesi Cerrahpasa-Internal Diseases ( Site 3503)
Istanbul- Fatih, Istanbul, 34098, Turkey (Türkiye)
ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 3507)
Ankara, 06230, Turkey (Türkiye)
Hacettepe Universite Hastaneleri ( Site 3500)
Ankara, 06230, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Gastroenterology ( Site 3501)
Ankara, 06800, Turkey (Türkiye)
Antalya Egitim ve Arastirma Hastanesi ( Site 3508)
Antalya, 07100, Turkey (Türkiye)
Trakya University Medical Faculty Hospital ( Site 3510)
Edirne, 22030, Turkey (Türkiye)
Eskisehir Osmangazi University Faculty of Medicine ( Site 3512)
Eskişehir, 26040, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 3505)
Istanbul, 34899, Turkey (Türkiye)
Kocaeli University Medical Faculty Hospital ( Site 3509)
Kocaeli, 41380, Turkey (Türkiye)
Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council" ( Site 4115)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008, Ukraine
Center of Family Medicine Plus-Treatment Prevention Unit ( Site 4103)
Kyiv, Kyivska Oblast, 04210, Ukraine
Communal Non-profit Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"-proctology ( Site 4109)
Lviv, Lviv Oblast, 79010, Ukraine
Limited liability company "Medical center Health Clinic"-Gastroenterology, Hepatology and Endocrino ( Site 4107)
Vinnytsia, Vinnytsia Oblast, 21009, Ukraine
Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical -Gastroenterology department ( Site 4114)
Vinnytsia, Vinnytsia Oblast, 21018, Ukraine
Communal Non-Commercial Enterprise "Vinnytsia City Clinical -Clinical Therapeutic Department #1 ( Site 4111)
Vinnytsia, Vinnytsia Oblast, 21029, Ukraine
Municipal Enterprise "Volyn Regional Clinical Hospital" of V-surgery department (abdominal, colopro ( Site 4113)
Lutsk, Volyn Oblast, 43005, Ukraine
Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 4100)
Kyiv, 03057, Ukraine
Dobrobut Medical Center ( Site 4101)
Kyiv, 03151, Ukraine
Medical Center of Private Enterprise "Sygma" ( Site 4108)
Kyiv, 04116, Ukraine
Southmead Hospital ( Site 2004)
Bristol, Bristol, City of, BS10 5NB, United Kingdom
Addenbrooke's Hospital ( Site 2005)
Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom
Royal Devon & Exeter Hospital-IBD Research Group ( Site 2001)
Exeter, Devon, EX2 5DW, United Kingdom
Doncaster Royal Infirmary ( Site 2006)
Doncaster, England, DN2 5LT, United Kingdom
Huddersfield Royal Infirmary ( Site 2010)
Huddersfield, England, HD3 3EA, United Kingdom
Whipps Cross University Hospital-Clinical Research Unit ( Site 2000)
London, England, E11 1NR, United Kingdom
St. George's Hospital ( Site 2007)
London, England, SW17 0QT, United Kingdom
Southampton General Hospital-Gastroenterology ( Site 2003)
Southampton, Hampshire, SO16 0YD, United Kingdom
University College London Hospital-Clinical Research Facility ( Site 2002)
London, London, City of, NW1 2PG, United Kingdom
Walsall Manor Hospital ( Site 2009)
West Midlands, Walsall, WS2 9PS, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Induction and maintenance treatments will be blinded. Reinduction will not be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2023
First Posted
September 25, 2023
Study Start
October 25, 2023
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2029
Last Updated
March 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf