Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)
Sponsor: Merck Sharp & Dohme LLC
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.
Official title: 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
Key Details
Gender
All
Age Range
16 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
1109
Start Date
2023-10-25
Completion Date
2029-08-01
Last Updated
2026-09-28
Healthy Volunteers
No
Conditions
Interventions
IV Tulisokibart
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
IV Placebo
Placebo matching IV tulisokibart
SC Tulisokibart
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously
SC Placebo
Placebo matching SC tulisokibart
Locations (476)
Digestive Health Specialists ( Site 0135)
Dothan, Alabama, United States
IMC-Gulf Coast Gastroenterology ( Site 0157)
Fairhope, Alabama, United States
Research Solutions of Arizona ( Site 3816)
Litchfield Park, Arizona, United States
One of a Kind Clinical Research Center ( Site 3852)
Scottsdale, Arizona, United States
GI Alliance - Sun City ( Site 0103)
Sun City, Arizona, United States
Clinnova Research ( Site 3803)
Anaheim, California, United States
Southern California Research Center ( Site 3828)
Coronado, California, United States
UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0113)
La Jolla, California, United States
Cedars-Sinai Medical Center ( Site 0119)
Los Angeles, California, United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3851)
Orange, California, United States
University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 0172)
Aurora, Colorado, United States
Peak Gastroenterology Associates ( Site 0116)
Colorado Springs, Colorado, United States
South Denver Gastroenterology, PC ( Site 3849)
Englewood, Colorado, United States
Rocky Mountain Gastroenterology/Topography Health ( Site 3838)
Littleton, Colorado, United States
Connecticut Clinical Research Institute ( Site 0126)
Bristol, Connecticut, United States
Medical Research Center of Connecticut ( Site 0151)
Hamden, Connecticut, United States
Yale University School of Medicine-Digestive Disease ( Site 0163)
New Haven, Connecticut, United States
Emerson Clinical Research Institute ( Site 3820)
Washington D.C., District of Columbia, United States
Gastroenterology Consultants of Clearwater ( Site 0152)
Clearwater, Florida, United States
University of Florida College of Medicine-Gastroenterology ( Site 3821)
Gainesville, Florida, United States
Nature Coast Clinical Research - Inverness ( Site 3806)
Inverness, Florida, United States
Central Florida Gastro Research ( Site 0124)
Kissimmee, Florida, United States
Research Associates of South Florida - Miami - Southwest 8th Street ( Site 3810)
Miami, Florida, United States
Orlando Health ( Site 0145)
Orlando, Florida, United States
USF Health ( Site 0169)
Tampa, Florida, United States
Emory University School of Medicine ( Site 3818)
Atlanta, Georgia, United States
Atlanta Gastroenterology Associates - Peachtree Dunwoody ( Site 0115)
Atlanta, Georgia, United States
Atlanta Center for Gastroenterology ( Site 0155)
Decatur, Georgia, United States
University of Chicago Medical Center ( Site 0134)
Chicago, Illinois, United States
GI Alliance - Glenview ( Site 0168)
Glenview, Illinois, United States
GI ALLIANCE - GURNEE ( Site 0107)
Gurnee, Illinois, United States
Iowa Digestive Disease Center ( Site 0123)
Clive, Iowa, United States
University of Louisville Hospital-Clinical Trials Unit ( Site 0165)
Louisville, Kentucky, United States
Baton Rouge General Medical Center - Bluebonnet ( Site 0112)
Baton Rouge, Louisiana, United States
Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 0154)
New Orleans, Louisiana, United States
Walter Reed National Military Medical Center ( Site 0121)
Bethesda, Maryland, United States
Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 3835)
Glen Burnie, Maryland, United States
Massachusetts General Hospital-Crohn's and Colitis Center ( Site 0132)
Boston, Massachusetts, United States
University of Michigan ( Site 0143)
Ann Arbor, Michigan, United States
Clinical Research Institute of Michigan, LLC ( Site 0108)
Clinton Township, Michigan, United States
Michigan Center of Medical Research (MICHMER) ( Site 3850)
Farmington Hills, Michigan, United States
Clinical Research Institute of Michigan, LLC ( Site 0150)
Troy, Michigan, United States
Huron Gastroenterology ( Site 3836)
Ypsilanti, Michigan, United States
Mayo Clinic in Rochester, Minnesota ( Site 0147)
Rochester, Minnesota, United States
BVL Research - Kansas ( Site 3847)
Liberty, Missouri, United States
Washington University School of Medicine ( Site 0129)
St Louis, Missouri, United States
Circuit Clinical /Middletown Medical PC ( Site 3831)
Middletown, New York, United States
NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 3846)
New York, New York, United States
Lenox Hill Hospital ( Site 0128)
New York, New York, United States
New York Gastroenterology Associates ( Site 0159)
New York, New York, United States
University of North Carolina Medical Center ( Site 0140)
Chapel Hill, North Carolina, United States
Carolina Digestive Diseases and Endoscopy Center ( Site 3809)
Greenville, North Carolina, United States
Hospital of the University of Pennsylvania ( Site 0170)
Philadelphia, Pennsylvania, United States
University Gastroenterology ( Site 0164)
Providence, Rhode Island, United States
Gastroenterology Associates of Orangeburg ( Site 0149)
Orangeburg, South Carolina, United States
Vanderbilt Inflammatory Bowel Disease Clinic ( Site 0131)
Nashville, Tennessee, United States
Quality Medical Research ( Site 3807)
Nashville, Tennessee, United States
GI Alliance - Garland ( Site 0109)
Garland, Texas, United States
Baylor College of Medicine Medical Center ( Site 3812)
Houston, Texas, United States
The University of Texas Health Science Center at Houston-Internal Medicine-Division of Gastroentero ( Site 0144)
Houston, Texas, United States
Clinical Trial Network ( Site 3819)
Houston, Texas, United States
GI Alliance - Lubbock ( Site 0167)
Lubbock, Texas, United States
Caprock Gastro Research ( Site 0101)
Lubbock, Texas, United States
GI Alliance: Mansfield ( Site 0161)
Mansfield, Texas, United States
CARTA - Clinical Associates In Research Therapeutics Of America ( Site 0122)
San Antonio, Texas, United States
Southern Star Research Institute ( Site 0106)
San Antonio, Texas, United States
GI Alliance - San Marcos ( Site 0130)
San Marcos, Texas, United States
GI Alliance - Southlake ( Site 0104)
Southlake, Texas, United States
Tyler Research Institute ( Site 0105)
Tyler, Texas, United States
Texas Digestive Disease Consultants ( Site 0136)
Webster, Texas, United States
Velocity Clinical Research, Salt Lake City ( Site 3801)
West Jordan, Utah, United States
Richmond VA Medical Center ( Site 3845)
Richmond, Virginia, United States
Washington Gastroenterology - Bellevue ( Site 3844)
Bellevue, Washington, United States
University of Washington Medical Center - Montlake ( Site 0137)
Seattle, Washington, United States
Washington Gastroenterology - Tacoma ( Site 0102)
Tacoma, Washington, United States
Medical College of Wisconsin ( Site 0141)
Milwaukee, Wisconsin, United States
Centro de Investigaciones Médicas Mar del Plata ( Site 2101)
Mar del Plata, Buenos Aires, Argentina
CER medical Institute-Gastroenterology ( Site 2110)
Quilmes, Buenos Aires F.D., Argentina
Hospital Provincial del Centenario ( Site 2108)
Rosario, Santa Fe Province, Argentina
C.I.C.E. 9 de Julio-CICE 9 DE JULIO ( Site 2103)
San Miguel de Tucumán, Tucumán Province, Argentina
Nepean Hospital-Gastroenterology/Hepatology ( Site 2501)
Kingswood, New South Wales, Australia
Concord Repatriation General Hospital-Gastroenterology and Liver Services ( Site 2508)
Sydney, New South Wales, Australia
Royal Brisbane and Women's Hospital ( Site 2500)
Brisbane, Queensland, Australia
Mater Misericordiae Limited-Gastroenterology ( Site 2506)
Brisbane, Queensland, Australia
Royal Adelaide Hospital-Gastroenterology/Hepatology ( Site 2504)
Adelaide, South Australia, Australia
Monash Health-Gastroenterology ( Site 2505)
Clayton, Victoria, Australia
The Alfred Hospital-Gastroenterology ( Site 2503)
Melbourne, Victoria, Australia
St Vincent's Hospital ( Site 2510)
Melbourne, Victoria, Australia
Medizinische Universität Wien-Klinik für Innere Medizin III - Abteilung für Gastroenterologie und H ( Site 0202)
Vienna, State of Vienna, Austria
Universitaetsklinik fuer Innere Medizin I Innsbruck ( Site 0200)
Innsbruck, Tyrol, Austria
Uniklinikum Salzburg-Innere Medizin I ( Site 0201)
Salzburg, Austria
UZ Gent ( Site 0300)
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven-Gastroenterology - Inflammatory Bowel Disease ( Site 0301)
Leuven, Vlaams-Brabant, Belgium
L2IP - Instituto de Pesquisas Clínicas ( Site 5104)
Brasília, Federal District, Brazil
Endogastro Clínica de Gastroenterologia e Endoscopia Digestiva Lida - Galileo Pesquisa Clínica ( Site 5100)
Juiz de Fora, Minas Gerais, Brazil
Hospital Moinhos de Vento ( Site 5108)
Porto Alegre, Rio Grande do Sul, Brazil
Pesquisare Saude ( Site 5112)
Santo André, São Paulo, Brazil
Centro de Pesquisa Kaiser - CEPEK ( Site 5103)
São José do Rio Preto, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 5107)
São José do Rio Preto, São Paulo, Brazil
MC Velingrad 2017 EOOD ( Site 0406)
Velingrad, Pazardzhik, Bulgaria