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A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
Sponsor: Merck Sharp & Dohme LLC
Summary
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease
Key Details
Gender
All
Age Range
16 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
1200
Start Date
2024-06-05
Completion Date
2029-11-12
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
IV Tulisokibart
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
SC Tulisokibart
Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
IV Placebo
Placebo matching IV tulisokibart
SC Placebo
Placebo matching SC tulisokibart
Locations (499)
Digestive Health Specialists ( Site 5064)
Dothan, Alabama, United States
Arizona Arthritis & Rheumatology Research, PC ( Site 5094)
Phoenix, Arizona, United States
GI Alliance - Sun City ( Site 5118)
Sun City, Arizona, United States
University of Arizona Clinical and Translational Sciences Research Center ( Site 5111)
Tucson, Arizona, United States
University of Arkansas for Medical Sciences ( Site 5147)
Little Rock, Arkansas, United States
Clinnova Research ( Site 5110)
Anaheim, California, United States
Southern California Research Center ( Site 5044)
Coronado, California, United States
Om Research LLC ( Site 5038)
Lancaster, California, United States
Cedars Sinai Medical Center ( Site 5080)
Los Angeles, California, United States
UCLA Clinical & Translational Research Center (CTRC) ( Site 5116)
Los Angeles, California, United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 5128)
Orange, California, United States
Om Research LLC ( Site 5045)
Oxnard, California, United States
Clinical Applications Laboratories ( Site 5123)
San Diego, California, United States
Amicis Research Center ( Site 5055)
Valencia, California, United States
University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 5026)
Aurora, Colorado, United States
Peak Gastroenterology Associates ( Site 5023)
Colorado Springs, Colorado, United States
South Denver Gastroenterology, PC ( Site 5132)
Englewood, Colorado, United States
Rocky Mountain Gastroenterology ( Site 5082)
Lakewood, Colorado, United States
Medical Research Center of Connecticut ( Site 5005)
Hamden, Connecticut, United States
Yale University School of Medicine-Digestive Disease ( Site 5019)
New Haven, Connecticut, United States
Emerson Clinical Research Institute ( Site 5051)
Washington D.C., District of Columbia, United States
Gastroenterology Consultants of Clearwater ( Site 5052)
Clearwater, Florida, United States
Covenant Metabolic Specialists, LLC ( Site 5150)
Fort Myers, Florida, United States
Nature Coast Clinical Research - Inverness ( Site 5042)
Inverness, Florida, United States
Atlantic Medical Research ( Site 5073)
Margate, Florida, United States
Sanchez Clinical Research ( Site 5144)
Miami, Florida, United States
AdventHealth Orlando ( Site 5131)
Orlando, Florida, United States
Endoscopic Research Inc ( Site 5061)
Orlando, Florida, United States
Orlando Health-Digestive Health Institute ( Site 5010)
Orlando, Florida, United States
USF Health Carol and Frank Morsani Center for Advanced Healthcare ( Site 5039)
Tampa, Florida, United States
Covenant Metabolic Specialists, LLC ( Site 5143)
University Park, Florida, United States
Morehouse School Of Medicine ( Site 5071)
Atlanta, Georgia, United States
Atlanta Center for Gastroenterology ( Site 5035)
Decatur, Georgia, United States
Gastroenterology Associates of Central Georgia ( Site 5048)
Macon, Georgia, United States
Eagle Clinical Research ( Site 5089)
Chicago, Illinois, United States
University of Chicago Medical Center ( Site 5066)
Chicago, Illinois, United States
Endeavor Health ( Site 5018)
Evanston, Illinois, United States
GI ALLIANCE - GURNEE ( Site 5003)
Gurnee, Illinois, United States
Indiana University Health University Hospital ( Site 5022)
Indianapolis, Indiana, United States
Iowa Digestive Disease Center ( Site 5007)
Clive, Iowa, United States
University of Kansas Medical Center ( Site 5091)
Kansas City, Kansas, United States
Cotton O'Neil Digestive Health Center ( Site 5033)
Topeka, Kansas, United States
University of Louisville Hospital ( Site 5120)
Louisville, Kentucky, United States
Southern Clinical Research ( Site 5095)
Zachary, Louisiana, United States
Walter Reed National Military Medical Center ( Site 5006)
Bethesda, Maryland, United States
Massachusetts General Hospital-Crohn's and Colitis Center ( Site 5037)
Boston, Massachusetts, United States
University of Michigan ( Site 5060)
Ann Arbor, Michigan, United States
Clinical Research Institute of Michigan, LLC ( Site 5002)
Clinton Township, Michigan, United States
Mayo Clinic in Rochester, Minnesota ( Site 5024)
Rochester, Minnesota, United States
Mid-America GI Clinical Research ( Site 5130)
Kansas City, Missouri, United States
BVL Research - Kansas ( Site 5099)
Liberty, Missouri, United States
Washington University School of Medicine ( Site 5058)
St Louis, Missouri, United States
HMH Justice Marie Garibaldi Medical Plaza ( Site 5072)
Hackensack, New Jersey, United States
Northwell Health Physician Partners Center for Advanced IBD Care ( Site 5017)
Great Neck, New York, United States
Circuit Clinical /Crystal Run Healthcare LLP ( Site 5050)
Middletown, New York, United States
NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 5078)
New York, New York, United States
Weill Cornell Medical College, New-York Presbyterian Hospital ( Site 5079)
New York, New York, United States
New York Gastroenterology Associates ( Site 5013)
New York, New York, United States
Northwell Mather Hospital ( Site 5138)
Port Jefferson, New York, United States
University of North Carolina Medical Center ( Site 5034)
Chapel Hill, North Carolina, United States
Atrium Health Gastroenterology MMP ( Site 5105)
Charlotte, North Carolina, United States
Javara - Tryon Medical Partners ( Site 5046)
Charlotte, North Carolina, United States
Great Lakes Gastroenterology Research, LLC ( Site 5016)
Mentor, Ohio, United States
Digestive Disease Specialists Inc. ( Site 5117)
Oklahoma City, Oklahoma, United States
Penn State University Milton S. Hershey Medical Center ( Site 5102)
Hershey, Pennsylvania, United States
Thomas Jefferson University Hospital ( Site 5133)
Philadelphia, Pennsylvania, United States
Frontier Clinical Research, LLC ( Site 5098)
Uniontown, Pennsylvania, United States
University Gastroenterology - Providence - West River Street ( Site 5057)
Providence, Rhode Island, United States
Sanford USD Medical Center ( Site 5129)
Sioux Falls, South Dakota, United States
Vanderbilt Inflammatory Bowel Disease Clinic ( Site 5049)
Nashville, Tennessee, United States
Quality Medical Research ( Site 5114)
Nashville, Tennessee, United States
Baylor University Medical Center ( Site 5031)
Dallas, Texas, United States
GI Alliance - Dallas - Gaston Avenue ( Site 5054)
Dallas, Texas, United States
Epic Medical Research - Mesquite ( Site 5153)
Denton, Texas, United States
Baylor College of Medicine Medical Center ( Site 5020)
Houston, Texas, United States
Michael E. DeBakey VA Medical Center ( Site 5086)
Houston, Texas, United States
GI Alliance - Lubbock ( Site 5012)
Lubbock, Texas, United States
Caprock Gastro Research ( Site 5077)
Lubbock, Texas, United States
GI Alliance: Mansfield ( Site 5015)
Mansfield, Texas, United States
Southern Star Research Institute ( Site 5000)
San Antonio, Texas, United States
GI Alliance - Southlake ( Site 5109)
Southlake, Texas, United States
Tyler Research Institute ( Site 5001)
Tyler, Texas, United States
Richmond VA Medical Center ( Site 5021)
Richmond, Virginia, United States
Washington Gastroenterology - Bellevue ( Site 5040)
Bellevue, Washington, United States
Swedish Medical Center ( Site 5112)
Seattle, Washington, United States
University of Washington ( Site 5115)
Seattle, Washington, United States
Washington Gastroenterology - Tacoma ( Site 5004)
Tacoma, Washington, United States
Concord Repatriation General Hospital-Gastroenterology and Liver Services ( Site 3202)
Concord, New South Wales, Australia
Royal Brisbane and Women's Hospital ( Site 3200)
Brisbane, Queensland, Australia
Mater Misericordiae Limited ( Site 3209)
Brisbane, Queensland, Australia
Royal Adelaide Hosp - GI Clinical Trials ( Site 3203)
Adelaide, South Australia, Australia
Monash Health-Gastroenterology ( Site 3206)
Clayton, Victoria, Australia
The Alfred Hospital-Gastroenterology ( Site 3201)
Melbourne, Victoria, Australia
Medizinische Universität Wien-Klinik für Innere Medizin III - Abteilung für Gastroenterologie und H ( Site 0202)
Vienna, State of Vienna, Austria
Medizinische Universitaet Innsbruck-Innere Medizin 1 ( 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
AZ Delta vzw-Gastroenterology ( Site 0304)
Roeselare, West-Vlaanderen, Belgium
Hospital de Clinicas de Porto Alegre ( Site 6310)
Porto Alegre, Rio Grande do Sul, Brazil