Tests tulisokibart in people with moderate to severe Crohn's disease
Tests tulisokibart against placebo in people with active Crohn's disease.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
Key facts
- Where
- Anaheim, Ann Arbor, Atlanta, Aurora, Bellevue, Bethesda, Boston, Chapel Hill, Charlotte, Chicago, Clearwater, Clinton Township, Clive, Colorado Springs, Coronado, Dallas, Decatur, Denton, Dothan, Englewood, Evanston, Fort Myers, Great Neck, Gurnee, Hackensack, Hamden, Hershey, Houston, Indianapolis, Inverness, Kansas City, Lakewood, Lancaster, Liberty, Little Rock, Los Angeles, Louisville, Lubbock, Macon, Mansfield, Margate, Mentor, Miami, Middletown, Nashville, New Haven, New York, Oklahoma City, Orange, Orlando, Oxnard, Philadelphia, Phoenix, Port Jefferson, Providence, Richmond, Rochester, San Antonio, San Diego, Seattle, Sioux Falls, Southlake, St Louis, Sun City, Tacoma, Tampa, Topeka, Tucson, Tyler, Uniontown, University Park, Valencia, Washington D.C., and Zachary, United StatesSee the 87 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 80 years old?
Source: NCT06430801, who can take part
Where in United States
- Clinnova Research (Site 5110)Anaheim, United StatesTaking people
- University of Michigan (Site 5060)Ann Arbor, United StatesTaking people
- Morehouse School Of Medicine (Site 5071)Atlanta, United StatesTaking people
- University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology (Site 5026)Aurora, United StatesTaking people
- Washington Gastroenterology - Bellevue (Site 5040)Bellevue, United StatesNo longer taking part
- Walter Reed National Military Medical Center (Site 5006)Bethesda, United StatesTaking people
- Massachusetts General Hospital-Crohn's and Colitis Center (Site 5037)Boston, United StatesTaking people
- University of North Carolina Medical Center (Site 5034)Chapel Hill, United StatesTaking people
- Atrium Health Gastroenterology MMP (Site 5105)Charlotte, United StatesTaking people
- Javara - Tryon Medical Partners (Site 5046)Charlotte, United StatesNo longer taking part
- University of Chicago Medical Center (Site 5066)Chicago, United StatesTaking people
- Eagle Clinical Research (Site 5089)Chicago, United StatesNo longer taking part
- Gastroenterology Consultants of Clearwater (Site 5052)Clearwater, United StatesNo longer taking part
- Clinical Research Institute of Michigan, LLC (Site 5002)Clinton Township, United StatesTaking people
- Iowa Digestive Disease Center (Site 5007)Clive, United StatesTaking people
- Peak Gastroenterology Associates (Site 5023)Colorado Springs, United StatesTaking people
- Southern California Research Center (Site 5044)Coronado, United StatesTaking people
- Baylor University Medical Center (Site 5031)Dallas, United StatesTaking people
- GI Alliance - Dallas - Gaston Avenue (Site 5054)Dallas, United StatesNo longer taking part
- Atlanta Center for Gastroenterology (Site 5035)Decatur, United StatesNo longer taking part
- Epic Medical Research - Mesquite (Site 5153)Denton, United StatesTaking people
- Digestive Health Specialists (Site 5064)Dothan, United StatesNo longer taking part
- South Denver Gastroenterology, PC (Site 5132)Englewood, United StatesTaking people
- Endeavor Health (Site 5018)Evanston, United StatesTaking people
- Covenant Metabolic Specialists, LLC (Site 5150)Fort Myers, United StatesTaking people
- Northwell Health Physician Partners Center for Advanced IBD Care (Site 5017)Great Neck, United StatesTaking people
- GI ALLIANCE - GURNEE (Site 5003)Gurnee, United StatesTaking people
- HMH Justice Marie Garibaldi Medical Plaza (Site 5072)Hackensack, United StatesTaking people
- Medical Research Center of Connecticut (Site 5005)Hamden, United StatesNo longer taking part
- Penn State University Milton S. Hershey Medical Center (Site 5102)Hershey, United StatesTaking people
- Baylor College of Medicine Medical Center (Site 5020)Houston, United StatesTaking people
- Michael E. DeBakey VA Medical Center (Site 5086)Houston, United StatesTaking people
- Indiana University Health University Hospital (Site 5022)Indianapolis, United StatesTaking people
- Nature Coast Clinical Research - Inverness (Site 5042)Inverness, United StatesTaking people
- Mid-America GI Clinical Research (Site 5130)Kansas City, United StatesTaking people
- University of Kansas Medical Center (Site 5091)Kansas City, United StatesTaking people
- Rocky Mountain Gastroenterology (Site 5082)Lakewood, United StatesTaking people
- Om Research LLC (Site 5038)Lancaster, United StatesTaking people
- BVL Research - Kansas (Site 5099)Liberty, United StatesTaking people
- University of Arkansas for Medical Sciences (Site 5147)Little Rock, United StatesTaking people
- Cedars Sinai Medical Center (Site 5080)Los Angeles, United StatesTaking people
- UCLA Clinical & Translational Research Center (CTRC) (Site 5116)Los Angeles, United StatesTaking people
- University of Louisville Hospital (Site 5120)Louisville, United StatesTaking people
- Caprock Gastro Research (Site 5077)Lubbock, United StatesTaking people
- GI Alliance - Lubbock (Site 5012)Lubbock, United StatesNo longer taking part
- Gastroenterology Associates of Central Georgia (Site 5048)Macon, United StatesTaking people
- GI Alliance: Mansfield (Site 5015)Mansfield, United StatesNo longer taking part
- Atlantic Medical Research (Site 5073)Margate, United StatesNo longer taking part
- Great Lakes Gastroenterology Research, LLC (Site 5016)Mentor, United StatesTaking people
- Sanchez Clinical Research (Site 5144)Miami, United StatesTaking people
- Circuit Clinical /Crystal Run Healthcare LLP (Site 5050)Middletown, United StatesNo longer taking part
- Quality Medical Research (Site 5114)Nashville, United StatesTaking people
- Vanderbilt Inflammatory Bowel Disease Clinic (Site 5049)Nashville, United StatesTaking people
- Yale University School of Medicine-Digestive Disease (Site 5019)New Haven, United StatesTaking people
- New York Gastroenterology Associates (Site 5013)New York, United StatesTaking people
- NYU Langone Health - Inflammatory Bowel Disease Center (IBD) (Site 5078)New York, United StatesTaking people
- Weill Cornell Medical College, New-York Presbyterian Hospital (Site 5079)New York, United StatesTaking people
- Digestive Disease Specialists Inc. (Site 5117)Oklahoma City, United StatesTaking people
- University of California, Irvine (UCI) Health - UC Irvine Medical Center (Site 5128)Orange, United StatesTaking people
- AdventHealth Orlando (Site 5131)Orlando, United StatesTaking people
- Endoscopic Research Inc (Site 5061)Orlando, United StatesTaking people
- Orlando Health-Digestive Health Institute (Site 5010)Orlando, United StatesNo longer taking part
- Om Research LLC (Site 5045)Oxnard, United StatesTaking people
- Thomas Jefferson University Hospital (Site 5133)Philadelphia, United StatesTaking people
- Arizona Arthritis & Rheumatology Research, PC (Site 5094)Phoenix, United StatesNo longer taking part
- Northwell Mather Hospital (Site 5138)Port Jefferson, United StatesTaking people
- University Gastroenterology - Providence - West River Street (Site 5057)Providence, United StatesTaking people
- Richmond VA Medical Center (Site 5021)Richmond, United StatesTaking people
- Mayo Clinic in Rochester, Minnesota (Site 5024)Rochester, United StatesTaking people
- Southern Star Research Institute (Site 5000)San Antonio, United StatesTaking people
- Clinical Applications Laboratories (Site 5123)San Diego, United StatesTaking people
- University of Washington (Site 5115)Seattle, United StatesTaking people
- Swedish Medical Center (Site 5112)Seattle, United StatesNo longer taking part
- Sanford USD Medical Center (Site 5129)Sioux Falls, United StatesTaking people
- GI Alliance - Southlake (Site 5109)Southlake, United StatesTaking people
- Washington University School of Medicine (Site 5058)St Louis, United StatesTaking people
- GI Alliance - Sun City (Site 5118)Sun City, United StatesTaking people
- Washington Gastroenterology - Tacoma (Site 5004)Tacoma, United StatesTaking people
- USF Health Carol and Frank Morsani Center for Advanced Healthcare (Site 5039)Tampa, United StatesTaking people
- Cotton O'Neil Digestive Health Center (Site 5033)Topeka, United StatesTaking people
- University of Arizona Clinical and Translational Sciences Research Center (Site 5111)Tucson, United StatesTaking people
- Tyler Research Institute (Site 5001)Tyler, United StatesTaking people
- Frontier Clinical Research, LLC (Site 5098)Uniontown, United StatesTaking people
- Covenant Metabolic Specialists, LLC (Site 5143)University Park, United StatesTaking people
- Amicis Research Center (Site 5055)Valencia, United StatesNo longer taking part
- Emerson Clinical Research Institute (Site 5051)Washington D.C., United StatesTaking people
- Southern Clinical Research (Site 5095)Zachary, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT06430801EU 2023-508636-61-00
- Record updated
- 10 November 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: Has had a diagnosis of Crohn's disease (CD) at least 3 months before study; Has moderately to severely active CD; Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies; Adolescent participants ≥16 and <18 years of age can participate if approved by the country or regulatory/health authority.
Exclusion: Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study; Has surgical bowel resection within 3 months of study; Has prior or current gastrointestinal dysplasia; Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab); Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD; Has chronic infection requiring ongoing antimicrobial treatment; Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV); Has active tuberculosis; Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection; Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years; Has diagnosis of ulcerative colitis (UC) or indeterminate colitis; Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement; Has current stoma or need for colostomy or ileostomy; Is missing >2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
The main inclusion and exclusion criteria include but are not limited to the following:.