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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)
RecruitingPhase 3
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
Who can join
Ages 16 to 80 · All sexes
Full eligibility criteria
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* 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 Criteria:
* 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.
* 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 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.
* Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD.
* Has surgical bowel resection within 3 months of study.
* Has prior or current gastrointestinal dysplasia.
* Has chronic infection requiring ongoing antimicrobial treatment.
* 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.
* 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.
* Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).
About the study
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).
What is being tested
- IV Tulisokibart (drug)
- SC Tulisokibart (drug)
- IV Placebo (other)
- SC Placebo (other)
Sponsor: Merck Sharp & Dohme LLC · Participants: 1,200 · Started: Jun 5, 2024
Contact the study team
Official record on ClinicalTrials.gov — NCT06430801
Locations in the U.S.
| Arizona | GI Alliance - Sun City ( Site 5118), Sun City University of Arizona Clinical and Translational Sciences Research Center ( Site 5111), Tucson |
| Arkansas | University of Arkansas for Medical Sciences ( Site 5147), Little Rock |
| California | Clinnova Research ( Site 5110), Anaheim Southern California Research Center ( Site 5044), Coronado Om Research LLC ( Site 5038), Lancaster Cedars Sinai Medical Center ( Site 5080), Los Angeles UCLA Clinical & Translational Research Center (CTRC) ( Site 5116), Los Angeles University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 5128), Orange Om Research LLC ( Site 5045), Oxnard Clinical Applications Laboratories ( Site 5123), San Diego |
| Colorado | University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 5026), Aurora Peak Gastroenterology Associates ( Site 5023), Colorado Springs South Denver Gastroenterology, PC ( Site 5132), Englewood Rocky Mountain Gastroenterology ( Site 5082), Lakewood |
| Connecticut | Yale University School of Medicine-Digestive Disease ( Site 5019), New Haven |
| District of Columbia | Emerson Clinical Research Institute ( Site 5051), Washington D.C. |
| Florida | Covenant Metabolic Specialists, LLC ( Site 5150), Fort Myers Nature Coast Clinical Research - Inverness ( Site 5042), Inverness Sanchez Clinical Research ( Site 5144), Miami AdventHealth Orlando ( Site 5131), Orlando Endoscopic Research Inc ( Site 5061), Orlando USF Health Carol and Frank Morsani Center for Advanced Healthcare ( Site 5039), Tampa Covenant Metabolic Specialists, LLC ( Site 5143), University Park |
| Georgia | Morehouse School Of Medicine ( Site 5071), Atlanta Gastroenterology Associates of Central Georgia ( Site 5048), Macon |
| Illinois | University of Chicago Medical Center ( Site 5066), Chicago Endeavor Health ( Site 5018), Evanston GI ALLIANCE - GURNEE ( Site 5003), Gurnee |
| Indiana | Indiana University Health University Hospital ( Site 5022), Indianapolis |
| Iowa | Iowa Digestive Disease Center ( Site 5007), Clive |
| Kansas | University of Kansas Medical Center ( Site 5091), Kansas City Cotton O'Neil Digestive Health Center ( Site 5033), Topeka |
| Kentucky | University of Louisville Hospital ( Site 5120), Louisville |
| Maryland | Walter Reed National Military Medical Center ( Site 5006), Bethesda |
| Massachusetts | Massachusetts General Hospital-Crohn's and Colitis Center ( Site 5037), Boston |
| Michigan | University of Michigan ( Site 5060), Ann Arbor Clinical Research Institute of Michigan, LLC ( Site 5002), Clinton Township |
| Minnesota | Mayo Clinic in Rochester, Minnesota ( Site 5024), Rochester |
| Missouri | Mid-America GI Clinical Research ( Site 5130), Kansas City BVL Research - Kansas ( Site 5099), Liberty Washington University School of Medicine ( Site 5058), St Louis |
| New Jersey | HMH Justice Marie Garibaldi Medical Plaza ( Site 5072), Hackensack |
| New York | Northwell Health Physician Partners Center for Advanced IBD Care ( Site 5017), Great Neck NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 5078), New York New York Gastroenterology Associates ( Site 5013), New York Weill Cornell Medical College, New-York Presbyterian Hospital ( Site 5079), New York Northwell Mather Hospital ( Site 5138), Port Jefferson |
| North Carolina | University of North Carolina Medical Center ( Site 5034), Chapel Hill Atrium Health Gastroenterology MMP ( Site 5105), Charlotte |
| Ohio | Great Lakes Gastroenterology Research, LLC ( Site 5016), Mentor |
| Oklahoma | Digestive Disease Specialists Inc. ( Site 5117), Oklahoma City |
| Pennsylvania | Penn State University Milton S. Hershey Medical Center ( Site 5102), Hershey Thomas Jefferson University Hospital ( Site 5133), Philadelphia Frontier Clinical Research, LLC ( Site 5098), Uniontown |
| Rhode Island | University Gastroenterology - Providence - West River Street ( Site 5057), Providence |
| South Dakota | Sanford USD Medical Center ( Site 5129), Sioux Falls |
| Tennessee | Quality Medical Research ( Site 5114), Nashville Vanderbilt Inflammatory Bowel Disease Clinic ( Site 5049), Nashville |
| Texas | Baylor University Medical Center ( Site 5031), Dallas Epic Medical Research - Mesquite ( Site 5153), Denton Baylor College of Medicine Medical Center ( Site 5020), Houston Michael E. DeBakey VA Medical Center ( Site 5086), Houston Caprock Gastro Research ( Site 5077), Lubbock GI Alliance: Mansfield ( Site 5015), Mansfield Southern Star Research Institute ( Site 5000), San Antonio GI Alliance - Southlake ( Site 5109), Southlake Tyler Research Institute ( Site 5001), Tyler |
| Virginia | Richmond VA Medical Center ( Site 5021), Richmond |
| Washington | University of Washington ( Site 5115), Seattle Washington Gastroenterology - Tacoma ( Site 5004), Tacoma |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.