NCT06430801From ClinicalTrials.govRecruiting

A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)

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

Crohn's Disease

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Merck Sharp & Dohme LLC
Enrolment target: 1,200
Started: 5 June 2024
Main results due: 30 October 2028
Study sites: 499
Registry updated: 29 September 2026

Can you take part?

Ages 16 years to 80 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the 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).

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(499)

Digestive Health Specialists ( Site 5064)
Dothan, Alabama, United States
Completed
Arizona Arthritis & Rheumatology Research, PC ( Site 5094)
Phoenix, Arizona, United States
Completed
GI Alliance - Sun City ( Site 5118)
Sun City, Arizona, United States
Recruiting
University of Arizona Clinical and Translational Sciences Research Center ( Site 5111)
Tucson, Arizona, United States
Recruiting
University of Arkansas for Medical Sciences ( Site 5147)
Little Rock, Arkansas, United States
Recruiting
Clinnova Research ( Site 5110)
Anaheim, California, United States
Recruiting
Southern California Research Center ( Site 5044)
Coronado, California, United States
Recruiting
Om Research LLC ( Site 5038)
Lancaster, California, United States
Recruiting
Cedars Sinai Medical Center ( Site 5080)
Los Angeles, California, United States
Recruiting
UCLA Clinical & Translational Research Center (CTRC) ( Site 5116)
Los Angeles, California, United States
Recruiting
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 5128)
Orange, California, United States
Recruiting
Om Research LLC ( Site 5045)
Oxnard, California, United States
Recruiting
Clinical Applications Laboratories ( Site 5123)
San Diego, California, United States
Recruiting
Amicis Research Center ( Site 5055)
Valencia, California, United States
Active, not recruiting
University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 5026)
Aurora, Colorado, United States
Recruiting
Peak Gastroenterology Associates ( Site 5023)
Colorado Springs, Colorado, United States
Recruiting
South Denver Gastroenterology, PC ( Site 5132)
Englewood, Colorado, United States
Recruiting
Rocky Mountain Gastroenterology ( Site 5082)
Lakewood, Colorado, United States
Recruiting
Medical Research Center of Connecticut ( Site 5005)
Hamden, Connecticut, United States
Completed
Yale University School of Medicine-Digestive Disease ( Site 5019)
New Haven, Connecticut, United States
Recruiting
Emerson Clinical Research Institute ( Site 5051)
Washington D.C., District of Columbia, United States
Recruiting
Gastroenterology Consultants of Clearwater ( Site 5052)
Clearwater, Florida, United States
Active, not recruiting
Covenant Metabolic Specialists, LLC ( Site 5150)
Fort Myers, Florida, United States
Recruiting
Nature Coast Clinical Research - Inverness ( Site 5042)
Inverness, Florida, United States
Recruiting
Atlantic Medical Research ( Site 5073)
Margate, Florida, United States
Active, not recruiting
Sanchez Clinical Research ( Site 5144)
Miami, Florida, United States
Recruiting
AdventHealth Orlando ( Site 5131)
Orlando, Florida, United States
Recruiting
Endoscopic Research Inc ( Site 5061)
Orlando, Florida, United States
Recruiting
Orlando Health-Digestive Health Institute ( Site 5010)
Orlando, Florida, United States
Completed
USF Health Carol and Frank Morsani Center for Advanced Healthcare ( Site 5039)
Tampa, Florida, United States
Recruiting
Covenant Metabolic Specialists, LLC ( Site 5143)
University Park, Florida, United States
Recruiting
Morehouse School Of Medicine ( Site 5071)
Atlanta, Georgia, United States
Recruiting
Atlanta Center for Gastroenterology ( Site 5035)
Decatur, Georgia, United States
Completed
Gastroenterology Associates of Central Georgia ( Site 5048)
Macon, Georgia, United States
Recruiting
Eagle Clinical Research ( Site 5089)
Chicago, Illinois, United States
Completed
University of Chicago Medical Center ( Site 5066)
Chicago, Illinois, United States
Recruiting
Endeavor Health ( Site 5018)
Evanston, Illinois, United States
Recruiting
GI ALLIANCE - GURNEE ( Site 5003)
Gurnee, Illinois, United States
Recruiting
Indiana University Health University Hospital ( Site 5022)
Indianapolis, Indiana, United States
Recruiting
Iowa Digestive Disease Center ( Site 5007)
Clive, Iowa, United States
Recruiting
University of Kansas Medical Center ( Site 5091)
Kansas City, Kansas, United States
Recruiting
Cotton O'Neil Digestive Health Center ( Site 5033)
Topeka, Kansas, United States
Recruiting
University of Louisville Hospital ( Site 5120)
Louisville, Kentucky, United States
Recruiting
Southern Clinical Research ( Site 5095)
Zachary, Louisiana, United States
Completed
Walter Reed National Military Medical Center ( Site 5006)
Bethesda, Maryland, United States
Recruiting
Massachusetts General Hospital-Crohn's and Colitis Center ( Site 5037)
Boston, Massachusetts, United States
Recruiting
University of Michigan ( Site 5060)
Ann Arbor, Michigan, United States
Recruiting
Clinical Research Institute of Michigan, LLC ( Site 5002)
Clinton Township, Michigan, United States
Recruiting
Mayo Clinic in Rochester, Minnesota ( Site 5024)
Rochester, Minnesota, United States
Recruiting
Mid-America GI Clinical Research ( Site 5130)
Kansas City, Missouri, United States
Recruiting
BVL Research - Kansas ( Site 5099)
Liberty, Missouri, United States
Recruiting
Washington University School of Medicine ( Site 5058)
St Louis, Missouri, United States
Recruiting
HMH Justice Marie Garibaldi Medical Plaza ( Site 5072)
Hackensack, New Jersey, United States
Recruiting
Northwell Health Physician Partners Center for Advanced IBD Care ( Site 5017)
Great Neck, New York, United States
Recruiting
Circuit Clinical /Crystal Run Healthcare LLP ( Site 5050)
Middletown, New York, United States
Completed
NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 5078)
New York, New York, United States
Recruiting
Weill Cornell Medical College, New-York Presbyterian Hospital ( Site 5079)
New York, New York, United States
Recruiting
New York Gastroenterology Associates ( Site 5013)
New York, New York, United States
Recruiting
Northwell Mather Hospital ( Site 5138)
Port Jefferson, New York, United States
Recruiting
University of North Carolina Medical Center ( Site 5034)
Chapel Hill, North Carolina, United States
Recruiting

Showing 60 of 499 sites — filter to narrow it down. 450 of the 499 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06430801. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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