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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

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.

ArizonaGI Alliance - Sun City ( Site 5118), Sun City
University of Arizona Clinical and Translational Sciences Research Center ( Site 5111), Tucson
ArkansasUniversity of Arkansas for Medical Sciences ( Site 5147), Little Rock
CaliforniaClinnova 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
ColoradoUniversity 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
ConnecticutYale University School of Medicine-Digestive Disease ( Site 5019), New Haven
District of ColumbiaEmerson Clinical Research Institute ( Site 5051), Washington D.C.
FloridaCovenant 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
GeorgiaMorehouse School Of Medicine ( Site 5071), Atlanta
Gastroenterology Associates of Central Georgia ( Site 5048), Macon
IllinoisUniversity of Chicago Medical Center ( Site 5066), Chicago
Endeavor Health ( Site 5018), Evanston
GI ALLIANCE - GURNEE ( Site 5003), Gurnee
IndianaIndiana University Health University Hospital ( Site 5022), Indianapolis
IowaIowa Digestive Disease Center ( Site 5007), Clive
KansasUniversity of Kansas Medical Center ( Site 5091), Kansas City
Cotton O'Neil Digestive Health Center ( Site 5033), Topeka
KentuckyUniversity of Louisville Hospital ( Site 5120), Louisville
MarylandWalter Reed National Military Medical Center ( Site 5006), Bethesda
MassachusettsMassachusetts General Hospital-Crohn's and Colitis Center ( Site 5037), Boston
MichiganUniversity of Michigan ( Site 5060), Ann Arbor
Clinical Research Institute of Michigan, LLC ( Site 5002), Clinton Township
MinnesotaMayo Clinic in Rochester, Minnesota ( Site 5024), Rochester
MissouriMid-America GI Clinical Research ( Site 5130), Kansas City
BVL Research - Kansas ( Site 5099), Liberty
Washington University School of Medicine ( Site 5058), St Louis
New JerseyHMH Justice Marie Garibaldi Medical Plaza ( Site 5072), Hackensack
New YorkNorthwell 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 CarolinaUniversity of North Carolina Medical Center ( Site 5034), Chapel Hill
Atrium Health Gastroenterology MMP ( Site 5105), Charlotte
OhioGreat Lakes Gastroenterology Research, LLC ( Site 5016), Mentor
OklahomaDigestive Disease Specialists Inc. ( Site 5117), Oklahoma City
PennsylvaniaPenn 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 IslandUniversity Gastroenterology - Providence - West River Street ( Site 5057), Providence
South DakotaSanford USD Medical Center ( Site 5129), Sioux Falls
TennesseeQuality Medical Research ( Site 5114), Nashville
Vanderbilt Inflammatory Bowel Disease Clinic ( Site 5049), Nashville
TexasBaylor 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
VirginiaRichmond VA Medical Center ( Site 5021), Richmond
WashingtonUniversity 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.