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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

The main inclusion and exclusion criteria include but are not limited to the following: Who May Qualify: - Has had a diagnosis of 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. Who Should NOT Join This Trial: - 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 Crohn's disease. - 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 weakened immune system virus (HIV). - Has active tuberculosis. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Has had a diagnosis of 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 Crohn's disease. * 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-TL1A antibody.

Treatments Being Tested

DRUG

IV Tulisokibart

Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously

DRUG

SC Tulisokibart

Humanized monoclonal antibody that binds human TL1A, administered subcutaneously

OTHER

IV Placebo

Placebo matching IV tulisokibart

OTHER

SC Placebo

Placebo matching SC tulisokibart

Locations (20)

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