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

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).

Conditions

Crohn's Disease

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Crohn's Disease
Intervention / Treatment

-

Contacts and Locations

Dothan

Digestive Health Specialists ( Site 5064), Dothan, Alabama, United States, 36301

Camarillo

Om Research LLC ( Site 5045), Camarillo, California, United States, 93012

Coronado

Southern California Research Center ( Site 5044), Coronado, California, United States, 92118

Lancaster

Om Research LLC ( Site 5038), Lancaster, California, United States, 93534

Orange

Clinnova Research - Orange ( Site 5110), Orange, California, United States, 92868

Valencia

Amicis Research Center - Valencia ( Site 5055), Valencia, California, United States, 91355

Aurora

University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 50, Aurora, Colorado, United States, 80045

Colorado Springs

Peak Gastroenterology Associates ( Site 5023), Colorado Springs, Colorado, United States, 80907

Hamden

Medical Research Center of Connecticut ( Site 5005), Hamden, Connecticut, United States, 06518

Washington

Emerson Clinical Research Institute ( Site 5051), Washington, District of Columbia, United States, 20009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

16 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2029-11-12