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Study to evaluate the efficacy and safety of Tulisokibart (MK-7240) in participants with moderate to severe Crohn's disease (MK-7240-008)-06430801

Study ID: 06430801

A phase 3, randomized, double-blind, placebo-controlled program to evaluate the efficacy and safety of Tulisokibart in participants with moderate to severe active Crohn's disease.

About the study:

 

The main inclusion and exclusion criteria include, but are not limited to, the following: Inclusion criteria: * Diagnosed with Crohn's disease (CD) at least 3 months prior to the study. * Moderate to severe active CD. * Demonstrated inadequate response, loss of response, or intolerance to one or more of the following drug categories: locally acting oral steroids, systemic steroids, immunomodulators, biologics, and/or advanced small-molecule therapies. * Adolescent participants ≥16 and <18 years of age may participate if approved by the country or health/regulatory authority. Exclusion criteria: * Diagnosed with ulcerative colitis (UC) or indeterminate colitis. * Isolated CD in the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement. * Currently has any of the following Crohn's disease complications: suspected or diagnosed intra-abdominal or perianal abscess, known symptomatic stricture or non-trantable colonic stricture on endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that may require surgery while enrolled in the study. * Has a current stoma or need for a 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 bowel syndrome or any other uncontrolled chronic diarrhea in addition to Crohn's disease. * Has had surgical bowel resection within 3 months of the study. * Has previous or current gastrointestinal dysplasia. * Has a chronic infection requiring continuous antimicrobial treatment. * Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical excision) and has been disease-free for <5 years. * You are infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV). * You have active tuberculosis. * You have confirmed or suspected coronavirus disease 2019 (COVID-19) infection. * You have had previous exposure to tulisokibart (MK-7240, PRA023) or another anti-TL1A antibody.

Total length

Target audiences

Ages: 6 Years - 80 years
Sex: All

Location

Merck Sharp & Dohme LLC

Associated diseases

  • Adults
  • Active Crohn's disease

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