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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)

clinicaltrials@northshore.org

ALL
16 years to 80 years old
PHASE3
This study is NOT accepting healthy volunteers
NCT06430801
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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.
DRUG: IV Tulisokibart, DRUG: SC Tulisokibart, OTHER: IV Placebo, OTHER: SC Placebo
Crohn's Disease
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