A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Crohn's Disease

  • STATUS
    Recruiting
  • End date
    Sep 25, 2024
  • participants needed
    240
  • sponsor
    Bristol-Myers Squibb
Updated on 24 October 2022
crohn's disease
enteropathy

Summary

The purpose of this study is to assess the safety and effectiveness of BMS-986165 compared to placebo in participants with moderately to severely active Crohn's Disease.

Details
Condition Granulomatous Colitis, Crohn's Disease, Crohn's Enteritis, Granulomatous Enteritis
Treatment Placebo, BMS-986165
Clinical Study IdentifierNCT03599622
SponsorBristol-Myers Squibb
Last Modified on24 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Documented diagnosis of Crohn's Disease (CD) of at least 3 months' duration, including ileal, colonic, or ileo-colonic disease distribution
Must have active moderate to severe CD
Men and women must agree to follow specific methods of contraception, if applicable

Exclusion Criteria

Severe or fulminant colitis that is likely to require surgery or hospitalization
Presence of a diagnosis of alternative forms of colitis (infectious, inflammatory including ulcerative colitis, malignant, toxic, indeterminate, etc.) other than Crohn's Disease
Previous exposure to BMS-986165 in any study
Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic, psychiatric, or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the participant
Other protocol-defined inclusion/exclusion criteria apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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