A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis
About the study
The purpose of this study is to assess the safety and tolerability, efficacy, and biomarker response of BMS-986165 administered orally in participants with moderate to severe ulcerative colitis. The study was originally designed to test deucravacitinib at two doses for 12 weeks compared to placebo. After the initial 12-Week period, all subjects receive active therapy (open-label extension). With protocol amendment 2, one of the dose treatment arms is being removed from the 12-week double blind period with no change to the open-label extension.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Confirmed diagnosis of ulcerative colitis (UC) at least 3 months' duration prior to screening
- Moderately to severely active UC as assessed by the modified Mayo score
- Documentation of an inadequate response, loss of response, or intolerance to a treatment course of 1 or more of the following standard of care medications: oral 5-aminosalicylic acids, corticosteroids, immunomodulators, anti-tumor necrosis factor (TNF) agents, integrin inhibitors[SA1]
- Documentation of prior treatment with corticosteroids for ≥ 4 weeks
- Males and females must agree to follow specific methods of contraception, if applicable
EXCLUSION CRITERIA
Exclusion Criteria:
- Current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC), ischemic colitis, or pseudomembranous colitis
- Current evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation
- History or evidence of any extensive colonic resection, or subtotal or total colectomy
- Women who are pregnant or breastfeeding
- Prior exposure to BMS-986165 or a tyrosine kinase 2 (TYK2) inhibitor
Other protocol-defined inclusion/exclusion criteria apply.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Colitis, Ulcerative
Age (in years)
18 - 65
Phase
Phase 2
Participants needed
38
Est. Completion Date
Mar 27, 2024
Treatment type
Interventional
Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov identifier
NCT04613518
Study number
IM011127
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