At a glance
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A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis
In Brief
A Phase 2 clinical trial evaluating BMS-986165 and Placebo Comparator for Colitis, Ulcerative. Completed, enrolled 38 participants across 26 sites in 8 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Specified Dose on Specified Days
Specified Dose on Specified Days