drugset / Trial / NCT04613518

A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis

NCT04613518

Phase 2 Completed 38 enrolled Bristol-Myers Squibb
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2021-03-15
Primary completion
2023-05-31
Completion
2023-11-29

Drugs

EvaluationDrugModalityDoseRoute
Subject CRAVACITINIB Small molecule Oral

Indications