NCT04613518

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	BMS-986165	Specified Dose on Specified Days
OTHER	Placebo Comparator	Specified Dose on Specified Days

Timeline

• Start date: 2021-03-15
• Primary completion: 2023-05-31
• Completion: 2023-11-29
• First posted: 2020-11-03
• Last updated: 2024-07-12
• Results posted: 2024-07-12

Locations

26 sites across 8 countries: United States, Australia, Canada, Germany, Netherlands, Poland, Puerto Rico, United Kingdom

Regulatory

• FDA-regulated drug study