drugset / Trial / NCT03934216

Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis

NCT03934216 ↗

Phase 2 Completed 131 enrolled Bristol-Myers Squibb
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the safety and efficacy of oral deucravacitinib in participants with moderate to severe ulcerative colitis (UC).

Timeline

Start
2019-07-01
Primary completion
2021-06-13
Completion
2023-04-04

Outcome

Missed primary endpoint

registry analysis (superiority test); Treatment vs Placebo; p = 0.5935; Odds Ratio (OR) 0.9 (95% CI 0.3 to 2.4); Stratified Cochran-Mantel-Haenszel NCT03934216 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject CRAVACITINIB Small molecule — Oral

Indications