drugset / Trial / NCT03599622

An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease

NCT03599622 ↗

Phase 2 Terminated 239 enrolled Bristol-Myers Squibb
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the safety and effectiveness of BMS-986165 compared to placebo in participants with moderately to severely active Crohn's Disease.

Timeline

Start
2018-07-16
Primary completion
2022-12-12
Completion
2023-10-23

Outcome

Mixed primary results

Stopped: “Trial terminated because of lack of efficacy in the short term acute phase”

registry Placebo vs 3 mg BMS-986165; p = 0.5812; Risk Difference (RD) 4.3 (95% CI -11.0 to 19.5) NCT03599622 ↗

registry Placebo vs 3 mg BMS-986165; p = 0.0198; Risk Difference (RD) 15.0 (95% CI 3.7 to 26.3) NCT03599622 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject CRAVACITINIB Small molecule — —

Indications