drugset / Trial / NCT03599622
An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CRAVACITINIB | Small molecule | — | — |