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Clinical Trial Details

Title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease
Study Description

The purpose of this research study is to see how well BMS-986165 (the study drug) works and how safe it is in patients with moderate to severe Crohn’s Disease (CD). The duration of study participation is approximately 112 weeks (785 days) in 5 periods, as follows:

1. Screening Period: up to 4 weeks (28 days)
2. Induction Period: 12 weeks (84 days)
3. Maintenance Period: 40 weeks (280 days)
4. Open-label Extension Period: 52 weeks (364 days)
5. Post Treatment Follow-up Period: 4 weeks (28 days) In this study, you will be assigned to a group to receive either BMS-986165 (study drug) or placebo (no drug). The chances of you receiving BMS-986165 are 3 in 4 (75%).

Approximately 240 participants (men and women ages 18 to 75 years) will participate in this research study.

Open Enrollment
Contact Name: Katrina Maloney
Contact Phone: (904) 633-0177
Contact Email: katrina.maloney@jax.ufl.edu
Investigators

Principal Investigator
Maged P. Ghali, M.D.
Medicine

Sub Investigator
Ron Schey, M.D.
Medicine