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A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Crohn's Disease
The purpose of this study is to determine whether BMS-936557 is effective for the treatment of moderate to severely active Crohn's Disease in patients who have had insufficient response and/or intolerance to conventional therapy for Crohn's Disease.
Details
| Lead sponsor | Bristol-Myers Squibb |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 121 |
| Start date | 2011-12 |
| Completion | 2014-12 |
Conditions
- Crohn's Disease
Interventions
- Placebo
- Placebo
- BMS-936557 (Anti-IP-10 Antibody)
- BMS-936557 (Anti-IP-10 Antibody)
- BMS-936557 (Anti-IP-10 Antibody)
- BMS-936557 (Anti-IP-10 Antibody)
- BMS-936557 (Anti-IP-10 Antibody)
Primary outcomes
- Clinical remission (CDAI score of <150) — Week 11
CDAI: Crohn's Disease Activity Index
Countries
United States, Belgium, France, Hungary, Israel, Poland, Puerto Rico, South Africa