Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2011 |
| End Date: | December 2014 |
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.
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.
Anti-IP10: Anti Interferon-inducible ligand 10
Inclusion Criteria:
- Adults subjects with confirmed Crohn's Disease (CD) for at least 3 months
- Moderate to severely active CD as defined by Crohn's Disease Activity Index (CDAI)
220 to 450
- In the past have had insufficient response and or intolerance to ≥ 1 of the
conventional therapy (immunosuppressants, corticosteroids and/or approved biologic
therapy)
Exclusion Criteria:
- Ulcerative colitis (UC) or indeterminate colitis
- Short bowel syndrome
- Known stricture or noninflammatory stenosis leading to symptoms of obstruction
- Current stoma or current need for colostomy or ileostomy
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