Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins

Criteria

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