Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis

• 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 in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical therapy for ulcerative colitis

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

Details

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

Criteria

Inclusion Criteria:

• Clinical diagnosis of moderate to severe UC confirmed by endoscopic and histologic evidence

• Mayo score ≥6 with an endoscopic subscore of ≥2

• Inadequate response and/or intolerance to one or more conventional therapy (i.e. oral aminosalicylates, immunosuppressants, corticosteroids, and/or TNF antagonist)

Exclusion Criteria:

• Diagnosis of Crohn's Disease or Indeterminate Colitis

• Diagnosis of UC that is limited to the rectum

• Evidence of fulminant colitis, toxic megacolon, or bowel perforation

• Current need for a colostomy or ileostomy

• Previous total or subtotal colectomy