A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Ulcerative Colitis (UC)

NCT01294410 Phase 2 COMPLETED

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

Details

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 2
Status	COMPLETED
Enrolment	305
Start date	2011-03
Completion	2014-12

Conditions

• Colitis, Ulcerative

Interventions

• Placebo
• Placebo
• Anti-IP-10 Antibody
• Anti-IP-10 Antibody
• Anti-IP-10 Antibody
• Anti-IP-10 Antibody
• Anti-IP-10 Antibody
• Anti-IP-10 Antibody

Primary outcomes

• Proportion of the subjects with clinical remission (defined as Mayo score ≤ 2 points with no individual subscore > 1 point) of BMS-936557 with that of the placebo — End of Induction [Week 11, Induction Period-78 (IP-78)]

Countries

United States, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Hungary, Italy, Mexico, Netherlands, Poland, South Africa