NCT01294410

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 305 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	Placebo	Normal Saline, Intravenous, 0mg, Once a week for the first two weeks and every other week thereafter, 7 Weeks
DRUG	Placebo	Normal Saline, Intravenous, 0 mg, Every other week, Up to 757 days
DRUG	Anti-IP-10 Antibody	Solution for IV administration, Intravenous, 15 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
DRUG	Anti-IP-10 Antibody	Solution for IV administration, Intravenous, 25 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
DRUG	Anti-IP-10 Antibody	Solution for IV administration, Intravenous, 5 mg/kg, Every other week, Up to 757 days
DRUG	Anti-IP-10 Antibody	Intravenous, Solution for IV administration, 10 mg/kg, Every other week, Up to 757 days
DRUG	Anti-IP-10 Antibody	Intravenous, Solution for IV administration, 20 mg/kg, Every other week, Up to 757 days
DRUG	Anti-IP-10 Antibody	Intravenous, Solution for IV administration, 15 mg/kg or optimal dose, Every other week. Open

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-12-01
• Completion: 2014-12-01
• First posted: 2011-02-11
• Last updated: 2015-06-25

Locations

75 sites across 14 countries: United States, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Hungary, Italy, Mexico, Netherlands, Poland, South Africa