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

Phase 2 Completed 305 enrolled Bristol-Myers Squibb

RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start: 2011-03
Primary completion: 2012-12
Completion: 2014-12

Outcome

Missed primary endpoint

paper The primary endpoint was not achieved with induction treatment with eldelumab 15 or 25 mg/kg in patients with UC. PMID 26721935 ↗

Publications

Sandborn WJ, Colombel JF, Ghosh S, Sands BE, Dryden G, Hebuterne X, Leong RW, Bressler B, Ullman T, Lakatos PL, Reinisch W, Xu LA, Luo A. Eldelumab [Anti-IP-10] Induction Therapy for Ulcerative Colitis: A Randomised, Placebo-Controlled, Phase 2b Study. J Crohns Colitis. 2016 Apr;10(4):418-28. doi: 10.1093/ecco-jcc/jjv224. Epub 2015 Dec 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eldelumab	Monoclonal antibody	5 mg/kg	Intravenous
Subject	Eldelumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Eldelumab	Monoclonal antibody	15 mg/kg	Intravenous
Subject	Eldelumab	Monoclonal antibody	20 mg/kg	Intravenous
Subject	Eldelumab	Monoclonal antibody	25 mg/kg	Intravenous