A Study of MDX-1100 in Subjects With Active Ulcerative Colitis

Phase 2 Completed 110 enrolled Bristol-Myers Squibb

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to determine the safety and tolerability of the MDX-1100 regimen in subjects with active Ulcerative colitis(UC) and determine the response rate at day 57 in patients administered MDX-1100.

Timeline

Start: 2008-04
Primary completion: 2009-09
Completion: 2009-09

Outcome

Missed primary endpoint

paper Prespecified primary and secondary endpoints were not met; clinical response rate at Day 57 was 52.7% versus 35.2% for BMS-936557 versus placebo (p=0.083), PMID 23461895 ↗

Publications

Mayer L, Sandborn WJ, Stepanov Y, Geboes K, Hardi R, Yellin M, Tao X, Xu LA, Salter-Cid L, Gujrathi S, Aranda R, Luo AY. Anti-IP-10 antibody (BMS-936557) for ulcerative colitis: a phase II randomised study. Gut. 2014 Mar;63(3):442-50. doi: 10.1136/gutjnl-2012-303424. Epub 2013 Mar 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eldelumab	Monoclonal antibody	10 mg/kg	Intravenous