drugset / Trial / NCT01466374
Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to determine whether BMS-936557 is effective for the treatment of moderate to severely active Crohn's Disease in patients who have had insufficient response and/or intolerance to conventional therapy for Crohn's Disease.
Timeline
- Start
- 2011-12
- Primary completion
- 2014-06
- Completion
- 2014-12
Outcome
Missed primary endpoint
paper The eldelumab exposure-remission relationship was not significant at Week 11. PMID 28333187 ↗
Publications
- Sandborn WJ, Rutgeerts P, Colombel JF, Ghosh S, Petryka R, Sands BE, Mitra P, Luo A. Eldelumab [anti-interferon-gamma-inducible protein-10 antibody] Induction Therapy for Active Crohn's Disease: a Randomised, Double-blind, Placebo-controlled Phase IIa Study. J Crohns Colitis. 2017 Jul 1;11(7):811-819. doi: 10.1093/ecco-jcc/jjx005.
- Khanna R, Zou G, D'Haens G, Rutgeerts P, McDonald JW, Daperno M, Feagan BG, Sandborn WJ, Dubcenco E, Stitt L, Vandervoort MK, Donner A, Luo A, Levesque BG. Reliability among central readers in the evaluation of endoscopic findings from patients with Crohn's disease. Gut. 2016 Jul;65(7):1119-25. doi: 10.1136/gutjnl-2014-308973. Epub 2015 May 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eldelumab | Monoclonal antibody | 7.5 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 |