A Phase 2 Study to Evaluate the Safety and Efficacy of Intravenously Administered Benralizumab (MEDI-563).

Phase 2 Completed 110 enrolled MedImmune LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The study will evaluate the effect of two intravenous dose regimens of benralizumab (MEDI-563) on the proportion of adult subjects with asthma exacerbations who required an urgent healthcare visit for treatment of an acute asthma exacerbation.

Timeline

Start: 2009-02-02
Primary completion: 2010-12-17
Completion: 2011-03-10

Outcome

Missed primary endpoint

paper The proportion of subjects with greater than or equal to 1 asthma exacerbation at 12 weeks was not different between placebo and the combined benralizumab groups (38.9% vs 33.3%; P = .67). PMID 25445859 ↗

registry analysis (unspecified test); Placebo vs Benralizumab 0.3 mg/kg; p = 0.312; Fisher Exact NCT00768079 ↗

registry analysis (unspecified test); Placebo vs Benralizumab 1.0 mg/kg; p = 1.000; Fisher Exact NCT00768079 ↗

Publications

Nowak RM, Parker JM, Silverman RA, Rowe BH, Smithline H, Khan F, Fiening JP, Kim K, Molfino NA. A randomized trial of benralizumab, an antiinterleukin 5 receptor alpha monoclonal antibody, after acute asthma. Am J Emerg Med. 2015 Jan;33(1):14-20. doi: 10.1016/j.ajem.2014.09.036. Epub 2014 Oct 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Benralizumab	Monoclonal antibody	0.3 mg/kg	Intravenous
Subject	Benralizumab	Monoclonal antibody	1 mg/kg	Intravenous