Study to Evaluate the Efficacy and Safety of Reslizumab Treatment in Patients With Moderate to Severe Asthma

Phase 3 Completed 511 enrolled Teva Branded Pharmaceutical Products R&D, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the study is to characterize the efficacy of reslizumab treatment, at a dosage of 3.0 milligrams per kilogram (mg/kg) every 4 weeks for a total of 4 doses, in improving pulmonary function in relation to baseline blood eosinophil levels in patients with moderate to severe asthma, as assessed by the change from baseline to week 16 in forced expiratory volume in 1 second (FEV1).

Timeline

Start: 2012-02
Primary completion: 2013-08
Completion: 2013-08

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Placebo vs Reslizumab 3.0 mg/kg; p = 0.2407; slope difference 0.3007 NCT01508936 ↗

paper In the overall population, mean FEV1 change from baseline to week 16 was not significantly different between reslizumab and placebo PMID 27018175 ↗

Publications

Corren J, Weinstein S, Janka L, Zangrilli J, Garin M. Phase 3 Study of Reslizumab in Patients With Poorly Controlled Asthma: Effects Across a Broad Range of Eosinophil Counts. Chest. 2016 Oct;150(4):799-810. doi: 10.1016/j.chest.2016.03.018. Epub 2016 Mar 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Reslizumab	Monoclonal antibody	3 mg/kg	Intravenous