A Study to Evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) With Eosinophilic Asthma

Phase 3 Completed 315 enrolled Teva Branded Pharmaceutical Products R&D, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3 or 3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than placebo in improving lung function in patients with eosinophilic asthma as assessed by the overall change from baseline in forced expiratory volume in 1 second (FEV1).

Timeline

Start: 2011-02
Primary completion: 2013-09
Completion: 2013-09

Outcome

Met primary endpoint

registry Placebo vs Reslizumab - 3.0 mg/kg; p = 0.0018; Mean Difference (Final Values) 0.160 (95% CI 0.060 to 0.259) NCT01270464 ↗

registry Placebo vs Reslizumab - 0.3 mg/kg; p = 0.0237; Mean Difference (Final Values) 0.115 (95% CI 0.016 to 0.215) NCT01270464 ↗

Publications

Bjermer L, Lemiere C, Maspero J, Weiss S, Zangrilli J, Germinaro M. Reslizumab for Inadequately Controlled Asthma With Elevated Blood Eosinophil Levels: A Randomized Phase 3 Study. Chest. 2016 Oct;150(4):789-798. doi: 10.1016/j.chest.2016.03.032. Epub 2016 Apr 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Reslizumab	Monoclonal antibody	0.3 mg/kg	Intravenous
Subject	Reslizumab	Monoclonal antibody	3 mg/kg	Intravenous