Study of Reslizumab in Participants With Uncontrolled Asthma and Elevated Blood Eosinophils

Phase 3 Completed 468 enrolled Teva Branded Pharmaceutical Products R&D, Inc. PPD Development, LP · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study is to determine the effect of reslizumab (110 mg) administered subcutaneously every 4 weeks on clinical asthma exacerbations in adults and adolescents with asthma and elevated blood eosinophils who are inadequately controlled on standard-of-care asthma therapy.

Timeline

Start: 2015-09-28
Primary completion: 2017-12-04
Completion: 2018-01-31

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Reslizumab 110 mg; p = 0.194; CAE rate ratio (reslizumab vs placebo) 0.79 (95% CI 0.562 to 1.124); NCT02452190 ↗

release “A Phase III registration study evaluating subcutaneously administered reslizumab (110 mg) in a pre-filled syringe did not meet its primary endpoint” tevapharm.com ↗

Publications

Bernstein JA, Virchow JC, Murphy K, Maspero JF, Jacobs J, Adir Y, Humbert M, Castro M, Marsteller DA, McElhattan J, Hickey L, Garin M, Vanlandingham R, Brusselle G. Effect of fixed-dose subcutaneous reslizumab on asthma exacerbations in patients with severe uncontrolled asthma and corticosteroid sparing in patients with oral corticosteroid-dependent asthma: results from two phase 3, randomised, double-blind, placebo-controlled trials. Lancet Respir Med. 2020 May;8(5):461-474. doi: 10.1016/S2213-2600(19)30372-8. Epub 2020 Feb 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Reslizumab	Monoclonal antibody	110 mg	Subcutaneous