An Efficacy and Safety Study of Reslizumab Subcutaneous in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils

Summary

The primary objective of the study is to determine the ability of reslizumab administered by subcutaneous injection to produce a corticosteroid-sparing effect in patients with oral corticosteroid (OCS)-dependent asthma and elevated blood eosinophils, without loss of asthma control.

Timeline

Start

2015-09-29

Primary completion

2017-06-19

Completion

2017-12-04

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Reslizumab 110 mg; p = 0.468; Odds Ratio (OR) 1.23 (95% CI 0.702 to 2.157); NCT02501629 ↗

paper In study 2, we found no difference between placebo and fixed-dose subcutaneous reslizumab in categorised percentage reduction in daily oral corticosteroid dose PMID 32066536 ↗

release “A Phase III claim-support study evaluating subcutaneously administered reslizumab in patients with oral corticosteroid (OCS)-dependent asthma 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

Indications