At a glance
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A Double-blind, Randomised, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis in Subjects Receiving Standard of Care Therapy
In Brief
A Phase 3 clinical trial evaluating Mepolizumab and Placebo for Churg-Strauss Syndrome. Completed, enrolled 136 participants across 32 sites in 9 countries.
Detailed Summary
The purpose of this randomized, double-blind study is to investigate the efficacy and safety of mepolizumab (300 milligram \[mg\] administered subcutaneously \[SC\] every 4 weeks) compared with placebo over a 52-week study treatment period in subjects with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care therapy including background corticosteroid therapy with or without immunosuppressive therapy. During the treatment period, in accordance with standard of care, corticosteroid dose will be tapered. The key outcomes in the study focus on evaluation of clinical remission, defined as Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of \<=4 mg/day prednisolone/prednisone, reduction in disease relapse and reduction in corticosteroid requirement.
Study Details
Timeline
Interventions
Mepolizumab will be provided as a lyophilized cake in sterile vials for individual use to be reconstituted with sterile water for Injection, just prior to use.
Placebo will be available as 0.9% sodium chloride