A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis
Status:
Completed
Trial end date:
2016-09-05
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
GlaxoSmithKline
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)