The purpose of this randomized, double-blind study is to investigate the efficacy and safety of mepolizumab (300 milligram mg administered subcutaneously every four weeks) compared with a placebo over a 52-week study treatment period in subjects with relapsing or refractory Eosinophilic granulomatosis with polyangiitis (EGPA/Churg Strauss syndrome) receiving standard of care therapy including background corticosteroid therapy with or without immunosuppressive therapy. During the treatment period, in accordance with standard of care, the 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.
Estimated Enrollment: 130
Study Start Date: February 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Experimental: Mepolizumab 300 mg
Each subject will receive mepolizumab 300 mg subcutaneous (SC) injection every 4 weeks (13 administrations) along with standard care. It will be administered as 3 separate injections (100 mg each- total dose 300 mg); individual injection sites will be separated by at least 5 cm. It will be administered into any of the upper arm, thigh or anterior abdominal wall.
Placebo Comparator: Placebo
Each subject will receive placebo (0.9% sodium chloride) SC injection every four weeks (13 administrations) along with standard care. It will be administered as three separate injections; individual injection sites will be separated by at least 5 cm. It will be administered into any of the upper arm, thigh or anterior abdominal wall.
Sponsors and Collaborators
United States: National Institutes of Health; National Institute of Allergy and Infectious Diseases