A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis
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.
Timeline
- Start
- 2014-02-05
- Primary completion
- 2016-09-05
- Completion
- 2016-09-05
Outcome
Met primary endpoint
registry analysis (other test); Placebo vs Mepolizumab 300mg; p <0.001; Odds Ratio (OR) 5.91 (95% CI 2.68 to 13.03); Proportional odds regression model NCT02020889 ↗
registry analysis (other test); Placebo vs Mepolizumab 300mg; p <0.001; Odds Ratio (OR) 16.74 (95% CI 3.61 to 77.56); Regression, Logistic NCT02020889 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mepolizumab | Monoclonal antibody | 300 mg | Subcutaneous |