好酸球性多発血管炎性肉芽腫症の治療におけるメポリズマブの効果を調査する研究

基本情報

NCT ID

NCT02020889

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

136

治験依頼者名

GlaxoSmithKline

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (2)