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鼻ポリープを伴う慢性副鼻腔炎（CRSwNP）／好酸球性慢性副鼻腔炎（ECRS）の成人患者におけるメポリズマブの有効性と安全性
基本情報
- NCT ID
- NCT04607005
- 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
- 169
- 治験依頼者名
- GlaxoSmithKline
概要
This is a randomized, double blind, placebo controlled, parallel group phase III study designed to assess the clinical efficacy and safety of 100 milligrams (mg) subcutaneous (SC) mepolizumab treatment in adults with CRSwNP/ECRS for the purpose of registration in Japan and China. Approximately 160 participants will be randomized in a 1:1 ratio to receive either 100 mg SC mepolizumab or placebo SC. The study will include a 4-week run-in period followed by randomization to a 52-week treatment period, where participants will be administered 4-weekly doses of mepolizumab or placebo via a pre-filled safety syringe device (SSD) injection.
対象疾患
Nasal Polyps
介入
Mepolizumab(DRUG)
Placebo(DRUG)
Standard of care(DRUG)