jRCT2031230526招募中不适用
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of NS-229 in the Treatment of Eosinophilic Granulomatosis with Polyangiitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 主要终点
- The proportion of subjects in remission (oral glucocorticoid [OGC] 4.0)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •(1)Male or female subjects aged >=18 years at the time the informed consent form is signed
- •(2)Diagnosis of EGPA
- •(3)Subjects receive background OGC dose of>=7.5 mg/day with or without stable treatment with mepolizumab or benralizumab.
排除标准
- •(1) Current diagnosis of either granulomatosis with polyangiitis or microscopic polyangiitis
- •(2) Imminently life-threatening EGPA disease
结局指标
主要结局
The proportion of subjects in remission (oral glucocorticoid [OGC] 4.0)
时间窗: Week 28 of the study treatment period
Definition of remission (OGC 4.0): Birmingham Vasculitis Activity Score (BVAS) of 0 AND OGC dose of prednisolone/prednisone <=4.0 mg/day.
次要结局
未报告次要终点
研究者
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