2025-521661-27-00招募中3 期
A Phase 2b/3 Adaptive, Randomized, Active controlled Study Evaluating the Efficacy, Safety, and Tolerability of Povetacicept Versus Calcineurin Inhibitor in the Treatment of Primary Membranous Nephropathy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 7
- 试验地点
- 6
- 主要终点
- Proportion of Participants with Complete Clinical Remission Definition 1 (CR1) CR1 [Time Frame: At Week 72]
研究概览
简要总结
To evaluate the efficacy of povetacicept in subjects with pMN
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with pMN with confirmatory historical biopsy. If no historical biopsy was performed that confirmed pMN, a biopsy can be performed during Screening to confirm eligibility.
- •Other protocol defined Inclusion/Exclusion criteria will apply
排除标准
- •Hypersensitivity to investigational medicinal product or to any of its excipients.
- •Other protocol defined Inclusion/Exclusion criteria will apply
结局指标
主要结局
Proportion of Participants with Complete Clinical Remission Definition 1 (CR1) CR1 [Time Frame: At Week 72]
Proportion of Participants with Complete Clinical Remission Definition 1 (CR1) CR1 [Time Frame: At Week 72]
次要结局
- Proportion of Participants with Complete Clinical Remission Definition 2 (CR2). [Time Frame: At Week 72]
- Proportion of Participants with Overall Clinical Remission (OR). [Time Frame: At Week 72]
- Safety and tolerability as determined by AEs, clinical laboratory values, standard 12-lead ECGs, and vital signs
研究者
Clinical Trials and Medical Info
Scientific
Vertex Pharmaceuticals Inc.
研究点 (6)
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