NCT07204275招募中2 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
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 136
- 主要终点
- Proportion of Participants with Complete Clinical Remission Definition 1 (CR1)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, and tolerability of povetacicept in participants with primary membranous nephropathy (pMN).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
排除标准
- •Hypersensitivity to investigational medicinal product or to any of its excipients
- •Other protocol defined Inclusion/Exclusion criteria will apply
研究组 & 干预措施
Phase 2b: Povetacicept
Experimental
Participants will be randomized to receive one of the two doses of Povetacicept.
干预措施: Povetacicept (Drug)
Phase 3: Calcineurin Inhibitor (CNI)
Active Comparator
Participants will be randomized to receive the calcineurin inhibitor (CNI) Tacrolimus.
干预措施: Tacrolimus (Drug)
Phase 3: Povetacicept
Experimental
Participants will be randomized to receive one of the two doses of Povetacicept (dose selected based on Phase 2b).
干预措施: Povetacicept (Drug)
结局指标
主要结局
Proportion of Participants with Complete Clinical Remission Definition 1 (CR1)
时间窗: At Week 104
Proportion of Participants with Complete Clinical Remission Definition 1 (CR1)
时间窗: At Week 104
次要结局
- Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)(From Day 1 up to Week 112)
- Proportion of Participants with Complete Clinical Remission Definition 2 (CR2)(At Week 104)
- Proportion of Participants with Complete Clinical Remission Definition 2 (CR2)(At Week 104)
- Proportion of Participants with Overall Clinical Remission (OR)(At Week 104)
研究者
研究点 (136)
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