A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With a Long-term Extension of Povetacicept in Adults With Generalized Myasthenia Gravis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 28
- 主要终点
- Percent change in Total Immunoglobulin G (IgG)
研究概览
简要总结
The purpose of this study is to evaluate the pharmacodynamic (PD) effect, safety, and tolerability of Povetacicept in participants with generalized myasthenia gravis (gMG).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to (>=) 18 years
- •Diagnosis of generalized myasthenia gravis with generalized muscle weakness and fitting MGFA clinical classification II-IV
- •Additional inclusion criteria are defined in the protocol
排除标准
- •History of thymic surgery within 6 months of screening
- •History of malignancy within the last 5 years
- •Additional exclusion criteria are defined in the protocol
- •Other protocol defined Inclusion/Exclusion criteria will apply.
研究组 & 干预措施
Povetacicept
Participants will be randomized to receive one of the two doses of povetacicept for the initial 12 weeks. Eligible participants can receive povetacicept for an additional 96 weeks.
干预措施: Povetacicept (Drug)
Placebo
Participants will be randomized to receive placebo matched to povetacicept for the initial 12 weeks. Eligible participants can receive povetacicept for an additional 96 weeks.
干预措施: Placebo (Drug)
Placebo
Participants will be randomized to receive placebo matched to povetacicept for the initial 12 weeks. Eligible participants can receive povetacicept for an additional 96 weeks.
干预措施: Povetacicept (Drug)
结局指标
主要结局
Percent change in Total Immunoglobulin G (IgG)
时间窗: Baseline and At Week 12
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: From Baseline Up to Week 116
次要结局
未报告次要终点