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
- 5
- 试验地点
- 7
- 主要终点
- Phase 2: Percent change in total immunoglobulin G (IgG) [Time Frame: Baseline and At Week 12]
研究概览
简要总结
Phase 2: To evaluate the PD effect of povetacicept in subjects with gMG, Phase 2 and LTE: To evaluate the safety and tolerability of povetacicept in subjects with gMG
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
- 否
入选标准
- •Age ≥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
研究组 & 干预措施
ALPN-303 solution for injection in pre-filled syringe
干预措施: ALPN-303 solution for injection in pre-filled syringe (Drug)
Test IMP without active substance
干预措施: Test IMP without active substance (Drug)
结局指标
主要结局
Phase 2: Percent change in total immunoglobulin G (IgG) [Time Frame: Baseline and At Week 12]
Phase 2: Percent change in total immunoglobulin G (IgG) [Time Frame: Baseline and At Week 12]
Phase 2 and LTE: Safety and tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Phase 2 and LTE: Safety and tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
次要结局
未报告次要终点
研究者
Clinical Trials and Medical Info
Scientific
Vertex Pharmaceuticals Inc.