NCT04225871已完成3 期
A Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects With Generalized Myasthenia Gravis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 139
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
The RAISE-XT study is an open-label extension study to evaluate the long-term efficacy, safety, and tolerability of zilucoplan in subjects with gMG who have previously participated in a qualifying Ra Pharmaceuticals sponsored zilucoplan study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of a qualifying zilucoplan study
排除标准
- •With the exception of a prior zilucoplan trial, participation in another concurrent clinical trial involving an experimental therapeutic intervention (participation in observational studies and/or registry studies is permitted)
研究组 & 干预措施
0.3 mg/kg zilucoplan (RA101495)
Experimental
干预措施: zilucoplan (RA101495) (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: From Baseline (Day 1) to Safety Follow-Up Visit (up to 36 months)
A treatment-emergent adverse event is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication.
次要结局
- Change from Baseline to Week 12 in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score(From Baseline (Day 1) to Week 12)
- Change from Baseline to Week 12 in the the Quantitative Myasthenia Gravis (QMG) Score(From Baseline (Day 1) to Week 12)
- Change from Baseline to Week 12 in the Myasthenia Gravis Composite (MGC) Score(From Baseline (Day 1) to Week 12)
- Change from Baseline to Week 12 in the Myasthenia Gravis - Quality of Life revised (MG-QOL15r) Score(From Baseline (Day 1) to Week 12)
研究者
研究点 (139)
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