A Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety and Efficacy of Aritinercept, a Dual BAFF/APRIL Inhibitor, in Patients With Generalized Myasthenia Gravis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 81
- 试验地点
- 11
研究概览
简要总结
This clinical study will enroll patients with generalized myasthenia gravis (gMG). The goal of this clinical study is to assess the safety, tolerability, effectiveness, pharmacokinetics (how the body processes the drug) and pharmacodynamics (how the drug affects the body) of aritinercept.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18-85 years old)
- •Myasthenia Gravis Foundation of America (MGFA) Class II-IV gMG
- •Additional inclusion criteria are defined in the protocol
排除标准
- •Current or medical history of malignancy within the last 5 years
- •Pregnant, breastfeeding or intending to become pregnant during the Study
- •Additional exclusion criteria are defined in the protocol
研究组 & 干预措施
Aritinercept
Double-Blind Treatment Period: Aritinercept by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection
干预措施: Aritinercept (Drug)
Placebo
Double-Blind Treatment Period: Placebo by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection
干预措施: Aritinercept (Drug)
Placebo
Double-Blind Treatment Period: Placebo by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection
干预措施: Placebo (Other)