jRCT2021230001进行中（未招募）不适用
A Phase 3, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants with Generalized Myasthenia Gravis (gMG)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 主要终点
- MG-ADL score
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Age >= 18 years of age at the Screening Visit.
- •Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification Class II, III, or IVa at the Screening Visit.
- •Have a QMG score >= 11 at the Screening and Baseline Visits.
- •Have a MG-ADL score of >= 5 at the Screening and Baseline Visits.
- •Additional inclusion criteria are defined in the protocol.
排除标准
- •Have experienced myasthenic crisis within 3 months of the Screening Visit.
- •Have had a thymectomy performed < 6 months prior to the Screening Visit or have a planned thymectomy during the study period.
- •Have any active or untreated malignant thymoma.
- •Have received any agent or therapy (exclusive of those identified within inclusion criteria) with immunosuppressive properties (e.g., stem cell therapy, chemotherapies, etc.) within the past year.
- •Have used anti-FcRN treatment within 3 months prior to the Screening Visit or have a documented history of non-response to prior anti-FcRN treatment.
- •Additional exclusion criteria are defined in the protocol.
结局指标
主要结局
MG-ADL score
时间窗: Period 1 baseline to Week 12
Change from Period 1 baseline in MG-ADL score to Week 12 for AChRAb+ participants
次要结局
未报告次要终点
研究者
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