2024-512258-91-00招募中3 期
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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 31
- 主要终点
- Change from Period 1 baseline in MG-ADL score to Week 12 for AChRAb+ participants (Timeframe: Period 1 baseline to Week 12).
研究概览
简要总结
To evaluate the efficacy of batoclimab 680 mg SC QW or 340 mg SC QW compared to placebo as Induction Therapy in AChRAb+ participants as assessed by change in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Are ≥ 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
Change from Period 1 baseline in MG-ADL score to Week 12 for AChRAb+ participants (Timeframe: Period 1 baseline to Week 12).
Change from Period 1 baseline in MG-ADL score to Week 12 for AChRAb+ participants (Timeframe: Period 1 baseline to Week 12).
次要结局
- Change from Period 1 baseline in QMG score to Week 12 for AChRAb+ participants (Timeframe: Period 1 baseline to Week 12).
- Change from Period 2 baseline in MG-ADL score to Week 24 for AChRAb+ randomized withdrawal participants (Timeframe: Week 12 to Week 24).
- Proportion of AChRAb+ participants with ≥ 3-point improvement (decrease in score) in QMG from Period 1 baseline to Week 12 (Timeframe: Period 1 baseline to Week 12).
- Proportion of AChRAb+ participants achieving MG-ADL score of 0 or 1 by Week 12 (Timeframe: Period 1 baseline to Week 12).
- Change from Period 1 baseline in MG-ADL score to Week 12 for AChRAb- participants (Timeframe: Period 1 baseline to Week 12).
研究者
Immunovant Clinical Trials
Scientific
Immunovant Sciences GmbH
研究点 (31)
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