NCT07039916招募中3 期
A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of IMVT-1402 in Patients With Mild to Severe Generalized Myasthenia Gravis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 231
- 试验地点
- 120
- 主要终点
- Change from Baseline in MG-ADL Score for Antibody-positive Participants
研究概览
简要总结
The purpose of the study is to assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The Sponsor will also be blinded.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.
- •Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification of Class II, III, or IVa at the Screening Visit
- •Have an MG activities of daily living (MG-ADL) score of ≥ 6 at the Screening Visit and Baseline Visit (Day 1)
- •Additional inclusion criteria are defined in the protocol.
排除标准
- •Have experienced myasthenic crisis within 12 weeks prior to the Screening Visit.
- •Have had a thymectomy performed < 6 months prior to the Screening Visit or have a planned thymectomy during the study
- •Have any active or untreated malignant thymoma
- •Additional exclusion criteria are defined in the protocol.
研究组 & 干预措施
Group 1: IMVT-1402 Dose 1
Experimental
干预措施: IMVT-1402 (Drug)
Placebo/ IMVT-1402
Placebo Comparator
干预措施: IMVT-1402 (Drug)
Group 2: IMVT-1402 Dose 2
Experimental
干预措施: IMVT-1402 (Drug)
Placebo/ IMVT-1402
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in MG-ADL Score for Antibody-positive Participants
时间窗: Baseline to Week 12
次要结局
- Change from Baseline in Quantitative Myasthenia Gravis (QMG) Score for Antibody-positive Participants(Baseline to Week 12)
- Percentage of Antibody-positive Participants Achieving MG-ADL Score of 0 or 1(Week 12)
- Percentage of Antibody-positive Participants with ≥50% Improvement in MG-ADL Score(Baseline to Week 12)
研究者
研究点 (120)
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