jRCT2021210052招募中不适用
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3, Pivotal Study With an Open-Label Extension Period to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-Associated Disease (MOG-AD) (MOG001)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 11
- 主要终点
- Time from randomization to first independently centrally adjudicated relapse (TTFR)
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 89age old under（—）
- 性别
- All
入选标准
- •Confirmed diagnosis of MOG-AD consistent with published diagnostic
- •criteria for MOG-AD
- •Participant has history of relapsing MOG-AD with at least 1 documented relapse over the last 12 months and a documented positive serum MOG Ab test using a cell-based assay (CBA) within 6 months prior to randomization
- •Participant must be clinically stable at the time of the Screening Visit and during the Screening Period
排除标准
- •Participant has been diagnosed with a neurological autoimmune disease (including multiple sclerosis (MS) and aquaporin-4 positive neuromyelitis optica spectrum disorder (NMOSD)), or a systemic autoimmune disease that in the opinion of the investigator can interfere with the safety of the participant
- •Participant has a clinically important active infection (including unresolved or not adequately treated infection) as assessed by the investigator, including participants with a serious infection within 6 weeks prior to the first dose of the investigational medicinal product (IMP).
- •Participant has a current or medical history of primary immunodeficiency
- •Participant tests positive for aquaporin-4 antibodies at screening
- •Participant has a serum total IgG level 5.5g/L or less
结局指标
主要结局
Time from randomization to first independently centrally adjudicated relapse (TTFR)
时间窗: Double Blind (DB) Treatment Period
Time from randomization to first independently centrally adjudicated relapse during the Double Blind (DB) Treatment Period
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Open-Label Extension (OLE) Treatment Period
Incidence of treatment-emergent adverse events during Open-Label Extension (OLE) Treatment Period
Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP)
时间窗: OLE Treatment Period
Incidence of treatment-emergent adverse events leading to permanent withdrawal of investigational medicinal product during OLE Treatment Period
次要结局
- Change from Baseline in Low-Contrast Monocular Visual Acuity (Worst Affected Eye)(at the End of Double-Blind/Early Withdrawal (EDB/EWD) Visit)
研究者
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