JPRN-jRCT2021210052招募中3 期
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
MATSUO TETSUO0 个研究点目标入组 11 人开始时间: 2021年11月24日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 89age old（—）
- 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
研究者
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