EUCTR2021-000352-19-PT进行中（未招募）1 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 MyelinOligodendrocyte Glycoprotein (MOG) Antibody-Associated Disease (MOG-AD) - cosMOG
CB Biopharma SR0 个研究点目标入组 104 人开始时间: 2021年11月11日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 104
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
- 性别
- All
入选标准
- •- Participants must be =18 to =89 years of age, at the time of signing the informed consent
- •- Participant must have a history of myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD) with any of the following clinical presentations:
- •a) Optic neuritis (single, recurrent, or simultaneous bilateral)
- •b) Transverse myelitis (including Longitudinally extensive spinal cord lesion (LETM))
- •c) Acute disseminated encephalomyelitis or MOG antibody-associated encephalitis, brain stem encephalitis
- •d) Combined presentations
- •- Positivity for serum MOG-Immunglobulin G (IgG) antibodies using cell-based assay at Screening
- •- Participant has history of relapsing MOG-AD with at least 1 documented relapse over the last 12 months prior to randomization
- •- Participant must be clinically stable at the time of the Screening Visit and during the Screening Period
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
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 relevant active infection (eg, sepsis, pneumonia, or abscess), or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of investigational medicinal product (IMP)
- •- Participant has a current or medical history of primary immunodeficiency
- •- Participant has a current or medical history of IgA deficiency
- •- Participant tests positive for aquaporin-4 antibodies at screening
- •- Participant has a serum total IgG level =5.5g/L
研究者
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