NCT06724809进行中（未招募）3 期
An Open-label, Single-arm, Multi-Center, Interventional Study to Evaluate the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Chinese Adult Participants With Anti-Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorders (NMOSD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- The efficacy of eculizumab in anti-AQP4 antibody positive participants with NMOSD measured by Adjudicated On-trial annualized relapse rate (ARR).
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of Eculizumab in Chinese Adults with Neuromyelitis Optica Spectrum Disorders (NMOSD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with diagnosis of NMOSD as defined by the 2015 international consensus diagnostic criteria
- •Anti-AQP4 antibody positive
- •At least 1 attack or relapse in the last 12 months prior to the Screening Period
- •EDSS score ≤ 7
- •If a participant enters the study receiving IST(s) for relapse prevention, the participant must be on a stable maintenance dose of IST(s) as follows, prior to screening and must remain on that dose for the duration of the study, unless the participant experiences a relapse
- •Female participants of childbearing potential must have a negative pregnancy test (serum HCG at screening
- •Male participants are eligible to participate if they agree to the following during the study intervention Treatment Period and for at least 5 months after the last dose of study intervention:
- •Refrain from donating fresh unwashed semen. PLUS, either,
- •Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR
- •Must agree to use barrier as detailed below:
- •Agree to use a male condom when having sexual intercourse with a WOCBP who is not currently pregnant.
排除标准
- •Pregnant, breastfeeding, or intending to conceive during the course of the study
- •Prior history of N meningitidis infection or unresolved meningococcal disease
- •Any systemic bacterial or other infection which is clinically significant in the opinion of the Investigator and has not been treated with appropriate antibiotics
- •Presence of fever ≥ 38 C within 7 days prior to study intervention administration on Day 1
- •Hypersensitivity to murine proteins or to one of the excipients of study intervention
- •Use of rituximab, inebilizumab, or other B cell-depleting therapy within 6 months prior to Day 1 and during the study
- •Use of mitoxantrone or satralizumab within 3 months prior to screening and during the study
- •Use of IVIg within 3 weeks prior to screening
- •If a participant enters the study receiving oral corticosteroid(s) with or without other ISTs, the daily corticosteroid dose must be no more than prednisone 20 mg/day (or equivalent) prior to screening and the participant must remain on that dose for the duration of the study or until the participant experiences a relapse (specific medications listed in Section 6.9.1 may be allowed)
- •Has previously received treatment with C5 inhibitors
- •Participation in any other investigational drug study or exposure to an investigational drug or device within 5 half-lives of treatment (if known) or 30 days, which is longer, before the first dose administration
研究组 & 干预措施
eculizumab
Experimental
All participants will receive open-label eculizumab by intravenous infusion during the Treatment Period, starting on Day 1 for a total of up to 52 weeks.
干预措施: eculizumab (Drug)
结局指标
主要结局
The efficacy of eculizumab in anti-AQP4 antibody positive participants with NMOSD measured by Adjudicated On-trial annualized relapse rate (ARR).
时间窗: Baseline through Week 52
Intercurrent Event (ICE): * ICE1: Premature discontinuation of study intervention * ICE2: Initiation of disallowed therapy or medicine
次要结局
- The efficacy of eculizumab by assessing change from baseline to end of study in Expanded Disability Status Scale (EDSS) Score(Baseline through Week 52)
- The efficacy of eculizumab by assessing change from baseline to end of study in Ambulatory Function as Measured by Hauser Ambulation Index (HAI)(Baseline through Week 52)
- The efficacy of eculizumab by assessing change from baseline to end of study in European Quality of Life 5-Dimension Questionnaire (EQ-5D) Index Score(Baseline through Week 52)
- Change From Baseline to end of study in EQ-5D Visual Analogue Scale (VAS) Score(Baseline through Week 52)
- Serum Eculizumab Concentrations Over Time(Baseline through Week 52)
- Serum Free Complement Component 5 (C5) Concentrations Over Time(Baseline through Week 52)
- Number of Treatment-emergent Antidrug Antibody (ADA) Positive Participants(Baseline through Week 52)
- To characterize the overall safety of eculizumab in the treatment of NMOSD(Baseline through Week 52)
研究者
研究点 (1)
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