NCT07557420招募中3 期
A Phase 3b, Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Ravulizumab in Chinese Adult Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)
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
- 19
- 试验地点
- 15
- 主要终点
- Adjudicated On-Trial Annualized Relapse Rate (ARR)
研究概览
简要总结
The primary objective of this study is to confirm the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ravulizumab in the treatment of Chinese adults with anti-aquaporin-4 (AQP4) antibody (Ab) + neuromyelitis optica spectrum disorder (NMOSD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Key Inclusion (essential)
- •Diagnosis: NMOSD per 2015 international consensus criteria, and anti AQP4 antibody positive at Screening.
- •Disease activity: ≥1 attack/relapse in the past 12 months.
- •Disability: EDSS ≤
- •Background therapy: If on IST and/or oral corticosteroids, participant should be on a stable maintenance regimen prior to Screening and plan to remain stable during the study unless relapse occurs. (Detailed agent specific duration/dose rules to be confirmed at screening.)
- •Body weight: ≥40 kg.
- •Vaccinated against meningococcal infections from serogroups A, C, W, Y (and B where available) within the 3 years prior to study intervention administration on Day
- •Key Exclusion (essential)
- •Pregnancy/lactation: Pregnant, breastfeeding, or intending to conceive during the study.
- •Infection risk: History of meningococcal disease or unresolved meningococcal disease, active systemic infection within 14 days, or fever ≥38°C within 7 days before Day
- •Hypersensitivity: To murine proteins or ravulizumab excipients.
- •Serious comorbidities: Any condition that in the Investigator's judgment adds risk or interferes with participation/assessment.
- •Viral infections: Known HIV, active HBV, or active HCV.
- •Prior/concomitant immunomodulatory treatments:
- •B cell-depleting therapy (e.g., rituximab, inebilizumab) within 3 months before Screening.
- •Mitoxantrone or satralizumab within 3 months before Screening.
- •IVIg within 3 weeks before Screening.
- •Any prior or current complement inhibitor.
- •Note: Other protocol-defined criteria may apply and should be verified during full eligibility review.
排除标准
- 未提供
研究组 & 干预措施
Ravulizumab
Experimental
Participants will receive a weight-based loading dose of ravulizumab on Day 1, followed by a weight-based maintenance treatment dose on Day 15 and every 8 weeks (q8w) thereafter for up to 50 weeks.
干预措施: Ravulizumab (Drug)
结局指标
主要结局
Adjudicated On-Trial Annualized Relapse Rate (ARR)
时间窗: Baseline up to Week 50
次要结局
- Number of Participants With Clinically Important Change From Baseline in Hauser Ambulation Index (HAI) Score(Baseline up to Week 50)
- Number of Participants With Clinically Important Worsening From Baseline in Expanded Disability Status Scale (EDSS) Score(Baseline up to Week 50)
- Change From Baseline in European Quality of Life Health 5-item Questionnaire (EQ-5D) Index Score(Baseline, Week 50)
- Change From Baseline in EQ-5D Visual Analog Scale (VAS) Score(Baseline, Week 50)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interests (AESIs)(Baseline up to Week 50)
- Serum Ravulizumab Concentration(Day 1 to Day 351)
- Change From Baseline in Serum Free Complement Component 5 (C5) Concentration(Baseline Up to Day 351)
- Number of Participants With Anti-Drug Antibodies (ADAs)(Day 1 up to Day 351)
- Number of Participants With Neutralizing Antibodies (NAb)(Day 1 up to Day 351)
研究者
研究点 (15)
Loading locations...
相似试验
招募中
3 期
A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia AHemophilia ANCT07416526Hoffmann-La Roche126
招募中
3 期
A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia AHemophilia ANCT07416604Hoffmann-La Roche360
招募中
1 期
A First-in-Human Study of BG-C0979 in Adults With Advanced Solid TumorsNCT07414836BeOne Medicines84
招募中
1 期
A Study of DB-1324 in Advanced/Metastatic Gastrointestinal TumorsNCT07263594DualityBio Inc.127
招募中
3 期
Randomized, multicenter, double-blind, Phase 3 study investigating the safety and efficacy of dostarlimab plus belrestotug compared with pembrolizumab plus placebo in participants with previously untreated, unresectable, locally advanced or metastatic Non-small-cell lung cancerCTRI/2024/10/075244GlaxoSmithKline1,000