NCT06723106Enrolling By Invitation1 期
Phase 1b Open-label, Long-term Extension Basket Trial of RAY121 to Inhibit Classical Complement Pathway in Immunological Diseases (RAINBOW-LTE Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 144
- 试验地点
- 102
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
This is a long-term extension trial of RAY121 in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM) and immune thrombocytopenia (ITP).
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form
- •Have completed 4 doses of RAY121 administrations in RAY902CT trial and shown clinical responses
- •Ability to comply with the study protocol, in the investigator's judgment
- •For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods during the treatment period and 20 weeks (140 days) after the last dose of RAY121
- •For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
排除标准
- •History of anaphylaxis or hypersensitivity to a biologic agent
- •Known active infection with encapsuled bacteria
- •History of Neisseria meningitidis infection
- •Planned surgery
- •Pregnant or breastfeeding, or intending to become pregnant
- •Clinically significant electrocardiogram abnormalities
- •Illicit drug or alcohol abuse
- •Known or suspected immune deficiency
- •Treatment with investigational therapy other than RAY121
- •Vaccination with a live vaccine within 4 weeks
研究组 & 干预措施
RAY121
Experimental
All enrolled patients will receive RAY121 multiple dose
干预措施: RAY121 (Drug)
结局指标
主要结局
Adverse events (AEs)
时间窗: Baseline to Week 52
Incidence, severity, and causal relationship of AEs
次要结局
- RAY121 concentration(Baseline to Week 52)
- Change from baseline in active C1s(Baseline to Week 52)
- Change from baseline in total C1s(Baseline to Week 52)
- Change from baseline in complement activity (classical pathway)(Baseline to Week 52)
- Anti-RAY121 antibodies(Baseline to Week 52)
研究者
研究点 (102)
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