2025-524316-11-00招募中3 期
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 398
- 试验地点
- 143
研究概览
简要总结
To evaluate the efficacy of orelabrutinib compared to placebo in delaying disability progression in PPMS
研究设计
- 分配方式
- Na
- 主要目的
- Safety Follow-up Period
- 盲法
- Double (Carer, Monitor, Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •18 to 60 years of age, inclusive, at the time of signing the informed consent.
- •Diagnosed with Primary Progressive MS (PPMS) according to McDonald criteria.
- •Participant must have documented evidence of disability progression independent of clinical relapse observed during the 24 months before Screening.
- •EDSS score between 3.0 to 6.5 points, inclusive, at Screening.
排除标准
- •Diagnosed with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)
- •Immunologic disorder other than MS or any other conditions requiring oral, intravenous (IV), intramuscular, or intra-articular corticosteroid therapy.
- •History or current diagnosis of other neurological disorders that may mimic MS
- •History of any other significant active medical condition
研究组 & 干预措施
Orelabrutinib
Test
干预措施: Orelabrutinib (Drug)
Placebo tablets match with that of orelabrutinib (ICP-022) tablets in appearance, shape, size, and weight.
Placebo
干预措施: Placebo tablets match with that of orelabrutinib (ICP-022) tablets in appearance, shape, size, and weight. (Drug)
研究者
Patient and Medical Information
Scientific
Zenas Biopharma (USA) LLC
研究点 (143)
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