2025-524322-18-00招募中3 期
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-Active Secondary Progressive Multiple Sclerosis
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
- 486
- 试验地点
- 154
- 主要终点
- Time to onset of confirmed disability progression (CDP) events, confirmed over at least 24 weeks (24-week CDP).
研究概览
简要总结
To evaluate the efficacy of orelabrutinib compared to placebo in delaying disability progression in naSPMS
研究设计
- 分配方式
- Na
- 主要目的
- Screening
- 盲法
- None
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
- •Participants are eligible to be included in the study only if all the following criteria apply: 18 to 60 years of age, inclusive, at the time of signing the informed consent.
- •Participants are eligible to be included in the study only if all the following criteria apply: Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald Criteria.
- •Participants are eligible to be included in the study only if all the following criteria apply: Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013
- •Participants are eligible to be included in the study only if all the following criteria apply: Participant must have documented evidence of disability progression independent of clinical relapse observed during the 24 months before Screening. A written summary of the clinical evidence of disability progression must be discussed and aligned between the Investigator and the Sponsor’s dedicated qualified person(s).
- •Participants are eligible to be included in the study only if all the following criteria apply: Absence of clinical relapses for at least 24 months.
- •Participants are eligible to be included in the study only if all the following criteria apply: Absence of GdE T1 brain lesions as measured by MRI at screening.
- •Participants are eligible to be included in the study only if all the following criteria apply: Absence of GdE T1 brain lesions as measured by MRI for at least 12 months only applicable if an MRI is available.
- •Participants are eligible to be included in the study only if all the following criteria apply: 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)
结局指标
主要结局
Time to onset of confirmed disability progression (CDP) events, confirmed over at least 24 weeks (24-week CDP).
Time to onset of confirmed disability progression (CDP) events, confirmed over at least 24 weeks (24-week CDP).
次要结局
- 1) Time to onset of CDP events on EDSS, confirmed over at least 12 weeks (12-week CDP)
- 2) The total number of new or enlarging T2 lesions on MRI scans of the brain
研究者
Patient and Medical Information
Scientific
Zenas Biopharma (USA) LLC
研究点 (154)
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