NCT07067463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
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 705
- 试验地点
- 66
- 主要终点
- Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 12 weeks (12-week cCDP)
研究概览
简要总结
Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with PPMS. Patients will be treated for approximately 30 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 705 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 60 years of age, inclusive
- •Diagnosed with Primary Progressive MS (PPMS) according to 2017 McDonald criteria
- •Participant must have documented evidence of disability progression observed during the 24 months before screening.
- •Expanded disability status scale (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
- •History of suicidal behavior within 6 months prior to Screening
- •Any prior history of malignancy if no recurrence within 5 years
- •Patients on anticoagulation, or antiplatelet therapy will be excluded
- •Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducerswithin 14 days
- •Clinically significant laboratory abnormalities at Screening.
- •Any allergy, contraindication, or inability to tolerate orelabrutinib or any of the excipients in the study intervention
- •Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening
- •History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening.
研究组 & 干预措施
Placebo Group
Placebo Comparator
干预措施: Placebo (Drug)
Orelabrutinib Group
Experimental
干预措施: Orelabrutinib (Drug)
结局指标
主要结局
Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 12 weeks (12-week cCDP)
时间窗: Up to approximately 120 weeks
* Expanded disability status scale (EDSS) score increase ≥ 1.0 point from baseline when the baseline score is ≤ 5.0, or ≥ 0.5 points from baseline when the baseline score is \> 5.0, OR * ≥ 20% increase in the Timed 25-Foot Walk Test (T25FWT), OR * ≥ 20% increase in the 9-hole Peg Test (9HPT)
次要结局
- Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 24 weeks (24-week cCDP)(Up to approximately 120 weeks)
- MRI T2 lesion(Up to approximately 120 weeks)
- Time to onset of confirmed disability progression (CDP) , confirmed over at least 24 weeks (24-week CDP)(Up to approximately 120 weeks)
- 12-week CDP(Up to approximately 120 weeks)
- Time to onset of CDP defined as ≥ 20% increase on 9-hole Peg Test (9HPT) from baseline, confirmed over at least 12 weeks (12-week CDP-9HPT)(Up to approximately 120 weeks)
- Time to onset of CDP defined as ≥ 20% increase on Timed 25-Foot Walk Test (T25FWT) from baseline, confirmed over at least 12 weeks (12-week CDP-T25FWT)(Up to approximately 120 weeks)
- 24-week CDI(Up to approximately 120 weeks)
- 24-week cCDI(Up to approximately 120 weeks)
- 24-week CDI-9HPT(Up to approximately 120 weeks)
- 24-week CDI-T25FWT(Up to approximately 120 weeks)
- SDMT(Up to approximately 120 weeks)
- AEs(Up to approximately 120 weeks)
研究者
研究点 (66)
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