CTRI/2026/01/100232尚未招募3 期
A randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,275
- 试验地点
- 10
- 主要终点
- To demonstrate efficacy of remibrutinib compared to placebo in delaying disability progression based on EDSS
研究概览
简要总结
This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, parallel-group, event-driven study to evaluate the efficacy, safety and tolerability of remibrutinib in SPMS patients. Approximately 1275 eligible participants will be randomized in a ratio of 2:1 to receive either remibrutinib or matching placebo. The study consists of an event-driven Core Part with double-blind treatment, followed by an Extension Part with open-label remibrutinib treatment. The purpose of this trial is to learn about the effects of LOU064, also called remibrutinib, compared to placebo in people with secondary progressive multiple sclerosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •• Signed informed consent must be obtained prior to any assessment performed.
- •• Male or female participants aged 18 to 65 years (inclusive) at Screening.
- •• Diagnosis of SPMS according to the 2017 revised McDonald criteria (Thompson et al 2018) at Screening.
- •• Absence of documented clinical relapses in the 24 months before Screening and randomization.
- •• EDSS score of 3.0 to 6.0 (inclusive) at Screening.
- •• Documented evidence of disability progression in the 12 months before Screening.
排除标准
- •• Unwilling or unable to undergo MRI scans as per protocol (for example, claustrophobia, or presents absolute contraindications to MRI (e.g., metallic implants, metallic foreign bodies, pacemaker, defibrillator)).
- •• History of clinically significant central nervous system (CNS) disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic multiple sclerosis (MS).
- •• Ongoing substance abuse (drug or alcohol) or any other factor (e.g. serious psychiatric condition) that may interfere with the participant ability to cooperate and comply with the study procedures.
- •• Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symptoms consistent with PML.
- •• Women of childbearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure rate less than 1 percent per year) while taking study treatment and for at least 1 week after stopping study treatment.
- •• Significant bleeding risk or coagulation disorders, at Screening.
- •• Use of exclusionary medication prior to Screening/randomization as listed in the protocol.
结局指标
主要结局
To demonstrate efficacy of remibrutinib compared to placebo in delaying disability progression based on EDSS
时间窗: Time to 6-month confirmed disability progression | (6mCDP)
次要结局
- To assess whether remibrutinib is superior to placebo in:(- Delaying disability progression based on EDSS)
- To assess the safety and tolerability of remibrutinib(Adverse events, laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating Scale (C-SSRS) from Baseline till End of Study)
研究者
Murugananthan K
Novartis Healthcare Private Limited
研究点 (10)
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