2025-521546-23-00招募中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
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 677
- 试验地点
- 189
- 主要终点
- Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS)
研究概览
简要总结
To demonstrate efficacy of remibrutinib compared to placebo in delaying disability progression based on EDSS
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent must be obtained prior to any assessment performed.
- •Male or female participants aged 18-65 (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 CNS disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic MS at Screening.
- •Ongoing substance abuse (drug or alcohol) or any other factor (e.g. serious psychiatric condition) that may interfere with the participant’s 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 < 1% 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.
研究组 & 干预措施
Placebo to Remibrutinib (LOU064) film-coated tablets
Placebo
干预措施: Placebo to Remibrutinib (LOU064) film-coated tablets (Drug)
LOU064
Test
干预措施: LOU064 (Drug)
结局指标
主要结局
Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS)
Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS)
次要结局
- Time to 6-month confirmed disability improvement (6mCDI) on EDSS (key secondary)
- Time to 3-month worsening by at least 20% in Timed 25-Foot Walk (T25FW) (key secondary)
- Time to 3-month worsening by at least 20% in 9-Hole Peg Test (9-HPT) (key secondary)
- Annualized rate of new or enlarging T2 lesions (key secondary)
- Percentage of participants with annualized rate of brain atrophy > XX (key secondary)
- Time to 6-month worsening by at least 4 points in Symbol Digit Modalities Test (SDMT)
- Adverse events, laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating Scale (C-SSRS)
- Time to 3-month confirmed disability progression (3mCDP) on EDSS (key secondary)
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (189)
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