REMASTER
What it found
No result yet.
What was tested
Treatment tested
- Remibrutinib
Placebo or sham
- Placebo
- Placebo to Remibrutinib (LOU064) film-coated tablets
What it measured
Main measures
Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS)
From baseline up to approximately 5 years
Disability progression
Other measures (10)
Time to 3-month confirmed disability progression (3mCDP) on EDSS
From baseline up to approximately 5 years
Disability progressionTime to 6-month confirmed disability improvement (6mCDI) on EDSS
From baseline up to approximately 5 years
Disability progressionTime to 3-month worsening by at least 20% in Timed 25-Foot Walk (T25FW)
From baseline up to approximately 5 years
Disability progressionWalking and mobilityTime to 3-month worsening by at least 20% in 9-Hole Peg Test (9-HPT)
From baseline up to approximately 5 years
Disability progressionArm and hand functionAnnualized rate of new or enlarging T2 lesions
From baseline up to approximately 5 years
MRI lesionsAnnualized rate of brain atrophy
From baseline up to approximately 5 years
MRI lesionsBrain volume lossTime to 6-month worsening by at least 4 points in Symbol Digit Modalities Test (SDMT)
From baseline up to approximately 5 years
Thinking and memoryNumber of participants with Adverse events and Serious adverse events (SAE)
From baseline up to approximately 5 years
SafetyPercentage of participants with annualized rate of brain atrophy > XX (key secondary)
Brain volume lossAdverse events, laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating Scale (C-SSRS)
Safety
Who could take part
Progressive MS · 18 to 65
Inclusion Criteria: * Signed informed consent must be obtained prior to any assessment performed. * Male or female participants aged 18-65 (inclusive) at Screening. * Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018), with current SPMS in accordance with the revised clinical course (Lublin et al 2014) 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. Exclusion Criteria: * 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'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), 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. Other protocol-defined inclusion/exclusion critria may apply
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)
Papers
Loading reviews and guidelines…
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History
Started
Nov 2025
Main results due
Dec 2030
Finished
Jan 2034
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