NCT07225504 · Novartis Pharmaceuticals
A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis
(REMASTER)
What this study is about
The purpose of this study is to provide effectiveness and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)
View original scientific description
The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)
Interventions
DRUG
Remibrutinib (blinded)
Remibrutinib (Blinded) active treatment, oral tablet
DRUG
Placebo
Matching placebo (binded), oral tablet
DRUG
Remibrutinib (Open label)
Remibrutinib (Open Label), oral tablet
Primary outcome measures
Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS)
Time frame: From baseline up to approximately 5 years
The EDSS is an ordinal scale used for assessing neurologic impairment in MS based on a neurological examination. It consists of scores in each of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). 6mCDP is defined as an increase from baseline in EDSS sustained for at least 6 months.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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.
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), 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. Other protocol-defined inclusion/exclusion critria may apply
Where
- Birmingham, Alabama
- Phoenix, Arizona
- Tucson, Arizona
- Fullerton, California
- West Hollywood, California
- Aurora, Colorado
- Washington D.C., District of Columbia
- Altamonte Springs, Florida
- Gainesville, Florida
- Homestead, Florida
- Maitland, Florida
- Miami, Florida
And 19 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 29, 2026 · Source of record for eligibility and locations