A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis
REMASTER
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis
2 other identifiers
interventional
1,275
30 countries
231
Brief Summary
The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2025
Longer than P75 for phase_3
231 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2025
CompletedFirst Posted
Study publicly available on registry
November 6, 2025
CompletedStudy Start
First participant enrolled
November 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 3, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 2, 2034
July 29, 2026
July 1, 2026
5.1 years
November 4, 2025
July 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS)
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.
From baseline up to approximately 5 years
Secondary Outcomes (8)
Time to 3-month confirmed disability progression (3mCDP) on EDSS
From baseline up to approximately 5 years
Time to 6-month confirmed disability improvement (6mCDI) on EDSS
From baseline up to approximately 5 years
Time to 3-month worsening by at least 20% in Timed 25-Foot Walk (T25FW)
From baseline up to approximately 5 years
Time to 3-month worsening by at least 20% in 9-Hole Peg Test (9-HPT)
From baseline up to approximately 5 years
Annualized rate of new or enlarging T2 lesions
From baseline up to approximately 5 years
- +3 more secondary outcomes
Study Arms (2)
Remibrutinib (LOU064)
EXPERIMENTALCore Part: Remibrutinib film-coated tablet taken orally \[Extension Part: Open-label remibrutinib film-coated tablet taken orally\]
Placebo
PLACEBO COMPARATORCore Part: Matching placebo film-coated tablet taken orally \[Extension Part: Open-label remibrutinib film-coated tablet taken orally\]
Interventions
Remibrutinib (Blinded) active treatment, oral tablet
Remibrutinib (Open Label), oral tablet
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (256)
Alabama Neurology Associates PC
Birmingham, Alabama, 35209, United States
Ctr for Neurology and Spine
Phoenix, Arizona, 85018, United States
AZ Integrated Neuro and Spine
Phoenix, Arizona, 85037, United States
Center for Neurosciences
Tucson, Arizona, 85718, United States
Fullerton Neuro and Headache Ctr
Fullerton, California, 92835, United States
Regina Berkovich MD PhD Inc
West Hollywood, California, 90048, United States
UC Health Neuroscience Ctr
Aurora, Colorado, 80045, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Medstar Washington Hosp Ctr
Washington D.C., District of Columbia, 20010, United States
Neurology of Central FL Res Ctr
Altamonte Springs, Florida, 32714, United States
UF Health Cancer Center
Gainesville, Florida, 32610, United States
Homestead Assoc In Research Inc
Homestead, Florida, 33033, United States
Neurology Associates PA
Maitland, Florida, 32751, United States
Miami NS Ins Baptist Health S FL
Miami, Florida, 33176, United States
Aqualane Clinical Research
Naples, Florida, 34105, United States
Orlando Health Clinical Trials
Orlando, Florida, 32806, United States
Comprehensive Neurology Clinic
Orlando, Florida, 32825, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, 32174, United States
Axiom Brain Health
Tampa, Florida, 33609, United States
University Of South Florida
Tampa, Florida, 33612, United States
Joi Life Wellness Group LLC
Smyrna, Georgia, 30080, United States
Hawaii Pacific Neuroscience LLC
Honolulu, Hawaii, 96817, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
University of Kansas Hospital
Kansas City, Kansas, 66160, United States
Mid Atlantic Epilepsy and Sleep Ctr
Bethesda, Maryland, 20817-1807, United States
Neuro Institute of New England P C
Foxborough, Massachusetts, 02035, United States
Elliot Lewis MS Center
Wellesley, Massachusetts, 02481, United States
U Mass Memorial Medical Center
Worchester, Massachusetts, 01605, United States
Michigan Institute of Neurological
Farmington Hills, Michigan, 48334, United States
University of New Mexico Hospital
Albuquerque, New Mexico, 87106, United States
Premier Neurology
Greenville, South Carolina, 29605, United States
Neurology Clinic PC
Cordova, Tennessee, 38018, United States
Carum Research
Dallas, Texas, 75231, United States
Saturn Research Solution
Plano, Texas, 75024, United States
Citta Clinical Research
Spokane, Washington, 99202, United States
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Capital Federal, Buenos Aires, 1424, Argentina
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Buenos Aires, Buenos Aires F.D., 1221, Argentina
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Bombal, Mendoza Province, M5500DXO, Argentina
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San Juan, San Juan Province, J5402DIL, Argentina
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Rosario, Santa Fe Province, 2000, Argentina
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Rosario, Santa Fe Province, S2000DSW, Argentina
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Santiago del Estero, Santiago del Estero Province, G4200AIR, Argentina
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San Miguel de, Tucumán Province, T4000, Argentina
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MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double blind on Core part and Open label on Extension part
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
November 4, 2025
First Posted
November 6, 2025
Study Start
November 11, 2025
Primary Completion (Estimated)
December 3, 2030
Study Completion (Estimated)
January 2, 2034
Last Updated
July 29, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com