A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

NCT07225504
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,275
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Lead sponsor
Novartis Pharmaceuticals
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Start date
2025-11-11
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Number of sites
256
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Summary
The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)
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Acronym
REMASTER
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Short title
A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis
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Official title
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2034-01-02
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First posted
2025-11-06
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Registry last updated
2026-07-29
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Primary completion date
2030-12-03
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Start date
2025-11-11
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Participants
1,275
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Participant count basis
Estimated
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Planned participants
1,275
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Protocol amendments
1
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Number of sites
256
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Novartis Pharmaceuticals
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07225504
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ClinicalTrials.gov ID
NCT07225504
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masking description
Double blind on Core part and Open label on Extension part
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS)

    Timeframe: 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.

  1. Time to 3-month confirmed disability progression (3mCDP) on EDSS

    Timeframe: 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)). 3mCDP is defined as an increase from baseline in EDSS sustained for at least 3 months.

  2. Time to 6-month confirmed disability improvement (6mCDI) on EDSS

    Timeframe: 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)). A 6mCDI is defined as a decrease from baseline in EDSS sustained for at least 6 months.

  3. Time to 3-month worsening by at least 20% in Timed 25-Foot Walk (T25FW)

    Timeframe: From baseline up to approximately 5 years

    The T25FW is an ambulation measurement assessing speed of walking: a timed (in seconds) walk of 25 feet (7.62 meters). Longer time indicates poorer lower limb function. 3-month worsening by at least 20% in T25FW is defined as an increase from baseline in T25FW of at least 20% sustained for at least 3 months.

  4. Time to 3-month worsening by at least 20% in 9-Hole Peg Test (9-HPT)

    Timeframe: From baseline up to approximately 5 years

    The 9-HPT is an objective quantitative test of neurological function. It is measured to assess both right and left arm scores, the metric is the time, in seconds, required to insert and remove 9 pegs. Longer time indicates poorer upper limb function. A 3-month worsening by at least 20% in 9-HPT is defined as an increase from baseline in 9-HPT of at least 20% sustained for at least 3 months

  5. Annualized rate of new or enlarging T2 lesions

    Timeframe: From baseline up to approximately 5 years

    Number of new or enlarging T2 lesions per year based on MRI

  6. Annualized rate of brain atrophy

    Timeframe: From baseline up to approximately 5 years

    Percentage change in brain volume relative to baseline per year based on MRI assessments

  7. Time to 6-month worsening by at least 4 points in Symbol Digit Modalities Test (SDMT)

    Timeframe: From baseline up to approximately 5 years

    The SDMT is a sensitive and specific test to assess information processing speed which is typically affected in cognitively impaired MS participants, The test scoring is calculated based on the number of correct answers in 90 seconds. A 6-month worsening by at least 4 points in SDMT is defined as an increase from baseline in SDMT of at least 4 points sustained for at least 6 months.

  8. Number of participants with Adverse events and Serious adverse events (SAE)

    Timeframe: From baseline up to approximately 5 years

    Incidence of adverse events including changes in laboratory data, vital signs, electrocardiogram (ECG) and Columbia Suicide Severity Rating Scale (C-SSRS) qualifying and reported as AEs.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No

  • 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.

  • 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

Sources for eligibility
clinicaltrials.gov

  • Alabama Neurology Associates PCBirmingham, United StatesRecruiting
  • Ctr for Neurology and SpinePhoenix, United StatesRecruiting
  • AZ Integrated Neuro and SpinePhoenix, United StatesRecruiting
  • Center for NeurosciencesTucson, United StatesRecruiting
  • Fullerton Neuro and Headache CtrFullerton, United StatesRecruiting
  • Regina Berkovich MD PhD IncWest Hollywood, United StatesRecruiting
  • UC Health Neuroscience CtrAurora, United StatesRecruiting
  • Georgetown University HospitalWashington D.C., United StatesRecruiting
  • Medstar Washington Hosp CtrWashington D.C., United StatesRecruiting
  • Neurology of Central FL Res CtrAltamonte Springs, United StatesRecruiting
  • UF Health Cancer CenterGainesville, United StatesRecruiting
  • Homestead Assoc In Research IncHomestead, United StatesRecruiting
  • Neurology Associates PAMaitland, United StatesRecruiting
  • Miami NS Ins Baptist Health S FLMiami, United StatesRecruiting
  • Aqualane Clinical ResearchNaples, United StatesRecruiting
  • Orlando Health Clinical TrialsOrlando, United StatesRecruiting
  • Comprehensive Neurology ClinicOrlando, United StatesRecruiting
  • Neurology Associates of Ormond BeachOrmond Beach, United StatesRecruiting
  • Axiom Brain HealthTampa, United StatesRecruiting
  • University Of South FloridaTampa, United StatesRecruiting
  • Joi Life Wellness Group LLCSmyrna, United StatesRecruiting
  • Hawaii Pacific Neuroscience LLCHonolulu, United StatesRecruiting
  • Northwestern Memorial HospitalChicago, United StatesRecruiting
  • University of Kansas HospitalKansas City, United StatesRecruiting
  • Mid Atlantic Epilepsy and Sleep CtrBethesda, United StatesRecruiting

And 231 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-521546-23
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (3)