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NCT Number: NCT07225504

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

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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Key information

Conditions

Secondary Progressive Multiple Sclerosis (SPMS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Capital Federal, Buenos Aires, Argentina

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About this study

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, parallel-group, event-driven study to evaluate the efficacy, safety and tolerability of remibrutinib in SPMS patients. Approximately 1275 eligible participants will be randomized to receive either remibrutinib or matching placebo.

The study consists of an event-driven Core Part with double-blind treatment, followed by an Extension Part with open-label remibrutinib treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remibrutinib (blinded)

Drug

Remibrutinib (Blinded) active treatment, oral tablet

Other names: LOU064

Placebo

Drug

Matching placebo (binded), oral tablet

Remibrutinib (Open label)

Drug

Remibrutinib (Open Label), oral tablet

Other names: LOU064

Primary outcomes

  1. 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.

Secondary outcomes

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

    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

    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)).

    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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

1-888-669-6682

Novartis Pharmaceuticals

CONTACT

+41613241111

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: REMASTER

Important dates

Study start
2025
Primary completion
2030
Study completion
2034
First posted
Nov 6, 2025
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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