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A study to evaluate the effectiveness and safety of remibrutinib in patients with secondary progressive multiple sclerosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is being conducted to evaluate the effectiveness and safety of a medication called remibrutinib, also referred to by the code name LOU064, in individuals living with secondary progressive multiple sclerosis. This condition is a type of autoimmune disease where the body's immune system attacks the protective covering of nerves, leading to a gradual worsening of physical and cognitive functions over time.

Participants in this trial will receive either the study drug, remibrutinib, in the form of a film-coated tablet taken by mouth, or a placebo. The purpose of the study is to determine if this treatment can help delay the progression of disability. During the study, individuals will be monitored over a period of time to observe how the medication affects their physical abilities and overall health.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in the study

    The study involves receiving either the test medication, known as remibrutinib, or a placebo. a placebo is a pill that looks, tastes, and smells like the actual medication but contains no active medicine.

    The medication is provided in the form of a film-coated tablet and is taken by mouth.

  2. Step 2

    Monitoring disability and progression

    The effectiveness of the treatment is measured by tracking changes in physical disability using a scale called the expanded disability status scale (edss), which assesses how much the condition affects physical functions.

    Changes in disability are monitored over 3-month and 6-month periods to confirm if the condition is progressing or improving.

  3. Step 3

    Physical and cognitive assessments

    Physical performance is evaluated through specific tests, including a timed 25-foot walk to measure walking speed and a 9-hole peg test to measure hand dexterity and finger coordination.

    Cognitive function is monitored using the symbol digit modalities test (sdmt), which checks the ability to process information quickly.

    Brain changes are tracked by looking for new or growing t2 lesions (areas of damage seen on brain scans) and measuring the rate of brain atrophy, which is the shrinking of brain tissue.

  4. Step 4

    Safety monitoring

    Regular safety checks are conducted, including laboratory tests (blood work), monitoring of vital signs (such as blood pressure and heart rate), and an electrocardiogram (ecg) to check heart activity.

    The columbia suicide severity rating scale (c-ssrs) is used to monitor mood and mental well-being.

Who can join the trial?

7 criteria

  • You must provide a signed informed consent, which is a formal document where you agree to join the study after understanding all the details.
  • You must be a man or a woman between the ages of 18 and 65 at the time of the initial screening.
  • You must have a diagnosis of secondary progressive multiple sclerosis (SPMS), which is a stage of multiple sclerosis where symptoms gradually worsen over time.
  • Your diagnosis must meet the 2017 revised McDonald criteria, which is a specific set of medical rules used by doctors to confirm a diagnosis of multiple sclerosis.
  • You must not have had any clinical relapses, which are sudden increases in symptoms or new neurological problems, in the 24 months before starting the study.
  • Your EDSS score must be between 3.0 and 6.0. The Expanded Disability Status Scale (EDSS) is a method used by doctors to measure how much disability a person with multiple sclerosis has.
  • There must be documented proof that your disability has progressed, meaning your physical limitations have become more noticeable or severe, within the 12 months before the screening.

Who cannot join the trial?

8 criteria

  • You are unwilling or unable to have MRI scans, which are detailed pictures of the inside of your body taken with a large magnet. This includes people with claustrophobia (an extreme fear of enclosed spaces) or those with metallic implants, metallic foreign bodies, pacemakers, or defibrillators (devices implanted in the chest to control heart rhythm) that make it unsafe to be near a strong magnet.
  • You have a history of serious central nervous system (CNS) disease, which refers to issues with the brain or spinal cord, such as a stroke, a traumatic brain or spinal injury, or myelopathy (damage to the spinal cord).
  • You have other neurological disorders (problems with the brain or nervous system) that might look like multiple sclerosis (MS) during the initial health check.
  • You are currently struggling with substance abuse, such as drugs or alcohol, or have a serious psychiatric condition (a mental health disorder) that might make it difficult for you to follow the study rules.
  • You have a history of, or show symptoms of, Progressive Multifocal Leukoencephalopathy (PML), which is a rare and serious infection that affects the brain.
  • You are a woman who is capable of becoming pregnant and are not using highly effective contraception (birth control methods with a failure rate of less than 1% per year) while taking the study medicine and for at least one week after stopping it.
  • You have a high bleeding risk or coagulation disorders, which are conditions that prevent your blood from clotting properly.
  • You are using any of the specific exclusionary medications (medicines that are not allowed for this study) listed in the study rules.
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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

  • Amsterdam UMC

    Responsive

    The NetherlandsAmsterdam, The Netherlands

  • CHRU De Nancy

    Responsive

    FranceVandoeuvre Les Nancy, France

  • KBC Zagreb

    Responsive

    CroatiaZagreb, Croatia

Trial locations

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Investigated drugs

Remibrutinib is an oral tablet being tested to see if it can help slow down the progression of physical disability in people living with secondary progressive multiple sclerosis.

What is already known about the treatment

Remibrutinib - This medication is taken by mouth in the form of a film-coated tablet. Currently being studied in late-stage clinical trials, it is being investigated for its ability to treat secondary progressive multiple sclerosis. It works by blocking a specific protein called Bruton's tyrosine kinase, which helps reduce the harmful activity of certain immune cells that attack the nervous system. This drug belongs to a class of medications known as Bruton's tyrosine kinase inhibitors.

Investigated diseases

Secondary progressive multiple sclerosis - This is a form of multiple sclerosis characterized by a steady worsening of neurological functions over time. It typically follows an initial period of clearly defined attacks or episodes of neurological symptoms. Unlike other forms, the physical or cognitive impairments gradually increase without distinct periods of recovery. The progression involves ongoing damage to the protective covering of nerve fibers in the central nervous system. This damage can lead to difficulties with movement, coordination, and sensation.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521546-23-00Protocol codeCLOU064P12301Estimated enrolment1 285 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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