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Study on the Effectiveness and Safety of Remibrutinib Compared to Teriflunomide for Patients with Relapsing Multiple Sclerosis

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What is this trial about?

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

This clinical trial is focused on studying the effects of a new treatment for Multiple Sclerosis (MS), a condition that affects the brain and spinal cord, leading to a range of symptoms such as fatigue, difficulty walking, and vision problems. The study compares the effectiveness and safety of a medication called remibrutinib with another medication known as teriflunomide. Remibrutinib is a new drug that works by targeting specific proteins in the body to reduce inflammation, while teriflunomide is an existing treatment that helps to modulate the immune system and reduce inflammation.

The purpose of this study is to determine if remibrutinib is more effective than teriflunomide in reducing the frequency of relapses in people with relapsing forms of MS. Participants in the study will be randomly assigned to receive either remibrutinib, teriflunomide, or a placebo, which is a substance with no active medication. The study will begin with a period where participants receive either remibrutinib or teriflunomide, followed by an extended treatment phase where all participants will receive remibrutinib. This approach helps researchers understand the long-term effects of remibrutinib on MS.

Throughout the study, participants will take the medications orally, and their health will be monitored regularly to assess the impact of the treatments. The study aims to provide valuable information on how well remibrutinib works compared to teriflunomide and to ensure the safety of participants. By participating in this study, researchers hope to find a more effective treatment option for those living with relapsing MS.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Participants are randomly assigned to receive either remibrutinib or teriflunomide. This process ensures that each participant has an equal chance of receiving either treatment.

  2. Step 2

    Treatment phase

    Participants receive their assigned treatment. If assigned to remibrutinib, the dosage is 100 mg in the form of a film-coated tablet, taken orally. If assigned to teriflunomide, the dosage is 14 mg in the form of a hard capsule, also taken orally.

    The treatment is administered daily. The duration of this phase is not specified in the provided data.

  3. Step 3

    Monitoring and assessment

    Participants undergo regular monitoring to assess the effectiveness and safety of the treatment. This includes tracking the annualized relapse rate (ARR) of confirmed relapses and other health indicators.

    Additional assessments may include MRI scans to evaluate the number of new or enlarging T2 lesions, and blood tests to measure neurofilament light chain (NfL) concentration.

  4. Step 4

    Extended treatment phase

    Participants may enter an extended treatment phase with open-label remibrutinib. This means all participants will receive remibrutinib regardless of their initial assignment.

    The specific duration of this phase is not detailed in the provided data.

  5. Step 5

    Completion and follow-up

    Upon completion of the treatment phases, participants may undergo final assessments to evaluate long-term outcomes and any potential side effects.

    The trial is estimated to conclude by October 30, 2030.

Who can join the trial?

8 criteria

  • The patient must provide a signed informed consent before any assessments are done.
  • The patient must be between 18 and 55 years old.
  • The patient must have a diagnosis of **RMS**. RMS stands for **Relapsing Multiple Sclerosis**, which is a type of multiple sclerosis where symptoms come and go.
  • The patient must have had at least one of the following:
    • One documented relapse in the past year.
    • Two documented relapses in the past two years.
    • One active **Gadolinium-enhancing lesion** in the past year. This is a type of brain scan finding that shows active inflammation.
    • The patient must have an **EDSS score** between 0 and 5.5. The **EDSS** is a scale used to measure disability in people with multiple sclerosis.
    • The patient must be neurologically stable for at least one month before the screening and randomization. This means no new or worsening symptoms of multiple sclerosis during this time.

Who cannot join the trial?

5 criteria

  • Patients who have a different condition than Multiple Sclerosis cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial group cannot participate.
  • Patients who are not male or female cannot participate.
  • Patients who are considered part of a vulnerable population cannot participate.
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Investigated drugs

  • Remibrutinib

    is a medication being studied for its potential to reduce the frequency of relapses in people with relapsing multiple sclerosis. It is being compared to another medication to see if it is more effective in managing the symptoms of this condition.

  • Teriflunomide

    is a medication currently used to treat relapsing multiple sclerosis. It works by reducing inflammation and slowing down the immune system's attack on the nervous system, which can help decrease the number of relapses experienced by patients.

What is already known about the treatment

  • Remibrutinib

    Remibrutinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating relapsing multiple sclerosis. It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for remibrutinib is to reduce the frequency of confirmed relapses in multiple sclerosis patients. At the molecular level, remibrutinib works by inhibiting Bruton's tyrosine kinase, which plays a role in the immune response. It is classified as a kinase inhibitor.

  • Teriflunomide

    Teriflunomide is an oral medication that is already approved and used in the treatment of relapsing forms of multiple sclerosis. It is well-documented in medical literature and is commonly prescribed to help reduce the frequency of relapses. Teriflunomide works by inhibiting the enzyme dihydroorotate dehydrogenase, which is involved in the proliferation of activated lymphocytes. It is classified as an immunomodulatory agent.

Investigated diseases

Multiple Sclerosis – Multiple Sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It is characterized by the immune system mistakenly attacking the protective sheath (myelin) that covers nerve fibers, leading to communication problems between the brain and the rest of the body. Over time, the disease can cause permanent damage or deterioration of the nerves themselves. Symptoms vary widely and can include fatigue, difficulty walking, numbness or tingling, muscle weakness, and problems with coordination and balance. The progression of the disease can be unpredictable, with periods of remission and relapses. The severity and specific symptoms can differ greatly from person to person.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509372-41-00Protocol codeCLOU064C12302Estimated enrolment1 058 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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