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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 two treatments for Multiple Sclerosis, a disease that affects the brain and spinal cord, leading to symptoms like fatigue, difficulty walking, and vision problems. The study compares the effectiveness and safety of a new medication called remibrutinib with an existing treatment known as teriflunomide. Participants will receive either remibrutinib or teriflunomide, and some may receive a placebo, which looks like the real medication but does not contain the active ingredient.

The purpose of the study is to determine if remibrutinib is better than teriflunomide in reducing the number of relapses, which are periods when symptoms of multiple sclerosis suddenly get worse. The study will begin with a period where participants are randomly assigned to receive either remibrutinib or teriflunomide. After this initial phase, all participants will have the opportunity to receive remibrutinib for an extended period. This approach helps researchers understand the long-term effects of remibrutinib on multiple sclerosis.

Throughout the study, participants will take their assigned medication by mouth, and their health will be monitored regularly. This includes checking for any new symptoms, changes in their condition, and any side effects from the medication. The study aims to provide valuable information about how well remibrutinib works compared to teriflunomide and to ensure the safety of participants while they are taking these medications.

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

    Upon joining the study, participants are randomly assigned to one of two groups. This process is called randomization and ensures that each participant has an equal chance of receiving either the study medication or the comparison medication.

  2. Step 2

    Initial treatment phase

    Participants receive either remibrutinib or teriflunomide. Remibrutinib is administered as a 100 mg film-coated tablet taken orally. Teriflunomide is given as a 14 mg capsule, also taken orally.

    The purpose of this phase is to compare the effectiveness and safety of remibrutinib against teriflunomide in reducing the frequency of relapses in individuals with relapsing multiple sclerosis.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, participants undergo regular monitoring and assessments. These include evaluations of disability progression, the number of new or enlarging lesions on MRI scans, and other health indicators.

    Participants' blood samples are collected to measure the concentration of neurofilament light chain, a marker of nerve damage, and remibrutinib levels.

  4. Step 4

    Extended treatment phase

    After the initial treatment phase, all participants receive open-label remibrutinib. This means that both the participants and the researchers know that remibrutinib is being administered.

    The extended treatment phase allows for the long-term evaluation of remibrutinib's safety and effectiveness.

  5. Step 5

    Completion and follow-up

    The trial is expected to conclude by October 2030. Upon completion, participants may undergo final assessments to evaluate the overall impact of the treatment.

    Follow-up procedures may be conducted to monitor participants' health and gather additional data on the long-term effects of the treatment.

Who can join the trial?

8 criteria

  • Participants must provide a signed informed consent before any study-related assessments are done.
  • Participants can be male or female and must be between 18 and 55 years old at the time of screening.
  • Participants must have a diagnosis of **RMS** (Relapsing Multiple Sclerosis) according to the 2017 McDonald diagnostic criteria. This includes **RRMS** (Relapsing-Remitting Multiple Sclerosis) or active **SPMS** (Secondary Progressive Multiple Sclerosis).
  • Participants must have had at least one of the following:
    • 1 documented relapse in the past year,
    • 2 documented relapses in the past 2 years,
    • 1 active **Gadolinium (Gd)-enhancing lesion** in the past 12 months. A Gadolinium-enhancing lesion is a spot on an MRI scan that shows active inflammation in the brain.
    • Participants must have an **EDSS score** between 0 and 5.5 at screening and randomization. The EDSS score is a way to measure disability in people with Multiple Sclerosis.
    • Participants must be neurologically stable for at least 1 month before screening and randomization, meaning no MS relapses 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 considered part of a vulnerable population may not be eligible.
  • Patients who do not meet other specific criteria set by the study may not be eligible.
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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 treatment 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 in tablet form. It is currently being studied in clinical trials for its effectiveness in treating relapsing multiple sclerosis. The main therapeutic indication is to reduce the frequency of confirmed relapses in patients with this condition. At the molecular level, remibrutinib works by inhibiting Bruton's tyrosine kinase, which plays a role in the activation of immune cells that contribute to the disease process. It is classified as a kinase inhibitor.

  • Teriflunomide

    Teriflunomide is also taken orally in tablet form. It is an established medication used in the treatment of relapsing forms of multiple sclerosis. The primary therapeutic indication is to decrease the frequency of relapses and slow the progression of physical disability. Teriflunomide works by inhibiting the enzyme dihydroorotate dehydrogenase, which is involved in the proliferation of activated lymphocytes, thereby modulating the immune response. 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 covering of nerve fibers, leading to communication problems between the brain and the rest of the body. Over time, this can cause permanent damage or deterioration of the nerves themselves. The disease often presents with symptoms such as fatigue, difficulty walking, numbness or tingling, muscle weakness, and problems with coordination and balance. The progression of Multiple Sclerosis can vary widely among individuals, with some experiencing mild symptoms and others facing more severe challenges. The course of the disease can include periods of relapses and remissions, or it may progress steadily over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509345-12-00Protocol codeCLOU064C12301Estimated enrolment1 009 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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