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Study comparing remibrutinib and ocrelizumab in patients with relapsing multiple sclerosis who switch from ocrelizumab treatment

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This study focuses on people with Relapsing Multiple Sclerosis, a condition where the immune system attacks the protective covering of nerve cells, causing episodes of neurological symptoms. The study compares two medications: remibrutinib, a new oral medication that works by blocking a specific protein called Bruton's tyrosine kinase, and ocrelizumab, an existing treatment that is given either through an infusion into a vein or as an injection under the skin.

The main purpose of this research is to determine if remibrutinib is as effective as ocrelizumab in controlling disease activity as seen on magnetic resonance imaging (MRI) scans. The study will look at patients who are currently using ocrelizumab and switch them to either continue ocrelizumab or start taking remibrutinib. The study will track participants' progress for 24 months to compare how well both treatments work.

During the study, participants will receive either remibrutinib tablets taken by mouth or ocrelizumab given through injection or infusion. Doctors will monitor participants' health through regular check-ups and MRI scans to track any changes in their condition. After the initial 24-month comparison period, all participants will have the opportunity to receive remibrutinib for an extended period.

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

    Initial screening and baseline assessment

    A medical evaluation will be performed to confirm eligibility for the study

    An MRI scan will be taken to establish baseline brain imaging

    Your current multiple sclerosis status will be assessed

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either remibrutinib (taken as oral tablets) or continue ocrelizumab treatment

    If assigned to remibrutinib, you will switch from your current ocrelizumab treatment to taking tablets by mouth

    If assigned to ocrelizumab, you will continue receiving it through intravenous (into the vein) or subcutaneous (under the skin) injection

  3. Step 3

    24-month main study period

    Regular medical assessments will monitor your health status

    MRI scans will track any changes in brain lesions

    Your physical abilities will be evaluated to check for any changes in disability

    Blood tests, vital signs checks, and heart monitoring (ECG) will be performed

    Any symptoms or health changes will be recorded

  4. Step 4

    Extension period

    After the main study period, you may continue in an extension phase

    During this time, monitoring will continue with regular health assessments

    MRI scans will continue to track brain lesions

    Safety monitoring will include blood tests, vital signs, and heart activity checks

Who can join the trial?

8 criteria

  • Must sign an informed consent form before any study procedures begin
  • Must be 40 years or older at the time of screening
  • Must have a confirmed diagnosis of relapsing multiple sclerosis (RMS) according to the 2017 McDonald criteria
  • Must be currently receiving treatment with ocrelizumab (a medication used to treat multiple sclerosis) at standard doses as part of regular medical care
  • Must be neurologically stable for at least 30 days before screening, which means:
    • No MS relapses (periods when symptoms get worse) during this time
    • No significant changes in neurological symptoms
    • Must be considered suitable by their doctor to switch to the study medication remibrutinib, or have a personal preference to make this change
    • Both men and women can participate in the study

Who cannot join the trial?

15 criteria

  • History of other neurological conditions besides multiple sclerosis
  • Current pregnancy or breastfeeding
  • Severe allergic reactions to similar medications in the past
  • Active serious infections, including hepatitis B or tuberculosis
  • Significant heart problems or uncontrolled high blood pressure
  • History of cancer in the past 5 years (except for successfully treated skin cancer)
  • Severe liver problems or abnormal liver function tests
  • Severe kidney problems or abnormal kidney function
  • Recent live vaccinations (within 6 weeks before starting treatment)
  • Current participation in other clinical trials
  • Inability to undergo MRI scans (magnetic resonance imaging - a type of medical imaging that uses magnetic fields)
  • History of drug or alcohol abuse within the past 6 months
  • Mental health conditions that could interfere with following study procedures
  • Taking medications that could interact with the study drug
  • Blood disorders or significant abnormalities in blood tests
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Investigated drugs

  • Remibrutinib

    is a medication being studied for treating relapsing multiple sclerosis. It belongs to a class of drugs known as BTK inhibitors, which work by blocking specific proteins involved in inflammation. This medication aims to control the inflammatory activity in the brain and spinal cord of people with multiple sclerosis.

  • Ocrelizumab

    is an established medication used to treat relapsing multiple sclerosis. It works by targeting and reducing specific B cells in the immune system that are thought to contribute to nerve damage in multiple sclerosis. It is given through an intravenous infusion and is currently used as a standard treatment for multiple sclerosis.

What is already known about the treatment

  • Remibrutinib

    A novel oral BTK (Bruton's tyrosine kinase) inhibitor administered in tablet form that is currently being investigated for the treatment of relapsing multiple sclerosis. This medication works by blocking specific enzymes involved in B-cell development and inflammatory processes, potentially reducing the immune system's attack on nerve cells. It belongs to the class of targeted immunotherapy drugs and represents a new approach in MS treatment, offering the convenience of oral administration compared to traditional injectable therapies.

  • Ocrelizumab

    An intravenously administered monoclonal antibody approved for treating relapsing and primary progressive forms of multiple sclerosis. This medication works by targeting and eliminating specific B cells (CD20-positive) that contribute to nerve damage in multiple sclerosis, reducing inflammation and disease progression. It belongs to the class of biological disease-modifying therapies and is typically administered every six months under medical supervision in an infusion center.

Investigated diseases

Multiple Sclerosis (Relapsing) - A chronic neurological condition where the immune system attacks the protective covering of nerve fibers in the central nervous system. In the relapsing form, people experience distinct episodes of symptoms followed by periods of partial or complete recovery. During relapses, inflammation causes new damage to nerve cells, leading to various symptoms such as vision problems, muscle weakness, and coordination difficulties. Between relapses, patients may feel relatively well, though some symptoms might persist. The disease typically follows a pattern where new symptoms appear or existing ones worsen during relapses, which can last days to weeks.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509275-17-00Protocol codeCLOU064C12306Estimated enrolment400 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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