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Remibrutinib for Relapsing Multiple Sclerosis

This study is looking at a new daily pill, remibrutinib, for people with relapsing multiple sclerosis (RMS). It compares remibrutinib to ocrelizumab, which is given as an infusion or injection. The main goal is to see if switching from ocrelizumab to remibrutinib is as effective and safe as continuing ocrelizumab. Researchers will measure the annual rate of new or growing T2 lesions (areas of damage in the brain or spinal cord seen on MRI) over 24 months to see if the treatment is successful. You might be able to join if you are 40 to 70 years old, have RMS, are currently taking ocrelizumab, and your doctor thinks switching to remibrutinib is a good option for you. The study is currently recruiting participants.

Study design
This is a randomized, open-label (meaning you and your doctor will know which treatment you are receiving) Phase 3b study involving about 360 participants. It compares remibrutinib to continuous ocrelizumab treatment.
What's involved
The study involves an initial Core Part lasting up to 24 months. If eligible, you may then continue in an Extension Part for up to another 24 months, taking remibrutinib.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured from the start of the study up to month 24. Participants may continue in an Extension Part for up to 24 months after the Core Part.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06846281

Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.

Recruiting
PHASE3Ages 40–70InterventionalTreatment
Novartis Pharmaceuticals
~400 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Remibrutinib oral treatmentOcrelizumab

At a glance

Recruiting sites
126 of 129 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Annualized rate of new or enlarging T2 lesions_Core Part
Measured over Baseline up to month 24

Conditions

Relapsing Multiple Sclerosis

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NCT06846281

Where you'd take part

This study runs at 129 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Advent Health Orlando

    Orlando, Floridastudy coordinator listed

    Recruiting

  • Aqualane Clinical Research

    Naples, Floridastudy coordinator listed

    Recruiting

  • Austin Regional Clinic

    Austin, Texasstudy coordinator listed

    Recruiting

  • Center for Neurological Disorders G

    Greenfield, Wisconsinstudy coordinator listed

    Recruiting

  • Cleveland Clinic Foundation

    Las Vegas, Nevadastudy coordinator listed

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohiostudy coordinator listed

    Recruiting

  • Elite Clinical Research

    Miami, Floridastudy coordinator listed

    Recruiting

  • Holy Name Medical Center

    Teaneck, New Jerseystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

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Eligibility criteria

Inclusion

Male or female aged 40 to 70 years (inclusive)
Diagnosis of RMS according to the 2017 McDonald diagnostic criteria
Treated with ocrelizumab according to routine clinical practice and at standard dose
Neurologically stable within 30 days
Suitable to be switched to remibrutinib based on physician judgement or patient preference

Exclusion

Diagnosis of primary progressive multiple sclerosis (PPMS) according to the revised 2017 McDonald criteria
History of clinically significant Central Nervous System disease or neurological disorders
History of confirmed Progressive Multifocal Leukoencephalopathy or neurological symptoms consistent
Active clinically significant systemic bacterial, viral, parasitic or fungal infections
Active, chronic disease of the immune system other than MS
Severe cardiac disease or significant findings on the ECG
Participant who is unable to undergo MRI scans
History of life-threatening infusion or injection reaction related to ocrelizumab
Participants not adequately controlled on ocrelizumab (CD19+ B-cell count ≥10 cells/µL at screening)

What this trial measures

  • Annualized rate of new or enlarging T2 lesions_Core PartBaseline up to month 24

    Number of new/enlarging T2 lesions per year on MRI at month 24 (relative to baseline)