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Remibrutinib after switching from ocrelizumab for relapsing multiple sclerosis

A Randomized, Open-label, Parallel-group, Non-inferiority Study Comparing Efficacy, Safety, and Tolerability of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis, Followed by Open-label Treatment With Remibrutinib

Phase 3 Interventional Novartis · NCT06846281

This study will see if remibrutinib, a daily oral BTK inhibitor, keeps relapsing MS under control in people switching from ocrelizumab compared with continuing ocrelizumab.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment360 (estimated)
Ages40 Years to 70 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsocrelizumab, remibrutinib
Locations102 sites (Scottsdale, Arizona and 101 other locations)
Trial IDNCT06846281 on ClinicalTrials.gov

What this trial studies

This randomized, open-label, phase 3b non-inferiority study randomizes people with relapsing MS who are being treated with ocrelizumab to either switch to oral remibrutinib or continue standard-dose ocrelizumab. The Core Part follows participants for up to 24 months to collect efficacy, safety and tolerability data, and eligible participants may join a 24-month open-label extension where all receive remibrutinib. Key inclusion criteria include age 40–70, a relapsing MS diagnosis by 2017 McDonald criteria, neurological stability, and suitability to switch from ocrelizumab, while key exclusions include primary progressive MS, active serious infections, prior PML, major immune or cardiac comorbidities, or inability to undergo MRI. The trial is conducted at multiple centers globally, including sites in the United States, and is sponsored by Novartis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40–70 with relapsing MS (2017 McDonald criteria) who are currently treated with ocrelizumab, neurologically stable, and judged suitable by their physician to switch.

Not a fit: Patients with primary progressive MS, active significant infections, prior PML, other major immune or cardiac diseases, or those unable to undergo MRI are unlikely to be eligible or to benefit from switching in this study.

Why it matters

Potential benefit: If successful, remibrutinib could provide an effective oral alternative to infused ocrelizumab, improving convenience while maintaining disease control.

How similar studies have performed: Other BTK inhibitors and earlier-phase MS studies have shown encouraging MRI and relapse signals, but definitive phase 3 evidence that remibrutinib can substitute for ocrelizumab is still pending.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* 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

Key Exclusion Criteria:

* 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

Other inclusion and exclusion criteria may apply

Where this trial is running

Scottsdale, Arizona and 101 other locations

+52 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsing Multiple SclerosisMSRMSRemibrutinibLOU064OcrelizumabAgeMRI
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.