Last Update: Aug 10, 2026 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 ClinicalTrials.gov Identifier: [NCT06846281](https://clinicaltrials.gov/ct2/show/NCT06846281) Novartis Reference Number:CLOU064C12306 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description The purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS). The study is a randomized, open-label, non-inferiority multi-center, Phase 3b study to provide efficacy, safety, and tolerability data for remibrutinib after switching from ocrelizumab and in comparison to continuous ocrelizumab in plwRMS. This study consists of an initial Core Part (CP) (maximum duration per participant of up to 24 months), followed by an Extension Part (EP) (of up to 24 months duration) for eligible participants. All participants completing the 24-month treatment of the Core Part of the study may be eligible to continue in the Extension Part, an open-label, single-arm, fixed-dose design in which participants are treated with remibrutinib for up to 24 months. The study will be conducted in the USA among other countries globally. Condition Relapsing Multiple Sclerosis Phase Phase3 Overall Status Recruiting Number of Participants360 Start Date Jun 23, 2025 Completion Date Jun 24, 2031 Gender All Age(s) 40 Years - 70 Years (Adult, Older Adult) ## Interventions Drug ### Ocrelizumab Ocrelizumab 600mg infusion or 920mg injection Drug ### Remibrutinib oral treatment Remibrutinib tablet taken daily ## Eligibility 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 Argentina #### Novartis Investigative Site Recruiting Rosario,Santa Fe Province,2000,Argentina #### Novartis Investigative Site Recruiting Rosario,Santa Fe Province,S2000bzl,Argentina #### Novartis Investigative Site Recruiting Buenos Aires,C1055aaf,Argentina #### Novartis Investigative Site Recruiting Caba,C1182,Argentina Australia #### Novartis Investigative Site Recruiting Parkville,Victoria,3050,Australia #### Novartis Investigative Site Recruiting Liverpool,2170,Australia #### Novartis Investigative 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