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Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
NCT06846281 · Novartis
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
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.
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
Study design
Enrollment target: 360 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-07-23
Estimated completion: 2031-06-20
Last updated: 2026-04-06
Interventions
Drug: Remibrutinib oral treatmentDrug: Ocrelizumab
Primary outcomes
- • Annualized rate of new or enlarging T2 lesions_Core Part (Baseline up to month 24)
Sponsor
Novartis Pharmaceuticals · industry
Contacts & investigators
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · 1-888-669-6682
ContactNovartis Pharmaceuticals · contact · +41613241111
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Perseverance Research CenterRecruiting
Scottsdale, Arizona, United States
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Washington D.C., District of Columbia, United States
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Altamonte Springs, Florida, United States
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