Clinical trial NCT06846281: Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Relapsing Multiple Sclerosis
Keywords: MS
RMS
Remibrutinib
LOU064
Ocrelizumab
Age
MRI
T2 lesions
NEDA-3
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-02-26
Enrollment: 360
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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 are 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.

Eligibility criteria: Key Inclusion Criteria:

* Male or female 40 years of age or older
* 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

Primary outcomes:
measure: Annualized rate of new or enlarging T2 lesions_Core Part
timeFrame: Baseline up to month 24
Secondary outcomes:
measure: Percentage of participants with no evidence of disease activity-3 (NEDA-3)_Core Part
timeFrame: Baseline up to month 24
measure: Number of adverse events (AEs) and serious adverse events (SAEs)_Core Part
timeFrame: Baseline up to month 24
measure: Annualized rate of new or enlarging T2 lesions_Extension Part
timeFrame: Month 24 up to month 48
measure: Percentage with no evidence of disease activity-3 (NEDA-3)_Extension Part
timeFrame: Month 24 up to month 48
measure: Number of Adverse events and serious adverse events_Extension Part
timeFrame: Month 24 up to month 48
Other outcomes:
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