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

Phase 3

Not yet recruiting

• Conditions: Relapsing Multiple Sclerosis
• Interventions: Drug: Remibrutinib oral treatment; Drug: Ocrelizumab

• Registration Number: NCT06846281
• Lead Sponsor: Novartis Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-24
• Study First Posted: 2025-02-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11
• Study Start: 2025-06-16
• Primary Completion: 2030-02-10
• Study Completion: 2032-03-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remibrutinib Core	Remibrutinib oral treatment	Remibrutinib tablet taken orally
Ocrelizumab Core	Ocrelizumab	Ocrelizumab at standard dose and route of administration (i.v. or s.c) per label
Remibrutinib Extension	Remibrutinib oral treatment	Remibrutinib tablet taken orally
Remibrutinib Extension (Ocrelizumab in Core)	Remibrutinib oral treatment	Remibrutinib tablet taken orally

Primary Outcome Measures

Name	Time	Method
Annualized rate of new or enlarging T2 lesions_Core Part	Baseline up to month 24	Number of new/enlarging T2 lesions per year on MRI at month 24 (relative to baseline)

Secondary Outcome Measures

Name	Time	Method
Percentage of participants with no evidence of disease activity-3 (NEDA-3)_Core Part	Baseline up to month 24	Percentage of participants with no evidence of disease activity-3 (NEDA-3), as assessed by absence of confirmed MS relapses, 6-month confirmed disability progression (6mCDP) and new/enlarging T2 lesions on MRI
Number of adverse events (AEs) and serious adverse events (SAEs)_Core Part	Baseline up to month 24	Adverse events will be collected throughout the trial. Any safety assessment findings such as laboratory, vital signs, electrocardiogram data that are considered clinically significant or meet the protocol definition of an adverse event will be reported as adverse event or serious adverse event, as appropriate
Annualized rate of new or enlarging T2 lesions_Extension Part	Month 24 up to month 48	Number of new/enlarging T2 lesions per year on MRI
Percentage with no evidence of disease activity-3 (NEDA-3)_Extension Part	Month 24 up to month 48	Percentage of participants with no evidence of disease activity-3 (NEDA-3), as assessed by absence of confirmed MS relapses, 6-month confirmed disability progression (6mCDP) and new/enlarging T2 lesions on MRI
Number of Adverse events and serious adverse events_Extension Part	Month 24 up to month 48	Adverse events will be collected throughout the trial. Any safety assessment findings such as laboratory, vital signs, electrocardiogram data that are considered clinically significant or meet the protocol definition of an adverse event will be reported as adverse event or serious adverse event, as appropriate