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

Novartis

Status and phase: Begins enrollment this month; Phase 3

Conditions: Relapsing Multiple Sclerosis

Treatments: Drug: Remibrutinib oral treatment; Drug: Ocrelizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06846281

CLOU064C12306

Details and patient eligibility

About

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).

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 40 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 4 patient groups

Remibrutinib Core

Experimental group

Description:

Remibrutinib tablet taken orally

Treatment:

Drug: Remibrutinib oral treatment

Ocrelizumab Core

Active Comparator group

Description:

Ocrelizumab at standard dose and route of administration (i.v. or s.c) per label

Treatment:

Drug: Ocrelizumab

Remibrutinib Extension

Experimental group

Description:

Remibrutinib tablet taken orally

Treatment:

Drug: Remibrutinib oral treatment

Remibrutinib Extension (Ocrelizumab in Core)

Experimental group

Description:

Remibrutinib tablet taken orally

Treatment:

Drug: Remibrutinib oral treatment