NCT06846281

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Remibrutinib oral treatment	Remibrutinib tablet taken daily
DRUG	Ocrelizumab	Ocrelizumab 600mg infusion or 920mg injection

Timeline

• Start date: 2025-07-23
• Primary completion: 2029-07-20
• Completion: 2031-06-20
• First posted: 2025-02-26
• Last updated: 2026-04-06

Locations

95 sites across 16 countries: United States, Argentina, Australia, Belgium, Canada, Denmark, France, Greece, Italy, Mexico, Portugal, Slovakia, South Africa, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study