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Remibrutinib vs Ocrelizumab in Relapsing Multiple Sclerosis
NCT06846281Phase 3
Key facts
- Status
- Recruiting
- Start
- Jun 2025
- Primary completion
- Jul 2029
- Countries
- 19
- Sponsor
- Novartis
- Modality
- Small Molecules
- Drugs
- remibrutinib
- Conditions
- multiple sclerosis (MS)
01
Overview
Phase 3, randomised, open-label trial of remibrutinib in multiple sclerosis (MS) (2 arms), sponsored by Novartis. Primary endpoint: Annualized rate of new or enlarging T2 lesions at 24 months. Started Jun 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Remibrutinib Arm
Participants receive Remibrutinib in the Core Part, followed by Remibrutinib in the Extension Part.
Ocrelizumab Arm
Participants receive Ocrelizumab in the Core Part, followed by a switch to Remibrutinib in the Extension Part.
03
Who it enrols
Adults aged 40-70 with Relapsing Multiple Sclerosis currently treated and adequately controlled on ocrelizumab, neurologically stable, without primary progressive MS, active infections, or severe cardiac disease.
04
Endpoints
Primary
Annualized rate of new or enlarging T2 lesions
Secondary
No evidence of disease activity-3
Number of adverse events and serious adverse events
Annualized rate of new or enlarging T2 lesions
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