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
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 70
Healthy Volunteers: f
View:
• Male or female aged 40 to 70 years (inclusive)
• 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
Locations
Other Locations
Australia
Novartis Investigative Site
RECRUITING
Liverpool
Novartis Investigative Site
RECRUITING
Melbourne
Novartis Investigative Site
RECRUITING
Parkville
Novartis Investigative Site
RECRUITING
St Leonards
Canada
Novartis Investigative Site
RECRUITING
Lévis
South Africa
Novartis Investigative Site
RECRUITING
Cape Town
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2025-07-23
Estimated Completion Date: 2032-01-08
Participants
Target number of participants: 360
Treatments
Experimental: Remibrutinib Core
Remibrutinib tablet taken orally
Active_comparator: Ocrelizumab Core
Ocrelizumab at standard dose and route of administration (i.v. or s.c) per label
Experimental: Remibrutinib Extension
Remibrutinib tablet taken orally
Experimental: Remibrutinib Extension (Ocrelizumab in Core)
Remibrutinib tablet taken orally
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals