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 (59) 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
United States
Florida
Neurology of Central FL Res Ctr
RECRUITING
Altamonte Springs
Tallahassee Neurological Clinic
RECRUITING
Tallahassee
Kansas
University of Kansas Hospital
RECRUITING
Kansas City
Michigan
Michigan Institute of Neurological
RECRUITING
Farmington Hills
South Carolina
Premier Neurology
RECRUITING
Greenville
Tennessee
Sibyl Wray MD Neurology PC
RECRUITING
Knoxville
Other Locations
Argentina
Novartis Investigative Site
RECRUITING
Buenos Aires
Novartis Investigative Site
RECRUITING
Buenos Aires
Novartis Investigative Site
RECRUITING
Rosario
Novartis Investigative Site
RECRUITING
Rosario
Australia
Novartis Investigative Site
RECRUITING
Liverpool
Novartis Investigative Site
RECRUITING
Melbourne
Novartis Investigative Site
RECRUITING
Parkville
Novartis Investigative Site
RECRUITING
St Leonards
Belgium
Novartis Investigative Site
RECRUITING
Bruges
Canada
Novartis Investigative Site
RECRUITING
Lévis
Novartis Investigative Site
RECRUITING
Montreal
Denmark
Novartis Investigative Site
RECRUITING
Aarhus N
Novartis Investigative Site
RECRUITING
Glostrup Municipality
France
Novartis Investigative Site
RECRUITING
Bordeaux
Novartis Investigative Site
RECRUITING
Clermont-ferrand
Novartis Investigative Site
RECRUITING
Lille
Novartis Investigative Site
RECRUITING
Nice
Novartis Investigative Site
RECRUITING
Nîmes
Novartis Investigative Site
RECRUITING
Paris
Novartis Investigative Site
RECRUITING
Strasbourg
Novartis Investigative Site
RECRUITING
Toulouse
Novartis Investigative Site
RECRUITING
Tours
Greece
Novartis Investigative Site
RECRUITING
Chaïdári
Novartis Investigative Site
RECRUITING
Larissa
Novartis Investigative Site
RECRUITING
Thessaloniki
Italy
Novartis Investigative Site
RECRUITING
Bergamo
Novartis Investigative Site
RECRUITING
Foggia
Novartis Investigative Site
RECRUITING
Genova
Novartis Investigative Site
RECRUITING
Pavia
Novartis Investigative Site
RECRUITING
Roma
Novartis Investigative Site
RECRUITING
Roma
Mexico
Novartis Investigative Site
RECRUITING
Mexico City
Novartis Investigative Site
RECRUITING
Mexico City
Portugal
Novartis Investigative Site
RECRUITING
Braga
Novartis Investigative Site
RECRUITING
Lisbon
Slovakia
Novartis Investigative Site
RECRUITING
Bratislava
Novartis Investigative Site
RECRUITING
Trnava
South Africa
Novartis Investigative Site
RECRUITING
Cape Town
Novartis Investigative Site
RECRUITING
Pretoria
Spain
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Córdoba
Novartis Investigative Site
RECRUITING
El Palmar
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Majadahonda
Novartis Investigative Site
RECRUITING
Málaga
Novartis Investigative Site
RECRUITING
Seville
Novartis Investigative Site
RECRUITING
Valencia
Novartis Investigative Site
RECRUITING
Valencia
Switzerland
Novartis Investigative Site
RECRUITING
Bern
Novartis Investigative Site
RECRUITING
Lausanne
Novartis Investigative Site
RECRUITING
Zurich
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: 2031-12-31
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