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Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
Sponsor: Novartis Pharmaceuticals
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).
Official title: 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
Key Details
Gender
All
Age Range
40 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2025-07-23
Completion Date
2031-06-20
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
Remibrutinib oral treatment
Remibrutinib tablet taken daily
Ocrelizumab
Ocrelizumab 600mg infusion or 920mg injection
Locations (95)
Perseverance Research Center
Scottsdale, Arizona, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Neurology of Central FL Res Ctr
Altamonte Springs, Florida, United States
University of Florida
Gainesville, Florida, United States
Neurology Associates PA
Maitland, Florida, United States
Aqualane Clinical Research
Naples, Florida, United States
Orlando Health Clinical Trials
Orlando, Florida, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, United States
University Of South Florida
Tampa, Florida, United States
Vero Beach Neurology
Vero Beach, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Kansas Hospital
Kansas City, Kansas, United States
MedStar Montgomery Medical Center
Olney, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Neurology Center of New England PC
Foxborough, Massachusetts, United States
Michigan Institute of Neurological
Farmington Hills, Michigan, United States
Memorial HC Ins for Neuroscience
Owosso, Michigan, United States
WA Uni School Of Med
St Louis, Missouri, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
Velocity Clinical Research
Raleigh, North Carolina, United States
Sanford Health
Fargo, North Dakota, United States
Premier Health
Centerville, Ohio, United States
Univ of Cincinnati Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio Health Research Institute
Columbus, Ohio, United States
Premier Neurology
Greenville, South Carolina, United States
Sibyl Wray MD Neurology PC
Knoxville, Tennessee, United States
Austin Regional Clinic
Austin, Texas, United States
Univ of Texas Southwest Med Center
Dallas, Texas, United States
John Peter Smith Hospital
Fort Worth, Texas, United States
Saturn Research Solutions LLC
Plano, Texas, United States
Center for Neurological Disorders G
Greenfield, Wisconsin, United States
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina
Novartis Investigative Site
Buenos Aires, Argentina
Novartis Investigative Site
Buenos Aires, Argentina
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Parkville, Victoria, Australia
Novartis Investigative Site
Liverpool, Australia
Novartis Investigative Site
St Leonards, Australia
Novartis Investigative Site
Bruges, Belgium
Novartis Investigative Site
Vancouver, British Columbia, Canada
Novartis Investigative Site
Lévis, Quebec, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Aarhus N, Denmark
Novartis Investigative Site
Glostrup Municipality, Denmark
Novartis Investigative Site
Bordeaux, France
Novartis Investigative Site
Clermont-Ferrand, France
Novartis Investigative Site
Lille, France
Novartis Investigative Site
Marseille, France
Novartis Investigative Site
Nice, France
Novartis Investigative Site
Nîmes, France
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Paris, France
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Poitiers, France
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Strasbourg, France
Novartis Investigative Site
Toulouse, France
Novartis Investigative Site
Tours, France
Novartis Investigative Site
Chaïdári, Greece
Novartis Investigative Site
Larissa, Greece
Novartis Investigative Site
Thessaloniki, Greece
Novartis Investigative Site
Bergamo, BG, Italy
Novartis Investigative Site
Foggia, FG, Italy
Novartis Investigative Site
Genova, GE, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Pavia, PV, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Mexico City, Mexico City, Mexico
Novartis Investigative Site
Mexico City, Mexico
Novartis Investigative Site
Braga, Portugal
Novartis Investigative Site
Coimbra, Portugal
Novartis Investigative Site
Lisbon, Portugal
Novartis Investigative Site
Bratislava, Slovakia
Novartis Investigative Site
Trnava, Slovakia
Novartis Investigative Site
Cape Town, Western Cape, South Africa
Novartis Investigative Site
Pretoria, South Africa
Novartis Investigative Site
Majadahonda, Madrid, Spain
Novartis Investigative Site
El Palmar, Murcia, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
Barcelona, Spain
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Córdoba, Spain
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Madrid, Spain
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Madrid, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Málaga, Spain
Novartis Investigative Site
Seville, Spain
Novartis Investigative Site
Valencia, Spain
Novartis Investigative Site
Bern, Switzerland
Novartis Investigative Site
Lausanne, Switzerland
Novartis Investigative Site
Zurich, Switzerland
Novartis Investigative Site
Sheffield, South Yorkshire, United Kingdom
Novartis Investigative Site
Leeds, United Kingdom
Novartis Investigative Site
Swansea, United Kingdom