RecruitingPhase 3NCT06846281

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

Sponsor

Novartis Pharmaceuticals

Enrollment

360 participants

Start Date

Jul 23, 2025

Study Type

INTERVENTIONAL

Conditions

Relapsing Multiple Sclerosis

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

Min Age: 40 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether switching from an infused multiple sclerosis (MS) drug called ocrelizumab to an oral pill called remibrutinib is safe and effective for people with relapsing MS who prefer a more convenient treatment option. **You may be eligible if...** - You are between 40 and 70 years old - You have relapsing MS diagnosed using the 2017 McDonald criteria - You are currently being treated with ocrelizumab at the standard dose - Your neurological condition has been stable for at least 30 days - Your doctor or you prefer to switch to an oral medication **You may NOT be eligible if...** - You have primary progressive MS (a type that doesn't involve relapses) - You have other significant neurological conditions - You have a history of serious infections or immune system problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRemibrutinib oral treatment

Remibrutinib tablet taken daily

DRUGOcrelizumab

Ocrelizumab 600mg infusion or 920mg injection

Locations(106)

Perseverance Research Center

Scottsdale, Arizona, United States

University of California Irvine

Irvine, California, 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

Advent Health Orlando

Orlando, 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

Cleveland Clinic Foundation

Las Vegas, Nevada, United States

Holy Name Medical Center

Teaneck, New Jersey, United States

University of New Mexico

Albuquerque, New Mexico, United States

SUNY Buffalo The Jacobs Neuro Inst

Buffalo, New York, 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

Caba, Argentina

Novartis Investigative Site

Melbourne, Victoria, Australia

Novartis Investigative Site

Parkville, Victoria, Australia

Novartis Investigative Site

Liverpool, Australia

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St Leonards, Australia

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Bruges, Belgium

Novartis Investigative Site

Overpelt, Belgium

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São Paulo, São Paulo, Brazil

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Vancouver, British Columbia, Canada

Novartis Investigative Site

Lévis, Quebec, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Brno, Czechia

Novartis Investigative Site

Hradec Králové, Czechia

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

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Nice, France

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Nîmes, France

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Paris, France

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Poitiers, France

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Strasbourg, France

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Toulouse, France

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Tours, France

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Bochum, Germany

Novartis Investigative Site

Ulm, Germany

Novartis Investigative Site

Chaïdári, Greece

Novartis Investigative Site

Larissa, Greece

Novartis Investigative Site

Thessaloniki, Greece

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Bergamo, BG, Italy

Novartis Investigative Site

Foggia, FG, Italy

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Genova, GE, Italy

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Milan, MI, Italy

Novartis Investigative Site

Pavia, PV, Italy

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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

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Coimbra, Portugal

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Lisbon, Portugal

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Bratislava, Slovakia

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Trnava, Slovakia

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Cape Town, Western Cape, South Africa

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Pretoria, South Africa

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Majadahonda, Madrid, Spain

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El Palmar, Murcia, Spain

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Valencia, Valencia, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Córdoba, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

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

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Lausanne, Switzerland

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Zurich, Switzerland

Novartis Investigative Site

Sheffield, South Yorkshire, United Kingdom

Novartis Investigative Site

Leeds, United Kingdom

Novartis Investigative Site

London, United Kingdom

Novartis Investigative Site

Swansea, United Kingdom

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NCT06846281

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