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NCT06846281PHASE3Recruiting

Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.

Novartis Pharmaceuticals

Start Date

6/23/2025

Completion Date

6/24/2031

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).

Detailed Description

The study is a randomized, open-label, non-inferiority multi-center, Phase 3b study to provide efficacy, safety, and tolerability data for remibrutinib after switching from ocrelizumab and in comparison to continuous ocrelizumab in plwRMS. This study consists of an initial Core Part (CP) (maximum duration per participant of up to 24 months), followed by an Extension Part (EP) (of up to 24 months duration) for eligible participants. All participants completing the 24-month treatment of the Core Part of the study may be eligible to continue in the Extension Part, an open-label, single-arm, fixed-dose design in which participants are treated with remibrutinib for up to 24 months. The study will be conducted in the USA among other countries globally.

Eligibility Criteria

Age Range: 40 years to 70 years

Key Inclusion Criteria: * 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 Key Exclusion Criteria: * Diagnosis of primary progressive multiple sclerosis (PPMS) according to the revised 2017 McDonald criteria * History of clinically significant Central Nervous System disease or neurological disorders * History of confirmed Progressive Multifocal Leukoencephalopathy or neurological symptoms consistent * Active clinically significant systemic bacterial, viral, parasitic or fungal infections * Active, chronic disease of the immune system other than MS * Severe cardiac disease or significant findings on the ECG * Participant who is unable to undergo MRI scans * History of life-threatening infusion or injection reaction related to ocrelizumab Other inclusion and exclusion criteria may apply

Interventions

DRUG

Remibrutinib oral treatment

DRUG

Ocrelizumab

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Conditions

Relapsing Multiple Sclerosis

Locations

Perseverance Research Center

Scottsdale, Arizona 85253

United States

University of California Irvine

Irvine, California 92697

United States

Medstar Washington Hospital Center

Washington D.C., District of Columbia 20010-2975

United States

Neurology of Central FL Res Ctr

Altamonte Springs, Florida 32714

United States

University of Florida

Gainesville, Florida 32610

United States

Neurology Associates PA

Maitland, Florida 32751

United States

Aqualane Clinical Research

Naples, Florida 34105

United States

Advent Health Orlando

Orlando, Florida 32803

United States

Orlando Health Clinical Trials

Orlando, Florida 32806

United States

Tallahassee Neurological Clinic

Tallahassee, Florida 32308

United States

University Of South Florida

Tampa, Florida 33612

United States

Vero Beach Neurology

Vero Beach, Florida 32960

United States

Rush University Medical Center

Chicago, Illinois 60607

United States

University of Kansas Hospital

Kansas City, Kansas 66160

United States

MedStar Montgomery Medical Center

Olney, Maryland 20832

United States

Tufts Medical Center

Boston, Massachusetts 02111

United States

Lahey Hospital and Medical Center

Burlington, Massachusetts 01805

United States

Neurology Center of New England PC

Foxborough, Massachusetts 02035

United States

Michigan Institute of Neurological

Farmington Hills, Michigan 48334

United States

Memorial HC Ins for Neuroscience

Owosso, Michigan 48867

United States

WA Uni School Of Med

St Louis, Missouri 63110

United States

Cleveland Clinic Foundation

Las Vegas, Nevada 89106

United States

Holy Name Medical Center

Teaneck, New Jersey 07666

United States

University of New Mexico

Albuquerque, New Mexico 87131-0001

United States

SUNY Buffalo The Jacobs Neuro Inst

Buffalo, New York 14203

United States

Velocity Clinical Research

Raleigh, North Carolina 27607

United States

Sanford Health

Fargo, North Dakota 58122

United States

Premier Health

Centerville, Ohio 45459

United States

Univ of Cincinnati Medical Center

Cincinnati, Ohio 45219

United States

Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States

Ohio Health Research Institute

Columbus, Ohio 43214

United States

Premier Neurology

Greenville, South Carolina 29605

United States

Sibyl Wray MD Neurology PC

Knoxville, Tennessee 37922

United States

Austin Regional Clinic

Austin, Texas 78731

United States

Univ of Texas Southwest Med Center

Dallas, Texas 75390-9034

United States

John Peter Smith Hospital

Fort Worth, Texas 76104

United States

Saturn Research Solutions LLC

Plano, Texas 75024

United States

Virginia Commonwealth University

Richmond, Virginia 23298-0111

United States

Center for Neurological Disorders G

Greenfield, Wisconsin 53228-1321

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Novartis Investigative Site

Rosario, Santa Fe Province 2000

Argentina

Novartis Investigative Site

Rosario, Santa Fe Province S2000BZL

Argentina

Novartis Investigative Site

Buenos Aires, C1055AAF

Argentina

Novartis Investigative Site

Caba, C1182

Argentina

Novartis Investigative Site

Melbourne, Victoria 3004

Australia

Novartis Investigative Site

Parkville, Victoria 3050

Australia

Novartis Investigative Site

Liverpool, 2170

Australia

Novartis Investigative Site

St Leonards, 2065

Australia

Novartis Investigative Site

Bruges, 8000

Belgium

Novartis Investigative Site

Overpelt, 3900

Belgium

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul 90430-001

Brazil

Novartis Investigative Site

Rio Grande, Rio Grande do Sul 90035-001

Brazil

Novartis Investigative Site

São Paulo, São Paulo 01244-030

Brazil

Novartis Investigative Site

São Paulo, São Paulo 04076-004

Brazil

Novartis Investigative Site

Edmonton, Alberta T6G 2B7

Canada

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Vancouver, British Columbia V6T 2A1

Canada

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Lévis, Quebec G6W 0M5

Canada

Novartis Investigative Site

Montreal, Quebec H4A 3T2

Canada

Novartis Investigative Site

Brno, 602 00

Czechia

Novartis Investigative Site

Hradec Králové, 500 05

Czechia

Novartis Investigative Site

Jihlava, 586 01

Czechia

Novartis Investigative Site

Pardubice, 532 03

Czechia

Novartis Investigative Site

Aarhus N, 8200

Denmark

Novartis Investigative Site

Glostrup Municipality, 2600

Denmark

Novartis Investigative Site

Bordeaux, 33076

France

Novartis Investigative Site

Clermont-Ferrand, 63003

France

Novartis Investigative Site

Lille, 59000

France

Novartis Investigative Site

Marseille, 13885

France

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Nice, 06001

France

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Nîmes, 30029

France

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Paris, 75940

France

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Poitiers, 86021

France

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Strasbourg, 67000

France

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Toulouse, 31059

France

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Tours, 37044

France

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Berlin, 13353

Germany

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Bochum, 44791

Germany

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Essen, 45147

Germany

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Greifswald, 17475

Germany

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Heidelberg, 69120

Germany

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Münster, 48149

Germany

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Ulm, 89073

Germany

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Ulm, 89081

Germany

Novartis Investigative Site

Chaïdári, 124 62

Greece

Novartis Investigative Site

Larissa, 411 10

Greece

Novartis Investigative Site

Thessaloniki, 53246

Greece

Novartis Investigative Site

Bergamo, BG 24127

Italy

Novartis Investigative Site

Foggia, FG 71122

Italy

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Genova, GE 16132

Italy

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Milan, MI 20132

Italy

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Pavia, PV 27100

Italy

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Roma, RM 00133

Italy

Novartis Investigative Site

Roma, RM 00168

Italy

Novartis Investigative Site

Mexico City, Mexico City 06700

Mexico

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Mexico City, 14050

Mexico

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Braga, 4710243

Portugal

Novartis Investigative Site

Coimbra, 3004-561

Portugal

Novartis Investigative Site

Lisbon, 1169-050

Portugal

Novartis Investigative Site

Bratislava, Slovakia 826 06

Slovakia

Novartis Investigative Site

Trnava, Slovakia 917 02

Slovakia

Novartis Investigative Site

Cape Town, Western Cape 7405

South Africa

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Pretoria, 0041

South Africa

Novartis Investigative Site

El Palmar, Murcia 30120

Spain

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Valencia, Valencia 46017

Spain

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Barcelona, 08035

Spain

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Córdoba, 14004

Spain

Novartis Investigative Site

Madrid, 28009

Spain

Novartis Investigative Site

Madrid, 28034

Spain

Novartis Investigative Site

Madrid, 28040

Spain

Novartis Investigative Site

Madrid, 28222

Spain

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Málaga, 29010

Spain

Novartis Investigative Site

Seville, 41009

Spain

Novartis Investigative Site

Valencia, 46026

Spain

Novartis Investigative Site

Bern, 3010

Switzerland

Novartis Investigative Site

Lausanne, 1011

Switzerland

Novartis Investigative Site

Zurich, 8091

Switzerland

Novartis Investigative Site

Sheffield, South Yorkshire S10 2JF

United Kingdom

Novartis Investigative Site

Leeds, LS1 3EX

United Kingdom

Novartis Investigative Site

London, W6 8RF

United Kingdom

Novartis Investigative Site

Swansea, SA6 6NL

United Kingdom