Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
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
Interventions
Remibrutinib oral treatment
Ocrelizumab
Conditions
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
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Rosario, Santa Fe Province S2000BZL
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Buenos Aires, C1055AAF
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Caba, C1182
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Melbourne, Victoria 3004
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Parkville, Victoria 3050
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Liverpool, 2170
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St Leonards, 2065
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Bruges, 8000
Belgium
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Overpelt, 3900
Belgium
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Porto Alegre, Rio Grande do Sul 90430-001
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Rio Grande, Rio Grande do Sul 90035-001
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São Paulo, São Paulo 01244-030
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São Paulo, São Paulo 04076-004
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Edmonton, Alberta T6G 2B7
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Vancouver, British Columbia V6T 2A1
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Lévis, Quebec G6W 0M5
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Montreal, Quebec H4A 3T2
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Brno, 602 00
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Hradec Králové, 500 05
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Jihlava, 586 01
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Pardubice, 532 03
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Aarhus N, 8200
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Glostrup Municipality, 2600
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Bordeaux, 33076
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Clermont-Ferrand, 63003
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Lille, 59000
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Marseille, 13885
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Nice, 06001
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Nîmes, 30029
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Paris, 75940
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Poitiers, 86021
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Strasbourg, 67000
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Toulouse, 31059
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Tours, 37044
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Berlin, 13353
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Bochum, 44791
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Essen, 45147
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Greifswald, 17475
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Heidelberg, 69120
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Münster, 48149
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Ulm, 89073
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Ulm, 89081
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Chaïdári, 124 62
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Larissa, 411 10
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Thessaloniki, 53246
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Bergamo, BG 24127
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Foggia, FG 71122
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Genova, GE 16132
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Milan, MI 20132
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Pavia, PV 27100
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Roma, RM 00133
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Roma, RM 00168
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Mexico City, Mexico City 06700
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Mexico City, 14050
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Braga, 4710243
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Coimbra, 3004-561
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Lisbon, 1169-050
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Bratislava, Slovakia 826 06
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Trnava, Slovakia 917 02
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Cape Town, Western Cape 7405
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Pretoria, 0041
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El Palmar, Murcia 30120
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Valencia, Valencia 46017
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Barcelona, 08035
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Córdoba, 14004
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Madrid, 28009
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Madrid, 28034
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Madrid, 28040
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Madrid, 28222
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Málaga, 29010
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Seville, 41009
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Valencia, 46026
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Bern, 3010
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Lausanne, 1011
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Zurich, 8091
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Sheffield, South Yorkshire S10 2JF
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Leeds, LS1 3EX
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London, W6 8RF
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Swansea, SA6 6NL
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