A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis
Start Date
11/11/2025
Completion Date
1/2/2034
Summary
The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)
Detailed Description
This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, parallel-group, event-driven study to evaluate the efficacy, safety and tolerability of remibrutinib in SPMS patients. Approximately 1275 eligible participants will be randomized to receive either remibrutinib or matching placebo. The study consists of an event-driven Core Part with double-blind treatment, followed by an Extension Part with open-label remibrutinib treatment.
Eligibility Criteria
Age Range: 18 years to 65 years
Interventions
Remibrutinib (blinded)
Placebo
Remibrutinib (Open label)
Conditions
Locations
Alabama Neurology Associates PC
Birmingham, Alabama 35209
United States
Ctr for Neurology and Spine
Phoenix, Arizona 85018
United States
AZ Integrated Neuro and Spine
Phoenix, Arizona 85037
United States
Center for Neurosciences
Tucson, Arizona 85718
United States
Fullerton Neuro and Headache Ctr
Fullerton, California 92835
United States
Regina Berkovich MD PhD Inc
West Hollywood, California 90048
United States
UC Health Neuroscience Ctr
Aurora, Colorado 80045
United States
Georgetown University Hospital
Washington D.C., District of Columbia 20007
United States
Medstar Washington Hosp Ctr
Washington D.C., District of Columbia 20010
United States
Neurology of Central FL Res Ctr
Altamonte Springs, Florida 32714
United States
UF Health Cancer Center
Gainesville, Florida 32610
United States
Homestead Assoc In Research Inc
Homestead, Florida 33033
United States
Neurology Associates PA
Maitland, Florida 32751
United States
Miami NS Ins Baptist Health S FL
Miami, Florida 33176
United States
Aqualane Clinical Research
Naples, Florida 34105
United States
Orlando Health Clinical Trials
Orlando, Florida 32806
United States
Comprehensive Neurology Clinic
Orlando, Florida 32825
United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida 32174
United States
Axiom Brain Health
Tampa, Florida 33609
United States
University Of South Florida
Tampa, Florida 33612
United States
Joi Life Wellness Group LLC
Smyrna, Georgia 30080
United States
Hawaii Pacific Neuroscience LLC
Honolulu, Hawaii 96817
United States
Northwestern Memorial Hospital
Chicago, Illinois 60611
United States
University of Kansas Hospital
Kansas City, Kansas 66160
United States
Mid Atlantic Epilepsy and Sleep Ctr
Bethesda, Maryland 20817-1807
United States
Neuro Institute of New England P C
Foxborough, Massachusetts 02035
United States
Elliot Lewis MS Center
Wellesley, Massachusetts 02481
United States
U Mass Memorial Medical Center
Worchester, Massachusetts 01605
United States
Michigan Institute of Neurological
Farmington Hills, Michigan 48334
United States
University of New Mexico Hospital
Albuquerque, New Mexico 87106
United States
Premier Neurology
Greenville, South Carolina 29605
United States
Neurology Clinic PC
Cordova, Tennessee 38018
United States
Carum Research
Dallas, Texas 75231
United States
Saturn Research Solution
Plano, Texas 75024
United States
Citta Clinical Research
Spokane, Washington 99202
United States
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CABA, Buenos Aires C1428AQK
Argentina
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Capital Federal, Buenos Aires 1424
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Buenos Aires, Buenos Aires F.D. 1221
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Bombal, Mendoza Province M5500DXO
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San Juan, San Juan Province J5402DIL
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Rosario, Santa Fe Province 2000
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Rosario, Santa Fe Province S2000DSW
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Santiago del Estero, Santiago del Estero Province G4200AIR
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San Miguel de, Tucumán Province T4000
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Buenos Aires, C1012AAR
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Caba, C1055AAF
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CABA, C1181ACH
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Caba, C1182
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Caba, C1424BYD
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Kogarah, New South Wales 2217
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New Lambton Heights, New South Wales 2305
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Westmead, New South Wales 2145
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Clayton, Victoria 3168
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Heidelberg, Victoria 3084
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Murdoch, Western Australia 6150
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Southport, 4215
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Innsbruck, Tyrol 6020
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Linz, Upper Austria 4020
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Linz, 4020
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Vienna, 1180
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Leuven, Vlaams Brabant 3000
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Roeselare, West-Vlaanderen 8800
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Bonheiden, 2820
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Brussels, 1070
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Porto Alegre, Rio Grande do Sul 90430-001
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Porto Alegre, Rio Grande do Sul 90560-032
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Porto Alegre, Rio Grande do Sul 90620-130
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Joinville, Santa Catarina 89202-165
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Santo André, São Paulo 09040 010
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São Paulo, São Paulo 04076-004
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Pleven, 5800
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Halifax, Nova Scotia B3H 4K4
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Ottawa, Ontario K1H 8L6
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Lévis, Quebec G6W 0M5
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Montreal, Quebec H2X 1R9
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Montreal, Quebec H3A 2B4
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Montreal, Quebec H4A 3T2
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Sherbrooke, Quebec J1H 5N4
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Guangzhou, Guangdong 510080
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Zhengzhou, Henan 450003
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Wuhan, Hubei 430030
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Wuhan, Hubei 430060
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Hohhot, Inner Mongolia 010017
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Taiyuan, Shanxi 030001
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