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A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis
Sponsor: Novartis Pharmaceuticals
Summary
The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)
Official title: A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
1275
Start Date
2025-11-11
Completion Date
2034-01-02
Last Updated
2026-05-27
Healthy Volunteers
No
Interventions
Remibrutinib (blinded)
Remibrutinib (Blinded) active treatment, oral tablet
Placebo
Matching placebo (binded), oral tablet
Remibrutinib (Open label)
Remibrutinib (Open Label), oral tablet
Locations (200)
Alabama Neurology Associates PC
Birmingham, Alabama, United States
AZ Integrated Neuro and Spine
Phoenix, Arizona, United States
Center for Neurosciences
Tucson, Arizona, United States
Fullerton Neuro and Headache Ctr
Fullerton, California, United States
Regina Berkovich MD PhD Inc
West Hollywood, California, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Medstar Washington Hosp Ctr
Washington D.C., District of Columbia, United States
Neurology of Central FL Res Ctr
Altamonte Springs, Florida, United States
UF Health Cancer Center
Gainesville, Florida, United States
Homestead Assoc In Research Inc
Homestead, Florida, United States
Neurology Associates PA
Maitland, Florida, United States
Miami NS Ins Baptist Health S FL
Miami, Florida, United States
Aqualane Clinical Research
Naples, Florida, United States
Orlando Health Clinical Trials
Orlando, Florida, United States
Comprehensive Neurology Clinic
Orlando, Florida, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, United States
Axiom Brain Health
Tampa, Florida, United States
Joi Life Wellness Group LLC
Smyrna, Georgia, United States
Hawaii Pacific Neuroscience LLC
Honolulu, Hawaii, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Mid Atlantic Epilepsy and Sleep Ctr
Bethesda, Maryland, United States
Neuro Institute of New England P C
Foxborough, Massachusetts, United States
Michigan Institute of Neurological
Farmington Hills, Michigan, United States
University of New Mexico Hospital
Albuquerque, New Mexico, United States
Premier Neurology
Greenville, South Carolina, United States
Neurology Clinic PC
Cordova, Tennessee, United States
Saturn Research Solution
Plano, Texas, United States
Citta Clinical Research
Spokane, Washington, United States
Novartis Investigative Site
Capital Federal, Buenos Aires, Argentina
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Bombal, Mendoza Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Buenos Aires, Argentina
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Caba, Argentina
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CABA, Argentina
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Caba, Argentina
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Caba, Argentina
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Santiago del Estero, Argentina
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Kogarah, New South Wales, Australia
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New Lambton Heights, New South Wales, Australia
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Westmead, New South Wales, Australia
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Clayton, Victoria, Australia
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Heidelberg, Victoria, Australia
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Murdoch, Western Australia, Australia
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Southport, Australia
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Linz, Upper Austria, Austria
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Linz, Austria
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Vienna, Austria
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Roeselare, West-Vlaanderen, Belgium
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Pleven, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Vancouver, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Ottawa, Ontario, Canada
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Lévis, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Guangzhou, Guangdong, China
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Zhengzhou, Henan, China
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Wuhan, Hubei, China
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Wuhan, Hubei, China
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Hohhot, Inner Mongolia, China
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Suzhou, Jiangsu, China
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Changchun, Jilin, China
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Shenyang, Liaoning, China
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Yinchuan, Ningxia, China
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Xianyang, Shaanxi, China
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Taiyuan, Shanxi, China
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Hangzhou, Zhejiang, China
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Hangzhou, Zhejiang, China
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Wenzhou, Zhejiang, China
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Beijing, China
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Beijing, China
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Chongqing, China
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Shanghai, China
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Tianjin, China
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Barranquilla, Atlántico, Colombia
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Bogotá, Colombia
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Medellín, Colombia
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Medellín, Colombia
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Brno, Czechia
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Hradec Králové, Czechia
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Jihlava, Czechia
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Prague, Czechia
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Prague, Czechia
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Teplice, Czechia
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Esbjerg, Denmark
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Tallinn, Estonia
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Limoges, Haute Vienne, France
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Ajaccio, France
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Amiens, France
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Clermont-Ferrand, France
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Gonesse, France
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Grenoble, France
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Lille, France
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Lille, France
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Montpellier, France
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Nancy, France
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Nice, France
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Nîmes, France
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Orsay, France
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Paris, France
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Paris, France
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Poitiers, France
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Rennes, France
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Rouen, France
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Strasbourg, France
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Toulouse, France
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Tours, France
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
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Mannheim, Baden-Wurttemberg, Germany
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Munich, Bavaria, Germany
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Unterhaching, Bavaria, Germany
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Halle, Saxony-Anhalt, Germany
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Erfurt, Germany
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Giessen, Germany
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Greifswald, Germany
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Heidelberg, Germany
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Itzehoe, Germany
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Tübingen, Germany
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Chaïdári, Greece
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Budapest, Hungary
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Kistarcsa, Hungary
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Gurugram, Haryana, India
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Mangalore, Karnataka, India
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Kochi, Kerala, India
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New Delhi, National Capital Territory of Delhi, India
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New Delhi, National Capital Territory of Delhi, India
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Chandigarh, Punjab, India
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Vellore, Tamil Nadu, India
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Hyderabad, Telangana, India
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Haifa, Israel
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Jerusalem, Israel
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Ramat Gan, Israel
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Rehovot, Israel
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Tel Aviv, Israel
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Ẕerifin, Israel
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Bergamo, BG, Italy
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Foggia, FG, Italy
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Pozzilli, IS, Italy
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Pavia, PV, Italy
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Roma, RM, Italy
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Arnhem, Gelderland, Netherlands
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's-Hertogenbosch, North Brabant, Netherlands
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Leiden, Netherlands
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Krakow, Lesser Poland Voivodeship, Poland
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Bydgoszcz, Woj Kujawsko Pomorskie, Poland
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Chojnice, Poland
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Katowice, Poland
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Katowice, Poland
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Krakow, Poland
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Rzeszów, Poland
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Skorzewo, Poland
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Warsaw, Poland
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Zabrze, Poland
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Żory, Poland
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Braga, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Constanța, ROM, Romania
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Bucharest, Romania
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Campulung Muscel, Romania
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Bratislava, Slovakia
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Komárno, Slovakia
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Nitra, Slovakia
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Trnava, Slovakia
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Cape Town, Western Cape, South Africa
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L'Hospitalet de Llobregat, Barcelona, Spain
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Pozuelo de Alarcón, Madrid, Spain
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Torrejón de Ardoz, Madrid, Spain
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El Palmar, Murcia, Spain
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Castilleja de la Cuesta, Sevilla, Spain
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Valencia, Valencia, Spain
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Barakaldo, Vizcaya, Spain
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Alicante, Spain
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Barcelona, Spain
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Las Palmas GC, Spain
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Lleida, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Málaga, Spain
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Salamanca, Spain
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Valencia, Spain
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Bern, Switzerland
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Lausanne, Switzerland
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Brighton, East Sussex, United Kingdom
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Coventry, United Kingdom
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Glasgow, United Kingdom
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Leeds, United Kingdom
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London, United Kingdom
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Nottingham, United Kingdom