A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis
The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)
Eligibility
Min Age: 18 YearsMax Age: 65 Years
Plain Language Summary
Simplified for easier understanding
This study is testing a new oral drug called remibrutinib for adults with secondary progressive multiple sclerosis (SPMS) — a form of MS where disability steadily worsens over time without clear relapses. Remibrutinib works by blocking a protein (BTK) involved in immune cell activity that is thought to drive disease progression in the brain and spinal cord.
**You may be eligible if...**
- You are between 18 and 65 years old
- You have been diagnosed with secondary progressive MS (confirmed by 2017 McDonald criteria)
- You have had no documented clinical relapses in the past 24 months
- Your disability score (EDSS) is between 3.0 and 6.0
- You have documented evidence of disability getting worse in the past 12 months
**You may NOT be eligible if...**
- You have a serious fear of enclosed spaces (claustrophobia) or a medical implant that prevents MRI scans
- You have a significant brain or spinal cord condition unrelated to MS (such as stroke or severe head injury)
- You have an ongoing substance abuse problem or serious psychiatric condition
- You are unable or unwilling to undergo regular MRI monitoring
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.
Interested in this trial?
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Interventions
DRUGRemibrutinib (blinded)
Remibrutinib (Blinded) active treatment, oral tablet
DRUGPlacebo
Matching placebo (binded), oral tablet
DRUGRemibrutinib (Open label)
Remibrutinib (Open Label), oral tablet
Locations(164)
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
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
University of Kansas Hospital
Kansas City, Kansas, United States
Mid Atlantic Epilepsy and Sleep Ctr
Bethesda, Maryland, United States
Michigan Institute of Neurological
Farmington Hills, Michigan, United States
University of New Mexico Hospital
Albuquerque, New Mexico, 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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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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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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Linz, Austria
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Vienna, Austria
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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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Vancouver, British Columbia, 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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Hohhot, Inner Mongolia, China
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Suzhou, Jiangsu, China
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Changchun, Jilin, 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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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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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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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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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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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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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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Leiden, Netherlands
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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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Rzeszów, Poland
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Zabrze, 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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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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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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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
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.