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RECRUITING
NCT07225504
PHASE3

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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

DRUG

Remibrutinib (blinded)

Remibrutinib (Blinded) active treatment, oral tablet

DRUG

Placebo

Matching placebo (binded), oral tablet

DRUG

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

Novartis Investigative Site

Bombal, Mendoza Province, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

Caba, Argentina

Novartis Investigative Site

CABA, Argentina

Novartis Investigative Site

Caba, Argentina

Novartis Investigative Site

Caba, Argentina

Novartis Investigative Site

Santiago del Estero, Argentina

Novartis Investigative Site

Kogarah, New South Wales, Australia

Novartis Investigative Site

New Lambton Heights, New South Wales, Australia

Novartis Investigative Site

Westmead, New South Wales, Australia

Novartis Investigative Site

Clayton, Victoria, Australia

Novartis Investigative Site

Heidelberg, Victoria, Australia

Novartis Investigative Site

Murdoch, Western Australia, Australia

Novartis Investigative Site

Southport, Australia

Novartis Investigative Site

Linz, Upper Austria, Austria

Novartis Investigative Site

Linz, Austria

Novartis Investigative Site

Vienna, Austria

Novartis Investigative Site

Roeselare, West-Vlaanderen, Belgium

Novartis Investigative Site

Pleven, Bulgaria

Novartis Investigative Site

Sofia, Bulgaria

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Sofia, Bulgaria

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

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

Novartis Investigative Site

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