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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

2026-04-06

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 (90)

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

Neurology of Central FL Res Ctr

Altamonte Springs, Florida, United States

UF Health Cancer Center

Gainesville, 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

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

Neurology Clinic PC

Cordova, Tennessee, United States

Saturn Research Solution

Plano, Texas, United States

Novartis Investigative Site

Buenos Aires, 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

Pleven, Bulgaria

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Vancouver, British Columbia, Canada

Novartis Investigative Site

Lévis, Quebec, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Sherbrooke, Quebec, Canada

Novartis Investigative Site

Wuhan, Hubei, China

Novartis Investigative Site

Hohhot, Inner Mongolia, China

Novartis Investigative Site

Suzhou, Jiangsu, China

Novartis Investigative Site

Hangzhou, Zhejiang, China

Novartis Investigative Site

Wenzhou, Zhejiang, China

Novartis Investigative Site

Chongqing, China

Novartis Investigative Site

Shanghai, China

Novartis Investigative Site

Tianjin, China

Novartis Investigative Site

Medellín, Colombia

Novartis Investigative Site

Medellín, Colombia

Novartis Investigative Site

Jihlava, Czechia

Novartis Investigative Site

Ajaccio, France

Novartis Investigative Site

Amiens, France

Novartis Investigative Site

Clermont-Ferrand, France

Novartis Investigative Site

Gonesse, France

Novartis Investigative Site

Grenoble, France

Novartis Investigative Site

Lille, France

Novartis Investigative Site

Lille, France

Novartis Investigative Site

Montpellier, France

Novartis Investigative Site

Nice, France

Novartis Investigative Site

Nîmes, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Poitiers, France

Novartis Investigative Site

Tours, France

Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Novartis Investigative Site

Halle, Saxony-Anhalt, Germany

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Kistarcsa, Hungary

Novartis Investigative Site

Gurugram, Haryana, India

Novartis Investigative Site

Mangalore, Karnataka, India

Novartis Investigative Site

Kochi, Kerala, India

Novartis Investigative Site

New Delhi, National Capital Territory of Delhi, India

Novartis Investigative Site

Vellore, Tamil Nadu, India

Novartis Investigative Site

Hyderabad, Telangana, India

Novartis Investigative Site

Jerusalem, Israel

Novartis Investigative Site

Ramat Gan, Israel

Novartis Investigative Site

Rehovot, Israel

Novartis Investigative Site

Tel Aviv, Israel

Novartis Investigative Site

Ẕerifin, Israel

Novartis Investigative Site

Foggia, FG, Italy

Novartis Investigative Site

Braga, Portugal

Novartis Investigative Site

Lisbon, Portugal

Novartis Investigative Site

Bucharest, Romania

Novartis Investigative Site

Campulung Muscel, Romania

Novartis Investigative Site

Cape Town, Western Cape, South Africa

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, Spain

Novartis Investigative Site

Valencia, Valencia, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Málaga, Spain

Novartis Investigative Site

Salamanca, Spain

Novartis Investigative Site

Bern, Switzerland

Novartis Investigative Site

Lausanne, Switzerland

Novartis Investigative Site

Glasgow, United Kingdom