RecruitingRecruiting
A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis
NCT07225504 · Novartis
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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
About this study
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
Inclusion Criteria:
* Signed informed consent must be obtained prior to any assessment performed.
* Male or female participants aged 18-65 (inclusive) at Screening.
* Diagnosis of SPMS according to the 2017 revised McDonald criteria (Thompson et al 2018) at Screening.
* Absence of documented clinical relapses in the 24 months before Screening and randomization.
* EDSS score of 3.0 to 6.0 (inclusive) at Screening.
* Documented evidence of disability progression in the 12 months before Screening.
Exclusion Criteria:
* Unwilling or unable to undergo MRI scans as per protocol (for example, claustrophobia, or presents absolute contraindications to MRI (e.g., metallic implants, metallic foreign bodies, pacemaker, defibrillator)).
* History of clinically significant central nervous system (CNS) disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic multiple sclerosis (MS).
* Ongoing substance abuse (drug or alcohol) or any other factor (e.g. serious psychiatric condition) that may interfere with the participant's ability to cooperate and comply with the study procedures.
* Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symptoms consistent with PML.
* Women of childbearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure rate \< 1% per year) while taking study treatment and for at least 1 week after stopping study treatment.
* Significant bleeding risk or coagulation disorders, at Screening.
* Use of exclusionary medication prior to Screening/randomization as listed in the protocol.
Other protocol-defined inclusion/exclusion critria may apply
Study design
Enrollment target: 1275 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-11-11
Estimated completion: 2034-01-02
Last updated: 2026-06-01
Interventions
Drug: Remibrutinib (blinded)Drug: PlaceboDrug: Remibrutinib (Open label)
Primary outcomes
- • Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS) (From baseline up to approximately 5 years)
Sponsor
Novartis Pharmaceuticals · industry
Contacts & investigators
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · 1-888-669-6682
ContactNovartis Pharmaceuticals · contact · +41613241111
All locations (208)
Alabama Neurology Associates PCRecruiting
Birmingham, Alabama, United States
AZ Integrated Neuro and SpineRecruiting
Phoenix, Arizona, United States
Center for NeurosciencesRecruiting
Tucson, Arizona, United States
Fullerton Neuro and Headache CtrRecruiting
Fullerton, California, United States
Regina Berkovich MD PhD IncRecruiting
West Hollywood, California, United States
Georgetown University HospitalRecruiting
Washington D.C., District of Columbia, United States
Medstar Washington Hosp CtrRecruiting
Washington D.C., District of Columbia, United States
Neurology of Central FL Res CtrRecruiting
Altamonte Springs, Florida, United States
UF Health Cancer CenterRecruiting
Gainesville, Florida, United States
Homestead Assoc In Research IncRecruiting
Homestead, Florida, United States
Neurology Associates PARecruiting
Maitland, Florida, United States
Miami NS Ins Baptist Health S FLRecruiting
Miami, Florida, United States
Aqualane Clinical ResearchRecruiting
Naples, Florida, United States
Orlando Health Clinical TrialsRecruiting
Orlando, Florida, United States
Comprehensive Neurology ClinicRecruiting
Orlando, Florida, United States
Neurology Associates of Ormond BeachRecruiting
Ormond Beach, Florida, United States
Axiom Brain HealthRecruiting
Tampa, Florida, United States
Joi Life Wellness Group LLCRecruiting
Smyrna, Georgia, United States
Hawaii Pacific Neuroscience LLCRecruiting
Honolulu, Hawaii, United States
Northwestern Memorial HospitalRecruiting
Chicago, Illinois, United States
University of Kansas HospitalRecruiting
Kansas City, Kansas, United States
Mid Atlantic Epilepsy and Sleep CtrRecruiting
Bethesda, Maryland, United States
Neuro Institute of New England P CRecruiting
Foxborough, Massachusetts, United States
Michigan Institute of NeurologicalRecruiting
Farmington Hills, Michigan, United States
University of New Mexico HospitalRecruiting
Albuquerque, New Mexico, United States
Premier NeurologyRecruiting
Greenville, South Carolina, United States
Neurology Clinic PCRecruiting
Cordova, Tennessee, United States
Saturn Research SolutionRecruiting
Plano, Texas, United States
University of Washington MS ClinicRecruiting
Seattle, Washington, United States
Citta Clinical ResearchRecruiting
Spokane, Washington, United States
Novartis Investigative SiteRecruiting
Capital Federal, Buenos Aires, Argentina
Novartis Investigative SiteRecruiting
Bombal, Mendoza Province, Argentina
Novartis Investigative SiteRecruiting
Rosario, Santa Fe Province, Argentina
Novartis Investigative SiteRecruiting
Buenos Aires, Argentina
Novartis Investigative SiteRecruiting
Caba, Argentina
Novartis Investigative SiteRecruiting
CABA, Argentina
Novartis Investigative SiteRecruiting
Caba, Argentina
Novartis Investigative SiteRecruiting
Caba, Argentina
Novartis Investigative SiteRecruiting
Santiago del Estero, Argentina
Novartis Investigative SiteRecruiting
Kogarah, New South Wales, Australia
Novartis Investigative SiteRecruiting
New Lambton Heights, New South Wales, Australia
Novartis Investigative SiteRecruiting
Westmead, New South Wales, Australia
Novartis Investigative SiteRecruiting
Clayton, Victoria, Australia
Novartis Investigative SiteRecruiting
Heidelberg, Victoria, Australia
Novartis Investigative SiteRecruiting
Murdoch, Western Australia, Australia
Novartis Investigative SiteRecruiting
Southport, Australia
Novartis Investigative SiteRecruiting
Linz, Upper Austria, Austria
Novartis Investigative SiteRecruiting
Linz, Austria
Novartis Investigative SiteRecruiting
Vienna, Austria
Novartis Investigative SiteRecruiting
Leuven, Vlaams Brabant, Belgium
Novartis Investigative SiteRecruiting
Roeselare, West-Vlaanderen, Belgium
Novartis Investigative SiteRecruiting
Bonheiden, Belgium
Novartis Investigative SiteRecruiting
Pleven, Bulgaria
Novartis Investigative SiteRecruiting
Sofia, Bulgaria
Novartis Investigative SiteRecruiting
Sofia, Bulgaria
Novartis Investigative SiteRecruiting
Sofia, Bulgaria
Novartis Investigative SiteRecruiting
Sofia, Bulgaria
Novartis Investigative SiteRecruiting
Sofia, Bulgaria
Novartis Investigative SiteRecruiting
Sofia, Bulgaria
Novartis Investigative SiteRecruiting
Sofia, Bulgaria
Novartis Investigative SiteRecruiting
Vancouver, British Columbia, Canada
Novartis Investigative SiteRecruiting
Halifax, Nova Scotia, Canada
Novartis Investigative SiteRecruiting
Ottawa, Ontario, Canada
Novartis Investigative SiteRecruiting
Lévis, Quebec, Canada
Novartis Investigative SiteRecruiting
Montreal, Quebec, Canada
Novartis Investigative SiteRecruiting
Montreal, Quebec, Canada
Novartis Investigative SiteRecruiting
Montreal, Quebec, Canada
Novartis Investigative SiteRecruiting
Sherbrooke, Quebec, Canada
Novartis Investigative SiteRecruiting
Guangzhou, Guangdong, China
Novartis Investigative SiteRecruiting
Zhengzhou, Henan, China
Novartis Investigative SiteRecruiting
Wuhan, Hubei, China
Novartis Investigative SiteRecruiting
Wuhan, Hubei, China
Novartis Investigative SiteRecruiting
Hohhot, Inner Mongolia, China
Novartis Investigative SiteRecruiting
Suzhou, Jiangsu, China
Novartis Investigative SiteRecruiting
Changchun, Jilin, China
Novartis Investigative SiteRecruiting
Shenyang, Liaoning, China
Novartis Investigative SiteRecruiting
Yinchuan, Ningxia, China
Novartis Investigative SiteRecruiting
Xianyang, Shaanxi, China
Novartis Investigative SiteRecruiting
Taiyuan, Shanxi, China
Novartis Investigative SiteRecruiting
Hangzhou, Zhejiang, China
Novartis Investigative SiteRecruiting
Hangzhou, Zhejiang, China
Novartis Investigative SiteRecruiting
Wenzhou, Zhejiang, China
Novartis Investigative SiteRecruiting
Beijing, China
Novartis Investigative SiteRecruiting
Beijing, China
Novartis Investigative SiteRecruiting
Chongqing, China
Novartis Investigative SiteRecruiting
Shanghai, China
Novartis Investigative SiteRecruiting
Tianjin, China
Novartis Investigative SiteRecruiting
Barranquilla, Atlántico, Colombia
Novartis Investigative SiteRecruiting
Bogotá, Colombia
Novartis Investigative SiteRecruiting
Medellín, Colombia
Novartis Investigative SiteRecruiting
Medellín, Colombia
Novartis Investigative SiteRecruiting
Brno, Czechia
Novartis Investigative SiteRecruiting
Hradec Králové, Czechia
Novartis Investigative SiteRecruiting
Jihlava, Czechia
Novartis Investigative SiteRecruiting
Prague, Czechia
Novartis Investigative SiteRecruiting
Prague, Czechia
Novartis Investigative SiteRecruiting
Teplice, Czechia
Novartis Investigative SiteRecruiting
Aarhus N, Denmark
Novartis Investigative SiteRecruiting
Esbjerg, Denmark
Novartis Investigative SiteRecruiting
Tallinn, Estonia
Novartis Investigative SiteRecruiting
Limoges, Haute Vienne, France
Novartis Investigative SiteRecruiting
Ajaccio, France
Novartis Investigative SiteRecruiting
Amiens, France
Novartis Investigative SiteRecruiting
Clermont-Ferrand, France
Novartis Investigative SiteRecruiting
Gonesse, France
Novartis Investigative SiteRecruiting
Grenoble, France
Novartis Investigative SiteRecruiting
Lille, France
Novartis Investigative SiteRecruiting
Lille, France
Novartis Investigative SiteRecruiting
Montpellier, France
Novartis Investigative SiteRecruiting
Nancy, France
Novartis Investigative SiteRecruiting
Nice, France
Novartis Investigative SiteRecruiting
Nîmes, France
Novartis Investigative SiteRecruiting
Orsay, France
Novartis Investigative SiteRecruiting
Paris, France
Novartis Investigative SiteRecruiting
Paris, France
Novartis Investigative SiteRecruiting
Poitiers, France
Novartis Investigative SiteRecruiting
Rennes, France
Novartis Investigative SiteRecruiting
Rouen, France
Novartis Investigative SiteRecruiting
Strasbourg, France
Novartis Investigative SiteRecruiting
Toulouse, France
Novartis Investigative SiteRecruiting
Tours, France
Novartis Investigative SiteRecruiting
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Novartis Investigative SiteRecruiting
Mannheim, Baden-Wurttemberg, Germany
Novartis Investigative SiteRecruiting
Munich, Bavaria, Germany
Novartis Investigative SiteRecruiting
Unterhaching, Bavaria, Germany
Novartis Investigative SiteRecruiting
Halle, Saxony-Anhalt, Germany
Novartis Investigative SiteRecruiting
Erfurt, Germany
Novartis Investigative SiteRecruiting
Giessen, Germany
Novartis Investigative SiteRecruiting
Greifswald, Germany
Novartis Investigative SiteRecruiting
Heidelberg, Germany
Novartis Investigative SiteRecruiting
Itzehoe, Germany
Novartis Investigative SiteRecruiting
Tübingen, Germany
Novartis Investigative SiteRecruiting
Chaïdári, Greece
Novartis Investigative SiteRecruiting
Ioannina, Greece
Novartis Investigative SiteRecruiting
Budapest, Hungary
Novartis Investigative SiteRecruiting
Kistarcsa, Hungary
Novartis Investigative SiteRecruiting
Gurugram, Haryana, India
Novartis Investigative SiteRecruiting
Mangalore, Karnataka, India
Novartis Investigative SiteRecruiting
Kochi, Kerala, India
Novartis Investigative SiteRecruiting
New Delhi, National Capital Territory of Delhi, India
Novartis Investigative SiteRecruiting
New Delhi, National Capital Territory of Delhi, India
Novartis Investigative SiteRecruiting
Chandigarh, Punjab, India
Novartis Investigative SiteRecruiting
Vellore, Tamil Nadu, India
Novartis Investigative SiteRecruiting
Hyderabad, Telangana, India
Novartis Investigative SiteRecruiting
Haifa, Israel
Novartis Investigative SiteRecruiting
Jerusalem, Israel
Novartis Investigative SiteRecruiting
Ramat Gan, Israel
Novartis Investigative SiteRecruiting
Rehovot, Israel
Novartis Investigative SiteRecruiting
Tel Aviv, Israel
Novartis Investigative SiteRecruiting
Ẕerifin, Israel
Novartis Investigative SiteRecruiting
Bergamo, BG, Italy
Novartis Investigative SiteRecruiting
Foggia, FG, Italy
Novartis Investigative SiteRecruiting
Pozzilli, IS, Italy
Novartis Investigative SiteRecruiting
Pavia, PV, Italy
Novartis Investigative SiteRecruiting
Roma, RM, Italy
Novartis Investigative SiteRecruiting
Arnhem, Gelderland, Netherlands
Novartis Investigative SiteRecruiting
's-Hertogenbosch, North Brabant, Netherlands
Novartis Investigative SiteRecruiting
Leiden, Netherlands
Novartis Investigative SiteRecruiting
Krakow, Lesser Poland Voivodeship, Poland
Novartis Investigative SiteRecruiting
Bydgoszcz, Woj Kujawsko Pomorskie, Poland
Novartis Investigative SiteRecruiting
Chojnice, Poland
Novartis Investigative SiteRecruiting
Katowice, Poland
Novartis Investigative SiteRecruiting
Katowice, Poland
Novartis Investigative SiteRecruiting
Krakow, Poland
Novartis Investigative SiteRecruiting
Lodz, Poland
Novartis Investigative SiteRecruiting
Rzeszów, Poland
Novartis Investigative SiteRecruiting
Skorzewo, Poland
Novartis Investigative SiteRecruiting
Warsaw, Poland
Novartis Investigative SiteRecruiting
Zabrze, Poland
Novartis Investigative SiteRecruiting
Żory, Poland
Novartis Investigative SiteRecruiting
Braga, Portugal
Novartis Investigative SiteRecruiting
Lisbon, Portugal
Novartis Investigative SiteRecruiting
Lisbon, Portugal
Novartis Investigative SiteRecruiting
Porto, Portugal
Novartis Investigative SiteRecruiting
Constanța, ROM, Romania
Novartis Investigative SiteRecruiting
Bucharest, Romania
Novartis Investigative SiteRecruiting
Campulung Muscel, Romania
Novartis Investigative SiteRecruiting
Bratislava, Slovakia
Novartis Investigative SiteRecruiting
Komárno, Slovakia
Novartis Investigative SiteRecruiting
Nitra, Slovakia
Novartis Investigative SiteRecruiting
Trnava, Slovakia
Novartis Investigative SiteRecruiting
Cape Town, Western Cape, South Africa
Novartis Investigative SiteRecruiting
L'Hospitalet de Llobregat, Barcelona, Spain
Novartis Investigative SiteRecruiting
Jerez de la Frontera, Cadiz, Spain
Novartis Investigative SiteRecruiting
Pozuelo de Alarcón, Madrid, Spain
Novartis Investigative SiteRecruiting
Torrejón de Ardoz, Madrid, Spain
Novartis Investigative SiteRecruiting
El Palmar, Murcia, Spain
Novartis Investigative SiteRecruiting
Castilleja de la Cuesta, Sevilla, Spain
Novartis Investigative SiteRecruiting
Valencia, Valencia, Spain
Novartis Investigative SiteRecruiting
Barakaldo, Vizcaya, Spain
Novartis Investigative SiteRecruiting
Alicante, Spain
Novartis Investigative SiteRecruiting
Barcelona, Spain
Novartis Investigative SiteRecruiting
Las Palmas GC, Spain
Novartis Investigative SiteRecruiting
Lleida, Spain
Novartis Investigative SiteRecruiting
Madrid, Spain
Novartis Investigative SiteRecruiting
Madrid, Spain
Novartis Investigative SiteRecruiting
Madrid, Spain
Novartis Investigative SiteRecruiting
Málaga, Spain
Novartis Investigative SiteRecruiting
Salamanca, Spain
Novartis Investigative SiteRecruiting
Valencia, Spain
Novartis Investigative SiteRecruiting
Bern, Switzerland
Novartis Investigative SiteRecruiting
Lausanne, Switzerland
Novartis Investigative SiteRecruiting
Brighton, East Sussex, United Kingdom
Novartis Investigative SiteRecruiting
Coventry, United Kingdom
Novartis Investigative SiteRecruiting
Glasgow, United Kingdom
Novartis Investigative SiteRecruiting
Leeds, United Kingdom
Novartis Investigative SiteRecruiting
London, United Kingdom
Novartis Investigative SiteRecruiting
Nottingham, United Kingdom