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

NCT07225504 · Novartis
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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: 2026-04-06
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 (90)
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
Neurology of Central FL Res CtrRecruiting
Altamonte Springs, Florida, United States
UF Health Cancer CenterRecruiting
Gainesville, 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
Hawaii Pacific Neuroscience LLCRecruiting
Honolulu, Hawaii, United States
University of Kansas HospitalRecruiting
Kansas City, Kansas, United States
Mid Atlantic Epilepsy and Sleep CtrRecruiting
Bethesda, Maryland, United States
Michigan Institute of NeurologicalRecruiting
Farmington Hills, Michigan, United States
Neurology Clinic PCRecruiting
Cordova, Tennessee, United States
Saturn Research SolutionRecruiting
Plano, Texas, United States
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Buenos Aires, 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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Pleven, 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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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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Wuhan, Hubei, China
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Hohhot, Inner Mongolia, China
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Suzhou, Jiangsu, China
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Hangzhou, Zhejiang, China
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Wenzhou, Zhejiang, China
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Chongqing, China
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Shanghai, China
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Tianjin, China
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Medellín, Colombia
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Medellín, Colombia
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Jihlava, Czechia
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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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Nice, France
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Nîmes, France
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Paris, France
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Poitiers, France
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Tours, France
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
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Halle, Saxony-Anhalt, Germany
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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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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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Foggia, FG, Italy
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Braga, Portugal
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Lisbon, Portugal
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Bucharest, Romania
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Campulung Muscel, Romania
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Cape Town, Western Cape, South Africa
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L'Hospitalet de Llobregat, Barcelona, Spain
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Valencia, Valencia, Spain
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Barcelona, Spain
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Málaga, Spain
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Salamanca, Spain
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Bern, Switzerland
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Lausanne, Switzerland
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Glasgow, United Kingdom
A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis · TrialPath