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A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis
RecruitingPhase 3
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis
Who can join
Ages 18 to 65 · All sexes
Full 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 MS according to the 2017 revised McDonald criteria (Thompson et al 2018), with current SPMS in accordance with the revised clinical course (Lublin et al 2014) 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), 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
About the study
The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)
What is being tested
- Remibrutinib (blinded) (drug)
- Placebo (drug)
- Remibrutinib (Open label) (drug)
Sponsor: Novartis Pharmaceuticals · Participants: 1,275 · Started: Nov 11, 2025
Contact the study team
- Novartis Pharmaceuticals · Phone: 1-888-669-6682
- Novartis Pharmaceuticals · Phone: +41613241111
Official record on ClinicalTrials.gov — NCT07225504
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.