Last Update: Jul 29, 2026 A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis ClinicalTrials.gov Identifier: [NCT07225504](https://clinicaltrials.gov/ct2/show/NCT07225504) Novartis Reference Number:CLOU064P12301 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS) 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. Condition Secondary Progressive Multiple Sclerosis (SPMS) Phase Phase3 Overall Status Recruiting Number of Participants1275 Start Date Nov 11, 2025 Completion Date Jan 02, 2034 Gender All Age(s) 18 Years - 65 Years (Adult, Older Adult) ## Interventions Drug ### Placebo Matching placebo (binded), oral tablet Drug ### Remibrutinib (blinded) Remibrutinib (Blinded) active treatment, oral tablet Drug ### Remibrutinib (Open label) Remibrutinib (Open Label), oral tablet ## 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. 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