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Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient.
Status
Recruiting
Phase
PHASE3
NCT ID
NCT07225504
Trial Summary
The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)
Sponsor: Novartis Pharmaceuticals
Participants: ALL
Start: 2025-11-11
Completion: 2030-12-03
Min Age: 18 Years
Max Age: 65 Years
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…
Data from ClinicalTrials.gov. Always verify on the primary source before clinical use.