Neurosciences Clinical Trials
A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis (REMASTER)
Learn moreWhat is the purpose of this study?
The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)
Eligibility
- 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.
- 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
Where can I participate?
Hoag Hospital Newport Beach
1 Hoag
Newport Beach, CA 92663
What is the full name of this Clinical Trial?
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis
- Disease Type/ConditionSecondary Progressive Multiple Sclerosis (SPMS)
- Principal InvestigatorYasir Jassam, MD
- Age GroupAdult, Older Adult
- PhaseIII
- ClinicalTrials.gov IDNCT07225504
- Key Eligibilityclinicaltrials.gov
- How do I learn more about this study?Neuroscience Research Team
neuroresearch@hoag.org
Pickup Family Neurosciences Institute
https://www.hoag.org/institute/neurosciences/
Hoag’s Pickup Family Neurosciences Institute offers Orange County’s most comprehensive neurologic care, with multidisciplinary specialists, advanced technology, and evidence-based treatment for complex brain, spine, and nervous system conditions. Patients have access to leading programs in brain tumors, memory and cognitive disorders, multiple sclerosis, epilepsy, Parkinson’s and movement disorders, headache and migraine, stroke, and clinical trials.
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