The study is an investigator-run, study following participants for 2 years with twice-daily remibrutinib. MRI is the main endpoint. Safety, tolerability, and efficacy are secondary endpoints. Approximately 20 participants with relapsing or progressive forms of MS will be recruited.
Written informed consent signed by participant.
English-speaking.
Male and female participants, 18-60 years of age inclusive.
Established diagnosis of relapsing or progressive MS, as defined by the 2024 revision of McDonald Diagnostic Criteria (any form of MS). A diagnosis of MS must be confirmed at the time of the screening visit.
Concurrent treatment with any disease modifying therapy for MS or systemic immunotherapy for other autoimmune or rheumatological disorders (e.g. rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease) according to study protocol.
Ongoing substance abuse (drug or alcohol) or any other factor that may interfere with the participant's ability to cooperate and comply with study procedures.
History of malignancy of any organ system (other than complete resection of localized basal cell carcinoma of the skin or in situ cervical cancer) within the past 5 years regardless of treatment or metastasis status.
History of severe renal disease or creatinine level above 1.5 x upper limit normal.
Single group
Remibrutinib (Open Label)
Drug100 mg remibrutinib, twice daily
Quantitative MRI volumetric measurements
Rate of change in regional brain volumes using 7T MRI over 24 months
Slowly expanding lesions (SELs)
Prevalence of SELs identified using 7T MRI over 24 months
Paramagnetic rim lesions (PRLs) -- count
Change in count of PRLs identified using 7T MRI over 24 months
Paramagnetic rim lesions (PRLs) -- size
Change in size of PRLs identified using 7T MRI over 24 months
Frequency of Treatment Emergent Adverse Events (TEAEs)
Frequency of Serious Adverse Events (SAEs)
Frequency of study medication discontinuation
Gadolinium Enhancing Lesions
Change in number of Gadolinium enhancing lesions over 24 months
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