Moein Amin
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.
The study is an investigator-run, open-label Phase 2 study with approximately 24 total months of observation, involving approximately 20 participants with relapsing or progressive forms of MS. Participants will be recruited from the patient populations followed at CCF. All participants will take 100 mg remibrutinib twice daily. They will receive 4 MRIs, blood tests, EKGs, physical exams, and clinical functioning exams periodically to assess safety, tolerability, and efficacy of the study drug. All study activities will be performed at the Cleveland Clinic Mellen Center.
Inclusion Criteria: To be eligible for the study, participants must meet the following eligibility criteria at the Screening visit: 1. Written informed consent signed by participant. 2. English-speaking. 3. Male and female participants, 18-60 years of age inclusive. 4. 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. 5. Expanded Disability Status Score (EDSS) of 0 - 6.5, inclusive. 6. Adequate vision and motor function to participate i…
100 mg remibrutinib, twice daily
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