IRB Study Number 26-114
Status Recruiting
Phase Phase 3
Location U Building - Mellen Center
Institute Neurological Institute
Description
The purpose of this study is to determine whether remibrutinib could be a safe and effective alternative therapy for use after anti-CD20 treatment (ocrelizumab) in the aging relapsing multiple sclerosis (RMS) population (40-70 years of age).
Remibrutinib (LOU064) is an experimental drug that works by blocking a molecule called "Bruton's tyrosine kinase (BTK)" in the blood and brain, which is present in B-cells and microglia cells involved in MS. The mechanism of action may help prevent progression of your disease and formation of new brain lesions. It is not approved by the FDA.
Participation includes 24 months of ocrelizumab vs remibrutinib treatment, and an optional 24 months open-label remibrutinib treatment. Activities are: study drug administration, blood sample collection, neurological/physical assessments, questionnaires, ECG, and MRIs.
Inclusion Criteria
- Age 40-70 years
- RMS diagnosis
- Receiving ocrelizumab at standard clinical dose
- Neurologically stable past 30 days
- Considered suitable to switch to remibrutinib by physician or patient preference
Exclusion Criteria
- Primary progressive MS (PPMS)
- Significant other CNS disease or neurological disorders
- History of PML or consistent neurological symptoms
- Active clinically significant systemic infections
- Active chronic immune disease other than MS
- Severe cardiac disease or abnormal ECG findings
- Inability to undergo MRI
- Prior life-threatening infusion/injection reaction to ocrelizumab
