Long-term open-label tolebrutinib safety study in multiple sclerosis

Phase 3, open-label, single-arm trial of tolebrutinib in multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS), sponsored by Sanofi. Primary endpoints: Number of participants with adverse events, serious adverse events, adverse events of special interest, and adverse events leading to permanent study intervention discontinuation and Number of participants with potentially clinically significant abnormalities. Planned start Mar 2024; status: withdrawn.