Long-term Safety and Tolerability of Tolebrutinib in Multiple Sclerosis (Extension Study)

Phase 3, open-label, single-arm trial of tolebrutinib in multiple sclerosis (MS), primary progressive multiple sclerosis (PPMS) and secondary-progressive multiple sclerosis (SPMS), 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 (PCSAs). Planned start Nov 2023; status: withdrawn.