The study aims to enroll at least 500 RMS patients across 100 centers in the US, capturing a diverse geographic and racial/ethnic population from a wide range of MS centers spanning academic hospitals and independent clinics. Enrollment is expected to take up to 24 months, and several sites have opened starting mid-2024. The primary endpoint is annualized relapse rates at week 96. The secondary endpoint is the proportion of participants experiencing adverse events in addition to documenting the incidence, severity, and type of infusion-related reactions (IRR) at each infusion. Exploratory endpoints include PROs (TSQM 1.4 and MSIS-29), infusion time (including premedication and post-infusion observation), and changes in immunoglobulins, B cell counts, MRI activity, Expanded Disability Status Scale, Symbol Digit Modalities Test (SDMT), Timed 25-foot Walk (T25-FW), and Nine-Hole Peg Test (9-HPT).

ENABLE will provide valuable real-world clinical evidence on the effectiveness, safety, and tolerability of ublituximab from MS centers across the US.