Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )

Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY)

This study determines the Annualized Relapse Rate (ARR) in participants with RMS after 96 weeks (approximately 2 years) treatment with intravenous (IV) infusion of ublituximab/oral placebo compared to 14 mg oral teriflunomide/IV placebo.

Inclusion Criteria:

• 18-55 age
• Diagnosis of RMS (McDonald criteria 2010)
• Active disease
• Expanded disability status scale (EDSS) 0-5.5 (inclusive) at screening

Exclusion Criteria:

• Treatment with prior Anti-cluster of differentiate 20 (CD20) or other B cell directed treatment
• Treatment with the following therapies at any time prior to randomization: alemtuzumab, natalizumab, teriflunomide, leflunomide and stem cell transplantation
• Diagnosed with Primary Progressive MS (PPMS)
• Pregnant or nursing