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

Phase III: UbLiTuximab in Multiple Sclerosis Treatment Effects (ULTIMATE II 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:

• Diagnosis of relapsing multiple sclerosis (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 multiple sclerosis (PPMS)
• Pregnant or nursing