Overview
The purpose of this study is to assess the pharmacokinetics of ublituximab when administered subcutaneously (SC) compared to intravenous (IV) administration in participants with RMS.
Description
This is a Phase 3, open label, parallel-group, multicenter study in participants with RMS.
Eligibility
Inclusion Criteria:
- Diagnosis of RMS (2017 Revised McDonald criteria).
- Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.
- Neurologically stable for > 30 days prior to Screening and Day 1.
- Female participants of childbearing potential must consent to use an effective method of contraception from consent and for 6 months after the last dose of ublituximab.
Exclusion Criteria:
- Primary-progressive Multiple Sclerosis (PPMS) or inactive Secondary Progressive Multiple Sclerosis (SPMS).
- Active chronic disease of the immune system other than MS or immunodeficiency syndrome.
- Participants with significantly impaired bone marrow function or significant leukopenia or thrombocytopenia.
- Participants who previously received anti-CD20 therapy at any time; any approved therapy to treat MS within 5 half-lives of the medication prior to screening.
Note: Other Inclusion/Exclusion criteria may apply.