IRB Study Number 24-678
Status Recruiting
Phase Phase 3
Location U Building - Mellen Center
Institute Neurological Institute
Description
This 48-week study is to determine the efficacy and safety of a different dosing schedule of ublituximab in participants new to RMS treatment or those switching from a current disease modifying therapy (DMT). Shorter ublituximab infusion times will also be evaluated for safety and tolerability.
Ublituximab is approved by the FDA. It is considered investigational in this study because the initial dose may be different than the initial dose currently approved by the FDA, or it will be administered over a shorter period of time.
You will be asked to attend multiple research visits, receive the study drug, provide blood and urine samples, attend clinical visits for neurological/physical exams, MRIs, and complete questionnaires. Participation will involve approximately 5 or more visits to the study site and will last about 48 weeks.
Inclusion Criteria
- Age 18-65
- Diagnosis of relapsing multiple sclerosis (RMS)
- EDSS ≤ 5.5
- Neurologically stable
Exclusion Criteria
- Previously treated with ublituximab, alemtuzumab, cyclophosphamide, mitoxantrone, cladribine, or daclizumab
- Any suboptimal response to anti-CD20 therapy in past 6 months
- Any documented relapse on anti-CD20 therapy in past 12 months
- Any Grade ≥3 IRR on prior anti-CD20 therapy
- Any active chronic immune disease other than MS
- Known history of clinically significant infections
