Study of Ublituximab for Ocrelizumab Wearing-Off in Multiple Sclerosis
NCT07389590 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-05-06
Summary
The proposed study is a pilot study of ublituximab involving people with multiple sclerosis (MS) who are experiencing a "wearing off" phenomenon (return or worsening of MS-related symptoms) while being treated with ocrelizumab, and exploring whether switching to ublituzimab can resolve, improve or delay this phenomenon.
Conditions
Interventions
- DRUG
-
Ublituximab
Ublituzimab will be administered via IV infusion as specified throughout the study period.
- DRUG
-
Ocrelizumab
Ocrelizumab will be administered via IV infusion as specified throughout the treatment period.
Sponsors & Collaborators
-
TG Therapeutics, Inc.
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Shiv Saidha, MD · Johns Hopkins University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-10
- Primary Completion
- 2028-10-31
- Completion
- 2029-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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