Actively Recruiting
Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis
Led by University of Maryland, Baltimore · Updated on 2026-05-06
30
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
U
University of Maryland, Baltimore
Lead Sponsor
T
TG Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of the research study is to explore new retinal imaging biomarkers of immune cell activity in MS during use of ublituximab (Briumvi) treatment. A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. This study will evaluate the efficacy of ublituximab to modulate MS pathology in a new manner. In order to assess this new biomarker, a specialized optical coherence tomography (OCT) scan will be performed at enrollment into the study and at 2 other timepoints throughout the study. Subjects asked to take part in this study should have been diagnosed with relapsing multiple sclerosis (MS) and have recently been advised to start the medication ublituximab (Briumvi) or are currently on another medication for the treatment of their MS. We plan to enroll 30 patients into this study. Fifteen (15) patients with Relapsing Remitting Multiple Sclerosis (RRMS) who are being initiated on B-cell depletion therapy by their treating physician at the University of Maryland Center for MS Treatment and Research will be offered enrollment into this study. Additionally, 15 age/sex matched patients with stable RRMS who are not undergoing any change in treatment and are not currently on B-cell depleting therapies will be enrolled as control subjects.
CONDITIONS
Official Title
Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18 to 65 years
- Diagnosis of relapsing MS (including relapsing-remitting and active secondary progressive MS) per 2017 Revised McDonald Criteria and recent referral for ublituximab treatment (Ublituximab Group)
- Ages 18 to 65 years
- Diagnosis of relapsing-remitting MS per 2017 Revised McDonald Criteria
- Currently on stable disease modifying treatment for MS with no plans for alternative therapy in the next year (Comparison Group)
You will not qualify if you...
- Known eye diseases that may prevent proper analysis, such as diabetic retinopathy, macular degeneration, or glaucoma
- Treatment with any B-cell depleting therapy for MS within the past 12 months
- History of life-threatening infusion reaction to ublituximab or prior anti-CD20 therapy
- Any chronic or active infection preventing anti-CD20 therapy, including active hepatitis B, tuberculosis, or HIV
- Receipt of live or live-attenuated vaccines within 4 weeks before first ublituximab dose
- Plans to start B-cell depleting therapy within the next year (Comparison Group)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
K
Kerry Naunton, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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