NCT06864936 · University of Maryland, Baltimore
Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis
What this study 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.
View original scientific description
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.
Interventions
DRUG
Ublituximab
ublituximab
OTHER
Other disease modifying therapies
Other disease modifying therapies for MS (not ublituximab)
Primary outcome measures
Evaluation of the effect of ublituximab on macular hyperreflective foci (HRF) in MS.
Time frame: From enrollment until the last OCT at Months 6 and 12
A change in the number of HRF seen on baseline compared to months 6 and 12 in the ublituximab grop compared to the comparison group
Evaluation of the effect of ublituximab on inner limiting membrane (ILM) macrophage-like cells (MLC).
Time frame: From enrollment until the last OCT at Months 6 and 12
A change in the number of MLCs seen from baseline to months 6 and 12 in the ublituximab group compared to the comparison group.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- For Ublituximab Group:
- A diagnosis of relapsing MS (to include relapsing-remitting MS and active secondary progressive MS) according to 2017 Revised McDonald Criteria.
- A recent referral for initiation of ublituximab for treatment of MS by the patient's treating physician. For Comparison Group:
- Ages 18 - 65
- A diagnosis of relapsing-remitting MS according to 2017 Revised McDonald Criteria.
- Currently on a stable dose of disease modifying treatment for MS with no plans for alternative therapy for the following year.
Exclusion criteria
- For Ublituximab Group:
- Known eye disease that may, in the opinion of the screening ophthalmologist, preclude proper analysis of data in this study. This includes, but is not limited to diabetic retinopathy, macular degeneration, and glaucoma.
- Treatment with any B-cell depleting disease modifying therapy for MS (i.e. rituximab, ocrelizumab, ofatumumab, ublituximab, etc.) within the past 12 months.
- History of life-threatening infusion reaction on ublituximab or prior anti-CD20 therapy
- Any chronic or active infection that would preclude anti-CD20 therapy. This may include but is not limited to active hepatitis B virus (HBV) confirmed by positive results for Hepatitis B surface antigen (HBsAg) and anti-HBV tests, tuberculosis, and human immunodeficiency virus (HIV).
- Receipt of any live of live-attenuated vaccines within 4 weeks prior to first ublituximab administration For Comparison Group:
- Known eye disease that may, in the opinion of the screening ophthalmologist, preclude proper analysis of data in this study. This includes, but is not limited to diabetic retinopathy, macular degeneration, and glaucoma.
- Treatment with any B-cell depleting disease modifying therapy (i.e. rituximab, ocrelizumab, ofatumumab, ublituximab, etc.) within the past 12 months, or plans to initiate such a therapy in the following year.
Where
- Baltimore, Maryland
Collaborators
TG Therapeutics, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations