Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis (MS) - Relapsing-remitting
• Intervention / Treatment: Drug: Ublituximab; Other: Other disease modifying therapies

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kerry Naunton, RN; Phone Number: 410-328-1885; Email: knaunton@som.umaryland.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland, Baltimore
      • Principal Investigator: Daniel Harrison, MD
      • Contact: Kerry Naunton, RN; Phone Number: 410-328-1885; Email: knaunton@som.umaryland.edu
      • Contact: Daniel Harrison, MD; Phone Number: 410-328-5605; Email: dharrison@som.umaryland.edu
      • Sub-Investigator: Osamah Saeedi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

For Ublituximab Group:

1. Ages 18-65
2. A diagnosis of relapsing MS (to include relapsing-remitting MS and active secondary progressive MS) according to 2017 Revised McDonald Criteria.
3. A recent referral for initiation of ublituximab for treatment of MS by the patient's treating physician.

For Comparison Group:

1. Ages 18 - 65
2. A diagnosis of relapsing-remitting MS according to 2017 Revised McDonald Criteria.
3. 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:

1. 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.
2. Treatment with any B-cell depleting disease modifying therapy for MS (i.e. rituximab, ocrelizumab, ofatumumab, ublituximab, etc.) within the past 12 months.
3. History of life-threatening infusion reaction on ublituximab or prior anti-CD20 therapy
4. 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).
5. Receipt of any live of live-attenuated vaccines within 4 weeks prior to first ublituximab administration

For Comparison Group:

1. 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.
2. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ublituximab; Subjects recently prescribed ublituximab will undergo a specialized OCT at Enrollment, Month 6 and Month 12 as well as other neurologic assessments typically used in MS clinical trials such as EDSS, MSFC and SDMT	Drug: Ublituximab; ublituximab
Active Comparator: Other Disease Modifying Therapy; People on stable doses of non-B-cell depleting multiple sclerosis disease modifying therapies will undergo the specialized OCT scan at baseline, 6 months, and 12 months.	Other: Other disease modifying therapies; Other disease modifying therapies for MS (not ublituximab)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the effect of ublituximab on macular hyperreflective foci (HRF) in MS.	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	From enrollment until the last OCT at Months 6 and 12
Evaluation of the effect of ublituximab on inner limiting membrane (ILM) macrophage-like cells (MLC).	A change in the number of MLCs seen from baseline to months 6 and 12 in the ublituximab group compared to the comparison group.	From enrollment until the last OCT at Months 6 and 12

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: TG Therapeutics, Inc.
• Investigators: Principal Investigator: Daniel Harrison, MD, University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): January 30, 2028

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 7, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; ublituximab
• Other Study ID Numbers: HP-00113916

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No