Recruiting

Ublituximab

Sponsor:

University of Maryland, Baltimore

Code:

NCT06864936

Conditions

Multiple Sclerosis (MS) - Relapsing-remitting

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Ublituximab

Other disease modifying therapies

Study Details

Brief summary:

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

Multiple Sclerosis (MS) - Relapsing-remitting

Study ID

NCT06864936

Start date

May 1, 2026

Status verified date

Jul, 2026

Completion date

Jan 30, 2028

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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

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.

Interventions

Ublituximab

ublituximab

Other disease modifying therapies

Other disease modifying therapies for MS (not ublituximab)

Primary outcome measure

  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Kerry Naunton, RN

410-328-1885knaunton@som.umaryland.edu

Locations

University of Maryland, Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Kerry Naunton, RN

410-328-1885knaunton@som.umaryland.edu

Daniel Harrison, MD

410-328-5605dharrison@som.umaryland.edu

Principal Investigator:

Daniel Harrison, MD

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-07-29.