Multiple Sclerosis (MS) - Relapsing-remittingNCT06864936
Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis
A study testing Ublituximab and Other disease modifying therapies in people with Multiple Sclerosis (MS) - Relapsing-remitting, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis (MS) - Relapsing-remitting
- What is being tested?
- Ublituximab and Other disease modifying therapies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 30 Jan 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Ublituximab Group:
- Ages 18-65
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Maryland, Baltimore
Baltimore, Maryland, 21201
Kerry Naunton, RN, 410-328-1885, knaunton@som.umaryland.edu
Daniel Harrison, MD, 410-328-5605, dharrison@som.umaryland.edu
About this study
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.
- Being tested
- Ublituximab, Other disease modifying therapies
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UblituximabDrug
ublituximab
Other disease modifying therapiesOther
Other disease modifying therapies for MS (not ublituximab)
| Study group | Role | What they receive |
|---|---|---|
| Ublituximab | Active comparator | 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 Receives: Drug: Ublituximab |
| Other Disease Modifying Therapy | Active comparator | 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. Receives: Other: Other disease modifying therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: From enrollment until the last OCT at Months 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start1 May 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS) - Relapsing-remittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- TG Therapeutics, Inc.
- Responsible party
- Principal investigator, Daniel Harrison, University of Maryland, Baltimore
- Investigators
- Daniel Harrison, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864936
- Sponsor's protocol ID
- HP-00113916
- Status last verified
- Jul 2026
- First submitted
- 3 Mar 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No