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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT06864936
Status
Recruiting
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Conditions

  • Multiple Sclerosis (MS) - Relapsing-remitting

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Ublituximab — DRUG
    ublituximab
  • Other disease modifying therapies — OTHER
    Other disease modifying therapies for MS (not ublituximab)

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Dec 30, 2027
Completion
Jan 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland, BaltimoreBaltimoreMaryland21201
Kerry Naunton, RN
[email protected]
410-328-1885
Daniel Harrison, MD
[email protected]
410-328-5605
Daniel Harrison, MD (PRINCIPAL_INVESTIGATOR)
Osamah Saeedi, MD (SUB_INVESTIGATOR)

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By research site
University of Maryland, Baltimore· Baltimore, MD

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