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Ublituximab for Early Relapsing Multiple Sclerosis

This study is looking at Ublituximab (Briumvi) for people with early forms of relapsing multiple sclerosis (MS). Researchers want to see how safe Ublituximab is and how well people tolerate it over about 12 months. They will also measure changes in a blood marker called plasma neurofilament light chain, which can indicate nerve damage, before and after treatment for 96 weeks. You might be able to join if you are 18 to 70 years old and have MS that meets specific criteria, including certain findings on imaging or in your spinal fluid. The study aims to enroll 40 participants, but its current recruitment status is unclear.

Study design
This is an open-label, single-arm study, meaning everyone receives Ublituximab and both you and the researchers will know what treatment you are getting. It plans to enroll 40 participants.
What's involved
You will be enrolled for about 96 weeks, with visits every 24 weeks. You will receive Ublituximab and report on your medication and health through surveys.
Compensation
Not stated in the trial record.
Follow-up
Your plasma neurofilament light chain will be measured at baseline and at 24, 48, 72, and 96 weeks after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07225361

Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis

Recruiting
PHASE4Ages 18–70InterventionalTreatment
Northwestern University
~40 participants
Updated 2026-03-17 on ClinicalTrials.gov
What's tested:Ublituximab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in plasma neurofilament light chain
Measured over Time Frame: Baseline (pre-treatment), and at 24, 48, 72, and 96 weeks post-treatment initiation

Conditions

Multiple Sclerosis
Multiple Sclerosis (MS) - Relapsing-remitting

Explore related trials

Multiple Sclerosis

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Farrah J Mateen, MD, PhD · PRINCIPAL_INVESTIGATOR · Northwestern University

Who to contact

Caroline Gebczak, B.S.
[email protected]
630-313-0470
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Meet 2024 Criteria for Multiple Sclerosis (Montalban et al.) as confirmed by a neurologist; Includes dissemination in space in two of five topographies (with optic nerve included) and/or biomarker evidence such as positive cerebrospinal fluid oligoclonal bands, elevated kappa free light chains, at least six central vein lesions, or at least one paramagnetic rim lesion;
Adult age 18-70 years,
EDSS \<2.5,
Able to provide individual informed consent,
MRI brain available to confirm the diagnosis of MS with fewer than 10 demyelinating lesions,
Diagnosis of MS within the past \<5 years,
Planning to start Ublituximab for the treatment of relapsing MS,

Exclusion

Prior exposure to Mavenclad, Lemtrada, Cyclophosphamide, stem cell transplant or related bone marrow suppressive treatment,
Prior exposure to other B-cell depleting agent including Ocrelizumab, Rituximab, Ofatumumab, and Inebilizumab.
Current clinical trial participant,
Unable to speak a language for which translation can be found in the hospital system,
Unclear documentation of MS diagnosis or prior or current MS treatment,
Recent major surgical procedure in the past 6 months,
History of life-threatening infusion reaction on Ublituximab or prior anti-CD20 therapy
Active hepatitis B virus (HBV) confirmed by positive results for Hepatitis B surface antigen (HBsAg) and anti-HBV tests.
Receipt of any live of live-attenuated vaccines within 4 weeks prior to first drug product administration
Moribund status,
Unable to provide consent voluntarily due to reasons of capacity or other reasons (e.g. incarcerated, etc.),
Unwilling to undergo blood draws,
Unable to access Ublituximab through clinical coverage throughout the full 96-week treatment study period,
Unable to complete the study activities for any reason as deemed by the study investigator.

What this trial measures

  • Change in plasma neurofilament light chainTime Frame: Baseline (pre-treatment), and at 24, 48, 72, and 96 weeks post-treatment initiation

    Change in plasma neurofilament light chain concentration from baseline (pre-Ublituximab IV) to follow-up visits while on treatment longitudinally.