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Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis

RecruitingPhase 4

Who can join

Ages 18 to 70 · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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.

About the study

In this prospective, open-label, single-arm, single-institution trial, the investigators will accomplish the following two aims:

1. study the safety and tolerability of Ublituximab (Briumvi) twice annually in participants with early MS over a treatment observation period of \~12 months. 2. study the pre- and post-treatment change in plasma neurofilament light chain, tested at baseline pre-Ublituximab treatment, and q24 weeks for 96 weeks post Ublituximab treatment initiation.

What is being tested

Sponsor: Northwestern University · Participants: 40 · Started: Nov 28, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07225361

Locations in the U.S.

IllinoisNorthwestern Memorial Hospital, Chicago

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.