Home › Multiple Sclerosis › NCT07225361
Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis
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
- Ublituximab (drug)
Sponsor: Northwestern University · Participants: 40 · Started: Nov 28, 2025
Contact the study team
- Caroline Gebczak, B.S. · Phone: 630-313-0470
- Dylan Rice, B.A. · Phone: 240-362-4800
Official record on ClinicalTrials.gov — NCT07225361
Locations in the U.S.
| Illinois | Northwestern 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.