Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis
Recruiting now · Phase 4
Conditions studied: Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting
In brief
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.
Key facts
- Study ID
- NCT07225361
- Run by
- Northwestern University
- People needed
- 40
- Starts
- 2025-11-28
- Expected to finish
- 2029-08-01
- Last updated by the study team
- 2026-03-17
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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,
You may not qualify if…
- 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.
Where it is running
- Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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