Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis
Key facts
- Where
- Chicago, United StatesSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07225361, who can take part
Where in United States
- Northwestern Memorial HospitalChicago, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Northwestern University
- Trial code
- NCT07225361
- Record updated
- 17 March 2026
- Original description
In this prospective, open-label, single-arm, single-institution trial, the investigators will accomplish the following two aims:Read full original descriptionShow less
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.
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; 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; Receipt of any live of live-attenuated vaccines within 4 weeks prior to first drug product administration; Active hepatitis B virus (HBV) confirmed by positive results for Hepatitis B surface antigen (HBsAg) and anti-HBV tests; Current clinical trial participant,; Unable to speak a language for which translation can be found in the hospital system,; 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.