NCT07225361RecruitingPhase 4
Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 17 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 29 Oct 2025
- Start date
- 28 Nov 2025
- Primary completion date
- 15 Mar 2029
- Lead sponsor
- Northwestern University
- Diseases
- Multiple sclerosis
- NCT number
- NCT07225361
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 40
- From 28 Nov 2025 to the primary completion date, 15 Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Active hepatitis B virus (HBV) confirmed by positive results for Hepatitis B surface antigen (HBsAg) and anti-HBV tests.
Other
- 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.
Who the study is looking for
- 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,
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northwestern Memorial Hospital Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.