Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis
Recruiting · NCT07225361 · Interventional (participants receive a specific treatment) · Lead sponsor: Northwestern University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Northwestern Memorial Hospital - Chicago, Illinois, United States