Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNorthwestern University
About this trial
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.
Eligibility criteria
Qualifiers
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,
Disqualifiers
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,
Trial design
Treatments tested in this trial
- Ublituximab
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Northwestern University
Lead sponsor
TG Therapeutics, Inc.
Collaborator
Source ClinicalTrials.gov