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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Ublituximab
DrugCurrently, many care plans may defer initiating high-efficacy DMTs, such as Ublituximab, for patients who previously would have been previously considered to have clinically isolated syndrome or not definite MS because of safety concerns. Recent label updates including a case of progressive multifocal leukoencephalopathy and transaminase elevations may exacerbate this worry. However, emerging evidence suggests treatment at the earliest timepoint has important, favourable impacts on long-term MS outcomes, far outweighing safety risks. Data in this early-diagnosis MS population are however lacking, and robust safety and tolerability data, underscored by biomarkers that are relevant to people with early MS, will guide prescribers in clinical decision making and likely encourage early MS treatment adoption.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Participants with Relapsing Multiple SclerosisExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in plasma neurofilament light chain
Change in plasma neurofilament light chain concentration from baseline (pre-Ublituximab IV) to follow-up visits while on treatment longitudinally.
Time frame
Time Frame: Baseline (pre-treatment), and at 24, 48, 72, and 96 weeks post-treatment initiationSecondary outcomes
1
Safety of Ublituximab
The severity as well as the number of adverse events (AEs) and serious adverse events (SAEs), laboratory abnormalities, and infusion-related reactions throughout the study period.
Time frame
From baseline through study completion, up to 96 weeksOther outcomes
1
Tolerability of Ublituximab
Number of participants that discontinue treatment or delay doses due to side effects, as assessed by participant self-report and clinician documentation.
Time frame
From baseline through study completion, up to 96 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Northwestern University
Lead sponsor
TG Therapeutics, Inc.
Collaborator
Source ClinicalTrials.gov