RECRUITINGPhase 4INTERVENTIONAL

Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form, - 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, Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Ublituximab

Currently, 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.

Locations (1)

Northwestern Memorial Hospital

Chicago, Illinois, United States