Ublituximab (Briumvi) for early relapsing MS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, single-arm Phase 4 study will enroll up to 40 adults with early relapsing MS who plan to start Ublituximab and follow them for approximately 96 weeks. Participants will receive Ublituximab on an every-24-week schedule (with flexibility to every 24–26 weeks for insurance reasons) and complete baseline and follow-up visits at 24, 48, 72, and 96 weeks. Safety and tolerability data will be collected through scheduled questionnaires and coordinator contacts, while plasma neurofilament light chain will be measured at baseline and every 24 weeks to track biomarker changes. All study visits are conducted at Northwestern Memorial Hospital and study activities are distinct from routine clinical care.

Why it matters

Who can join: the full rules

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's running

• Northwestern Memorial Hospital
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Farrah J Mateen, MD, PhD — Northwestern University
• Study coordinator: Caroline Gebczak, B.S.
• Email: caroline.gebczak@northwestern.edu
• Phone: 630-313-0470

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.