Who is eligible for clinical trial NCT07225361?

Participants must meet protocol criteria for Multiple Sclerosis. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07225361 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-03-16

Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis (NCT07225361)

🟢 Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: Northwestern University

🩺 Plain-English Summary (8th-Grade Level)

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 join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (15 items).

Location: Northwestern Memorial Hospital — Chicago, Illinois

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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,

Usually NOT eligible if any of the following apply:

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.),

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Northwestern Memorial Hospital — Chicago, Illinois

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗