RecruitingPhase 4NCT07225361

Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis


Sponsor

Northwestern University

Enrollment

40 participants

Start Date

Nov 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is examining the use of a drug called ublituximab (brand name Briumvi) in adults who have been newly diagnosed with multiple sclerosis (MS) and are starting treatment early in their disease course. Ublituximab is a B-cell depleting infusion therapy already approved for MS, and this study will follow participants over time to understand outcomes in early MS. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with MS within the past 5 years according to 2024 diagnostic criteria - Your EDSS disability score is below 2.5 (meaning minimal disability) - You have fewer than 10 demyelinating brain lesions on MRI - You are already planning to start ublituximab for relapsing MS **You may NOT be eligible if...** - You have previously received powerful immune-depleting treatments such as Mavenclad, Lemtrada, cyclophosphamide, or stem cell transplant - You have previously received other B-cell depleting drugs such as Ocrelizumab, Rituximab, Ofatumumab, or Inebilizumab - You have had major surgery in the past 6 months - You are currently in another clinical trial - Your MS diagnosis is unclear or poorly documented Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGUblituximab

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

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NCT07225361


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