NCT07225361 · Northwestern University
Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis
What this study is about
In this forward-looking, where both patients and doctors know the treatment given, single-treatment group$1, single-institution trial, the investigators will accomplish the following two aims: 1. study the safety and how well patients handle the treatment of Ublituximab (Briumvi) twice annually in participants with early MS over a treatment observation period of \~12 months. 2.
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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.
Interventions
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.
Primary outcome measures
Change in plasma neurofilament light chain
Time frame: Time Frame: Baseline (pre-treatment), and at 24, 48, 72, and 96 weeks post-treatment initiation
Change in plasma neurofilament light chain concentration from baseline (pre-Ublituximab IV) to follow-up visits while on treatment longitudinally.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Chicago, Illinois
Collaborators
TG Therapeutics, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 17, 2026 · Source of record for eligibility and locations