NCT07225361 Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis
| NCT ID | NCT07225361 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Northwestern University |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-11-28 |
| Primary Completion | 2029-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2025-11-28 with a primary completion date of 2029-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Farrah J Mateen, MD, PhD
PRINCIPAL INVESTIGATOR
Northwestern University
Frequently Asked Questions
Who can join the NCT07225361 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07225361 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07225361 currently recruiting?
Yes, NCT07225361 is actively recruiting participants. Contact the research team at caroline.gebczak@northwestern.edu for enrollment information.
Where is the NCT07225361 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT07225361 clinical trial?
NCT07225361 is sponsored by Northwestern University. The principal investigator is Farrah J Mateen, MD, PhD at Northwestern University. The trial plans to enroll 40 participants.
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