Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis

March 16, 2026 updated by: Farrah Mateen, Northwestern University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PROCEDURES INVOLVED:

Participants will be enrolled for an estimated 96 weeks: Measurements will be requested every 24 weeks on a specifically designed survey instrument for participants. Participants will be asked to report medication dosing, adherence to medicine, tolerability, etc. as per Table 1. It is planned that each participant will be enrolled for 96 weeks (screening visit, baseline visit and four follow up visits at 24, 48, 72, and 96 weeks respectively) and would receive Ublituximab on an every 24 week schedule through regular clinical care. Notably, insurance may cover Ublituximab at an every 26 week schedule in which case accommodations will be made to have each study visit at q24-26 week intervals.

Participants will be contacted and interviewed every 24 weeks to ensure study procedures are going as planned, verify data reported on medication and MS disease history, and ensure study procedures are operating smoothly. Participants who do not complete the surveys within 7 days of the scheduled timing will be contacted by a study coordinator by phone up to 3 times. Participants will also be asked to report any medication changes, dose changes, or discontinuations if they occur at any point between study visits.

Participants will be enrolled until a total of 40 individual participants are reached. All scheduled events listed here will be part of the study and not part of routine clinical care. Study screening will continue until 40 participants are fully enrolled. Once 40 participants are enrolled, additional patients will not be screened or enrolled regardless of whether existing participants drop out of the study or are lost to follow-up. Five screen failures are estimated based on our study team's experience with ENHANCE (Ublituximab clinical trial). Once a participant is enrolled, the study will follow an intention to treat analysis.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants with Relapsing Multiple Sclerosis
Participants with Relapsing Multiple Sclerosis will be treated with Ublituximab for the duration of the study.
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.
Other Names:
  • Briumvi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Baseline (pre-treatment), and at 24, 48, 72, and 96 weeks post-treatment initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of Ublituximab
Time Frame: From baseline through study completion, up to 96 weeks
The severity as well as the number of adverse events (AEs) and serious adverse events (SAEs), laboratory abnormalities, and infusion-related reactions throughout the study period.
From baseline through study completion, up to 96 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability of Ublituximab
Time Frame: From baseline through study completion, up to 96 weeks.
Number of participants that discontinue treatment or delay doses due to side effects, as assessed by participant self-report and clinician documentation.
From baseline through study completion, up to 96 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

TG Therapeutics, Inc.

Investigators

  • Principal Investigator: Farrah J Mateen, MD, PhD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2025

Primary Completion (Estimated)

March 15, 2029

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

October 29, 2025

First Submitted That Met QC Criteria

November 5, 2025

First Posted (Actual)

November 6, 2025

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00224712

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis

Clinical Trials on Ublituximab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe