Recruiting

Ublituximab

Sponsor:

Northwestern University

Code:

NCT07225361

Conditions

Multiple Sclerosis

Multiple Sclerosis (MS) - Relapsing-remitting

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Ublituximab

Study Details

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.

Conditions

Multiple Sclerosis

Multiple Sclerosis (MS) - Relapsing-remitting

Study ID

NCT07225361

Start date

Nov 28, 2025

Status verified date

Mar, 2026

Completion date

Aug 1, 2029

Anticipated

Primary completion date

Mar 15, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants with Relapsing Multiple Sclerosis

Participants with Relapsing Multiple Sclerosis will be treated with Ublituximab for the duration of the study.

Interventions

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 measure

  • Change in plasma neurofilament light chain [ Time Frame: Time Frame: Baseline (pre-treatment), and at 24, 48, 72, and 96 weeks post-treatment initiation ]

Central Contacts and Locations

Central contacts

Caroline Gebczak, B.S.

630-313-0470caroline.gebczak@northwestern.edu

Dylan Rice, B.A.

240-362-4800dylan.rice@northwestern.edu

Locations

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Caroline Gebczak, B.S.

630-313-0470caroline.gebczak@northwestern.edu

Dylan Rice, B.A.

240-362-4800dylan.rice@northwestern.edu

Principal Investigator:

Farrah J Mateen, MD, PhD

More Information

Sponsor

Northwestern University

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Keywords

  • Ublituximab
  • Briumvi
  • Multiple Sclerosis
  • Relapsing Multiple Sclerosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-03-17.