Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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,

Locations
United States
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
Contact Information
Primary
Nomin Enkhtsetseg, B.A.
nomin.enkhtsetseg@northwestern.edu
312 503 5298
Backup
Justin B Hill, B.A.
justin.hill@northwestern.edu
312 503 5184
Time Frame
Start Date: 2025-11-28
Estimated Completion Date: 2029-08-01
Participants
Target number of participants: 40
Treatments
Experimental: Participants with Relapsing Multiple Sclerosis
Participants with Relapsing Multiple Sclerosis will be treated with Ublituximab for the duration of the study.
Sponsors
Collaborators: TG Therapeutics, Inc.
Leads: Northwestern University

This content was sourced from clinicaltrials.gov