Actively Recruiting
Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis
Led by Northwestern University · Updated on 2026-03-17
40
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
T
TG Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet 2024 criteria for multiple sclerosis confirmed by a neurologist, including specific diagnostic and biomarker evidence
- Adults aged 18 to 70 years
- Expanded Disability Status Scale (EDSS) score less than 2.5
- Able to give informed consent
- MRI of the brain available showing fewer than 10 demyelinating lesions
- Diagnosis of multiple sclerosis within the past 5 years
- Planning to start Ublituximab for relapsing multiple sclerosis treatment
You will not qualify if you...
- Prior treatment with Mavenclad, Lemtrada, Cyclophosphamide, stem cell transplant, or other bone marrow suppressive therapies
- Prior use of B-cell depleting agents such as Ocrelizumab, Rituximab, Ofatumumab, or Inebilizumab
- Currently enrolled in another clinical trial
- Unable to communicate in a language supported by the hospital translation services
- Unclear documentation of multiple sclerosis diagnosis or treatment history
- Major surgery within the past 6 months
- History of life-threatening infusion reaction to Ublituximab or other anti-CD20 therapies
- Active hepatitis B virus infection confirmed by relevant tests
- Received live or live-attenuated vaccines within 4 weeks before first drug administration
- Moribund status
- Unable to voluntarily provide consent (e.g., due to incarceration)
- Unwillingness to have blood drawn
- Unable to access Ublituximab through insurance or clinical coverage for the full 96-week study
- Unable to complete study activities as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
C
Caroline Gebczak, B.S.
CONTACT
D
Dylan Rice, B.A.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here