No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Northwestern University · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 70 who have been diagnosed with early forms of relapsing multiple sclerosis. Participants will receive the medication Ublituximab twice a year while the effects are monitored over about 12 months.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with multiple sclerosis in the past 5 years.
I am between 18 and 70 years old.
I can give my consent to participate.
I have an EDSS score of less than 2.5.
I have less than 10 demyelinating lesions on my MRI.
I plan to start Ublituximab for my relapsing MS.
You may not be able to join if
I have had any prior treatments with certain MS drugs like Mavenclad or Ocrelizumab.
I am currently participating in another clinical trial.
I have had major surgery in the last 6 months.
I have a history of serious allergic reactions to Ublituximab.
I have tested positive for active hepatitis B.
I cannot provide consent voluntarily.
I am unable to access Ublituximab throughout the study period.
I am unwilling to have my blood drawn.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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-Ublitux…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 …
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.