RightFit
RecruitingPhase 4

Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 4 visits
  • Time periods mentioned: 96 weeks
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of ublituximab (Briumvi), given twice a year, in adults with early relapsing multiple sclerosis (MS). It checks side effects for about 12 months. It also measures a blood protein called neurofilament light chain before treatment and every 24 weeks for 96 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18 to 70 years old.
  • Have MS confirmed by a nerve specialist using the 2024 rules for diagnosing MS.
  • Have an EDSS score below 2.5, a measure of disability from MS.
  • Can give your own informed consent to join.
  • Have a brain MRI showing fewer than 10 areas where the protective coating around nerves is damaged.
  • Were diagnosed with MS less than 5 years ago.
  • Plan to start ublituximab for relapsing MS.

Who can't join

  • Have received Mavenclad, Lemtrada, cyclophosphamide, a stem cell transplant, or a related treatment that slows bone marrow activity.
  • Have received a drug that removes B cells, a type of immune cell, such as ocrelizumab, rituximab, ofatumumab, or inebilizumab.
  • Are in another clinical trial, or have unclear records of your MS diagnosis or treatment.
  • Had major surgery in the past 6 months, have active hepatitis B confirmed by blood tests, or are near death.
  • Had a life-threatening reaction during an infusion of ublituximab or another anti-CD20 drug, or received a live or weakened-live vaccine within 4 weeks before the first study dose.
  • Cannot give consent freely, including because of limited ability to make decisions or being in prison, or speak a language the hospital cannot provide translation for.
  • Are unwilling to have blood drawn, or the study doctor believes you cannot complete study activities.
  • Cannot get ublituximab through your health care coverage for the full 96-week study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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 sites (1)

IL