Multiple Sclerosis study: Ublituximab
Official title Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis
ClinicalTrials.gov ID: NCT07225361
What this study is testing
What is Ublituximab?
This is an investigational medicine being studied as a potential treatment for early multiple sclerosis. It is designed to target and reduce specific immune cells in the blood that may contribute to the disease.
Also referred to as Briumvi.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to check if the medicine is safe and to see how it affects a blood marker of nerve damage.
- Who it's for
- This study is looking for people with early relapsing multiple sclerosis.
- What's involved
- Participants will receive the medicine twice a year and have blood tests to check for nerve damage markers.
- Time commitment
- The study involves about 12 months of treatment observation and blood tests every 24 weeks for 96 weeks.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Meet 2024 Criteria for Multiple Sclerosis (Montalban et al.) as confirmed by a neurologist
- 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,
You likely can't join if
- 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,
See the full eligibility 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...
- 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,
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.