Ublituximab for Multiple Sclerosis

Overseen By Justin B Hill, B.A.

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Northwestern University

Must be taking: Ublituximab

Must not be taking: Mavenclad, Lemtrada, others

Disqualifiers: Active hepatitis B, Recent surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 96 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effects of Ublituximab, a medication for early-stage multiple sclerosis (MS), to determine its tolerability over about a year. Researchers aim to assess how the treatment affects a specific protein linked to nerve damage, measured in the blood before and after treatment. Individuals diagnosed with relapsing MS in the last five years who plan to start Ublituximab treatment may be suitable candidates for this trial. As a Phase 4 trial, Ublituximab is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have taken certain medications like Mavenclad, Lemtrada, or other B-cell depleting agents, you cannot participate in the trial.

What is the safety track record for Ublituximab?

Research has shown that ublituximab has been tested for safety in people with relapsing multiple sclerosis. In one study, 5% of people using ublituximab experienced serious infections, compared to 2.9% of those using another treatment called teriflunomide. However, another study found that 89.9% of patients on ublituximab for six years did not have a relapse, indicating it is generally well-tolerated. The FDA has approved ublituximab for treating relapsing forms of multiple sclerosis, which supports its safety for this use. Still, more research is needed to fully understand all potential risks. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Ublituximab is unique because it targets a specific protein called CD20 on the surface of B-cells, which are part of the immune system and play a role in multiple sclerosis (MS). Most current MS treatments, like interferons and glatiramer acetate, work by broadly dampening immune responses. Ublituximab, however, specifically depletes B-cells, potentially reducing relapses more effectively and offering a more targeted approach. Researchers are excited because this could lead to improved outcomes for those with relapsing forms of MS, with potentially fewer side effects compared to broader immunosuppressive therapies.

What is the effectiveness track record for Ublituximab in treating multiple sclerosis?

Studies have shown that Ublituximab effectively treats relapsing multiple sclerosis (MS). Patients taking Ublituximab were nearly five times more likely to show no signs of disease activity compared to those taking teriflunomide. Over six years, the chance of a relapse was very low, with only one relapse expected every 83 years. This long-term research highlights Ublituximab's strong ability to manage the condition effectively. As an approved treatment for relapsing MS, it offers significant benefits for patients. Participants in this trial will receive Ublituximab for the study's duration. ^{1 2 4 6 7}

Who Is on the Research Team?

Farrah J Mateen, MD, PhD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for individuals with early stages of relapsing Multiple Sclerosis. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and may be required to have a confirmed diagnosis of MS.

Inclusion Criteria

Able to provide individual informed consent

MRI brain available to confirm the diagnosis of MS with fewer than 10 demyelinating lesions

I have been diagnosed with Multiple Sclerosis according to the 2024 criteria.

Exclusion Criteria

Current clinical trial participant

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline assessments and initial Ublituximab treatment

1 day

1 visit (in-person)

Treatment

Participants receive Ublituximab every 24-26 weeks and are monitored for safety and tolerability

96 weeks

4 visits (in-person) at 24, 48, 72, and 96 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ublituximab

Trial Overview

The trial is testing Ublituximab (Briumvi), administered twice yearly, for safety and tolerability over approximately 12 months. It also aims to measure changes in plasma neurofilament light chain as an indicator of treatment effect.

How Is the Trial Designed?

Group I: Participants with Relapsing Multiple Sclerosis Experimental Treatment 1 Intervention

Participants with Relapsing Multiple Sclerosis will be treated with Ublituximab for the duration of the study.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

TG Therapeutics, Inc.

Industry Sponsor

Trials

41

Recruited

6,900+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12534265/

Efficacy and safety of ublituximab for relapsing multiple ...

Ublituximab-treated RMS patients were 4.8 times more likely to achieve NEDA-3 during Weeks 24–96 compared to those receiving teriflunomide (77.9 ...

2.

ir.tgtherapeutics.com

ir.tgtherapeutics.com/news-releases/news-release-details/new-data-briumvir-demonstrate-899-patients-relapsing-multiple

New Data for BRIUMVI® Demonstrate 89.9% of Patients ...

During year 6 of continuous treatment with BRIUMVI the annualized relapse rate was 0.012, equivalent to one relapse occurring every 83 years ...

3.

briumvihcp.com

briumvihcp.com/efficacy-data/

MS Clinical Trial Results | BRIUMVI® (ublituximab-xiiy) HCP

Long-Term Efficacy and Safety of Ublituximab in Relapsing Multiple Sclerosis: Results from 6 Years of ULTIMATE I and II Open-Label Extension. Presented at ...

4.

neurology.org

neurology.org/doi/10.1212/WNL.0000000000211909

ENABLE: The First Phase 4 Observational Study for ...

Ublituximab, approved for treating relapsing multiple sclerosis (RMS), has demonstrated significant clinical benefits vs teriflunomide in two identical ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03277261

NCT03277261 | Study to Assess the Efficacy and Safety of ...

Improvements in no evidence of disease activity with ublituximab vs. teriflunomide in the ULTIMATE phase 3 studies in relapsing multiple sclerosis. Front ...

6.

neurology.org

neurology.org/doi/10.1212/WNL.0000000000210671

Five Years of Ublituximab in Relapsing Multiple Sclerosis

In ULTIMATE I and II studies, ublituximab (UBL) demonstrated significant reduction in disease activity vs. teriflunomide (TER) over 2 years.

7.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2201904

Ublituximab versus Teriflunomide in Relapsing Multiple ...

Serious infections occurred in 5.0% in the ublituximab group and in 2.9% in the teriflunomide group. Conclusions. Among participants with ...