Ublituximab for Multiple Sclerosis

Overseen By Kerry Naunton, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must be taking: B-cell depleting

Must not be taking: B-cell depleting

Disqualifiers: Eye disease, Chronic infection, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how ublituximab, a type of immunotherapy, affects the immune system in people with multiple sclerosis (MS) by using a special eye scan to detect changes. The goal is to determine if this treatment can alter MS in new ways by examining these changes as markers of the disease's activity. Participants should have relapsing MS and either be starting ublituximab or already on a stable MS treatment. The trial includes special eye scans and other typical neurological assessments to track progress. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could redefine MS treatment strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are in the Ublituximab group, you should not have been on any B-cell depleting therapies in the past 12 months. If you are in the Comparison group, you should be on a stable dose of your current MS treatment with no plans to change it for the next year.

What prior data suggests that this retinal imaging biomarker study is safe?

Research has shown that ublituximab is generally safe for treating relapsing multiple sclerosis (MS). Studies have found that after six years of continuous treatment, most patients tolerate it well. One study reported that 89.9% of patients experienced very low relapse rates, averaging only one relapse every 83 years.

Further research consistently shows that ublituximab remains safe, with no new or unexpected side effects over extended periods. This treatment is already approved for relapsing MS, indicating a strong safety record. However, individual experiences can vary, so discussing potential risks with a healthcare provider before joining a trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for multiple sclerosis, which often involve non-B-cell depleting therapies, Ublituximab works by specifically targeting and depleting B-cells, which are crucial in the progression of the disease. This targeted approach is exciting because it has the potential to more effectively reduce inflammation and slow down the progression of MS compared to traditional therapies. Additionally, Ublituximab may offer a more convenient dosing schedule, which could improve patient adherence and overall quality of life. Researchers are eager to explore these advantages and see how they translate into real-world benefits for those living with multiple sclerosis.

What evidence suggests that ublituximab might be an effective treatment for multiple sclerosis?

Studies have shown that ublituximab, also known as Briumvi, effectively treats relapsing multiple sclerosis (MS). In one study, 89.9% of patients who continuously used ublituximab experienced low and decreasing relapse rates. Another study found that 44.6% of patients showed no signs of disease activity, compared to 12.4% of those taking another MS medication, teriflunomide. In this trial, participants will either receive ublituximab or continue on other non-B-cell depleting MS disease-modifying therapies. These results suggest that ublituximab significantly reduces disease activity and relapses in people with relapsing MS. Long-term data, covering up to six years, further supports its effectiveness and safety. ^{1 2 3 6 7}

Who Is on the Research Team?

Daniel Harrison, MD

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

This trial is for people with relapsing multiple sclerosis (MS). Participants should either be starting treatment with ublituximab or currently on another MS medication. The study aims to enroll 30 patients, including both those beginning B-cell depletion therapy and a control group not changing their current stable MS treatments.

Inclusion Criteria

I am on a stable MS treatment with no change expected this year.

My doctor has recently referred me to start Ublituximab for MS.

I have been diagnosed with relapsing MS according to the 2017 criteria.

Exclusion Criteria

I haven't had B-cell depleting therapy for MS in the last year.

I do not have eye diseases like diabetic retinopathy, macular degeneration, or glaucoma.

I have not used B-cell depleting therapy in the last year and don't plan to start it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ublituximab treatment and undergo specialized OCT scans at enrollment, Month 6, and Month 12

12 months

3 visits (in-person)

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 study is testing the effectiveness of ublituximab in altering MS pathology using new retinal imaging biomarkers detected by OCT scans. These biomarkers may indicate how well the body responds to treatment. Patients will undergo OCT scans at the start and two other times during the study.

How Is the Trial Designed?

Group I: Other Disease Modifying Therapy Active Control 1 Intervention

People on stable doses of non-B-cell depleting multiple sclerosis disease modifying therapies will undergo the specialized OCT scan at baseline, 6 months, and 12 months.

Group II: Ublituximab Active Control 1 Intervention

Subjects recently prescribed ublituximab will undergo a specialized OCT at Enrollment, Month 6 and Month 12 as well as other neurologic assessments typically used in MS clinical trials such as EDSS, MSFC and SDMT

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

TG Therapeutics, Inc.

Industry Sponsor

Trials

41

Recruited

6,900+

Published Research Related to This Trial

Ublituximab, an anti-CD20 antibody, significantly reduces the annualized relapse rate (ARR) in patients with relapsing multiple sclerosis, showing a favorable effect size in a meta-analysis of 1,094 participants.

MRI results at 96 weeks indicate that Ublituximab leads to a greater reduction in T1 and T2 lesions compared to Teriflunomide, and patients on Ublituximab experience less disease activity overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Ublituximab compared to Teriflunomide for relapsing multiple sclerosis: A meta-analysis. Mukhtar, H., Yasmeen, U., Siddiqa, S., et al.[2022]

In two phase 3 trials involving 1,094 participants with relapsing multiple sclerosis, ublituximab significantly reduced the annualized relapse rate compared to teriflunomide, demonstrating its efficacy in preventing relapses.

Ublituximab also resulted in fewer gadolinium-enhancing lesions on MRI, indicating better control of disease activity, although it did not significantly lower the risk of worsening disability and was associated with infusion-related reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis. Steinman, L., Fox, E., Hartung, HP., et al.[2022]

Ublituximab is a newly approved anti-CD20 monoclonal antibody for treating multiple sclerosis (MS), specifically designed to deplete B cells, which play a crucial role in the disease's progression.

It is unique as it requires only two infusions per year after initial doses, making it a convenient treatment option for adults with relapsing forms of MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ublituximab: First Approval. Lee, A.[2023]

Ublituximab, a monoclonal antibody targeting B-cells, was found to be more effective than teriflunomide in reducing the annualized relapse rates in patients with relapsing multiple sclerosis, based on the ULTIMATE I and II trials.

While ublituximab showed superior efficacy in reducing relapse rates and MRI endpoints, further long-term studies are needed to assess its safety, and it is still under FDA review.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ULTIMATE trials: are there advantages of ublituximab over teriflunomide in relapsing multiple sclerosis? Doggrell, SA.[2022]

Ublituximab is a newly FDA-approved treatment for relapsing forms of Multiple Sclerosis (MS) that effectively depletes B cells while preserving long-lived plasma cells, distinguishing it from other anti-CD20 monoclonal antibodies.

In phase 3 clinical trials (ULTIMATE I and II), ublituximab was compared to teriflunomide, highlighting its potential for different clinical outcomes due to variations in dosing, administration routes, and mechanisms of action among anti-CD20 therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ublituximab: A new FDA-approved anti-CD20 mAb for relapsing forms of multiple sclerosis. Boldrini, VO., Mader, S., Kümpfel, T., et al.[2023]

Citations

1. 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 ... Patients on continuous BRIUMVI treatment exhibited low and decreasing annualized relapse rate (ARR) throughout the observation period, ARR: ...

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

Efficacy and safety of ublituximab for relapsing multiple ... Although ublituximab shows great promise and five-year data are already available, further research is required to fully explore its potential ...

3. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1473284/full

Improvements in no evidence of disease activity with ... Results: NEDA rates in the ublituximab vs. teriflunomide cohorts by treatment epoch were: Weeks 0–96, 44.6% vs. 12.4% (3.6× improvement); Weeks ...

4. 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.

5. 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07220252

NCT07220252 | Study to Assess Effects of Ublituximab in ... The study will further evaluate long-term safety and efficacy of ublituximab in RMS in pediatric participants during its extension period (Part ...

7. neurologyadvisor.com neurologyadvisor.com/reports/continuous-ublituximab-treatment-lasting-efficacy-safety/

Ublituximab Demonstrates Efficacy, Safety in Relapsing ... Ublituximab demonstrates sustained efficacy and a favorable safety profile through 6 years of treatment for relapsing MS.