300 Participants Needed

Ublituximab for Multiple Sclerosis

(ENHANCE Trial)

Recruiting at 32 trial locations
JP
JC
JN
KC
KB
CG
KK
MC
Overseen ByMimi Crum
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab as measured by T1 Gadolinium (Gd)-enhancing lesions.

Will I have to stop taking my current medications?

The trial requires that participants who have been treated with a disease-modifying therapy (DMT) must stop their treatment before joining the study and meet specific washout requirements (time without taking certain medications). If you are currently on a DMT, you will need to discontinue it before participating.

What data supports the effectiveness of the drug Ublituximab for treating multiple sclerosis?

Research shows that Ublituximab, a drug that targets B-cells, is effective in reducing the relapse rate in people with relapsing multiple sclerosis. In clinical trials, it was found to be more effective than another drug, Teriflunomide, in decreasing the frequency of relapses and improving MRI outcomes.12345

Is Ublituximab safe for humans?

Ublituximab, also known as Briumvi, is a treatment for multiple sclerosis that has been approved in the USA, indicating it has undergone safety evaluations. It works by targeting B cells, which are part of the immune system, and is similar to other treatments like rituximab, which have been studied for safety in multiple sclerosis.14567

How is the drug ublituximab different from other treatments for multiple sclerosis?

Ublituximab is unique because it is the first anti-CD20 treatment for multiple sclerosis that is administered as a one-hour infusion twice a year after initial doses, targeting B cells which play a key role in the disease. This makes it different from other treatments that may have more frequent dosing schedules or different mechanisms of action.13458

Eligibility Criteria

This trial is for people with Relapsing Multiple Sclerosis (RMS) who've been stable on anti-CD20 therapy like ocrelizumab or rituximab. They should have an EDSS score ≤ 5.5 and diagnosed within the last 10 years. Exclusions include recent relapses, certain infections, vaccine restrictions, IVIG treatments in the past year, severe infusion reactions to previous therapies, and other active immune diseases.

Inclusion Criteria

I have been diagnosed with RMS according to the latest criteria.
My neurological condition has been stable for over a month.
Participants that are currently being treated with other selected DMTs
See 2 more

Exclusion Criteria

I haven't received any live vaccines in the last 4 weeks.
My condition is either PPMS or inactive SPMS.
I have or had hepatitis B or C, but if C, my PCR test for the virus is negative.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a modified regimen of ublituximab with infusions on Day 1 of Week 1, Day 15 if applicable, and at Week 24

24 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks
Regular monitoring up to Week 48

Treatment Details

Interventions

  • Ublituximab
Trial OverviewThe study tests if switching from current anti-CD20 therapies to Ublituximab maintains its effectiveness against MS. Effectiveness is measured by checking brain lesions using a special MRI scan that highlights active inflammation.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: UblituximabExperimental Treatment1 Intervention
Participants will receive a modified regimen of ublituximab intravenous (IV) including infusions on Day 1 of Week 1 (W1D1), Day 15, if applicable, and ublituximab 450 milligrams (mg) IV infusion at Week 24.

Find a Clinic Near You

Who Is Running the Clinical Trial?

TG Therapeutics, Inc.

Lead Sponsor

Trials
41
Recruited
6,900+

Findings from Research

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.
Ublituximab: First Approval.Lee, A.[2023]
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.
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.
Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis.Steinman, L., Fox, E., Hartung, HP., et al.[2022]

References

Ublituximab: First Approval. [2023]
Outcomes of Ublituximab compared to Teriflunomide for relapsing multiple sclerosis: A meta-analysis. [2022]
Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis. [2022]
Ublituximab: A new FDA-approved anti-CD20 mAb for relapsing forms of multiple sclerosis. [2023]
The ULTIMATE trials: are there advantages of ublituximab over teriflunomide in relapsing multiple sclerosis? [2022]
Efficacy and safety of rituximab in multiple sclerosis: a systematic review and meta-analysis. [2023]
Serious safety events in rituximab-treated multiple sclerosis and related disorders. [2021]
Ublituximab-xiiy as a treatment option for relapsing multiple sclerosis. [2023]