Ublituximab for Multiple Sclerosis
(ENHANCE Trial)
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a modified regimen of ublituximab with infusions on Day 1 of Week 1, Day 15 if applicable, and at Week 24
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ublituximab
Find a Clinic Near You
Who Is Running the Clinical Trial?
TG Therapeutics, Inc.
Lead Sponsor