Ublituximab for Multiple Sclerosis

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.

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.

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.¹²³⁴⁵

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.

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.¹²⁴⁶⁷