Current phase of trial: Phase 3
Type of MS: Relapsing MS
Find out more about ublituximab
How does ublituximab work?
• Ublituximab is an antibody, just like those found in the immune system (where antibodies help fight infection)
• It is allso being tested in phase 3 trials for cancer, including leukaemia and lymphoma
• Ublituximab works in a similar way to Ocrevus (ocrelizumab), binding to the surface of a type of immune cell (called a B cell) and reducing their numbers. These cells are thought to be one of the immune cells that attacks myelin in MS.
How is ublituximab taken?
Ublituximab is given as an infusion.
In a phase 2 trial, ublituximab was given as an infusion at Day 1, 15 and then at 6 months.
ULTIMATE 1 and ULTIMATE 2
• These phase 3 trials are testing if ublituximab infusion can reduce relapse rate more effectively than the licensed treatment Aubagio (terifluorimide):
• The trials will involve approximately 880 people with relapsing MS. They began recruiting in August 2017 and are due to finish in September 2021.
Phase 2 trial A small trial of 40 people due to finish in November 2018. It’s testing whether different doses of ublituximab (150 – 600 mg) can reduce B cell numbers in people with relapsing MS. It is also looking to see whether ublituximab can reduce the number of relapses people have.
In February 2018, preliminary results from this trial were announced at ACTRIMS. At week 4, ublituximab nearly wiped out B cells, with only 1% remaining. This was sustained at week 24. Ublituximab also completely suppressed the development of new MRI lesions, and 97.5% of people taking the treatment were relapse free at week 24.
What are the side effects of ublituximab?
Ublituximab has not been widely tested in people with MS. In the phase 2 trial, ublituximab was reported to be well-tolerated after 24 weeks. The most common side effect reported was a reaction to the infusion .
How does ublituximab compare with other therapies?
Ublituximab is being compared with Aubagio in Phase 3 trials, but the results have not yet been reported. This means it isn’t possible to draw conclusions about its relative effectiveness at this time.
When is ublituximab likely to become available?
We will need to wait for the results of the two phase 3 trials to be able to assess the effectiveness of ublituximab in a larger number of people. This could take several years.