Patients with relapsing multiple sclerosis (MS) are being recruited for a clinical trial evaluating an experimental monoclonal antibody called ublituximab, the National MS Society announced in a recent news release. The study, being conducted at seven U.S. sites, will enroll at least 24 patients, but this number can go up to 100.
MS is considered to be an immune-mediated disease in which a person’s own immune cells attack and damage certain structures of the central nervous system, including the myelin sheath that surrounds nerve cells, the myelin producing cells (oligodendrocytes), and the nerve fibers themselves.
B-cells, which have a variety of immune functions, are thought to participate in the immune-mediated damage to the brain and spinal cord that is characteristic of MS. Therefore, a number of therapies targeting B-cells, such as Rituxan/Mabthera (rituximab) and Ocrevus (ocrelizumab), have shown beneficial effects in clinical trials with MS patients.
These drugs target the CD20 molecule that is found at the surface of CD20 B-cells, depleting their circulation, which eventually decreases or halts the immune-mediated damage.
Ublituximab, the drug being tested, also targets CD20-positive B cells, but the researchers claim that it binds to CD20 in a unique way, which may confer on ublituximab higher B-cell depleting capabilities than those observed with rituximab or ocrelizumab.
The study (NCT02738775) will be evaluating ublituximab’s efficacy and safety in relapsing MS patients. The primary outcomes to be assessed are the levels of B-cell depletion and the number of patients who experience adverse events. Secondary outcomes include monitoring disease activity through magnetic resonance imaging (MRI) and relapses.
Participants will be initially assigned to receive either ublituximab or placebo intravenous infusions, which can take up to four hours, and after 28 days those assigned to the placebo group will also receive ublituximab.
To enroll, participants should be ages 18 to 55, have a confirmed diagnosis of relapsing MS, and have had more than one relapse in the previous two years. More information is available by contacting Koby Mok, PhD, either by phone at 949-422-2468 or via e-mail at [email protected]. Study sites are in Arizona, Colorado, Kentucky, Ohio, Tennessee, and Texas.
MS affects more than 2.3 million people around the world, and continuing research and clinical trials are needed to gain both a better understanding of the disease and more effective treatments.