Investigators nationwide are recruiting 60 people with all types of MS for a phase I study to determine the safety and tolerability of rHIgM22, an experimental antibody. The study is funded by Acorda Therapeutics, Inc.
Although the body repairs some damage to nerve-insulating myelin that occurs in MS, this repair is insufficient. One strategy under study encourages internal “repair” capabilities of immune-system proteins called antibodies. With funding from the National MS Society, Moses Rodriguez, MD, and colleagues (Mayo Clinic Foundation, Rochester, MN) identified a human antibody -- rHIgM22 – that targets and attaches to oligodendrocytes (myelin-making cells). When given to mice with an MS-like disease, the antibodies promote myelin repair. This is the first study of rHIgM22 in humans.
Eligibility and Details:
Men and women between the ages of 18 and 70 with a diagnosis of MS are eligible. Women of childbearing potential must have a negative serum pregnancy test, and both men and women must practice adequate contraception for at least 60 days after being dosed. There are detailed exclusion criteria related to laboratory, cardiac, immune and other factors. For more information on these criteria, please contact the site nearest you.
Investigators are testing 6 dose levels sequentially. For each dose, ten participants are being enrolled; 8 are being randomly assigned to receive active treatment (rHIgM22) and 2 are being randomly assigned to receive inactive placebo, both via a single intravenous infusion. Blood samples will be collected from participants before and at specified times for up to 48 hours after dosing, so participants must agree to remain in the hospital for that time. Participants are being followed for 90 days after dosing.
The primary outcome of the study is to determine the safety and tolerability of rHIgM22 in people with MS. Adverse events are being monitored throughout the study. The investigators will also evaluate how this experimental treatment is absorbed in the body, and how the immune and nervous systems react to it.
To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact the site nearest you. An up-to-date listing of active sites is available on the trial’s listing on clinicaltrials.gov
. The listing is updated as new sites are activated.
Currently, sites are recruiting in the following cities: Long Beach, CA, Knoxville, TN, Seattle, WA, and Burlington, VT. Sites will soon be recruiting in Sacramento, CA, Indianapolis, IN, Baltimore, MD, Rochester, NY, Denver, CO, Kansas City, KS/MO, Palo Alto, CA, Providence, RI, and San Francisco, CA.
a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).