Summary: Investigators nationwide are recruiting 30 people with MS for a phase I study to determine the safety and tolerability of rHIgM22, an experimental antibody. Participants may remain on their current therapy throughout the study. The study is enrolling participants experiencing a clinical acute relapse (new or worsening neurological symptoms attributable to MS preceded by a stable or improving neurological state of at least 30 days) and with at least one new, active lesion (damaged area) on MRI scans. The study is funded by Acorda Therapeutics, Inc.
Rationale: Although the body repairs some damage to nerve-insulating myelin that occurs in MS, this repair is insufficient. One strategy under study is to stimulate the body’s own internal repair capabilities. With funding from the Hilton Foundation, NIH, the National MS Society and others, Moses Rodriguez, MD, and colleagues (Mayo Clinic Foundation) identified a human antibody – rHIgM22 – that targets and attaches to myelin-making cells. When given to mice with an experimental MS-like disease, rHIgM22 promotes myelin repair. This antibody was well tolerated in another phase I study (trial NCT01803867, as listed on clinicaltrials.gov) in 55 people with all types of MS. (Abstract #P4.339, Annual Meeting of the American Academy of Neurology 2015)
Eligibility and Details: Men and women between the ages of 18 and 70 with a diagnosis of MS are eligible. The study is enrolling participants with a clinical acute relapse; an MRI will be performed to confirm that there is an active lesion (damaged area). There are detailed exclusion criteria related to laboratory, cardiac, immune and other factors. For more information on these criteria, please use the contact information below.
Participants will remain on their current therapy throughout the study. Upon entering the study with an acute relapse, subjects will receive high-dose oral steroids for five days, a standard treatment for an acute relapse. Following completion of the oral steroids for the acute relapse the subjects will receive either a single dose of rHIgM22 or placebo.
Investigators are testing 2 dose levels. For each dose, 10 participants are being randomly assigned to receive active treatment (rHIgM22) and 5 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 180 days after dosing, which includes return visits to the clinic and MRI scans.
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. Phase I studies are the first of three stages of clinical trials that determine whether an exploratory treatment is safe and beneficial.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact Kevin Cronin, Manager Corporate Communications, email@example.com, 914-326-5279, or visit the trial’s listing on clinicaltrials.gov to find the site nearest you.
Sites are recruiting in the following cities:
Centennial, CO (Denver metro-area)
Long Beach, CA
Saint Louis, MO
San Francisco, CA
Teaneck, NJ (NY metro area)
Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).