Investigators are seeking people to participate in a phase 2 clinical trial, sponsored by Idera Pharmaceuticals, to evaluate the effect of the experimental drug IMO-8400 on skin lesions and muscle weakness in dermatomyositis.
While the cause of dermatomyositis is unclear in most cases, it is known that ongoing inflammation triggered by the disease, over time, leads to destruction of muscle, skin and other tissues.
Idera’s approach builds upon published research demonstrating that levels of proteins called Toll-like receptors (TLRs) are increased in individuals with dermatomyositis. It is possible these excess TLRs may become activated and further amplify the already ongoing inflammatory process. IMO-8400 is designed to block the activation of specific TLRs, which researchers hope might interrupt any potential contribution these proteins may make to the harmful cycle of inflammation and tissue damage in dermatomyositis.
Trial participants will be randomly assigned to receive either placebo or one of two doses of IMO-8400, delivered once weekly by subcutaneous (under-the-skin) injection for the duration of the study. Investigators will evaluate the drug for safety and ability to decrease skin lesions and muscle weakness.
Participation in the study, from screening to end of treatment, is expected to include 27 visits, at least eight of which will be to the study site, over a period of 32 weeks. Participants must be 18 to 75 years old, have a diagnosis of dermatomyositis, have both active disease-related skin and muscle disease, and meet other eligibility criteria.
The study will be conducted at approximately 25 trial sites in the United States, United Kingdom and Europe. Study participants may be able to receive support for qualified travel, including reimbursement for mileage and tolls, parking, meals and incidentals. Participants traveling long distances to clinic appointments may also be eligible to receive additional support for air or train travel, a hotel close to the study site, and/or ground transportation, such as taxi service or a rental car.
For more information about this trial, including complete inclusion and exclusion criteria, please see Idera’s clinical trials website, or visit ClinicalTrials.gov and enter NCT02612857. For information about a trial site near you, contact Idera Patient Advocacy at patientinfo@Iderarpharma.com or toll free at (877) 888-6550, ext. 2. For information on any PIONEER trial site, please contact Kate Tighe, Manager, Patient Advocacy, at patientinfo@Iderapharma.com or (617) 679-5541.
