PIONEER, a new clinical trial for adults with dermatomyositis
This study is no longer available as it did not meet its endpoint.
Investigators are seeking people with dermatomyositis to participate in a phase 2 clinical trial of the experimental drug IMO-8400. The goals of the trial are to evaluate whether IMO-8400 can be given safely and if it can improve DM-related skin lesions and muscle weakness. The biopharmaceutical company Idera Pharmaceuticals is the clinical trial sponsor.
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. IMO-8400 is designed to inhibit the activity of key regulators of the immune system, called Toll-like receptors (TLRs). By inhibiting TLRs, it is believed that IMO-8400 may interrupt this cycle of inflammation, potentially offering a novel treatment approach.
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, which is approximately 6 months long.
The trial is being conducted at 17 centers in the United States, as well as additional centers in the United Kingdom and Europe. To participate in the study, patients must be adults, aged 18-75, and have active disease that is not well controlled with current treatments. In addition, eligible patients may be receiving an oral corticosteroid and one additional immunomodulatory treatment. Additional detail about the trial, including a full list of eligibility criteria, can be found at ideraclinicaltrials.com/dermatomyositis.
To reduce the amount of travel to trial sites, study participants may be able to receive financial support for qualified travel, including reimbursement for mileage and tolls, parking, meals, and incidentals. Participants traveling extended 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 ground transportation, such as taxi service or a rental car. Additionally, a nursing program may also be available for participants to receive weekly study drug treatment at home or in the workplace between monthly clinic visits.
For more information about this trial – Study no longer available.
Tags: clinical trials dermatomyositis