Study on Acthar Gel Completes Phase 4 Enrollment
FDA approved, H.P. Acthar® Gel (repository corticotropin injection), an injectable therapy commonly used to treat lupus, is under investigation. The researchers aim to capture additional data to help prescribers better understand how Acthar may be utilized in the management of more difficult-to-manage people with lupus.
The ongoing Phase 4 clinical trial, the research phase conducted to identify and evaluate the long-term effects of new drugs and treatments over a lengthy period for a greater number of patients, has enrolled 172 patients across 74 clinical sites in six countries. Trial participants will be treated for 24 weeks, to include treatment under the skin, with an end goal of measuring reduction of disease activity at week 16.
Acthar contains a naturally occurring, highly purified hormone called ACTH, which stands for adrenocorticotropic hormone. One-way Acthar is thought to work is by helping your body produce its own natural steroid hormones, such as cortisol. These hormones may assist your immune system by helping your body defend itself against inflammation.
Phase 4 first results are expected early 2020. Anca D. Askanase, MD, MPH, Director, Columbia University Lupus Center at Columbia University College of Physicians and Surgeons is a primary investigator on the study and is also a member of the Lupus Foundation of America, Medical-Scientific Advisory Council. Continue to follow the Lupus Foundation of America for updates on Acthar Gel. Read about medications used to treat lupus.