UK-based biopharmaceutical company Mallinckrodt has begun enrolment for its Phase IV clinical study of HP Acthar Gel to treat systemic lupus erythematosus (SLE) patients with persistently active disease.
HP Acthar Gel has been developed as a highly purified preparation of adrenocorticotropic hormone (ACTH) in a gel designed to trigger extended release of the ACTH after being injected.
ACTH stimulates the adrenal cortex gland to secrete cortisol, corticosterone and aldosterone.
SLE is an autoimmune disease that causes the immune system to produce antibodies to cells within the body leading to inflammation and damaging tissue.
The Phase IV study is titled as 'a multicentre, randomised, double-blind, placebo-controlled study to assess the efficacy and safety of H.P. Acthar Gel in subjects with persistently active SLE despite moderate dose corticosteroids' and is based on data from a pilot study of HP Acthar Gel in patients with active SLE.
Mallinckrodt chief scientific officer and executive vice-president Steven Romano said: "The data generated in our pilot clinical study support the use of Acthar to treat lupus patients, for which it is already indicated who have clinically significant disease activity despite receiving standard of care therapies.
"We are pleased to enrol the first patient in this follow-on trial, which will generate additional data to better understand how clinicians may utilise Acthar in the management of these more difficult to manage patients with SLE."
The study is primarily focused on assessing the efficacy of the gel in reducing disease activity as reflected by the SLE Responder Index (SRI) after 16 weeks.
The SRI is a composite endpoint with three different measures of disease activity to map response of SLE to therapy.
The company is planning to enrol 160 SLE patients in the trial.
Image: SLE-affected woman with characteristic butterfly rash. Photo: courtesy of Doktorinternet.