Mallinckrodt has enrolled the first patient in its Phase lV trial to further evaluate the efficacy of HP Acthar Gel as a therapy option to treat patients with pulmonary sarcoidosis.
Entitled ‘Pilot Study to Assess the Efficacy and Safety of HP ActharGel in Subjects With Pulmonary Sarcoidosis’, the trial is a multicentre, randomised, double-blind, placebo-controlled pilot programme.
During the study, patients required to receive prednisone treatment and meeting other criteria will be randomly assigned to receive either 1ml of HP Acthar Gel or 1ml of a matching placebo subcutaneously two times a week.
Enrolled patients will also be assigned to treatment in a 1:1 ratio with up to 50 subjects an arm for a total of up to 100 subjects.
Patients completing the 24-week randomised, double-blind, placebo-controlled treatment period will be allowed to take part in an optional 24-week open-label extension.
The study response will be assessed by a sarcoidosis treatment score (STS) with a timeframe of baseline to 24 weeks.
Mallinckrodt chief medical officer Tunde Otulana said: “The enrolment of the first patient in this study is an important milestone in our further assessment of Acthar's efficacy as a treatment option for sarcoidosis patients.
“We believe this exploratory evaluation of the more challenging patients who may still have disease activity after previous therapies can potentially help physicians better understand, which individuals may benefit from the drug as a treatment alternative.”
Mallinckrodt’s HP Acthar Gel is an injectable drug approved by the US Food and Drug Administration (FDA) for treatment of 19 indications.