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Patient Enrollment in Phase 4 trial of H.P.Acthar gel for Pulmonary Sarcoidosis Begins by Mallinckrodt.

Patient Enrollment in Phase 4 trial of H.P.Acthar gel for Pulmonary Sarcoidosis Begins by Mallinckrodt.

A global pharmaceutical company, Mallinckrodt has started its Phase 4 multi-centre, randomized, double-blind, placebo-controlled trial for H.P. Acthar gel as a therapy option for patients with pulmonary sarcoidosis. H.P. Acthar Gel is US US Food and Drug Administration (FDA) approved in symptomatic sarcoidosis. The company announced the enrolment of the first patient as an important milestone to facilitate assessment of Acthar’s efficacy as a viable treatment option for patients with symptomatic sarcoidosis.

The Chief Medical Officer of Mallinckrodt said in an interview that the exploratory evaluation of more patients with sarcoidosis who failed previous therapies can potentially help researchers understand the H.P. Acthar gel’s efficacy and safety on patients having persistent disease which did not resolved by first-line treatment.

The study titled as “Pilot Study to Assess the Efficacy and Safety of H.P. Acthar Gel in Subjects With Pulmonary Sarcoidosis Patients” is Phase-4 study, multicentre, randomized, double-blind, placebo-controlled study. Subjects are required to meet eligibility criteria- which include a requirement to be receiving prednisone treatment. Subjects were randomly assigned to receive either 1 mL (80 units) of H.P. Acthar Gel or 1mL of a matching placebo subcutaneously 2 times/week. Subjects will be assigned to treatment in a 1:1 ratio with up to 50 subjects per arm for a total of up to 100 subjects. Subjects who complete the 24-week randomized, double-blind, placebo-controlled treatment period will be eligible to continue in an optional 24-week open-label extension.

Sarcoidosis Treatment Score (STS) with a time frame of baseline to 24 weeks will be evaluated. STS is a composite score comprising of results of pulmonary function tests, high-resolution computed tomography, quality of life and corticosteroid tapering.

Response will be evaluated by Sarcoidosis Treatment Score (STS) with a time frame of baseline to 24 weeks. STS is an exploratory newly developed composite score that combines the results of pulmonary function tests (forced vital capacity; diffusing capacity of the lungs for carbon monoxide), high-resolution computed tomography, quality of life (King’s Sarcoidosis Questionnaire; Fatigue Assessment Scale) and corticosteroid tapering.

Sarcoidosis is a challenging, yet treatable, rare multisystem disease.

FDA has approved H.P. Acthar gel is an injectable dosage form in the treatment of 19 indications.