Acthar Gel in Participants With Pulmonary Sarcoidosis

A Multicenter, Randomized, Double Blind, Placebo Controlled Exploratory Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Pulmonary Sarcoidosis

The purpose of this study is to find out if Acthar Gel is safe and effective to treat pulmonary sarcoidosis.

Participants will be randomly assigned (like flipping a coin) to receive a shot under their skin of Acthar Gel or a matching placebo gel that has no drug in it. They will receive their assigned shot twice a week for 24 weeks.

All participants who complete the 24-week treatment period will be eligible to receive Acthar Gel for 24 more weeks, even if they were originally in the placebo group.

Inclusion Criteria:

• Has biopsy-confirmed sarcoidosis meeting American Thoracic Society criteria ≥ 1 year at screening (Visit 1)
• Has protocol-defined symptomatic pulmonary disease
• Has been receiving a stable prednisone dose between 5 mg and 40 mg (or equivalent) for pulmonary sarcoidosis, for at least 4 weeks before screening, or a stable dose of another disease-modifying anti-sarcoidosis drug for at least 3 months before screening
• Has lung function within protocol-defined parameters

Exclusion Criteria:

• Has at least a 10% change in forced vital capacity (FVC) on spirometry between Visits 1 and 2
• Has pulmonary arterial hypertension requiring treatment
• Has been treated with antitumor necrosis factor-α antibody within the past 3 months
• Has any pulmonary condition that requires treatment, therefore impeding corticosteroid tapering