Acthar Gel in Participants With Pulmonary Sarcoidosis

• Status: Active, not recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mallinckrodt
• Treatments: Adrenocorticotropic Hormone

Criteria

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