Mallinckrodt

A Phase 4 Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Access the Efficacy and Safety of H.P. Acthar Gel® in Subjects with Pulmonary Sarcoidosis

Objective

The purpose of this study is to evaluate the efficacy and safety of H.P. Acthar® Gel (Acthar) in the treatment of pulmonary sarcoidosis.

Eligibility

  • Subject with biopsy-confirmed sarcoidosis meeting American Thoracic Society criteria ≥ 1 year at screening (Visit 1)
  • Symptomatic pulmonary disease
  • Subject receiving ≥ 5 mg and ≤ 40 mg prednisone (or equivalent) for pulmonary sarcoidosis
  • Stable prednisone dose ≥ 4 weeks prior to screening (Visit 1)
  • Subjects treated with any disease modifying antisarcoidosis drugs (eg, methotrexate) must be on stable dose for ≥ 3 months prior to screening (Visit 1)
  • Forced vital capacity (FVC) ≥ 45% ≤ 95% predicted
  • Diffusing capacity of the lung for carbon monoxide (DLCO) ≥ 30%

NCT ID

NCT03320070