Last updated on November 2019

Pilot Study to Assess the Efficacy and Safety of H.P. Acthar Gel in Subjects With Pulmonary Sarcoidosis


Brief description of study

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

Detailed Study Description

This is a Phase 4, multicenter, randomized, double-blind, placebo-controlled pilot study evaluating the efficacy and safety of Acthar gel in the treatment of pulmonary sarcoidosis. All subjects who meet eligibility criteria will be randomly assigned to receive either 1 mL (80 U) of Acthar or 1 mL of a matching placebo subcutaneously (SC) 2 x/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.

Clinical Study Identifier: NCT03320070

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Albany Medical Center

Albany, NY United States
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