Results From a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Repository Corticotropin Injection for the Treatment of Pulmonary Sarcoidosis.

ABSTRACT:

Introduction

Long-term treatment of pulmonary sarcoidosis with glucocorticoids has been associated with toxicity and other adverse events, highlighting the need for alternative therapies. The goal of this study was to evaluate the efficacy and safety of repository corticotropin injection (RCI, Acthar^® Gel) in patients with pulmonary sarcoidosis and to validate endpoints for use in future clinical trials.

Methods

In this multicenter, randomized, placebo-controlled trial, subjects received subcutaneous RCI (80 U) twice weekly or matching placebo through 24 weeks in a double-blind treatment phase, followed by an optional 24-week open-label extension. Efficacy was measured by glucocorticoid tapering, pulmonary function tests, chest imaging, patient-reported outcomes,

SUBMITTER: Mirsaeidi M 

PROVIDER: S-EPMC10113127 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature