Summary

Eligibility
for people ages 18-90 (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

A Phase 4, Multicenter, Randomized, Double Blind, Placebo Controlled Pilot Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Pulmonary Sarcoidosis

Keywords

Sarcoidosis, Pulmonary Sarcoidosis Adrenocorticotropic Hormone Acthar Gel

Eligibility

You can join if…

Open to people ages 18-90

  • 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

You CAN'T join if...

  • 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

Locations

  • David Geffen School of Medicine
    Los Angeles California 90095 United States
  • National Jewish Health
    Denver Colorado 80206 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mallinckrodt
ID
NCT03320070
Phase
Phase 4
Study Type
Interventional
Last Updated