Status:
COMPLETED
Acthar Gel in Participants With Pulmonary Sarcoidosis
Lead Sponsor:
Mallinckrodt
Conditions:
Sarcoidosis, Pulmonary
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief 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 thei...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2021
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03320070
Start Date
February 21 2018
End Date
November 15 2021
Last Update
February 27 2023
Active Locations (29)
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1
UAB Lung Health Center
Birmingham, Alabama, United States, 35294
2
David Geffen School of Medicine
Los Angeles, California, United States, 90095
3
National Jewish Health
Denver, Colorado, United States, 80206
4
University of Florida Division of Pulmonary, Critical Care, and Sleep Medicine
Gainesville, Florida, United States, 32610