Acthar Gel in Participants With Pulmonary Sarcoidosis
Completed · Phase 4 · Has a placebo group
Conditions studied: Sarcoidosis, Pulmonary
In brief
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.
Key facts
- Study ID
- NCT03320070
- Run by
- Mallinckrodt
- People needed
- 55
- Starts
- 2018-02-21
- Expected to finish
- 2021-11-15
- Last updated by the study team
- 2023-02-27
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify 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
Where it is running
- UAB Lung Health Center — Birmingham, Alabama, United States
- David Geffen School of Medicine — Los Angeles, California, United States
- National Jewish Health — Denver, Colorado, United States
- University of Florida Division of Pulmonary, Critical Care, and Sleep Medicine — Gainesville, Florida, United States
- University of Miami Miller School of Medicine — Miami, Florida, United States
- Central Florida Pulmonary Group PA — Orlando, Florida, United States
- Rush University Medical Center — Chicago, Illinois, United States
- Laporte County Institute For Clinical Research — Michigan City, Indiana, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- Howard County Center for Lung and Sleep Medicine, LLC — Columbia, Maryland, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Valley Medical Group — Ridgewood, New Jersey, United States
- Albany Medical Center — Albany, New York, United States
- American Health Research Inc — Charlotte, North Carolina, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Clinical Research of Gastonia — Gastonia, North Carolina, United States
- University of Cincinnati Medical Center — Cincinnati, Ohio, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania, United States
- Temple Lung Center — Philadelphia, Pennsylvania, United States
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
- Berks Schuylkill Respiratory Specialists, Ltd — Wyomissing, Pennsylvania, United States
- VitaLink Research - Anderson — Anderson, South Carolina, United States
- Medical University of South Carolina - PPDS — Charleston, South Carolina, United States
- Clinical Research of Charleston — Mt. Pleasant, South Carolina, United States
Full record on ClinicalTrials.gov
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