Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
55 participants
INTERVENTIONAL
2018-02-21
2021-11-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Acthar Gel in DBT Then Acthar Gel in OLE
Participants received Acthar Gel as a 1 milliliter (mL) injection under the skin, twice weekly, for 24 weeks in the double-blind treatment (DBT) phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the optional open-label extension (OLE) phase.
Acthar Gel
Acthar Gel for subcutaneous (SC) injection (80 units per 1 mL)
Placebo in DBT Then Acthar Gel in OLE
Participants received Acthar Gel matching placebo as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the optional OLE phase.
Acthar Gel
Acthar Gel for subcutaneous (SC) injection (80 units per 1 mL)
Placebo
Placebo gel for SC injection
Interventions
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Acthar Gel
Acthar Gel for subcutaneous (SC) injection (80 units per 1 mL)
Placebo
Placebo gel for SC injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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Mallinckrodt
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Team Leader
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
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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
Clinical Research of Rock Hill
Rock Hill, South Carolina, United States
VitaLink Research - Spartanburg
Spartanburg, South Carolina, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Texas Health Science Center at Tyler
Tyler, Texas, United States
Countries
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References
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Mirsaeidi M, Baughman RP, Sahoo D, Tarau E. Results From a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Repository Corticotropin Injection for the Treatment of Pulmonary Sarcoidosis. Pulm Ther. 2023 Jun;9(2):237-253. doi: 10.1007/s41030-023-00222-2. Epub 2023 Apr 19.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MNK14344100
Identifier Type: -
Identifier Source: org_study_id
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