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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 90 Years |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03320070 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 4 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Mallinckrodt |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Clinical Team Leader |
Principal Investigator Affiliation | Mallinckrodt |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Sarcoidosis, Pulmonary |
07-Apr-2020: This trial is continuing for enrolled participants. Recruiting for new participants has stopped at all sites because of COVID-19. Overall Recruitment Status is "Active, Not Recruiting". The Actual Number of Participants is still "Anticipated". When it is safe, Overall Recruiting Status will change back to "Recruiting". When that happens, look at Locations to see which sites have started recruiting again.
Experimental: Acthar Gel
Participants receive Acthar Gel as a 1 mL injection under the skin twice weekly
Placebo Comparator: Placebo
Participants receive Placebo as a 1 mL injection under the skin twice weekly
Drug: - Acthar Gel
Acthar Gel for subcutaneous (SC) injection (80 units per 1 mL)
Drug: - Placebo
Placebo gel for SC injection
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Suspended
Address
University of Alabama
Birmingham, Alabama, 35233-1932
Status
Suspended
Address
David Geffen School of Medicine
Los Angeles, California, 90095
Status
Recruiting
Address
National Jewish Health
Denver, Colorado, 80206
Status
Withdrawn
Address
George Washington University
Washington, District of Columbia, 20037
Status
Suspended
Address
University of Florida Division of Pulmonary, Critical Care, and Sleep Medicine
Gainesville, Florida, 32610
Status
Recruiting
Address
University of Miami Miller School of Medicine
Miami, Florida, 33125
Status
Recruiting
Address
Central Florida Pulmonary Group PA
Orlando, Florida, 32803
Status
Withdrawn
Address
Piedmont Healthcare
Austell, Georgia, 30106
Status
Recruiting
Address
Rush University Medical Center
Chicago, Illinois, 60612
Status
Suspended
Address
Laporte County Institute For Clinical Research
Michigan City, Indiana, 46360
Status
Withdrawn
Address
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, 52242
Status
Recruiting
Address
University of Kansas Medical Center
Kansas City, Kansas, 66160
Status
Recruiting
Address
Howard County Center for Lung and Sleep Medicine, LLC
Columbia, Maryland, 21044
Status
Suspended
Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
Status
Suspended
Address
Valley Medical Group
Ridgewood, New Jersey, 07450
Status
Recruiting
Address
Albany Medical Center
Albany, New York, 12208
Status
Withdrawn
Address
Stony Brook University Medical Center
Stony Brook, New York, 11794
Status
Suspended
Address
American Health Research Inc
Charlotte, North Carolina, 28207
Status
Recruiting
Address
Duke University Medical Center
Durham, North Carolina, 27710
Status
Suspended
Address
Clinical Research of Gastonia
Gastonia, North Carolina, 28054
Status
Suspended
Address
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Status
Recruiting
Address
Cleveland Clinic
Cleveland, Ohio, 44195
Status
Suspended
Address
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
Status
Suspended
Address
Temple Lung Center
Philadelphia, Pennsylvania, 19140
Status
Recruiting
Address
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Status
Recruiting
Address
Berks Schuylkill Respiratory Specialists, Ltd
Wyomissing, Pennsylvania, 19610
Status
Suspended
Address
VitaLink Research - Anderson
Anderson, South Carolina, 29621
Status
Suspended
Address
Medical University of South Carolina - PPDS
Charleston, South Carolina, 29425
Status
Suspended
Address
Clinical Research of Charleston
Mount Pleasant, South Carolina, 29464
Status
Suspended
Address
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732
Status
Recruiting
Address
VitaLink Research - Spartanburg
Spartanburg, South Carolina, 29303
Status
Withdrawn
Address
Texas Pulmonary and Critical Care Consultants PA
Arlington, Texas, 76012
Status
Recruiting
Address
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Status
Withdrawn
Address
Metroplex Pulmonary and Sleep Center
McKinney, Texas, 75069
Status
Recruiting
Address
University of Texas Health Science Center at Tyler
Tyler, Texas, 75708
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