Acthar Gel in Participants With Pulmonary Sarcoidosis

Study Purpose

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.

Recruitment Criteria

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
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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 Criteria:

- 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

Trial Details

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
Additional Details

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.

Arms & Interventions

Arms

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

Interventions

Drug: - Acthar Gel

Acthar Gel for subcutaneous (SC) injection (80 units per 1 mL)

Drug: - Placebo

Placebo gel for SC injection

Contact a Trial Team

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.

University of Alabama, Birmingham, Alabama

Status

Suspended

Address

University of Alabama

Birmingham, Alabama, 35233-1932

David Geffen School of Medicine, Los Angeles, California

Status

Suspended

Address

David Geffen School of Medicine

Los Angeles, California, 90095

National Jewish Health, Denver, Colorado

Status

Recruiting

Address

National Jewish Health

Denver, Colorado, 80206

Site Contact

Study Staff

egidioc@njhealth.org

303-398-1708

George Washington University, Washington, District of Columbia

Status

Withdrawn

Address

George Washington University

Washington, District of Columbia, 20037

Gainesville, Florida

Status

Suspended

Address

University of Florida Division of Pulmonary, Critical Care, and Sleep Medicine

Gainesville, Florida, 32610

Miami, Florida

Status

Recruiting

Address

University of Miami Miller School of Medicine

Miami, Florida, 33125

Site Contact

Study Staff

awanner@med.miami.edu

305-243-2568

Central Florida Pulmonary Group PA, Orlando, Florida

Status

Recruiting

Address

Central Florida Pulmonary Group PA

Orlando, Florida, 32803

Site Contact

Study Staff

tkoenig@cfpulmonary.com

407-841-1100

Piedmont Healthcare, Austell, Georgia

Status

Withdrawn

Address

Piedmont Healthcare

Austell, Georgia, 30106

Rush University Medical Center, Chicago, Illinois

Status

Recruiting

Address

Rush University Medical Center

Chicago, Illinois, 60612

Site Contact

Study Staff

joyce_d_brown@rush.edu

312-942-6771

Michigan City, Indiana

Status

Suspended

Address

Laporte County Institute For Clinical Research

Michigan City, Indiana, 46360

University Of Iowa Hospitals And Clinics, Iowa City, Iowa

Status

Withdrawn

Address

University Of Iowa Hospitals And Clinics

Iowa City, Iowa, 52242

University of Kansas Medical Center, Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center

Kansas City, Kansas, 66160

Site Contact

Study Staff

sgreer3@kumc.edu

913-588-4424

Columbia, Maryland

Status

Recruiting

Address

Howard County Center for Lung and Sleep Medicine, LLC

Columbia, Maryland, 21044

Washington University School of Medicine, Saint Louis, Missouri

Status

Suspended

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Valley Medical Group, Ridgewood, New Jersey

Status

Suspended

Address

Valley Medical Group

Ridgewood, New Jersey, 07450

Albany Medical Center, Albany, New York

Status

Recruiting

Address

Albany Medical Center

Albany, New York, 12208

Site Contact

Study Staff

sirigak@amc.edu

518-262-2199

Stony Brook University Medical Center, Stony Brook, New York

Status

Withdrawn

Address

Stony Brook University Medical Center

Stony Brook, New York, 11794

American Health Research Inc, Charlotte, North Carolina

Status

Suspended

Address

American Health Research Inc

Charlotte, North Carolina, 28207

Duke University Medical Center, Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center

Durham, North Carolina, 27710

Site Contact

Study Staff

lisa1.holmes@duke.edu

919-684-8726

Clinical Research of Gastonia, Gastonia, North Carolina

Status

Suspended

Address

Clinical Research of Gastonia

Gastonia, North Carolina, 28054

University of Cincinnati Medical Center, Cincinnati, Ohio

Status

Suspended

Address

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267

Cleveland Clinic, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Hershey, Pennsylvania

Status

Suspended

Address

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033

Temple Lung Center, Philadelphia, Pennsylvania

Status

Suspended

Address

Temple Lung Center

Philadelphia, Pennsylvania, 19140

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

Site Contact

Study Staff

meyersma@upmc.edu

412-692-2149

Wyomissing, Pennsylvania

Status

Recruiting

Address

Berks Schuylkill Respiratory Specialists, Ltd

Wyomissing, Pennsylvania, 19610

Site Contact

Study Staff

lhill@lungmd.net

610-685-5864 #166

VitaLink Research - Anderson, Anderson, South Carolina

Status

Suspended

Address

VitaLink Research - Anderson

Anderson, South Carolina, 29621

Charleston, South Carolina

Status

Suspended

Address

Medical University of South Carolina - PPDS

Charleston, South Carolina, 29425

Clinical Research of Charleston, Mount Pleasant, South Carolina

Status

Suspended

Address

Clinical Research of Charleston

Mount Pleasant, South Carolina, 29464

Clinical Research of Rock Hill, Rock Hill, South Carolina

Status

Suspended

Address

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732

VitaLink Research - Spartanburg, Spartanburg, South Carolina

Status

Recruiting

Address

VitaLink Research - Spartanburg

Spartanburg, South Carolina, 29303

Site Contact

Study Staff

wtaylor@vitalinkresearch.com

864-515-0092

Arlington, Texas

Status

Withdrawn

Address

Texas Pulmonary and Critical Care Consultants PA

Arlington, Texas, 76012

Dallas, Texas

Status

Recruiting

Address

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

Metroplex Pulmonary and Sleep Center, McKinney, Texas

Status

Withdrawn

Address

Metroplex Pulmonary and Sleep Center

McKinney, Texas, 75069

Tyler, Texas

Status

Recruiting

Address

University of Texas Health Science Center at Tyler

Tyler, Texas, 75708

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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