Pilot Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Pulmonary Sarcoidosis

Study Purpose

The purpose of this study is to evaluate the efficacy and safety of H.P. Acthar® Gel (Acthar) in the treatment of pulmonary sarcoidosis.

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:

  • - Subject with biopsy confirmed sarcoidosis meeting American Thoracic Society criteria ≥ 1 year at screening (Visit 1).
  • - Symptomatic pulmonary disease defined as any one of the following criteria for pulmonary function test (PFT); imaging; steroid dose; or symptoms: 1.
Decrease ≥ 5% absolute change of % predicted in the best available FVC within the past 2 years. 2. Decrease ≥ 5% absolute change of % predicted in the best available DLCO within the past 2 years. 3. Radiographic progression in chest imaging on side by side comparison within the past 2 years. 4. Progression of pulmonary sarcoidosis necessitating increase in antisarcoidosis therapy in the past 2 years. 5. Dyspnea with Medical Research Council Scale of ≥ 1 at screening (Visit 1).
  • - Subject receiving ≥ 5 mg and ≤ 40 mg prednisone (or equivalent) for pulmonary sarcoidosis.
  • - Stable prednisone dose ≥ 4 weeks prior to screening (Visit 1).
  • - Subjects treated with any disease modifying antisarcoidosis drugs (eg, methotrexate) must be on stable dose for ≥ 3 months prior to screening (Visit 1).
  • - Forced vital capacity (FVC) ≥ 45% ≤ 95% predicted.
  • - Diffusing capacity of the lung for carbon monoxide (DLCO) ≥ 30%.

Exclusion Criteria:

  • - Any difference >10% in FVC on spirometry between the determination at screening (Visit 1) and the determination at Visit 2.
  • - Pulmonary arterial hypertension requiring or receiving treatment.
  • - Extra pulmonary involvement that per the Investigator's evaluation requires treatment that would impede corticosteroid tapering for pulmonary involvement.
  • - Treatment with antitumor necrosis factor-α antibody (eg, infliximab, adalimumab) in prior 3 months.

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.

Study Director
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

This is a Phase 4, multicenter, randomized, double-blind, placebo-controlled pilot study evaluating the efficacy and safety of Acthar gel in the treatment of pulmonary sarcoidosis. All subjects who meet eligibility criteria will be randomly assigned to receive either 1 mL (80 U) of Acthar or 1 mL of a matching placebo subcutaneously (SC) 2 x/week. Subjects will be assigned to treatment in a 1:1 ratio with up to 50 subjects per arm for a total of up to 100 subjects. Subjects who complete the 24 week randomized, double-blind, placebo-controlled treatment period will be eligible to continue in an optional 24 week open label extension.

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.

Tyler, Texas

Status

Recruiting

Address

University of Texas Health Science Center at Tyler

Tyler, Texas, 75708

Metroplex Pulmonary and Sleep Center, McKinney, Texas

Status

Recruiting

Address

Metroplex Pulmonary and Sleep Center

McKinney, Texas, 75069

Dallas, Texas

Status

Not yet recruiting

Address

University of Texas Southwestern Medical Center

Dallas, Texas, 75235

Dallas, Texas

Status

Recruiting

Address

University of Texas Southwestern Medical Center

Dallas, Texas, 15930

Arlington, Texas

Status

Recruiting

Address

Texas Pulmonary and Critical Care Consultants PA

Arlington, Texas, 76012

VitaLink Research - Spartanburg, Spartanburg, South Carolina

Status

Recruiting

Address

VitaLink Research - Spartanburg

Spartanburg, South Carolina, 29303

Clinical Research of Rock Hill, Rock Hill, South Carolina

Status

Recruiting

Address

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732

Clinical Research of Charleston, Mount Pleasant, South Carolina

Status

Not yet recruiting

Address

Clinical Research of Charleston

Mount Pleasant, South Carolina, 29464

Charleston, South Carolina

Status

Recruiting

Address

Medical University of South Carolina - PPDS

Charleston, South Carolina, 29425

VitaLink Research - Anderson, Anderson, South Carolina

Status

Recruiting

Address

VitaLink Research - Anderson

Anderson, South Carolina, 29621

Wyomissing, Pennsylvania

Status

Recruiting

Address

Berks Schuylkill Respiratory Specialists, Ltd

Wyomissing, Pennsylvania, 19610

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

Temple Lung Center, Philadelphia, Pennsylvania

Status

Recruiting

Address

Temple Lung Center

Philadelphia, Pennsylvania, 19140

Hershey, Pennsylvania

Status

Recruiting

Address

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033

Cleveland Clinic, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

University of Cincinnati Medical Center, Cincinnati, Ohio

Status

Recruiting

Address

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267

Clinical Research of Gastonia, Gastonia, North Carolina

Status

Recruiting

Address

Clinical Research of Gastonia

Gastonia, North Carolina, 28054

Duke University Medical Center, Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center

Durham, North Carolina, 27710

Clinical Research of Rock Hill, Charlotte, North Carolina

Status

Recruiting

Address

Clinical Research of Rock Hill

Charlotte, North Carolina, 28207

American Health Research Inc, Charlotte, North Carolina

Status

Recruiting

Address

American Health Research Inc

Charlotte, North Carolina, 28207

Stony Brook University Medical Center, Stony Brook, New York

Status

Not yet recruiting

Address

Stony Brook University Medical Center

Stony Brook, New York, 11794

Albany Medical Center, Albany, New York

Status

Recruiting

Address

Albany Medical Center

Albany, New York, 12208

Ridgewood, New Jersey

Status

Not yet recruiting

Address

Respiratory Health and Critical Care Associates

Ridgewood, New Jersey, 07450

Valley Medical Group, Hawthorne, New Jersey

Status

Recruiting

Address

Valley Medical Group

Hawthorne, New Jersey, 98374

Hawthorne, New Jersey

Status

Not yet recruiting

Address

Respiratory Health and Critical Care Associates

Hawthorne, New Jersey, 07506

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Columbia, Maryland

Status

Recruiting

Address

Howard County Center for Lung and Sleep Medicine, LLC

Columbia, Maryland, 21044

University of Kansas Medical Center, Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center

Kansas City, Kansas, 66160

Michigan City, Indiana

Status

Recruiting

Address

Laporte County Institute For Clinical Research

Michigan City, Indiana, 46360

Rush University Medical Center, Chicago, Illinois

Status

Recruiting

Address

Rush University Medical Center

Chicago, Illinois, 60612

Piedmont Healthcare, Austell, Georgia

Status

Recruiting

Address

Piedmont Healthcare

Austell, Georgia, 30106

Central Florida Pulmonary Group PA, Orlando, Florida

Status

Recruiting

Address

Central Florida Pulmonary Group PA

Orlando, Florida, 32803

Miami, Florida

Status

Recruiting

Address

University of Miami Miller School of Medicine

Miami, Florida, 33125

Gainesville, Florida

Status

Recruiting

Address

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

Gainesville, Florida, 32610

Tampa Bay Clinical Research Center, Brandon, Florida

Status

Not yet recruiting

Address

Tampa Bay Clinical Research Center

Brandon, Florida, 33511

George Washington University, Washington, District of Columbia

Status

Recruiting

Address

George Washington University

Washington, District of Columbia, 20037

National Jewish Health, Denver, Colorado

Status

Recruiting

Address

National Jewish Health

Denver, Colorado, 80206

David Geffen School of Medicine, Los Angeles, California

Status

Recruiting

Address

David Geffen School of Medicine

Los Angeles, California, 90095

UAB Lung Health Center, Birmingham, Alabama

Status

Not yet recruiting

Address

UAB Lung Health Center

Birmingham, Alabama, 35294

University of Alabama, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama

Birmingham, Alabama, 35233-1932

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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