Trial record 1 of 1 for:
NCT03320070
Pilot Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Pulmonary Sarcoidosis
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| ClinicalTrials.gov Identifier: NCT03320070 |
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Recruitment Status :
Recruiting
First Posted : October 25, 2017
Last Update Posted : May 28, 2018
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Sponsor:
Mallinckrodt
Information provided by (Responsible Party):
Mallinckrodt
- Study Details
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of H.P. Acthar® Gel (Acthar) in the treatment of pulmonary sarcoidosis.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sarcoidosis, Pulmonary | Drug: repository corticotropin injection Drug: Placebo | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 4, Multicenter, Randomized, Double Blind, Placebo Controlled Pilot Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Pulmonary Sarcoidosis |
| Actual Study Start Date : | January 24, 2018 |
| Estimated Primary Completion Date : | November 2019 |
| Estimated Study Completion Date : | May 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Sarcoidosis
Drug Information available for:
Corticotropin
| Arm | Intervention/treatment |
|---|---|
| Experimental: Acthar, 1 mL (80 U) |
Drug: repository corticotropin injection
Acthar administered twice weekly SC
Other Name: H.P. Acthar Gel |
| Placebo Comparator: Placebo, I mL |
Drug: Placebo
Placebo administered twice weekly SC |
Primary Outcome Measures :
- Response will be evaluated by Sarcoidosis Treatment Score (STS) [ Time Frame: Baseline to 24 weeks ]STS is an exploratory newly developed composite score that combines the results of pulmonary function tests (forced vital capacity; diffusing capacity of the lungs for carbon monoxide), high-resolution computed tomography, Quality of life (King's Sarcoidosis Questionnaire; Fatigue Assessment Scale) and corticosteroid tapering.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject with biopsy confirmed sarcoidosis meeting American Thoracic Society criteria ≥ 1 year at screening (Visit 1).
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Symptomatic pulmonary disease defined as any one of the following criteria for pulmonary function test (PFT); imaging; steroid dose; or symptoms:
- Decrease ≥ 5% absolute change of % predicted in the best available FVC within the past 2 years.
- Decrease ≥ 5% absolute change of % predicted in the best available DLCO within the past 2 years.
- Radiographic progression in chest imaging on side by side comparison within the past 2 years.
- Progression of pulmonary sarcoidosis necessitating increase in antisarcoidosis therapy in the past 2 years.
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320070
Contacts
| Contact: Lizelyn Foley | 800-556-3314 | clinicaltrials@mnk.com |
Locations
| United States, Alabama | |
| UAB Lung Health Center | Not yet recruiting |
| Birmingham, Alabama, United States, 35294 | |
| United States, Florida | |
| Tampa Bay Clinical Research Center | Not yet recruiting |
| Brandon, Florida, United States, 33511 | |
| University of Miami Miller School of Medicine | Recruiting |
| Miami, Florida, United States, 33125 | |
| Central Florida Pulmonary Group PA | Not yet recruiting |
| Orlando, Florida, United States, 32803 | |
| United States, Indiana | |
| Laporte County Institute For Clinical Research | Not yet recruiting |
| Michigan City, Indiana, United States, 46360 | |
| United States, Missouri | |
| Washington University School of Medicine | Not yet recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Respiratory Health and Critical Care Associates | Not yet recruiting |
| Hawthorne, New Jersey, United States, 07506 | |
| Respiratory Health and Critical Care Associates | Not yet recruiting |
| Ridgewood, New Jersey, United States, 07450 | |
| United States, New York | |
| Albany Medical Center | Not yet recruiting |
| Albany, New York, United States, 12208 | |
| Stony Brook University Medical Center | Not yet recruiting |
| Stony Brook, New York, United States, 11794 | |
| United States, North Carolina | |
| American Health Research Inc | Recruiting |
| Charlotte, North Carolina, United States, 28207 | |
| Clinical Research of Rock Hill | Not yet recruiting |
| Charlotte, North Carolina, United States, 28207 | |
| Clinical Research of Gastonia | Recruiting |
| Gastonia, North Carolina, United States, 28054 | |
| United States, Ohio | |
| University of Cincinnati Medical Center | Not yet recruiting |
| Cincinnati, Ohio, United States, 45267 | |
| Cleveland Clinic | Not yet recruiting |
| Cleveland, Ohio, United States, 44195 | |
| United States, South Carolina | |
| VitaLink Research - Anderson | Recruiting |
| Anderson, South Carolina, United States, 29621 | |
| Medical University of South Carolina - PPDS | Not yet recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Clinical Research of Charleston | Not yet recruiting |
| Mount Pleasant, South Carolina, United States, 29464 | |
| Clinical Research of Rock Hill | Recruiting |
| Rock Hill, South Carolina, United States, 29732 | |
| VitaLink Research - Spartanburg | Recruiting |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Texas | |
| Texas Pulmonary and Critical Care Consultants PA | Not yet recruiting |
| Arlington, Texas, United States, 76012 | |
| University of Texas Southwestern Medical Center | Not yet recruiting |
| Dallas, Texas, United States, 15930 | |
| University of Texas Southwestern Medical Center | Not yet recruiting |
| Dallas, Texas, United States, 75235 | |
| Metroplex Pulmonary and Sleep Center | Recruiting |
| McKinney, Texas, United States, 75069 | |
Sponsors and Collaborators
Mallinckrodt
Investigators
| Study Director: | Michael Tillinger | Mallinckrodt |
| Responsible Party: | Mallinckrodt |
| ClinicalTrials.gov Identifier: | NCT03320070 History of Changes |
| Other Study ID Numbers: |
MNK14344100 |
| First Posted: | October 25, 2017 Key Record Dates |
| Last Update Posted: | May 28, 2018 |
| Last Verified: | April 2018 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
| Product Manufactured in and Exported from the U.S.: | No | |
Additional relevant MeSH terms:
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Sarcoidosis Sarcoidosis, Pulmonary Lymphoproliferative Disorders Lymphatic Diseases Lung Diseases, Interstitial Lung Diseases |
Respiratory Tract Diseases Adrenocorticotropic Hormone Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |