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Trial record 143 of 211 for:    Recruiting, Not yet recruiting, Available Studies | "Lung Diseases, Interstitial"

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
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

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

Detailed Description:
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

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 :
  1. 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.



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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).
  • 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.

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:
Lung Diseases, Interstitial
Sarcoidosis
Sarcoidosis, Pulmonary
Lymphoproliferative Disorders
Lymphatic Diseases
Lung Diseases
Respiratory Tract Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs