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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 : January 8, 2019
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.



Information from the National Library of Medicine

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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: Anne Marie Viola 800-556-3314 clinicaltrials@mnk.com

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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: January 8, 2019
Last Verified: January 2019

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:
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