Clinical trial NCT03320070: Acthar Gel in Participants With Pulmonary Sarcoidosis
Official title: A Multicenter, Randomized, Double Blind, Placebo Controlled Exploratory Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Pulmonary Sarcoidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sarcoidosis, Pulmonary
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2017-10-25
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: DBT: Number of Participants in Each Category of Assessment Based on Forced Vital Capacity (FVC), a Pulmonary Function Test Parameter at Week 24
timeFrame: Week 24
measure: OLE: Number of Participants in Each Category of Assessment Based on FVC, a Pulmonary Function Test Parameter at Week 48
timeFrame: Week 48
measure: DBT: Number of Participants in Each Category of Assessment Based on the Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO), a Pulmonary Function Test Parameter at Week 24
timeFrame: Week 24
measure: OLE: Number of Participants in Each Category of Assessment Based on the DLCO, a Pulmonary Function Test Parameter at Week 48
timeFrame: Week 48
measure: DBT: Number of Participants in Each Category of Assessment Based on High Resolution Computer Tomography (HRCT) at Week 24
timeFrame: Week 24
measure: OLE: Number of Participants in Each Category of Assessment Based on HRCT at Week 48
timeFrame: Week 48
measure: DBT: Number of Participants in Each Category of Assessment Based on the King's Sarcoidosis Questionnaire (KSQ) (General Health), a Quality of Life Parameter at Week 24
timeFrame: Week 24
measure: OLE: Number of Participants in Each Category of Assessment Based on the KSQ (General Health), a Quality of Life Parameter at Week 48
timeFrame: Week 48
measure: DBT: Number of Participants in Each Category of Assessment Based on the Fatigue Assessment Score (FAS), a Quality of Life Parameter at Week 24
timeFrame: Week 24
measure: OLE: Number of Participants in Each Category of Assessment Based on FAS, a Quality of Life Parameter at Week 48
timeFrame: Week 48
measure: DBT: Number of Participants in Each Category of Assessment Based on Corticosteroid Taper Score in Participants Receiving Each Dose of Prednisone at Week 24
timeFrame: Week 24
measure: OLE: Number of Participants in Each Category of Assessment Based on Corticosteroid Taper Score in Participants Receiving Each Dose of Prednisone at Week 48
timeFrame: Week 48
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Lung Health Center
state: Alabama
city: Los Angeles
country: United States
facility: David Geffen School of Medicine
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Gainesville
country: United States
facility: University of Florida Division of Pulmonary, Critical Care, and Sleep Medicine
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary Group PA
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Michigan City
country: United States
facility: Laporte County Institute For Clinical Research
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Columbia
country: United States
facility: Howard County Center for Lung and Sleep Medicine, LLC
state: Maryland
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Ridgewood
country: United States
facility: Valley Medical Group
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Charlotte
country: United States
facility: American Health Research Inc
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Gastonia
country: United States
facility: Clinical Research of Gastonia
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Hershey
country: United States
facility: Penn State Milton S Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple Lung Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Wyomissing
country: United States
facility: Berks Schuylkill Respiratory Specialists, Ltd
state: Pennsylvania
city: Anderson
country: United States
facility: VitaLink Research - Anderson
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina - PPDS
state: South Carolina
city: Mount Pleasant
country: United States
facility: Clinical Research of Charleston
state: South Carolina
city: Rock Hill
country: United States
facility: Clinical Research of Rock Hill
state: South Carolina
city: Spartanburg
country: United States
facility: VitaLink Research - Spartanburg
state: South Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Tyler
country: United States
facility: University of Texas Health Science Center at Tyler
state: Texas
Study officials:
affiliation: Mallinckrodt
name: Clinical Team Leader
role: STUDY_DIRECTOR
References: