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



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 90
Updated:2/22/2019
Start Date:January 24, 2018
End Date:May 2020
Contact:Lizelyn Foley
Email:clinicaltrials@mnk.com
Phone:800-556-3314

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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

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

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.

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.
We found this trial at
39
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1447 Ebenezer Road
Spartanburg, South Carolina 29303
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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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326 North Mills Avenue
Orlando, Florida 32803
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Albany, New York 12208
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55 East Camperdown Way
Anderson, South Carolina 29621
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911C Medical Centre Drive
Arlington, Texas 76012
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Austell, Georgia 30106
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Birmingham, Alabama 35294
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Birmingham, Alabama 35294
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Brandon, Florida 33511
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96 Jonathan Lucas Street
Charleston, South Carolina 29425
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Charlotte, North Carolina 28207
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218 Baldwin Avenue
Charlotte, North Carolina 28207
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Gastonia, North Carolina 28054
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Hawthorne, New Jersey 07506
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Hawthorne, New Jersey 98374
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
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10833 Le Conte Avenue
Los Angeles, California 90095
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McKinney, Texas 75069
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180 Wingo Way
Mount Pleasant, South Carolina 29464
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Philadelphia, Pennsylvania 19140
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
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44 Godwin Avenue
Ridgewood, New Jersey 07450
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Rock Hill, South Carolina 29732
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
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101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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Washington, District of Columbia 20052
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Wyomissing, Pennsylvania 19610
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