Acthar Gel for Chronic Pulmonary Sarcoidosis (ACPS)

Status unconfirmed · Phase 4

Conditions studied: Sarcoidosis, Pulmonary Sarcoidosis

In brief

An randomized trial of two maintenance doses of Acthar Gel for patients with chronic pulmonary sarcoidosis. Patients will be observed for 24 weeks of treatment.

Key facts

Study ID

NCT02188017

Run by

University of Cincinnati

People needed

20

Starts

2014-06-01

Expected to finish

2017-09-01

Last updated by the study team

2015-12-08

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient with biopsy confirmed sarcoidosis meeting American Thoracic Society criteria 23
• Patient on >5 mg prednisone for pulmonary indications
• FVC <85% predicted
• Prednisone dose not reduced in prior 3 months
• Deterioration of pulmonary disease over the past year
• Decrease in FVC >5%
• Age: 18 through 90 (i.e., candidates must have had their 18th birthday, but not had their 91st birthday).

You may not qualify if…

• adrenal insufficiency (Addison's disease)
• Scleroderma
• a fungal infection
• herpes infection of the eyes
• osteoporosis
• a stomach ulcer
• congestive heart failure
• high blood pressure
• recent surgery
• if you are allergic to pork proteins
• Do not receive a smallpox vaccine or any "live" vaccine while you are using corticotropin.
• Patients receiving anti-Tumor Necrosis Factor antibody (e.g. infliximab, adalimumab) in prior six months
• Uncontrolled diabetes, hypertension, or other contra-indication to increased dosage of glucocorticoids
• Patients requiring therapy for pulmonary hypertension
• Females of childbearing potential who are known to be pregnant and/or lactating or who have a positive urine pregnancy test on screening.
• Current participation in another research drug treatment protocol (patient cannot start another experimental agent until after 90 days)
• Any other condition that the investigator feels would pose a significant hazard to the patient if Acthar Gel therapy is initiated.

Where it is running

• University of Cincinnati — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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