Acthar Gel for Chronic Pulmonary Sarcoidosis (ACPS)

• Status: Unknown status
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: Mallinckrodt
• Treatments: Adrenocorticotropic Hormone

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

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.