Acthar Gel for Chronic Pulmonary Sarcoidosis (ACPS)

University of Cincinnati

Status and phase: Unknown; Phase 4

Conditions: Sarcoidosis; Pulmonary Sarcoidosis

Treatments: Drug: Acthar gel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02188017

ACPS

Details and patient eligibility

About

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.

Full description

This is a multi-center double-blind trial to determine dose and effect size. A total of 20 chronic pulmonary sarcoidosis patients will be recruited at eight clinical sites across the United States.

After initial evaluation, including pulmonary function, CT and PET scanning, patients will be randomized to receive 80 Units if Acthar gel daily for 10days, followed by either 40 or 80 units of Acthar gel twice a week for an additional 22 weeks.

At the end of total 24 weeks of treatment, they will undergo repeat evaluation including pulmonary function, CT, and PET scanning.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

80 units

Active Comparator group

Description:

80 units ACTHAR gel will be given twice a week for 22 weeks after initial loading

Treatment:

Drug: Acthar gel

40 units

Active Comparator group

Description:

40 units of ACTHAR gel will be given twice a week for 22 weeks after loading

Treatment:

Drug: Acthar gel