Acthar Gel for Chronic Pulmonary Sarcoidosis (ACPS)

Phase 4

• Conditions: Pulmonary Sarcoidosis; Sarcoidosis
• Interventions: Drug: Acthar gel

• Registration Number: NCT02188017
• Lead Sponsor: University of Cincinnati

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-04-24
• Study Start: 2014-06
• Study First Submitted QC: 2014-07-08
• Study First Posted: 2014-07-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-04
• Last Update Posted: 2015-12-08
• Primary Completion: 2016-12
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
40 units	Acthar gel	40 units of ACTHAR gel will be given twice a week for 22 weeks after loading
80 units	Acthar gel	80 units ACTHAR gel will be given twice a week for 22 weeks after initial loading

Primary Outcome Measures

Name	Time	Method
Steroid toxicity	24 weeks	Cumulative toxicity between two arms of study over 24 weeks of study This will be assessed using a steroid toxicity questionnaire

Secondary Outcome Measures

Name	Time	Method
Chest x-ray	24 weeks	Change in chest x-ray
Forced Vital Capacity (FVC)	24 weeks	Change in FVC over course of study
PET scan	24 weeks	Change in lung uptake of PET scan during course of study
Sarcoidosis Health Questionnaire	24 weeks	Change in quality of life as assessed by King's Sarcoidosis Health Questionnaire

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States