Acthar Gel for Chronic Pulmonary Sarcoidosis (ACPS)

Sarcoidosis Clinical Trial

— ACPS  

Official title:

ACTHAR Gel for Chronic Pulmonary Sarcoidosis (ACPS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02188017
• Other study ID #: ACPS
• Status: Recruiting
• Phase: Phase 4
• First received: April 24, 2014
• Last updated: December 4, 2015
• Start date: June 2014
• Est. completion date: September 2017

Study information

• Verified date: December 2015
• Source: University of Cincinnati
• Contact: Robert P Baughman, MD
• Phone: 513-58405225
• Email: bob.baughman[@]uc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Sarcoidosis
• Sarcoidosis
• Sarcoidosis, Pulmonary

Intervention

Drug:
• Acthar gel
Given 80 units daily for 10 days, then randomized to receive either 40 or 80 units twice a week

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Steroid toxicity	Cumulative toxicity between two arms of study over 24 weeks of study This will be assessed using a steroid toxicity questionnaire	24 weeks
Secondary	Forced Vital Capacity (FVC)	Change in FVC over course of study	24 weeks
Secondary	Chest x-ray	Change in chest x-ray	24 weeks
Secondary	PET scan	Change in lung uptake of PET scan during course of study	24 weeks
Secondary	Sarcoidosis Health Questionnaire	Change in quality of life as assessed by King's Sarcoidosis Health Questionnaire	24 weeks