NCT02188017

Acthar Gel for Chronic Pulmonary Sarcoidosis (ACPS)

ACTHAR Gel for Chronic Pulmonary Sarcoidosis (ACPS)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sarcoidosis
• Pulmonary Sarcoidosis

Interventions

Type	Name	Description
DRUG	Acthar gel	Given 80 units daily for 10 days, then randomized to receive either 40 or 80 units twice a week

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-12-01
• Completion: 2017-09-01
• First posted: 2014-07-11
• Last updated: 2015-12-08

Locations

1 site across 1 country: United States