NCT03320070

Acthar Gel in Participants With Pulmonary Sarcoidosis

A Multicenter, Randomized, Double Blind, Placebo Controlled Exploratory Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Pulmonary Sarcoidosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if Acthar Gel is safe and effective to treat pulmonary sarcoidosis. Participants will be randomly assigned (like flipping a coin) to receive a shot under their skin of Acthar Gel or a matching placebo gel that has no drug in it. They will receive their assigned shot twice a week for 24 weeks. All participants who complete the 24-week treatment period will be eligible to receive Acthar Gel for 24 more weeks, even if they were originally in the placebo group.

Conditions

• Sarcoidosis, Pulmonary

Interventions

Type	Name	Description
DRUG	Acthar Gel	Acthar Gel for subcutaneous (SC) injection (80 units per 1 mL)
DRUG	Placebo	Placebo gel for SC injection

Timeline

• Start date: 2018-02-21
• Primary completion: 2021-11-15
• Completion: 2021-11-15
• First posted: 2017-10-25
• Last updated: 2023-02-27
• Results posted: 2023-02-27

Locations

29 sites across 1 country: United States

Regulatory

• FDA-regulated drug study