drugset
drugset / Trial / NCT03320070

Acthar Gel in Participants With Pulmonary Sarcoidosis

NCT03320070 ↗

Phase 4 Completed 55 enrolled Mallinckrodt
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2018-02-21
Primary completion
2021-11-15
Completion
2021-11-15

Outcome

Missed primary endpoint

registry analysis (superiority test); Acthar Gel in DBT Then Acthar Gel in OLE vs Placebo in DBT Then Acthar Gel in OLE; p = 0.5076; Chi-squared NCT03320070 ↗

registry analysis (superiority test); Acthar Gel in DBT Then Acthar Gel in OLE vs Placebo in DBT Then Acthar Gel in OLE; p = 1.0000; Chi-squared NCT03320070 ↗

registry analysis (superiority test); Acthar Gel in DBT Then Acthar Gel in OLE vs Placebo in DBT Then Acthar Gel in OLE; p = 0.0848; Chi-squared NCT03320070 ↗

registry analysis (superiority test); Acthar Gel in DBT Then Acthar Gel in OLE vs Placebo in DBT Then Acthar Gel in OLE; p = 0.2005; Chi-squared NCT03320070 ↗

registry analysis (superiority test); Acthar Gel in DBT Then Acthar Gel in OLE vs Placebo in DBT Then Acthar Gel in OLE; p = 0.9416; Chi-squared NCT03320070 ↗

registry analysis (superiority test); Acthar Gel in DBT Then Acthar Gel in OLE vs Placebo in DBT Then Acthar Gel in OLE; p = 0.1853; Chi-squared NCT03320070 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Acthar Peptide 80 iu Subcutaneous

Indications

pulmonary sarcoidosis