drugset / Trial / NCT02113735

Safety and Efficacy Study of Acthar in Subjects With ARDS

NCT02113735 ↗

Phase 2 Withdrawn Mallinckrodt
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is being performed to evaluate the potential efficacy and safety of Acthar as a treatment for moderate-severe Acute Respiratory Distress Syndrome (ARDS). Approximately 210 subjects will be randomized to 1 of 6 possible treatment groups in a 3:2:3:2:3:2 ratio. Study medication (SM) will be administered via subcutaneous (SC) injection for 4 weeks using a blinded gradually tapering regimen, and subjects will be followed for 60 days post-randomization.

Timeline

Start
2014-08
Primary completion
2016-08
Completion
2016-08

Outcome

Outcome not reported

Stopped: “A company decision was made not to proceed with the study.”

Drugs

EvaluationDrugModalityDoseRoute
Subject repository corticotropin injection Unknown 16 iu Subcutaneous
Subject repository corticotropin injection Unknown 32 iu Subcutaneous
Subject repository corticotropin injection Unknown 64 iu Subcutaneous