At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 19 enrolled
Drug / intervention
H.P. Acthar Geldrug
Likely dose
H.P. Acthar Gel 1 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis
In Brief
A Phase 4 clinical trial evaluating H.P. Acthar Gel for Dermatomyositis and Juvenile Dermatomyositis. Completed, enrolled 19 participants across 1 site.
Detailed Summary
This study will assess the safety and efficacy of H.P. Acthar gel for treating the cutaneous manifestations in patients with refractory classic dermatomyositis, juvenile dermatomyositis, and amyopathic dermatomyositis. Our hypothesis is that H.P. Acthar gel will be both safe and effective for such patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDermatomyositis, Juvenile Dermatomyositis
CountriesUnited States
CollaboratorsMallinckrodt
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 2014
Enrollment StartJun 2015
Primary CompletionJul 2021
TodayJul 2026
First PostedSep 22, 2014
Enrollment StartJun 15, 2015
Primary CompletionJul 14, 2021
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 11.8 years ago
Interventions
H.P. Acthar Geldrug
80 U (1 mL) of H.P. Acthar gel via subcutaneous injection twice weekly for 24 weeks