NCT02245841

Efficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis

Completed Phase 4 Results posted Last updated 11 June 2024

What this trial tests

Phase 4 trial testing H.P. Acthar Gel in Dermatomyositis in 19 participants. Completed in 14 July 2021.

Timeline

15 June 2015

Primary endpoint
14 July 2021

14 July 2021

Quick facts

Lead sponsor	The Cleveland Clinic
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	15 June 2015
Primary completion	14 July 2021
Estimated completion	14 July 2021
Sites	1 location across United States

Drugs / interventions tested

• H.P. Acthar Gel (REPOSITORY CORTICOTROPIN) — full drug profile →

Conditions studied

• Dermatomyositis — all drugs for Dermatomyositis →
• Juvenile Dermatomyositis — all drugs for Juvenile Dermatomyositis →

Sponsor

The Cleveland Clinic

Who can join

18 and older, any sex, with Dermatomyositis or Juvenile Dermatomyositis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Cutaneous Dermatomyositis at 6 Months Primary · 6 months

Change between baseline at 6 months in modified CDASI-A (Cutaneous Dermatomyositis Disease Area and Severity Index) scores at these timepoints. The CDASI-A score ranges from 0 to 100 with higher scores reflecting more severe disease activity.

Group	Value	95% CI
H.P Acthar Gel	-9	-18 – -5

Change in Physician's Global Assessment (PGA) Visual Acuity Score From Baseline to 6 Months Primary · 6 months

Change from baseline to 6 months in Physician's Global Assessment (PGA) visual acuity score. Scores range from 0-10 with Higher scores reflecting severe disease activity.

Group	Value	95% CI
H.P Acthar Gel	-1.9	-2.5 – -1.2

Change From Baseline in Patient Assessment of Dermatomyositis at 6 Months. Secondary · 6 months

Change between baseline and 6 months in patient assessed "Global Skin Score" at these timepoints. The Global Skin Score ranges from 0 to 10 with lower 0 representing "worst sign condition imaginable" and 10 representing "perfect health".

Group	Value	95% CI
H.P Acthar Gel	2	.5 – 6

Change From Baseline in Patient Global Itch Score of Dermatomyositis at 6 Months Secondary · 6 months

Change between baseline and 6 months in patient assessed "Global Itch Score" at these timepoints. The Global Itch score ranges from 0 to 10 with higher scores reflect more severe itching.

Group	Value	95% CI
H.P Acthar Gel	-1	-5 – 1

Change From Baseline in Patient Assessment of DLQI Dermatomyositis at 6 Months Secondary · 6 months

Change between baseline and 6 months in patient assessed Dermatology Life Quality Index (DLQI) scores at these timepoints. The DLQI ranges from 0 to 30 with higher scores implying more significant impact on quality of life.

Group	Value	95% CI
H.P Acthar Gel	-5	-11 – -4

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 Months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

H.P Acthar Gel

Serious: 0/19 (0%)

Deaths: 0/19

Other adverse events (2 terms — click to expand)

Reaction	System	H.P Acthar Gel
Weight Gain	General disorders	—
Difficulty Sleeping	General disorders	—

Data from ClinicalTrials.gov NCT02245841 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Biologics in refractory myositis: experience in juvenile vs. adult myositis; part II: emerging biologic and other therapies on the horizon.
   Patwardhan A, Spencer CH. · · 2019 · cited 8× · PMID 31429786 · DOI 10.1186/s12969-019-0361-2