Phase 4 N=19 Treatment

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

Dermatomyositis · Juvenile Dermatomyositis

Bottom Line

View on ClinicalTrials.gov: NCT02245841 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2024

Primary outcome: Primary: Change From Baseline in Cutaneous Dermatomyositis at 6 Months — -9 units on a scale — p=< .001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: H.P. Acthar Gel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Cleveland Clinic
Primary completion: Jul 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Cutaneous Dermatomyositis at 6 Months	-9	< .001 sig
PRIMARY Change in Physician's Global Assessment (PGA) Visual Acuity Score From Baseline to 6 Months	-1.9	<0.001 sig
SECONDARY Change From Baseline in Patient Assessment of Dermatomyositis at 6 Months.	2	0.002 sig
SECONDARY Change From Baseline in Patient Global Itch Score of Dermatomyositis at 6 Months	-1	0.050
SECONDARY Change From Baseline in Patient Assessment of DLQI Dermatomyositis at 6 Months	-5	<0.001 sig

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.

Eligibility Criteria

Inclusion Criteria

Must be 18 years of age or older with refractory cutaneous symptoms related to either classic dermatomyositis (CD), juvenile dermatomyositis (JD), or amyopathic dermatomyositis(AD). Diagnosis will be based on either Bohan and Peter criteria (CD and JD) or Sontheimer's criteria (AD)
Must have had a skin biopsy with histologic features consistent with dermatomyositis and current cutaneous manifestations consistent with dermatomyositis.
Although not mandatory, patients with evidence of current or previous active myositis will be eligible for enrollment. Patients will be considered to have refractory disease if cutaneous manifestations exist despite treatment with steroids and at least one steroid-sparing systemic treatment commonly found to be useful in patients with dermatomyositis. These may include azathioprine, cyclosporine, mycophenolate mofetil, IVIG, methotrexate, cyclophosphamide, chlorambucil, sirolimus, adalimumab, infliximab and rituximab.
Use of topical medications and sunscreen currently and in past will be noted but not weighed for assessment of refractory cutaneous disease.

Exclusion Criteria

Patients with dermatomyositis who have minimal-to-no active cutaneous features (focal involvement with less than 1% total body surface area involved or minimal modified CDASI activity score).
Patients whose cutaneous findings are not consistent with dermatomyositis and/or have previous biopsy results suggestive of an alternative diagnosis
Patients with inflammatory myositis other than dermatomyositis, such as polymyositis or inclusion body myositis.
Patients with malignancy-associated dermatomyositis
Patients with clear features of an overlap myositis
Patients younger than 18 years old
Patients with acutely active or chronic infections.
Patients with uncontrolled diabetes, hypertension, cardiovascular, hepatic, or renal disease
Pregnant or lactating females.
Patients with any medical condition that is felt by the primary investigator to place the patient at unreasonable risk for adverse effects during treatment with H.P. Acthar.
Hypersensitivity to H.P. Acthar, any of its components (allergy to pig-derived proteins)
Patients with osteoporosis
Patients who have had surgery within 8 weeks of screening
Patients with a history of or current gastric ulcers
Patients taking daily doses of systemic corticosteroids greater than the equivalent of 40mg prednisone.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02245841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.