Dermatomyositis, Dermatomyositis, Adult Type
Conditions
Keywords
skin-predominant dermatomyositis, dermatomyositis
Brief summary
This is a prospective, 12-week, open-label, single-arm study. The study population comprises individuals with refractory skin disease characteristic of dermatomyositis with no to minimal muscle involvement. After an up to 8-week Screening Period, eligible participants will receive brepocitinib 30 mg orally (PO) QD for 12 weeks.
Interventions
DRUGBrepocitinib
Oral Brepocitinib PO QD
Sponsors
Priovant Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* A diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies * Active cutaneous manifestations of dermatomyositis * Adult subjects (18-75 years old) * Weight \> 40 kg to \< 130 kg, and with a body mass index (BMI) \< 40 kg/m2.
Exclusion criteria
* Dermatomyositis with end-stage organ involvement * Dermatomyositis with irreversible muscle involvement History of: * Any lymphoproliferative disorder * Active malignancy; * History of cancer within 5 years prior to randomization (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.) Cancer-associated dermatomyositis * Overlap myositis/connective tissue disease (except for overlap with Sjögren's syndrome) * Participants at a risk of thrombosis or cardiovascular disease * Participants with a high risk for herpes zoster reactivation * Participants with active or recent infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the change in CDASI-A score from baseline through Week 12 | 12 weeks |
Countries
United States
Outcome results
None listed