Dermatomyositis Clinical Trial
Official title:
A 12-Week Open-Label Pilot Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults With Skin-Predominant Dermatomyositis
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.
Status | Not yet recruiting |
Enrollment | 5 |
Est. completion date | January 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Priovant Therapeutics, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary endpoint is the change in CDASI-A score from baseline through Week 12 | 12 weeks |
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