A 12-Week Open-Label Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Skin-Predominant Dermatomyositis
- Registration Number
- NCT06433999
- Lead Sponsor
- Priovant Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Brepocitinib Brepocitinib -
- Primary Outcome Measures
Name Time Method The primary endpoint is the change in CDASI-A score from baseline through Week 12 12 weeks
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie brepocitinib's efficacy in skin-predominant dermatomyositis through IL-23/JAK1 inhibition?
How does brepocitinib compare to methotrexate or corticosteroids in treating refractory skin-predominant dermatomyositis?
Which biomarkers predict response to brepocitinib in dermatomyositis patients with minimal muscle involvement?
What are the potential adverse events of brepocitinib in dermatomyositis and management strategies for JAK1 inhibitor-related toxicity?
What combination therapies or competitor drugs targeting IL-23 are being explored for dermatomyositis by companies like Novartis or Eli Lilly?
Trial Locations
- Locations (1)
Clinical Trial Site
🇺🇸Scottsdale, Arizona, United States
Clinical Trial Site🇺🇸Scottsdale, Arizona, United States