A 12-Week Open-Label Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Skin-Predominant Dermatomyositis
Completed · Phase 2
Conditions studied: Dermatomyositis, Dermatomyositis, Adult Type
In brief
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.
Key facts
- Study ID
- NCT06433999
- Run by
- Priovant Therapeutics, Inc.
- People needed
- 5
- Starts
- 2024-08-28
- Expected to finish
- 2025-02-28
- Last updated by the study team
- 2025-05-20
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Clinical Trial Site — Scottsdale, Arizona, United States
Full record on ClinicalTrials.gov
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