NCT06433999已完成2 期
A 12-Week Open-Label Pilot Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults With Skin-Predominant Dermatomyositis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- The primary endpoint is the change in CDASI-A score from baseline through Week 12
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Brepocitinib
Experimental
干预措施: Brepocitinib (Drug)
结局指标
主要结局
The primary endpoint is the change in CDASI-A score from baseline through Week 12
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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