CTIS2022-500367-12-00招募中1 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults with Dermatomyositis - PVT-2201-301
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 235
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Male or female participant who must be = 18 to =/< 75 years of age at the time of signing the informed consent form (ICF)., Participants with a diagnosis of dermatomyositis according to the 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies., Active muscle and skin disease at screening and baseline, Current therapy or past therapy with corticosteroids, hydroxychloroquine, and/or one non-steroid immunosuppressant, Participants with 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 Secondary Sjögren's syndrome), Participants at a risk of thrombosis and cardiovascular disease, Participants with a high risk for herpes zoster reactivation, Participants with active or recent infections
研究者
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