A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Cutaneous Sarcoidosis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 5
- 主要终点
- Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0
研究概览
简要总结
This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with cutaneous sarcoidosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults subjects
- •Cutaneous sarcoidosis with characteristic skin biopsy histology
- •A CSAMI activity score ≥ 10
- •Weight > 40 kg to < 130 kg, and with a body mass index (BMI) ≤ 45 kg/m2.
排除标准
- •History of cancer, with the exception of the following cancers with documentation of complete resection and no evidence of recurrence for ≥ 1 year: basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix.
- •High risk of thrombosis or cardiovascular disease
- •High risk of herpes zoster
- •Active or recent infection
研究组 & 干预措施
Part 1: Brepocitinib Dose Level 1
Oral Brepocitinib
干预措施: Oral Brepocitinib (Drug)
Part 1: Brepocitinib Dose Level 2
Oral Brepocitinib
干预措施: Oral Brepocitinib (Drug)
Part 1: Placebo
干预措施: Oral Placebo (Drug)
Part 2: Brepocitinib Dose Level 1
Oral Brepocitinib
干预措施: Oral Brepocitinib (Drug)
Part 2: Placebo
干预措施: Oral Placebo (Drug)
结局指标
主要结局
Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0
时间窗: Screening up to 28 days after the last dose of study drug at 16 weeks
Part 1: Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0
时间窗: Week 16
Part 2: Proportion of participants achieving at least a 50% reduction in Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) from baseline to Week 16.
时间窗: 16 Weeks
Part 2: Proportion of participants achieving a reduction in Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) from baseline to Week 16.
时间窗: 16 Weeks
次要结局
- Change from baseline in the Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) score through Week 16.(16 Weeks)
- Part 1: Change from baseline in the Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) score(16 Weeks)
- Part 2: Proportion of participants achieving a low Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) score(16 weeks)