NCT07532603招募中2 期
A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Lichen Planopilaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 342
- 试验地点
- 61
- 主要终点
- Proportion of participants achieving IGA score 0/1 and ≥ 2-step reduction from baseline at Week 24
研究概览
简要总结
This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with lichen planopilaris
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
- •Age ≥ 18 years
- •Scalp biopsy consistent with LPP
- •Active and symptomatic LPP at screening and baseline-
- •Weight > 40 kg to < 130 kg with BMI ≤ 45 kg/m2
排除标准
- •History of: Lymphoproliferative disorder; Active malignancy; History of cancer within 5 years prior to baseline (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid cancer).
- •High risk of thrombosis or cardiovascular disease
- •High risk of herpes zoster
- •Active or recent infection
研究组 & 干预措施
Brepocitinib Dose Level 1
Experimental
干预措施: Oral Brepocitinib (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of participants achieving IGA score 0/1 and ≥ 2-step reduction from baseline at Week 24
时间窗: Week 24
次要结局
- Change from baseline in LPP symptom numerical rating scale scores at Week 24(Week 24)
研究者
研究点 (61)
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