NCT06104839招募中2 期
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of NXC736 in Patients With Moderate and Severe Alopecia Areata
NEXTGEN Bioscience3 个研究点 分布在 2 个国家目标入组 73 人开始时间: 2024年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 73
- 试验地点
- 3
- 主要终点
- Change(%) in SALT score from baseline at Week 12
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of NXC-736 monotherapy in participants with severe alopecia areata (AA).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women between ≥19 and ≤65 years of age at the time of informed consent
- •Moderate and severe alopecia areata as assessed by a SALT score of 25% ≤ SALT < 95% at Screening and Day 1/Baseline
- •Current episode of hair loss for ≥6 months but <8 years
- •Stable disease condition (no significant growth of hair) in the last 6 months as assessed by the Investigator
- •Willing to keep the same hair style and color (eg, hair products, process, and timing for hair appointments) for the duration of the study
排除标准
- •Participants with the following medical history confirmed during screening:
- •ohter Types of alopecia other than alopecia areata (such as cicatricial/scarring alopecia [including central centrifugal cicatricial alopecia], traction alopecia, androgenic alopecia, telogen effluvium, etc.)
- •Active scalp inflammation, scalp infection, scalp psoriasis, or any other scalp condition that may interfere with the SALT assessment
- •Previous use of Janus kinase (JAK) inhibitor (oral or topical), including participation in clinical studies of JAK inhibitors
研究组 & 干预措施
NXC736
Experimental
干预措施: NXC736 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change(%) in SALT score from baseline at Week 12
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (3)
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