A Phase II Clinical Study to Evaluate the Efficacy and Safety of KX-826 Tincture in the Treatment of Adult Male Androgenetic Alopecia (AGA) Patients in China
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 9
- 主要终点
- change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24).
研究概览
简要总结
This is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study of KX-826 in Chinese adult male patients with AGA.
详细描述
Based on the results of the Phase I studies of KX-826 in Androgenetic Alopecia and the pre-clinical PD studies, the investigational product will be administered at 2.5 mg BID (0.25%), 5 mg QD (0.5%), and 5 mg BID (0.5%) in treatment groups A, B, and C, respectively, with 30 patients/group; a total of 30 patients will be administered in the placebo QD group (10) and placebo BID group (20). The investigational product will be administered in the evening once daily for all QD dose groups, and once in the morning and once in the evening for the BID dose groups.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Agreeing to follow the study treatment regimen and visit plan, voluntarily enroll the study, and sign the informed consent form (ICF) in writing;
- •Male, aged ≥ 18 years, in good general health;
- •Clinical diagnosis of AGA;
- •Stage IIIv, IV and V according to Hamilton-Norwood scale.
排除标准
- •Patients who have used external topical drugs for alopecia sites within 3 months prior to screening;
- •Patients who have taken androgen replacement therapy； immunosuppressants, corticosteroids and other drugs that may interfere with the efficacy evaluation within 3 months prior to screening;
- •Minoxidil use within 6 months prior to screening;
- •Treatment with finasteride or dutasteride within 12 months prior to screening; Scalp radiation and/or laser or surgical therapy within 12 months prior to screening; History of malignancy;
- •Other conditions that may affect compliance or ineligibility for participation of the study.
研究组 & 干预措施
KX-826-2.5 mg BID
treatment dose groups of 2.5 mg BID (0.25%)
干预措施: KX-826-2.5 mg (0.25%)/60 mL BID (Drug)
KX-826-5 mg QD
treatment dose groups of 5 mg QD (0.5%)
干预措施: KX-826-5 mg (5%)/60 mL QD (Drug)
KX-826-5 mg BID
treatment dose groups of 5 mg BID (0.5%)
干预措施: KX-826-5 mg (5%)/60 mL BID (Drug)
Placebo
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24).
时间窗: mean change from baseline after 24 weeks of treatment
change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24).
次要结局
- Hair growth assessment (HGA), including patient self-assessment, investigator assessment, and third-party professional physician assessment(change from baseline after 6, 12, 18, and 24 weeks of treatment, assessed using a 7-category method)
- Change in non-vellus hair diameter (width) in the target area (TAHW) (change from baseline at Weeks 6, 12, 18, 24 of treatment)(change from baseline after 6, 12, 18, and 24 weeks of treatment)