NCT06692465已完成2 期
A Multicenter, Randomized, Double-blind, Placebo -Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of GT20029 Solution in the Treatment of Androgenetic Alopecia (AGA) in Chinese Adult Males
Suzhou Kintor Pharmaceutical Inc,1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2023年4月13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
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change in non-vellus hair count (TAHC, Target Area Hair Counts) within target area (change from baseline at 12 weeks of treatment)
研究概览
简要总结
The study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of GT20029 solution.
详细描述
GT20029 is a new investigational androgen receptor (AR) degrader for the treatment of androgenetic alopecia. A total of 180 adult male subjects with androgenetic alopecia (AGA) (according to Hamilton-Norwood classification IIIv, IV and V) were enrolled in this study. All subjects were randomly assigned in a 1:1:1:1:1:1ratio to investigational drug groups A, B, C and D and placebo groups E and F (i.e., 30 subjects in each group) and treated for 12 weeks at the specified dose and frequency for each group. The primary endpoint of the study is to evaluate the efficacy and safety of GT20029 solution in the treatment of androgenetic alopecia (AGA) in Chinese adult males and to determine the recommended dose for phase III trials.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Agree to follow the trial treatment plan and visit plan, voluntarily enroll, and sign the informed consent form in writing.
- •Male, aged ≥ 18 years old, in good overall health;
- •Clinical diagnosis of androgenetic alopecia (refer to 2019 edition of Chinese Guidelines for the Diagnosis and Treatment of Androgenetic Alopecia);
- •Alopecia severity according to Hamilton-Norwood classification IIIv, IV, V;
- •Willing to maintain the same hair style, hair color and hair length throughout the trial;
- •No parenting plan and able to use highly effective contraception during the trial and for 3 months after the last dose.
排除标准
- •History of severe systemic diseases/surgical history, which may affect the safety and efficacy evaluation of the investigational drug, such as circulatory system, nervous system, blood system, digestive system (such as inflammatory bowel disease), immune system, mental system diseases;
- •Alopecia areata or diffuse alopecia areata, syphilis alopecia, cicatricial alopecia, malnutrition, chemotherapy/radiotherapy caused by alopecia;
- •Patients with scalp skin diseases that affect the efficacy evaluation, trauma in the target area of the scalp or other scalp skin lesions requiring topical drug treatment, such as fungal or bacterial infections, severe seborrheic dermatitis, scalp psoriasis, contact dermatitis, severe folliculitis or scalp atrophy;
- •Combined with diseases that have an impact on hair growth, such as connective tissue disease, moderate to severe anemia, and significant weight loss in a short period of time;
- •Patients who have a history of hair transplantation or need to wear wig hair cover for a long time during the trial treatment;
- •Combined with endocrine related diseases affecting androgen levels, including but not limited to male testicular disease, Klinefelter syndrome, diseases affecting the hypothalamus-pituitary-gonadal axis;
- •Use of Chinese patent medicine drugs, food and health products with alopecia treatment 1 month before screening, such as Yangxue Shengfa Capsules, Lingdan Tablets, Zhangguang 101 germinal fluid, and Caifei Germinative fluid;
- •Patients who have taken androgen replacement therapy, immunosuppressive agents, corticosteroids preparations and other drugs that may interfere with the efficacy evaluation within 3 months before screening;
- •Use of minoxidil within 6 months before screening;
- •Patients treated with oral finasteride or dutasteride within 12 months before screening;
- •Patients who have used topical drugs for alopecia sites within 3 months before screening;
- •Receiving scalp radiation and/or laser or surgical therapy within 3 months before screening;
- •Use of other medical shampoos or solutions containing ketoconazole or similar ingredients (eg. Terzolin) that may interfere with the efficacy evaluation within 1 month before screening;
- •Allergic to the investigational drug or known to be allergic to the ingredients of the study product;
- •Abnormal and clinically significant physical examination, vital signs, 12-lead ECG, blood routine, urine routine, blood biochemistry, sex hormone tests during the screening period, and judged by the investigator to affect the efficacy and safety evaluation of subjects and test results;
- •Any or more of the results of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen or hepatitis C virus antibody are positive;
- •Participating or participating in ongoing interventional drug or medical device clinical trials within 3 months before screening;
- •History of drug abuse within 1 year before screening;
- •Consumption of more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) within 3 months before screening;
- •Major surgery within 3 months before screening, or plan to undergo major surgery during the trial;
- •Other conditions that may affect compliance or unsuitable for participating in this study in the investigator 's opinion.
研究组 & 干预措施
Experimental: GT20029
Experimental
干预措施: GT20029 Tincture (Drug)
Placebo Comparator: GT20029 Matching Placebo
Placebo Comparator
干预措施: GT20029 matching placebo (Drug)
结局指标
主要结局
Change in non-vellus hair count (TAHC, Target Area Hair Counts) within target area (change from baseline at 12 weeks of treatment)
时间窗: 12 weeks
Changes from baseline in non-vellus TAHC (Target Area Hair Counts) (Non-vellus TAHC is the number of non-vellus hairs within 1 cm² scalp, which usually ranges from 0 to 300. Larger non-vellus TAHC implies thicker hair. In this study, larger change in non-vellus TAHC means better outcome.)
次要结局
- Hair growth (HGA) assessment, including subject self-assessment and investigator assessment (change from baseline at 6 and 12 weeks of treatment)(6 weeks, 12 weeks)
- TAHC assessment(6 weeks)
- TAHW assessment(6 weeks, 12 weeks)
- Terminal hair/vellus hair ratio assessment(6 weeks, 12 weeks)
研究者
研究点 (1)
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