NCT06118866已完成2 期
A Randomized, Multicenter, Double-blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety, Tolerability and Efficacy in Male Androgenetic Alopecia Treated With HMI-115 Over a 24-Week Treatment Period
Hope Medicine (Nanjing) Co., Ltd1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2023年9月11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
- 192
- 试验地点
- 1
- 主要终点
- The Rate of Target Arean Hair Count (TAHC)
研究概览
简要总结
To investigate the efficacy of HMI-115 compared to placebo in treating Androgenic Alopecia patients for 24 weeks
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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- •Male subjects, between 18 and 65 years of age, inclusive, at the time of signing informed consent.
- •Clinical diagnosis of androgenetic alopecia. Male subjects who meet Norwood-Hamilton scales III vertex, IV and V .
- •Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions, including having a small circle about 1 cm2 of hair clipped to approximate 1 mm in length and micro-dot-tattoo on the scalp of target area.
- •Subjects who are willing to keep the same hair color, refrain from hair weaving, and hair growth therapy and supplement (except for protocol specified IMP) during the study.
- •Subjects agree to use required birth control methods from signing the consent until 3 months after the last dose of IMP or complete whole study period whichever is longer.
排除标准
- •Subject with history of scalp radiation or surgery which could interfere study assessment (e.g., hair transplantation surgery).
- •Subject with history of scalp laser treatment within 6 months prior screening, including but not limited to, low level laser, and fractional laser, etc.
- •Subject with history of hair weaves within 3 months prior screening.
- •Subject has a current history of hyperthyroidism or uncontrolled hypothyroidism.
- •Subject has, in the Investigator's opinion, uncontrolled hypertension (systolic blood pressure [SBP] > 159 mmHg, diastolic blood pressure [DBP] > 99 mmHg).
- •Subject has any of the following conditions within 6 weeks prior to Screening:
- •Myocardial infarction, stroke, unstable angina, or transient ischemic attack.
- •Heart failure with classified as being in New York Heart Association Class III or IV.
- •Subject has high fever, major surgery, or ten percent or more weight decrease within three months before screening.
- •Subject with history of active malignancy (with or without systemic chemotherapy), except treated basal cell carcinoma of the skin (besides scalp).
- •Subject plans to schedule elective surgery during the study.
研究组 & 干预措施
placebo-Q2W
Placebo Comparator
placebo, 0mg/vials
干预措施: placebo-Q2W (Drug)
HMI-115-120mg-Q4W
Active Comparator
HMI-115, 60mg/vials
干预措施: HMI-115-120mg-Q4W (Drug)
HMI-115-240mg-Q4W
Active Comparator
HMI-115, 60mg/vials
干预措施: HMI-115-240mg-Q4W (Drug)
HMI-115-240mg-Q2W
Active Comparator
HMI-115, 60mg/vials
干预措施: HMI-115, 240mg-Q2W (Drug)
结局指标
主要结局
The Rate of Target Arean Hair Count (TAHC)
时间窗: 24 Weeks
The mean change in TAHC of non-vellus from baseline
次要结局
- Target Area Hair Count (TAHC) change from baseline(6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks)
- Subject Self-Assessment (SSA)(6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks)
- Norwood-Hamilton Grade change from baseline(12 weeks, 24 weeks, and 36 weeks)
- Blood Pressure change from baseline(36 Weeks)
- Hair Growth State Assessed by Hair Growth Questionnaire Assessment (HGQA)(6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks)
- Rate of Target Area Hair Width (TAHW)(6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks)
- Investigator Global Assessment (IGA)(6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks)
- Frequencies and percentages of Adverse event (AE)(36Weeks)
- Pulse change from baseline(36 Weeks)
- Body temperature change from baseline(36 Weeks)
- Respiratory rate(36 Weeks)
- Complete or brief physical examination, at a minimum of General appearance, HEENT (head, eyes, ears, nose, throat), Neck, Lung/pulmonary, Chest, Neurological or not, Extremities,ect.to assess the physical health state.(36 Weeks)
- Concomitant Medication(36 Weeks)
- Change in twelve-lead electrocardiogram parameters(36 Weeks)
- Clinical laboratory tests of hematology(36 Weeks)
- Clinical laboratory tests of coagulation(36 Weeks)
- Clinical laboratory tests of clinical chemistry(36 Weeks)
- Clinical laboratory tests of urinalysis(36 Weeks)
- Clinical laboratory tests of hormones(36 Weeks)
研究者
研究点 (1)
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