A Phase I/II Study Of The Efficacy,Safety and Pharmacokinetics Of Jaktinib Hydrochloride Cream In Subjects With Mild To Moderate Alopecia Areata
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving 90% Improvement of Severity of Alopecia Tool (SALT90)
研究概览
简要总结
This study includes a dose escalation part(phase I) and a dose extension part(phase II).
详细描述
In phase I of this study, a multi-center, randomized, placebo parallel control design was adopted. Enrolled subjects were randomly assigned to the experimental group or the placebo group.A total of 40 subjects are expected to be enrolled in about 4 centers.
In phase II of this study, a multi-center, randomized, double-blind parallel, placebo-controlled design was adopted. Enrolled subjects were randomly assigned to the experimental group or the placebo group.About 120 subjects are expected to be enrolled in about 10 centers.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 ~ 65 years old (including boundary value), regardless of gender;
- •Diagnosis of Alopecia Areata;
- •Hair loss accounts for 5% ~ 49% of the total scalp area;
- •The duration of hair loss is at least 6 months, the longest is not more than 5 years;
- •Patients can complete treatment for at least 6 months;
- •About Fertility needs meet the following criteria: The results of serum pregnancy tests performed by fertile women during screening visits must be negative, and the results of human chorionic gonadotropin tests performed before the initiation of the study drug must be negative;Women who were fertile and men who had not received vasectomies were required to use effective contraception throughout the study period beginning with the informed consent and up to six months after the last administration;
- •Subjects will voluntarily participate in the study after learning about the content and potential adverse drug reactions and must sign an IRC-approved informed consent prior to beginning any examination required by the study;
- •Subject is willing and able to comply with scheduled visits, treatment plan, study drug administration, and other study procedures.
排除标准
- •The following causes of hair loss should be excluded: hair loss caused by androgenic alopecia,syphilis, thyroid diseases, etc.
- •Acute Diffuse and Total Alopecia of the Female Scalp;
- •Prior history of serious chronic diseases, such as thyroid disease, liver disease, malnutrition, heart disease, nervous system disease, gastrointestinal dysfunction, tumor and mental illness, etc;
- •Human immunodeficiency virus infection, hepatitis C virus infection, hepatitis B virus infection;
- •Participated in a trial for a topical or oral JAK inhibitor;
- •Allergic reactions to active ingredients or excipients are known or determined by the investigator;
- •Receipt of treatment known to potentially affect the course of AA within last 3 month;
- •In the opinion of the investigator , the subject is inappropriate for entry into this study.
研究组 & 干预措施
Cohort 1,0.5% Bid
Jaktinib hydrochloride cream 0.5% concentration, twice daily
干预措施: Jaktinib hydrochloride cream (Drug)
Cohort 1,1.5% Bid
Jaktinib hydrochloride cream 1.5% concentration, twice daily
干预措施: Jaktinib hydrochloride cream (Drug)
Cohort 1,2.5% Qd
Jaktinib hydrochloride cream 2.5% concentration, once daily
干预措施: Jaktinib hydrochloride cream (Drug)
Cohort 1,2.5% Bid
Jaktinib hydrochloride cream 2.5% concentration, twice daily
干预措施: Jaktinib hydrochloride cream (Drug)
Dose extension: Placebo
Placebo, twice daily
干预措施: Placebo (Drug)
Dose extension: 1.5% Bid
Jaktinib hydrochloride cream 1.5% concentration, twice daily
干预措施: Jaktinib hydrochloride cream (Drug)
Dose extension: 2.5% Bid
Jaktinib hydrochloride cream 2.5% concentration, twice daily
干预措施: Jaktinib hydrochloride cream (Drug)
结局指标
主要结局
Percentage of Participants Achieving 90% Improvement of Severity of Alopecia Tool (SALT90)
时间窗: at week 24
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 90 response is a 90% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease.
次要结局
- Change in Severity of Alopecia Tool (SALT) Score(at baseline, at week 12 and at week 24)