A Phase I/II Study Of The Efficacy,Safety and PharmacokineticsOf Jaktinib Hydrochloride Cream In Subjects With Mild To Moderate Atopic Dermatitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear
研究概览
简要总结
This study includes a dose escalation part and a dose extension part.
详细描述
In the dose-increasing part, a multicenter, dose-increasing, randomized, double-blind, placebo-parallel control design was adopted. Subjects were enrolled into different dose groups in sequence according to the inclusion sequence, and each group was scheduled to give the drug for 8 weeks.Subjects in each group were observed for 4 weeks after administration. When the number of ≥2 grade drug-related adverse events (cases) was less than 50%, subjects in the next group could be enrolled.Otherwise, IDMC will decide whether to continue the next set of tests.Subjects in each group were randomly assigned to receive either Jaktinib cream (6 cases) or placebo (2 cases) in a ratio of 3 to 1.A total of 32 subjects are expected to be enrolled in 6 centers.
The dose expansion was a multicenter, randomized, double-blind, placebo-parallel control design in which subjects were randomly assigned to 3 groups (1 placebo group and 2 experimental drugs group).It is estimated that a total of 60 subjects will be enrolled in about 15 centers. This part is divided into two stages.Stage 2 test (9 ~ 16 weeks) : Extension test.
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), gender is not limited;
- •Have a clinical diagnosis of atopic dermatitis;
- •Have a PGA(Physician's Global Assessment) score of 2 (mild) or 3 (moderate) at baseline;
- •The total area of atopic dermatitis is about 10%~20% of the total area of the body surface at baseline.
排除标准
- •Evidence of certain skin conditions/infections at baseline;
- •Have certain laboratory abnormalities at baseline;
- •Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception;
- •Other conditions that the investigators considered inappropriate to participate in the trial.
研究组 & 干预措施
Part 1: Cohort 1, 0.5% Jaktinib Bid
Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 0.5% Cream will be applied topically twice daily.
干预措施: Jaktinib Hydrochloride Cream (Drug)
Part 1: Cohort 1, 0.5% Jaktinib Bid
Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 0.5% Cream will be applied topically twice daily.
干预措施: Placebo (Drug)
Part 1: Cohort 2,1.5% Jaktinib Bid
Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 1.5% Cream will be applied topically twice daily.
干预措施: Jaktinib Hydrochloride Cream (Drug)
Part 1: Cohort 2,1.5% Jaktinib Bid
Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 1.5% Cream will be applied topically twice daily.
干预措施: Placebo (Drug)
Part 1: Cohort 3, 2.5% Jaktinib Qd
Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 2.5% Cream will be applied topically Once daily.
干预措施: Jaktinib Hydrochloride Cream (Drug)
Part 1: Cohort 3, 2.5% Jaktinib Qd
Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 2.5% Cream will be applied topically Once daily.
干预措施: Placebo (Drug)
Part 1: Cohort 4, 2.5% Jaktinib Bid
Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 2.5% Cream will be applied topically twice daily.
干预措施: Jaktinib Hydrochloride Cream (Drug)
Part 1: Cohort 4, 2.5% Jaktinib Bid
Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 2.5% Cream will be applied topically twice daily.
干预措施: Placebo (Drug)
Dose extension: Vehicle Control
the Vehicle Control cream will be applied topically twice daily
干预措施: Placebo (Drug)
Dose extension: low-dose group, X%
X% based on results of part 1. The Jaktinib Hydrochloride X% Cream will be applied topically twice daily
干预措施: Jaktinib Hydrochloride Cream (Drug)
Dose extension: high-dose group, Y%
Y% based on results of part 1. The Jaktinib Hydrochloride Y% Cream will be applied topically twice daily
干预措施: Jaktinib Hydrochloride Cream (Drug)
结局指标
主要结局
Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear
时间窗: 7 days after the last dose
A total PGA score of 0 or 1 or a decrease of ≥2 from baseline
次要结局
- Proportion of Participants With Response of Clear or Almost Clear From Baseline(Treatment at 8,16 weeks)