A Phase 2 Study Investigating the Efficacy and Safety of HSK44459 Tablet Administered to Participants With Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Percent change from baseline to week 12 in EASI
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of HSK44459 in adults with Atopic Dermatitis
详细描述
This is a multicenter, randomized, double-blind, parallel group, placebo controlled phase 2 study to assess the efficacy and safety of HSK44459 in adult participants with Atopic Dermatitis.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained
- •Male or female, ≥18 years old and ≤75 years old
- •Willing and able to comply with study-specific procedures and the requirements of this study protocol.
- •Atopic dermatitis has been present for at least 1 year and subject meets Hanifin and Rajka criteria
- •EASI score≥16 at the screening and baseline visits
- •IGA score≥3 at the screening and baseline visits
- •≥10% body surface area (BSA) of AD involvement at the screening and baseline visits
- •Baseline WI-NRS≥4
- •History of inadequate response to TCS of medium to higher potency (with or without topical calcineurin inhibitors [TCI]) or systemic treatment for AD within 6 months prior to screening
- •Have applied a stable dose of topical emollient (moisturizer) twice daily for at least 7 days before the baseline visit
排除标准
- •Subjects have used AD treatments within the time frame specified in protocol prior to the baseline visit
- •Prior exposure to any PDE4 inhibitor systemic treatment
- •Systemic use of known strong CYP3A inhibitors or strong CYP3A inducers within 4 weeks or 5 half-lives prior to randomization or during the course of the study
- •Participation in other clinical studies within 4 weeks or 5 half-lives prior to randomization
- •Subjects have laboratory values meeting the criteria in protocol
- •Presence of skin comorbidities that may interfere with study assessments
- •Concurrent conditions and history of other diseases as described in protocol
研究组 & 干预措施
HSK44459-Dose level 1
Participants will receive HSK44459 for 12 weeks
干预措施: HSK44459 (Drug)
HSK44459-Dose level 2
Participants will receive HSK44459 for 12 weeks
干预措施: HSK44459 (Drug)
Placebo
Participants will receive Placebo for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change from baseline to week 12 in EASI
时间窗: From Day 1 (first dose) to Day 85 (week 12)
Evaluate the clinical efficacy of 2 dose levels of HSK44459, compared to placebo, in adult participants with atopic dermatitis (AD) using EASI. A total EASI score range from 0 to 72 points will be recorded for each assessment, with higher scores reflecting worse severity of AD
次要结局
- Proportion of patients with EASI-75 at week 12(From Day 1 (first dose) to Day 85 (week 12))
- Proportion of patients with both IGA 0 to 1and a reduction from baseline of ≥2 points at week 12(From Day 1 (first dose) to Day 85 (week 12))
- Proportion of patients with reduction of pruritus WI-NRS ≥3 or WI-NRS ≥4 from baseline to week 12(From Day 1 (first dose) to Day 85 (week 12))