A Phase 2b, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study to Determine the Safety, Tolerability, Pharmacokinetics, and Efficacy of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis (AD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Percentage change from baseline in Eczema Area and Severity Index Score (EASI) score at Week 4 (Day 28)
研究概览
简要总结
This is a Phase 2b study to determine the safety, tolerability, pharmacokinetic (PK), and efficacy of ATI-1777 in patients 12 to 65 years old with mild to severe Atopic Dermatitis. Eligible participants will apply either ATI-1777 or Vehicle Topical Solution once daily or twice daily for 4 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)
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to comprehend and willing to sign the IRB approved ICF/assent prior to administration of study-related procedures.
- •Male patients or non-pregnant, non-nursing female patients 12 to 65 years old, inclusive, at the time of informed consent/assent.
- •Have at least a 6-month history of AD prior to the Screening Visit, and no significant AD flares for the 4 weeks prior to the Screening Visit.
排除标准
- •Unstable course of AD (spontaneously improving or rapidly deteriorating) based on the patient history or as determined by the investigator during the Screening Period.
- •Concomitant skin disease or clinically infected AD or presence of other skin disease in the area to be dosed that may interfere with study assessments.
- •Female patients who are pregnant, nursing, or planning to become pregnant during the study.
研究组 & 干预措施
ATI-1777 topical solution 2.0% w/w (BID)
ATI-1777 topical solution 2.0% w/w, twice daily
干预措施: ATI-1777 2.0% w/w (Drug)
ATI-1777 topical solution 1.0% w/w (BID)
ATI-1777 topical solution 1.0% w/w, twice daily
干预措施: ATI-1777 1.0% w/w (Drug)
ATI-1777 topical solution 0.5% w/w (BID)
ATI-1777 topical solution 0.5% w/w, twice daily
干预措施: ATI-1777 0.5% w/w (Drug)
Vehicle (BID)
Vehicle topical solution, twice daily
干预措施: Vehicle (Drug)
ATI-1777 topical solution 2.0% w/w (QD)
ATI-1777 topical solution 2.0% w/w, once daily
干预措施: ATI-1777 2.0% w/w (Drug)
Vehicle (QD)
Vehicle topical solution, once daily
干预措施: Vehicle (Drug)
结局指标
主要结局
Percentage change from baseline in Eczema Area and Severity Index Score (EASI) score at Week 4 (Day 28)
时间窗: Baseline to Day 28
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
次要结局
- Proportion of patients who achieve 50%, 75%, and 90% improvement in EASI score (EASI 50, EASI 75, and EASI 90, respectively) at each post-baseline study visit(Baseline to Day 42)
- Percentage change from baseline in EASI score at each post-baseline study visit(Baseline to Day 42)
- Change from baseline in vIGA score at each post-baseline study visit(Baseline to Day 42)
- Change from baseline in Body Surface Area (BSA) at each post-baseline study visit(Baseline to Day 42)
- Change from baseline in Itch Numerical Rating Scale (PP NRS) from baseline to Day 28(Baseline to Day 28)
- Proportion achieving Investigator's Global Assessment-Treatment Success (IGA-TS) defined as Validated Investigator Global Assessment (vIGA) score of 0 or 1 with an improvement in vIGA of at least 2 points from baseline at each post-baseline study visit.(Baseline to Day 42)
- Number of Participants With At Least One Adverse Event (AEs) and as Per Severity(Baseline to Day 42)