Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Atopic Dermatitis (EASE)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 10
- 主要终点
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
研究概览
简要总结
This Phase 2a trial will evaluate the effects of EP262 in subjects 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically confirmed diagnosis of active atopic dermatitis for at least 1 year
- •BSA of 3% to 20% and a vIGA-AD score of ≥3
排除标准
- •Other active skin diseases associated with chronic pruritus
- •Clinically infected atopic dermatitis that requires antibiotic therapy
- •Use of specific treatments for atopic dermatitis
研究组 & 干预措施
EP262 150 mg
干预措施: Oral EP262 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
时间窗: up to Week 10
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. A TEAE is defined as an adverse event (AE) with an onset after the first dose of study drug or an existing event that worsened after the first dose during the study.
Number of Participants With Any ≥Grade 3 TEAE
时间窗: up to Week 10
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. A TEAE is defined as an adverse event (AE) with an onset after the first dose of study drug or an existing event that worsened after the first dose during the study. AEs were graded for severity using the the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v.5). CTCAE grades were scored as: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe or medically significant; Grade 4 = life threatening; Grade 5 = death related to the AE.
Number of Participants With Clinically Meaningful Changes From Baseline in Vital Signs
时间窗: up to Week 10
Clinical meaningfulness was determined by the investigator.
Number of Participants With Clinically Meaningful Changes From Baseline in Electrocardiograms (ECGs )
时间窗: up to Week 10
Clinical meaningfulness was determined by the investigator.
Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Hematology, Chemistry, or Coagulation Parameters
时间窗: up to Week 10
Clinical meaningfulness was determined by the investigator.
次要结局
- Number of Participants With a Change From Baseline to Week 6 in Gene Expression Signature and Skin Histology (Epidermal Thickness, Immune Cell Infiltration, Markers of Epidermal Proliferation) as Assessed From Biopsies of Lesional Skin(Baseline; Week 6)