A Phase 2, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 162
- 试验地点
- 38
- 主要终点
- Change From Baseline in Eczema Area Severity Index (EASI) Score
研究概览
简要总结
This is a randomized open label study to evaluate the long term safety of ASN002 in subjects with moderate to severe atopic dermatitis (AD).
详细描述
This is a randomized open label study where subjects with moderate to severe atopic dermatitis will roll over from the Phase 1 ASN002AD-101 (NCT03139981) and ASN002AD-201 (NCT03531957) Ph2b study and be randomized to receive ASN002 at 40mg, 60mg, or 80mg once daily for up to 24 months. This study will also characterize the pharmacokinetics of ASN002 through blood sampling from subjects who consent.
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
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ASN002 40 mg
ASN002 40 mg
干预措施: ASN002 (Drug)
ASN002 60 mg
ASN002 60 mg
干预措施: ASN002 (Drug)
ASN002 80 mg
ASN002 80 mg
干预措施: ASN002 (Drug)
结局指标
主要结局
Change From Baseline in Eczema Area Severity Index (EASI) Score
时间窗: 3 Months
The Eczema Area and Severity Index (EASI) is a composite score ranging from 0 to 72, the higher the value the worse the disease, that takes into account the degree of erythema, induration/infiltration (papules), excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body. Due to early termination of the study, all efficacy analyses were descriptive in nature
次要结局
- Number of Participants Achieving an Investigator Global Assessment (IGA) Scale of Clear (0) or Almost Clear (1)(3 months)
- Change From Baseline in Pruritus (Itch) Numeric Rating Scale (NRS)(3 months)
- Change From Baseline in 5-D Pruritus (Itch) Scale(3 months)
- Change From Baseline in Patient-Oriented Eczema Measure (POEM)(3 months)