A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of ANB032 in the Treatment of Subjects with Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 201
- 试验地点
- 78
- 主要终点
- Proportion of subjects who achieve ≥75% reduction (improvement) from Baseline in EASI-75 as Week 14
研究概览
简要总结
This study will evaluate the safety, tolerability, and efficacy of ANB032 in subjects with moderate to severe atopic dermatitis (AD).
详细描述
This is a Phase 2, randomized, double blind, placebo controlled, parallel group, multicenter study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of ANB032 in subjects with moderate to severe atopic dermatitis (AD).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 to 65 years and in good general health
- •Moderate to severe AD for at least 6 months prior to Randomization
- •History of inadequate response to treatment for AD with topical medications or for whom topical treatments are otherwise medically inadvisable
- •EASI score ≥ 16 at Screening and at Randomization
- •vIGA AD score ≥ 3 at Screening and at Randomization
- •AD involved BSA ≥ 10% at Screening and at Randomization
排除标准
- •Any factors that in the Investigator's opinion would predispose the subject to develop an infection
- •Known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject's immune status
- •Not able to tolerate SC drug administration
- •Tanning booth use or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks before Randomization
研究组 & 干预措施
ANB032 SC Dose 1
This arm will receive treatment SC
干预措施: ANB032 (Drug)
ANB032 SC Dose 2
This arm will receive treatment SC
干预措施: ANB032 (Drug)
ANB032 SC Dose 3
This arm will receive treatment SC
干预措施: ANB032 (Drug)
Placebo
This arm will receive Placebo SC
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of subjects who achieve ≥75% reduction (improvement) from Baseline in EASI-75 as Week 14
时间窗: Baseline to Week 14
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72.
次要结局
- Proportion of subjects who achieve a vIGA-AD score of 0 or 1 and ≥ 2-point reduction (improvement) from Baseline in vIGA-AD score at Week 14(Baseline to Week 14)
- Mean change from Baseline in EASI at Week 14(Baseline to Week 14)
- Mean percent change from Baseline in EASI at Week 14(Baseline to Week 14)