NCT04504279已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 16-Week Trial to Evaluate the Efficacy and Safety of FB-401 in Children, Adolescent and Adult Subjects (Ages 2 Years and Older) With Mild to Moderate Atopic Dermatitis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 29
- 主要终点
- EASI 50
研究概览
简要总结
The purpose of this study is to evaluate the potential improvement in atopic dermatitis signs and symptoms following the application of FB-401 in patients 2 years or older with mild to moderate atopic dermatitis. FB-401 will be applied topically for 16 weeks and progress will be assessed by assessment of the skin and patient reports.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, ≥ 2 years of age
- •Clinical diagnosis of atopic dermatitis as defined by Hanifin and Rajka criteria that has been present for ≥ 3 months before the screening visit
- •Investigator Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at Screening and Baseline/Day 1 using the validated IGA scale for atopic dermatitis
- •EASI score ≥ 5 at the screening and the Baseline visit
- •5% to 30% (inclusive) body surface area of atopic dermatitis involvement at the screening and the baseline visit
排除标准
- •Previous treatment within 4 weeks prior to the baseline visit with any of the following:
- •Immunosuppressive or immunomodulating systemic drugs such as systemic (intravenous, oral, intra-articular or intramuscular) corticosteroids, azathioprine, methotrexate, cyclosporine
- •Phototherapy or photo chemotherapy for atopic dermatitis
- •Previous treatment within 1 week prior to the baseline visit with any of the following:
- •Topical corticosteroids (does not include inhaled, intranasal or ophthalmic) or topical calcineurin inhibitors
- •Topical phosphodiesterase type 4 (PDE4) inhibitor
- •Use of emollients other than provided for the study
- •Bleach baths
- •Within 8 weeks or 5 half-lives (if known), whichever is longer, prior to the baseline visit with Janus kinase inhibitors or other investigational drug
- •Within16 weeks or 5 half-lives, whichever is longer, prior to the baseline visit with dupilumab or other biologic agent to treat atopic dermatitis
- •Within 1 year prior to the baseline visit with any live bacterial therapy
- •Pregnant (or planning to become pregnant during the period of the study) or lactating females
结局指标
主要结局
EASI 50
时间窗: 16 weeks
The proportion of subjects with 50% improvement in Eczema Area and Severity Index (EASI) score from baseline at Week 16
次要结局
- Includes percent change in EASI(16 weeks)
研究者
研究点 (29)
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