NCT04936113终止2 期
An Open-Label, Multicenter Study to Evaluate Continued Safety of FB-401 for up to 48 Weeks in Children, Adolescent and Adult Subjects (Ages 2 Years and Older) With Mild to Moderate Atopic Dermatitis Previously Enrolled in FB401-01 Phase 2 Study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 14
- 主要终点
- Number of adverse events
研究概览
简要总结
The purpose of this study is to evaluate the continued safety and tolerability of FB-401 in subjects 2 years of age or older with mild to moderate atopic dermatitis. FB-401 will be applied topically for up to 48 additional weeks and subjects will be evaluated for safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Participated in Protocol FB401-01, completed through Week 20 visit and able to directly enroll into this (FB401-02) study
- •Refrain from use of all other atopic dermatitis treatments, unless given permission by medical monitor
排除标准
- •Subject experienced a serious adverse event or severe adverse event attributable to study drug in Protocol FB401-01
- •Severe concomitant illness that, in the Investigator's opinion, would adversely affect subject participation in the study, whether medical or psychological
- •Pregnant (or planning to become pregnant during the period of the study) or lactating females
结局指标
主要结局
Number of adverse events
时间窗: 52 weeks
Safety evaluations
次要结局
未报告次要终点
研究者
研究点 (14)
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