An Open-Labeled Exploratory Study to Evaluate Safety and Efficacy of FB825 in Adults With Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- % Change From Baseline in Total IgE
研究概览
简要总结
The purpose of this study is to evaluate the Safety and Efficacy of FB825 in Adults with Atopic Dermatitis
详细描述
This is an open-labeled exploratory study to evaluate safety and efficacy of FB825 in adults with atopic dermatitis (AD). The study will be conduct at one medical center in Taiwan.
Approximately 12 subjects with atopic dermatitis (AD), who meet the criteria for study entry, will be enrolled to the one-arm-study.
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
- 20 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 subjects between 20 and 65 years of age, inclusive.
- •The subject has a physician-confirmed diagnosis of chronic atopic dermatitis based on 3 years history of symptoms defined by the Eichenfield revised criteria of Hannifin and Rajka and supported by positive allergen-specific IgE at the screening visit.
- •Eczema Area and Severity Index (EASI) score ≧14 at the screening and baseline visits.
- •Investigator's Global Assessment (IGA) score ≧ 3 (5-point scale) at the screening and baseline visits.
- •≧10 % body surface area (BSA) of AD involvement at the screening and baseline visits.
排除标准
- •Female subjects who are pregnant or lactating.
- •The subject is on diet or with poor intake.
- •The subject has a history of heart arrhythmias (any clinically relevant).
- •The subject has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 and 2 antibodies at screening.
- •The subject has a history of alcohol or drug abuse that would impair or risk the patients' full participation in the study, in the opinion of the investigator.
研究组 & 干预措施
FB825
Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.
干预措施: FB825, FB825-15D11, Anti-CemX (Drug)
结局指标
主要结局
% Change From Baseline in Total IgE
时间窗: Day 169
Detect total IgE in serum by ImmunoCAP.
% Change From Baseline in Allergen-specific IgE
时间窗: Day 169
Detect specific IgE in serum by ImmunoCAP. (ex. Ragweed)
次要结局
- % Changes From Baseline in Investigator Global Assessment (IGA) for Atopic Dermatitis(Days 169)
- % Changes From Baseline in Eczema Area and Severity Index (EASI)(Day 169)
- % Changes From Baseline in Severity Scoring of Atopic Dermatitis Index (SCORAD)(Days 169)
- Change From Baseline in Total IgE(Day 8, 15, 29, 57, and day 85 (And Day 92, 99, 113, 141 and 169 if received the second dose of FB825))
- % Change From Baseline in Allergen-specific IgE(Day 8, 15, 29, 57, and day 85 (And Day 92, 99, 113, 141 and 169 if received the second dose of FB825))
- % Changes From Baseline in Body Surface Area (BSA) Involved in Atopic Dermatitis(Days 169)
- Safety Will be Assessed by Monitoring and Recording of Adverse Events (AEs) and Serious Adverse Event (SAEs)(through study completion, an average of 1 year.)
- % Changes From Baseline in Irritability Visual Analogue Scale (VAS)(Days 85)