NCT00676884已完成2 期
A Phase 2a Study to Investigate the Effects of Repeated Administration of AeroDerm in Subjects With Atopic Eczema
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Eczema Area and Severity index (EASI) score
研究概览
简要总结
The primary objective of this study is to investigate the effect of AERODERM (also known as pitrakinra, AER 001, BAY 16-9996) on Eczema Area and Severity Index (EASI) score in subjects with moderate to severe atopic eczema
详细描述
The primary objective of this study is to investigate the effect of AERODERM (also known as pitrakinra, AER 001, BAY 16-9996) on Eczema Area and Severity Index (EASI) score in subjects with moderate to severe atopic eczema in a randomised, placebo controlled, parallel-group study with bid sc. dosing of AERODERM for 28 days
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males and females > 18 years.
- •Subjects who currently have allergic eczema with an EASI score in the range of 10-
- •Subjects who have been on a stable dose of topical medications for eczema for ≥ 1 month from screening but whose eczema is not adequately responsive to, or controlled by, conventional topical treatments (eg: topical steroids, Tracrolimus, Pimecrolimus).
- •Subjects who have not had systemic immunosuppressive therapy (eg systemic steroids) within 1 month of screening.
- •Subjects who if female, are not currently pregnant or breast feeding and are using medically acceptable methods of contraception.
- •Subjects who have a pre-study medical history, physical examination and vital signs acceptable to the investigator.
- •Subjects who have clinical laboratory tests within the reference ranges or clinically acceptable to the investigator.
- •Subjects who are negative for HbsAg, hepatitis C antibody and HIV II and I test at screening.
- •Subjects who are negative for drugs of abuse tests at screening and admission.
- •Subjects with stable, adequately treated medical conditions other than eczema may be enrolled provided the Investigator does not consider their study participation to place them at increased risk of adverse events. Subjects should continue their concomitant treatments for medical conditions (other than eczema).
- •Subjects who are able and willing to give written informed consent.
排除标准
- •Subjects who do not conform to the above inclusion criteria.
- •Subjects who have the following medical conditions: Diabetes mellitus, Thyroiditis, Rheumatiod arthritis, Multiple sclerosis, Uveitis, Sarcoidosis, Glomerulonephritis, Helminthic infection.
- •Subjects who have a history of relevant drug hypersensitivity.
- •Subjects who have a history of alcoholism.
- •Subjects who have a history of drug abuse.
- •Subjects who have a significant infection at the time of screening and/or admission.
- •Subjects who are having acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn), may be asked to reschedule their screening and/or admission to when they are not longer having acute symptoms.
- •Subjects who have an acute infection such as influenza at the time of screening and/or admission.
- •Female subjects who are not using an acceptable method of contraception.
- •Subjects who have used any investigational drug and /or participated in any clinical trial within 3 months of their first dosing.
- •Subjects who have previously received AeroDerm.
- •Subjects using medication, which in the opinion of the Investigator will affect the outcome of the study.
- •Subjects who have donated and/or received any blood or blood products within the previous 3 months prior to first dosing (to review on a case by case basis).
- •Subjects who cannot communicate reliably with the investigator.
- •Subjects who are unlikely to co-operate with the requirements of the study.
研究组 & 干预措施
1
Experimental
Aeroderm (also known as pitrakinra, AER 001, BAY 16-9996)
干预措施: Aeroderm (also known as pitrakinra, AER 001, BAY 16-9996) (Drug)
2
Placebo Comparator
placebo control
干预措施: placebo (Drug)
结局指标
主要结局
Eczema Area and Severity index (EASI) score
时间窗: weekly for 28 days of treatment
次要结局
- total IgE(after 28 days of treatment)
- Investigator Global Assessment (IGA)(daily for 28 days of treatment)
- levels of Tcell subsets(after 28 days of treatment)
研究者
研究点 (1)
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