EUCTR2017-005143-33-PL进行中（未招募）1 期
A randomised, double-blind, placebo-controlled, parallel-group, multi-centre trial to evaluate the efficacy, safety, and tolerability of tralokinumab monotherapy in adolescent subjects with moderate-to-severe atopic dermatitis who are candidates for systemic therapy - ECZTRA 6 (ECZema TRAlokinumab trial no.6)
EO Pharma A/S0 个研究点目标入组 301 人开始时间: 2018年7月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 301
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age 12 to 17.
- •Diagnosis of atopic dermatitis (AD) as defined by the Hanifin and Rajka (1980) criteria for AD.
- •History of AD for =1 year.
- •History of topical corticosteroid (TCS; Europe: Class 3 or higher; US: Class 4 or lower) and/or topical calcineurin inhibitor (TCI) treatment failure or subjects for whom these topical AD treatments are medically inadvisable.
- •AD involvement of =10% body surface area at screening and baseline.
- •Stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 294
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Active dermatologic conditions that may confound the diagnosis of AD.
- •Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
- •Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to randomisation.
- •Treatment with TCS, TCI, or topical phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks prior to randomisation.
- •Receipt of any marketed biological therapy (i.e. immunoglobulin, anti-immunoglobulin E) including dupilumab or investigational biologic agents.
- •Active skin infection within 1 week prior to randomisation.
- •Clinically significant infection within 4 weeks prior to randomisation.
- •A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
- •Tuberculosis requiring treatment within the 12 months prior to screening.
- •Known primary immunodeficiency disorder.
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