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 294 人开始时间: 2018年6月29日最近更新: 2021年5月10日

研究概览

暂无简介。

•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

•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.

发起方

EO Pharma A/S