A randomised, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroids in subjects with moderate-to-severe atopic dermatitis who are candidates for systemic therapy - ECZTRA 3

TFS Trial Form Support BV0 个研究点目标入组 43 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•* Age 18 and above.
•* Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
•* History of AD for *1 year.
•* Subjects who have a recent history of inadequate response to treatment with topical medications.
•* AD involvement of *10% body surface area at screening and baseline.
•* An EASI score of *12 at screening and 16 at baseline.
•* An IGA score of *3 at screening and at baseline.
•* A Worst Daily Pruritus NRS average score of *4 during the week prior to baseline.
•* Stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.

•* Subjects for whom TCSs are medically inadvisable e.g., due to important side effects or safety risks in the opinion of the investigator.
•* 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

TFS Trial Form Support BV