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

EO Pharma A/S0 个研究点目标入组 780 人开始时间: 2017年7月10日最近更新: 2020年5月4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.
•Diagnosis of AD for =1 year.
•Subjects who have a recent history of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable.
•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 numeric rating scale (NRS) average score of =4
•during the week prior to baseline.
•Stable dose of emollient twice daily for at least 14 days before randomisation.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 740
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•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 and/or TCI within 2 weeks prior to randomisation.
•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