An open-label, single-arm, multi-centre, long-term extension trial to evaluate the safety and efficacy of tralokinumab in subjects with atopic dermatitis who participated in previous tralokinumab clinical trials - ECZTEND

EO PHARMA A/S0 个研究点目标入组 1,500 人开始时间: 2021年1月21日最近更新: 2021年4月5日

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: 1,500

研究概览入排标准研究者记录与标识符相似试验

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

•-Completed the treatment period(s) of one of the parent trials: LP0162-1325, -1326, -1334, -1339, -1341 or -1342.
•-Complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator.
•-Able and willing to self-administer tralokinumab treatment (or have it administered by a caregiver) at home after the initial 3 injection visits at the trial site (in this trial).
•-Stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline.
•Are the trial subjects under 18? yes
•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 1235
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

排除标准

•-Any condition that required permanent discontinuation of trial treatment in the parent trial.
•-More than 26 weeks have elapsed since the subject received the last injection of investigational medicinal product (IMP) in the parent trial
•(to be assessed at baseline).
•-Subjects who, during their participation in the parent trial, developed a serious adverse event (SAE) deemed related to tralokinumab by the
•investigator, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable
•safety risk for the subject.
•-Subjects who, during their participation in the parent trial, developed an AE that was deemed related to tralokinumab by the investigator and
•led to temporary discontinuation of trial treatment, which in the opinion of the investigator could indicate that continued treatment with
•tralokinumab may present an unreasonable safety risk for the subject.
•-Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to baseline.
•-Treatment with topical phosphodiesterase 4 inhibitors within 2 weeks prior to baseline.
•-Receipt of any marketed biological therapy (that is, immunoglobulin or anti-immunoglobulin E) including dupilumab or investigational
•biologic agents:
•o Any cell-depleting agents, including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer.
•o Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to baseline.
•-Clinically significant infection within 4 weeks prior to baseline.
•-A helminth parasitic infection within 6 months prior to the date when informed consent is obtained.
•-Tuberculosis requiring treatment within 12 months prior to screening.
•- Known primary immunodeficiency disorder.

研究者

发起方

EO PHARMA A/S

相似试验

进行中（未招募）

1 期

ong-term extension trial in subjects with atopic dermatitis who participated in previous tralokinumab trials – ECZTENDMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Atopic Dermatitis

EUCTR2018-000746-19-PLEO Pharma A/S1,600

进行中（未招募）

1 期

ong-term extension trial in subjects with atopic dermatitis who participated in previous tralokinumab trials – ECZTENDMedDRA version: 20.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Atopic Dermatitis

EUCTR2018-000746-19-ESEO Pharma A/S1,125

进行中（未招募）

1 期

EUCTR2018-000746-19-CZEO Pharma A/S1,600

进行中（未招募）

1 期

ong-term extension trial in subjects with atopic dermatitis who participated in previous tralokinumab trials – ECZTENDAtopic Dermatitis

EUCTR2018-000746-19-GBEO Pharma A/S1,600

进行中（未招募）

1 期

EUCTR2018-000746-19-BEEO Pharma A/S1,600