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

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1500

Inclusion Criteria

-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

Exclusion Criteria

-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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety of tralokinumab;Secondary Objective: To evaluate the efficacy of tralokinumab given as continuous treatment, re-treatment, or introduced for the first time in tralokinumab naïve subjects;Primary end point(s): Number of adverse events (AEs) from baseline through the last treatment visit (up to Week 142)<br>;Timepoint(s) of evaluation of this end point: Week 142

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) IGA score of 0 (clear) or 1 (almost clear) at Weeks 16, 56, 80, 104, 128 and 142.<br>2) EASI75 at Weeks 16, 56, 80, 104, and 128;Timepoint(s) of evaluation of this end point: 1) Weeks 16, 56, 80, 104, and 128.<br>2) Weeks 16, 56, 80, 104, and 128.<br>

Updated 5/23/2022

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

Recruitment & Eligibility

Study & Design

Related Trials