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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 43

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Investigator*s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear)<br /><br>at Week 16.<br /><br>At least 75% reduction in Eczema Area and Severity Index (EASI) score from<br /><br>baseline (EASI75) at Week 16.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Change in Scoring Atopic Dermatitis (SCORAD) from baseline to Week 16.<br /><br>* Reduction of Worst Daily Pruritus numeric rating scale (NRS) (weekly average)<br /><br>of at least 4 from baseline to Week 16.<br /><br>Change in Dermatology Life Quality Index (DLQI) from baseline to Week 16.</p><br>