Efficacy and Safety of Tralokinumab in Adolescents With Moderate to Severe Atopic Dermatitis: The Phase 3 ECZTRA 6 Randomized Clinical Trial.

ABSTRACT:

Importance

Safe and effective long-term treatments for adolescents with moderate to severe atopic dermatitis (AD) are limited.

Objective

To evaluate the efficacy and safety of interleukin-13-targeted treatment with tralokinumab monotherapy in adolescents with AD.

Design, setting, and participants

The 52-week, randomized, double-blinded, placebo-controlled, phase 3 ECZTRA 6 trial was conducted from July 17, 2018, through March 16, 2021, at 72 centers across 10 countries in North America, Europe, Asia, and Australia. Enrolled patients were 12 to 17 years old with moderate to severe AD (Investigator's Global Assessment [IGA] score ≥3; Eczema Area and Severity Index [EASI] ≥16).

Interventions

Patients were randomized (1:1:1) to tralokinumab (150 or 300 mg) or place

SUBMITTER: Paller AS 

PROVIDER: S-EPMC10116386 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature