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A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre, Phase 3 Trial Investigating the Efficacy, Safety, and Tolerability of Tralokinumab Administered in Combination With Topical Corticosteroids to Adult Subjects With Severe Atopic Dermatitis

Trial Profile

A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre, Phase 3 Trial Investigating the Efficacy, Safety, and Tolerability of Tralokinumab Administered in Combination With Topical Corticosteroids to Adult Subjects With Severe Atopic Dermatitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 May 2023

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At a glance

  • Drugs Tralokinumab (Primary) ; Corticosteroids
  • Indications Atopic dermatitis
  • Focus Registrational; Therapeutic Use
  • Acronyms ECZTRA 7
  • Sponsors LEO Pharma
  • Most Recent Events

    • 27 Apr 2023 According to a LEO Pharma media release, Danish Medicines Council (DMC) today has published a new treatment guideline for atopic dermatitis. DMC recommends Adtralza (tralokinumab) as a first-line treatment option for moderate-to-severe AD patients aged 12 years and older with inefficient effect from conventional systemic treatments. This assessment of Adtralza is based on data from the pivotal phase 3 trials ECZTRA 1, 2, 3, ECZTRA 6 (adolescent trial) and ECZTRA 7 trial.
    • 26 Oct 2021 Primary endpoint (At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 16) has been met, according to Results published in the British Journal of Dermatology.
    • 26 Oct 2021 Results published in the British Journal of Dermatology
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