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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

Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Aug 2023

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At a glance

  • Drugs Tralokinumab (Primary) ; Corticosteroids; Mometasone
  • Indications Atopic dermatitis
  • Focus Registrational; Therapeutic Use
  • Acronyms ECZTRA 3
  • Sponsors LEO Pharma
  • Most Recent Events

    • 23 Aug 2023 Results of pooled post hoc analysis from ECZTRA 1 and 2 and ECZTRA 3 assessing assess safety published in the JAMA Dermatology
    • 27 Apr 2023 According to a LEO Pharma media release, Danish Medicines Council (DMC) 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.
    • 23 Dec 2022 According to a LEO Pharma media release, the Japan Ministry of Health, Labor and Welfare (MHLW) has granted approval for the manufacturing and marketing of Adtralza (tralokinumab) subcutaneous injection (S.C.) for adults with atopic dermatitis, which has inadequately responded to conventional therapies. The approval is based on results from the global pivotal trials ECZTRA 1, 2, 3, 8 and ECZTEND.
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