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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 Japanese Subjects With Moderate-to-severe Atopic Dermatitis Who Are Candidates for Systemic Therapy

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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 Japanese Subjects With Moderate-to-severe Atopic Dermatitis Who Are Candidates for Systemic Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Dec 2022

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At a glance

  • Drugs Tralokinumab (Primary) ; Corticosteroids
  • Indications Atopic dermatitis
  • Focus Registrational; Therapeutic Use
  • Acronyms ECZTRA 8
  • Sponsors LEO Pharma
  • Most Recent Events

    • 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.
    • 08 Sep 2021 Status changed from active, no longer recruiting to completed.
    • 25 Mar 2021 Planned End Date changed from 1 Sep 2021 to 1 Aug 2021.
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