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A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Tralokinumab Monotherapy in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) Who Are Candidates for Systemic Therapy

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Trial Profile

A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Tralokinumab Monotherapy in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) Who Are Candidates for Systemic Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Jan 2024

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At a glance

  • Drugs Tralokinumab (Primary)
  • Indications Atopic dermatitis
  • Focus Registrational; Therapeutic Use
  • Acronyms ECZTRA 6
  • Sponsors LEO Pharma

    • Most Recent Events

    • 12 Jan 2024 According to a LEO Pharma media release, the company will present data at the upcoming Winter Clinical and Maui Derm conferences this month. The 2024 Winter Clinical Conference will take place Jan. 12-17 in Honolulu, Hawaii, while Maui Derm is being held from Jan. 22-26 in Maui, Hawaii.
    • 15 Dec 2023 According to LEO PHARMA media release, based on results from this trial, the U.S. Food and Drug Administration (FDA) has expanded the approval of Adbry (tralokinumab-ldrm) to include pediatric patients aged 12-17 years with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
    • 20 Oct 2023 According to a LEO Pharma media release, data from this study has been accepted for presentation at the 2023 Fall Clinical Dermatology Conference.

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