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A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Dupilumab Monotherapy in Patients ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis

Trial Profile

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Dupilumab Monotherapy in Patients ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis

Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2018

At a glance

  • Drugs Dupilumab (Primary)
  • Indications Atopic dermatitis
  • Focus Registrational; Therapeutic Use
  • Sponsors Regeneron Pharmaceuticals
  • Most Recent Events

    • 06 Nov 2018 According to a U.S. Food and Drug Administration media release, the FDA has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) in adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis. The target action date for the FDA decision is March 11, 2019. The sBLA is supported by data from this study.
    • 15 Sep 2018 Detailed results from the study, presented in a Sanofi media release.
    • 14 Sep 2018 According to a Sanofi media release, data from this trial were presented at the 27th European Academy of Dermatology and Venereology (EADV) Congress
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