A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

Completed
Phase of Trial: Phase II

Latest Information Update: 03 Apr 2018

At a glance

  • Drugs Dupilumab (Primary)
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Sponsors Sanofi
  • Most Recent Events

    • 03 Apr 2018 According to a Sanofi media release, based on the results of this study and other two studies (Liberty Asthma VENTURE (700260017) and 700229411),European Medicines Agency (EMA) has accepted for review an application for DUPIXENT (dupilumab) as an add-on maintenance treatment in certain adults and adolescents (12 years of age and older) with inadequately controlled moderate-to-severe asthma.
    • 05 Mar 2018 Results of post hoc analysis examines the placebo cohort assessing relationship between severe asthma exacerbation rates and type 2-related biomarkers,were presented at the 2018 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.
    • 02 Mar 2018 According to a Sanofi media release, based on the results of this study and other two studies (Liberty Asthma QUEST and Liberty Asthma VENTURE), the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application for review of Dupixent (dupilumab) as an add-on maintenance treatment in certain adults and adolescents (12 years of age and older) with moderate-to-severe asthma. Per the Prescription Drug User Fee Act, the target action date is October 20, 2018.
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