A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Severe Steroid Dependent Asthma

Trial Profile

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Severe Steroid Dependent Asthma

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Apr 2018

At a glance

  • Drugs Dupilumab (Primary) ; Prednisolone; Prednisolone; Prednisone; Prednisone
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Acronyms LIBERTY ASTHMA VENTURE; VENTURE
  • Sponsors Sanofi
  • Most Recent Events

    • 03 Apr 2018 According to a Sanofi media release, data will be presented at the American Thoracic Society 2018 International Conference.
    • 02 Mar 2018 According to a Sanofi media release, detail results from the study will be present at the medical meetings later this year.
    • 02 Mar 2018 According to a Sanofi media release, based on the results of this study and other two studies (Liberty Asthma Quest (700255822) and 700229411), the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application for review of Dupixent 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 Oct 20, 2018.
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