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A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Nov 2024

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At a glance

  • Drugs Dupilumab (Primary)
  • Indications Eosinophilic oesophagitis
  • Focus Registrational; Therapeutic Use
  • Acronyms EoE KIDS
  • Sponsors Regeneron Pharmaceuticals

Most Recent Events

  • 06 Nov 2024 According to a Sanofi media release, the EMA approval expands the initial approval in the European Union (EU) for EoE in adults and adolescents and makes Dupixent the first and only medicine indicated to treat these young patients.
  • 06 Nov 2024 According to a Sanofi media release, based on results from this trial the company has received European Medicines Agency approval for Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as one year of age. Specifically, the approval covers children aged one to 11 years who weigh at least 15 kg and who are inadequately controlled by, intolerant to, or who are not candidates for conventional medicinal therapy.
  • 20 Sep 2024 According to a Regeneron Pharmaceuticals , company announced that the European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the expanded approval of Dupixent (dupilumab) in the European Union (EU) for eosinophilic esophagitis (EoE) in children down to 1 year of age on basis of this trial.

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