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A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients with Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) with Type 2 inflammation

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Trial Profile

A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients with Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) with Type 2 inflammation

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 May 2025

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At a glance

  • Drugs Dupilumab (Primary) ; Beta adrenergic receptor agonists; Corticosteroid; Muscarinic receptor antagonists
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Acronyms BOREAS
  • Sponsors Sanofi

Most Recent Events

  • 01 May 2025 According to a Regeneron Pharmaceuticals media release, new results from this pivotal study will be presented at the American Thoracic Society (ATS) International Conference 2025 being held from May 18 to 21 in San Francisco, California.
  • 31 Mar 2025 According to a Regeneron Pharmaceuticals media release, Ministry of Health, Labour and Welfare in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy based on data of this trial.
  • 27 Sep 2024 According to a Regeneron Pharmaceuticals media release, additional submissions for Dupixent in COPD are under review with regulatory authorities around the world, including Japan.

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