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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: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Jul 2024

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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 NOTUS
  • Sponsors Sanofi; Sanofi-Aventis Recherche & Developpement
  • Most Recent Events

    • 17 Jul 2024 This trial has been discontinued in Czechia, according to European Clinical Trials Database record.Czechia
    • 03 Jul 2024 According to a Regeneron Pharmaceuticals media release, based on results from the landmark Phase 3 BOREAS and NOTUS trials the European Commission (EC) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils.
    • 31 May 2024 According to a Regeneron Pharmaceuticals media release, The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Dupixent (dupilumab) in the European Union (EU) as an add-on maintenance treatment in adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. The EC is expected to announce a final decision on the Dupixent application in the coming months.
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