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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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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: 18 Oct 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

    • 15 Oct 2024 Status changed from active, no longer recruiting to completed.
    • 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 in the U.S. and Japan.
    • 27 Sep 2024 According to a Regeneron Pharmaceuticals media release, the approval by NMPA China covers patients already on a combination of an inhaled corticosteroid (ICS), a LABA and a LAMA, or on a combination of a LABA and a LAMA if ICS is not appropriate.

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