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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: 24 Apr 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

    • 06 Apr 2024 This trial has been completed in Portugal, according to European Clinical Trials Database record.
    • 21 Mar 2024 Planned End Date changed from 1 Aug 2024 to 22 May 2024.
    • 23 Feb 2024 According to a Sanofi media release, based on positive results from two phase 3 clinical studies (BOREAS and NOTUS) U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) in a sixth potential indication as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The target action date for the FDA decision is June 27, 2024.
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