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Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of SAR440340/ REGN3500/ Itepekimab (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

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Trial Profile

Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of SAR440340/ REGN3500/ Itepekimab (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 14 May 2024

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At a glance

  • Drugs Itepekimab (Primary)
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Acronyms AERIFY-2
  • Sponsors Sanofi; Sanofi-Aventis Recherche & Developpement
  • Most Recent Events

    • 02 Feb 2024 According to a Regeneron Pharmaceuticals media release, the company plans to complete enrollment of Phase 3 studies of itepekimab (IL-33 antibody) in COPD in second half 2024.
    • 28 Jul 2023 According to a Sanofi media release, the Itepekimab, passed a recent interim futility analysis of the AERIFY pivotal trials program. The analysis was conducted by the independent data monitoring committee (IDMC) and Sanofi and Regeneron remain blinded to the data.
    • 05 Apr 2023 Planned primary completion date changed from 30 May 2024 to 30 May 2025.
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