AERIFY-1/2: two phase 3, randomised, controlled trials of itepekimab in former smokers with moderate-to-severe COPD. Academic Article uri icon

Overview

abstract

  • BACKGROUND: Accumulating data implicate interleukin (IL)-33, a proinflammatory cytokine released locally upon epithelial cell damage, in the pathogenesis of COPD. In a phase 2 study, itepekimab, a human monoclonal antibody against IL-33, reduced exacerbations and improved lung function in a subgroup analysis of former smokers with COPD with an acceptable safety profile. METHODS: The study designs of AERIFY-1 and AERIFY-2 are described in this article. DISCUSSION: The primary objective of AERIFY-1/2 (NCT04701983/NCT04751487), two phase 3 randomised, double-blind, placebo-controlled trials, is to assess the efficacy and safety of itepekimab versus placebo in a population of former smokers with moderate-to-severe COPD over up to 52 weeks. An additional secondary population of current smokers are being enrolled in AERIFY-2. These two studies will enrol patients (aged 40-85 years) with COPD and chronic bronchitis who had ≥2 moderate or ≥ 1 severe exacerbations within the previous year despite standard-of-care triple or double background therapy. All participants are required to have ≥10-pack-year smoking history, and ≥6 months since smoking cessation for former smokers. The primary end-point is the annualised rate of moderate or severe acute exacerbation of COPD. Secondary end-points include change from baseline in pre- and post-bronchodilator forced expiratory volume in 1 s, and annualised frequency of severe exacerbations. Symptomatic end-points include Evaluating Respiratory Symptoms in COPD and St. George's Respiratory Questionnaire, safety and anti-drug antibody responses.

authors

  • Rabe, Klaus F
  • Martinez, Fernando J
  • Bhatt, Surya P
  • Kawayama, Tomotaka
  • Cosio, Borja G
  • Mroz, Robert M
  • Boomsma, Maarten M
  • Goulaouic, Helene
  • Nivens, Michael C
  • Djandji, Michel
  • Soler, Xavier
  • Liu, Ying
  • Kosloski, Matthew P
  • Xu, Christine R
  • Amin, Nikhil
  • Staudinger, Heribert
  • Lederer, David J
  • Abdulai, Raolat M

publication date

  • September 23, 2024

Identity

PubMed Central ID

  • PMC11417606

Scopus Document Identifier

  • 85205505523

Digital Object Identifier (DOI)

  • 10.1183/23120541.00718-2023

PubMed ID

  • 39319046

Additional Document Info

volume

  • 10

issue

  • 5