Klaus F. Rabe, Fernando J. Martinez, Surya P. Bhatt, Tomotaka Kawayama, B. Cosío, Robert M. Mroz, Maarten M. Boomsma, Helene Goulaouic, M. Nivens, Michel Djandji, Xavier Soler, Ying Liu, M. Kosloski, Christine R. Xu, Nikhil Amin, H. Staudinger, David J. Lederer, R. Abdulai
{"title":"AERIFY-1/-2: 2 phase 3 randomised controlled trials of itepekimab in former smokers with moderate-to-severe COPD","authors":"Klaus F. Rabe, Fernando J. Martinez, Surya P. Bhatt, Tomotaka Kawayama, B. Cosío, Robert M. Mroz, Maarten M. Boomsma, Helene Goulaouic, M. Nivens, Michel Djandji, Xavier Soler, Ying Liu, M. Kosloski, Christine R. Xu, Nikhil Amin, H. Staudinger, David J. Lederer, R. Abdulai","doi":"10.1183/23120541.00718-2023","DOIUrl":null,"url":null,"abstract":"Accumulating data implicate interleukin (IL)-33, a proinflammatory cytokine released locally upon epithelial cell damage, in the pathogenesis of chronic obstructive pulmonary disease (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.The study designs of AERIFY-1 and AERIFY-2 are described in this article.:The primary objective of AERIFY-1/2 (NCT04701983/NCT04751487), two phase 3 randomized, double-blind, placebo-controlled trials, is to assess the efficacy and safety of itepekimabversusplacebo 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 endpoint is the annualized rate of moderate or severe acute exacerbation of COPD. Secondary endpoints include change from baseline in pre- and post-bronchodilator FEV1, and annualized frequency of severe exacerbations. Symptomatic endpoints include Evaluating Respiratory Symptoms in COPD, and St. George's Respiratory Questionnaire, safety and anti-drug antibody responses.","PeriodicalId":11739,"journal":{"name":"ERJ Open Research","volume":null,"pages":null},"PeriodicalIF":4.3000,"publicationDate":"2024-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"ERJ Open Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1183/23120541.00718-2023","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"RESPIRATORY SYSTEM","Score":null,"Total":0}
引用次数: 0
Abstract
Accumulating data implicate interleukin (IL)-33, a proinflammatory cytokine released locally upon epithelial cell damage, in the pathogenesis of chronic obstructive pulmonary disease (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.The study designs of AERIFY-1 and AERIFY-2 are described in this article.:The primary objective of AERIFY-1/2 (NCT04701983/NCT04751487), two phase 3 randomized, double-blind, placebo-controlled trials, is to assess the efficacy and safety of itepekimabversusplacebo 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 endpoint is the annualized rate of moderate or severe acute exacerbation of COPD. Secondary endpoints include change from baseline in pre- and post-bronchodilator FEV1, and annualized frequency of severe exacerbations. Symptomatic endpoints include Evaluating Respiratory Symptoms in COPD, and St. George's Respiratory Questionnaire, safety and anti-drug antibody responses.
期刊介绍:
ERJ Open Research is a fully open access original research journal, published online by the European Respiratory Society. The journal aims to publish high-quality work in all fields of respiratory science and medicine, covering basic science, clinical translational science and clinical medicine. The journal was created to help fulfil the ERS objective to disseminate scientific and educational material to its members and to the medical community, but also to provide researchers with an affordable open access specialty journal in which to publish their work.