AERIFY-1/2: two phase 3, randomised, controlled trials of itepekimab in former smokers with moderate-to-severe COPD
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...
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| Format: | Article |
| Language: | English |
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European Respiratory Society
2024-09-01
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| Series: | ERJ Open Research |
| Online Access: | http://openres.ersjournals.com/content/10/5/00718-2023.full |
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| author | Klaus F. Rabe Fernando J. Martinez Surya P. Bhatt Tomotaka Kawayama Borja G. Cosio Robert M. Mroz Maarten M. Boomsma Helene Goulaouic Michael C. Nivens Michel Djandji Xavier Soler Ying Liu Matthew P. Kosloski Christine R. Xu Nikhil Amin Heribert Staudinger David J. Lederer Raolat M. Abdulai |
| author_facet | Klaus F. Rabe Fernando J. Martinez Surya P. Bhatt Tomotaka Kawayama Borja G. Cosio Robert M. Mroz Maarten M. Boomsma Helene Goulaouic Michael C. Nivens Michel Djandji Xavier Soler Ying Liu Matthew P. Kosloski Christine R. Xu Nikhil Amin Heribert Staudinger David J. Lederer Raolat M. Abdulai |
| author_sort | Klaus F. Rabe |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-3bd4edef6ab44bf1a5e1e7bec238bd0c |
| institution | OA Journals |
| issn | 2312-0541 |
| language | English |
| publishDate | 2024-09-01 |
| publisher | European Respiratory Society |
| record_format | Article |
| series | ERJ Open Research |
| spelling | doaj-art-3bd4edef6ab44bf1a5e1e7bec238bd0c2025-08-20T02:14:11ZengEuropean Respiratory SocietyERJ Open Research2312-05412024-09-0110510.1183/23120541.00718-202300718-2023AERIFY-1/2: two phase 3, randomised, controlled trials of itepekimab in former smokers with moderate-to-severe COPDKlaus F. Rabe0Fernando J. Martinez1Surya P. Bhatt2Tomotaka Kawayama3Borja G. Cosio4Robert M. Mroz5Maarten M. Boomsma6Helene Goulaouic7Michael C. Nivens8Michel Djandji9Xavier Soler10Ying Liu11Matthew P. Kosloski12Christine R. Xu13Nikhil Amin14Heribert Staudinger15David J. Lederer16Raolat M. Abdulai17 LungenClinic Grosshansdorf, Airway Research Center North, Grosshansdorf, Germany Weill Cornell Medical College, New York, NY, USA University of Alabama at Birmingham, Birmingham, AL, USA Kurume University School of Medicine, Fukuoka, Japan Hospital Universitario Son Espases-IdISBa-CIBERES, Palma de Mallorca, Spain Medical University of Bialystok, Bialystok, Poland Sanofi, Amsterdam, Netherlands Sanofi, Chilly-Mazarin, France Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA Sanofi, Cambridge, MA, USA Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA Sanofi, Bridgewater, NJ, USA Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA Sanofi, Bridgewater, NJ, USA Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA Sanofi, Bridgewater, NJ, USA Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA Former Sanofi employee 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.http://openres.ersjournals.com/content/10/5/00718-2023.full |
| spellingShingle | Klaus F. Rabe Fernando J. Martinez Surya P. Bhatt Tomotaka Kawayama Borja G. Cosio Robert M. Mroz Maarten M. Boomsma Helene Goulaouic Michael C. Nivens Michel Djandji Xavier Soler Ying Liu Matthew P. Kosloski Christine R. Xu Nikhil Amin Heribert Staudinger David J. Lederer Raolat M. Abdulai AERIFY-1/2: two phase 3, randomised, controlled trials of itepekimab in former smokers with moderate-to-severe COPD ERJ Open Research |
| title | AERIFY-1/2: two phase 3, randomised, controlled trials of itepekimab in former smokers with moderate-to-severe COPD |
| title_full | AERIFY-1/2: two phase 3, randomised, controlled trials of itepekimab in former smokers with moderate-to-severe COPD |
| title_fullStr | AERIFY-1/2: two phase 3, randomised, controlled trials of itepekimab in former smokers with moderate-to-severe COPD |
| title_full_unstemmed | AERIFY-1/2: two phase 3, randomised, controlled trials of itepekimab in former smokers with moderate-to-severe COPD |
| title_short | AERIFY-1/2: two phase 3, randomised, controlled trials of itepekimab in former smokers with moderate-to-severe COPD |
| title_sort | aerify 1 2 two phase 3 randomised controlled trials of itepekimab in former smokers with moderate to severe copd |
| url | http://openres.ersjournals.com/content/10/5/00718-2023.full |
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