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 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

• Rabe, K. F.
• Martinez, F. J.
• Bhatt, S. P.
• Kawayama, T.
• Cosio, B. G.
• Mroz, R. M.
• Boomsma, M. M.
• Goulaouic, H.
• Nivens, M. C.
• Djandji, M.
• Soler, X.
• Liu, Y.
• Kosloski, M. P.
• Xu, C. R.
• Amin, N.
• Staudinger, H.
• Lederer, D. J.
• Abdulai, R. M.