Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/​REGN3500/​Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) (AERIFY-1)

STUDY OVERVIEW

This multicenter, randomized, double-blind, placebo-controlled study sponsored by Sanofi aims to evaluate the efficacy of itepekimab compared with placebo in reducing the annualized rate of acute moderate-to-severe COPD exacerbations in former smokers with moderate-to-severe COPD, alongside assessing secondary outcomes including pulmonary function, respiratory symptoms, and health-related quality of life, while also evaluating safety, pharmacokinetics, and immunogenicity.

STUDY GOALS

Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in former smokers with moderate-to-severe COPD, while assessing secondary endpoints including pulmonary function, exacerbation occurrence, corticosteroid-treated exacerbations, respiratory symptoms, FEV1 slope, health-related quality of life, safety, tolerability, pharmacokinetics, and immunogenicity across a study duration involving screening (3-5 weeks), a placebo-controlled treatment period (52 weeks for initial participants and 24 to 52 weeks for subsequent enrollees), and a post-treatment follow-up period (20 weeks).

LOCATION

El Paso, Texas: Texas Tech University Center at El Paso

INCLUSION CRITERIA

  • Age 40 to 85 years.

  • Physician-diagnosed COPD for at least 1 year per GOLD criteria.

  • History of ≥10 pack-years of smoking, ceased for ≥6 months with intent to quit permanently.

  • Moderate-to-severe COPD.

  • Participant-reported chronic bronchitis symptoms.

  • History of high exacerbation risk (≥2 moderate or ≥1 severe exacerbations in the previous year, treated with systemic corticosteroids).

  • Stable controller therapy (ICS + LABA, LAMA + LABA, or LAMA + LABA + ICS) for ≥3 months.

  • BMI ≥18.0 kg/m² (≥16.0 kg/m² for East-Asian countries).

  • Non-pregnant, non-breastfeeding female participants must follow contraception guidance.

exclusion criteria

  • Current asthma diagnosis or history of asthma after age 18.

  • Active smoking or vaping within the past 6 months.

  • Clinically significant ECG abnormalities within 6 months.

  • Other clinically significant pulmonary diseases.

  • Cor pulmonale, severe pulmonary hypertension, or hypercapnia requiring BiPAP.

  • Moderate or severe COPD exacerbation within 4 weeks.

  • History or planned lung surgeries affecting COPD.

  • Unstable ischemic heart disease or significant cardiac arrhythmias.

  • Uncontrolled hypertension.

  • Active or latent TB, recent BCG vaccination.

  • HIV infection.

  • Suspected or confirmed COVID-19 infection or recent exposure.

  • Recent or ongoing systemic infections.

  • Active autoimmune disease or immunosuppressive therapy.

  • History of malignancy within 5 years, except specified cases.

  • Previous use of itepekimab.

For more information, visit ClinicalTrials.gov.