Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) (AERIFY-2)

• Status: Recruiting
• Trial end date: 2024-07-01

Summary

Primary Objective:

Primary population (former smokers cohort):

• 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

Secondary Objectives:

Primary population (former smokers cohort):

• Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD

• Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD

• Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD

• Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD

• Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD

• Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD

• Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD

• Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD

• Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD

• Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD

Secondary population (current smokers cohort)

• Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD

• Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD

• Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD

• Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD

• Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD

• Phase: Phase 3

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals