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Itepekimab SAR440340 · AERIFY-2

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

Ensayo de Sanofi en EPOC.

Más ensayos de: EPOC.

Fase

Fase 3

Estado

Completado

Participantes

1.239

previstos

Centros

297

Fin del objetivo primario

abr 2025

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en feb 2021.

Qué mide

Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) in former smokers (Baseline up to End Of Treatment (EOT) (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary 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

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04751487), actualizada en abr 2026.