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Study identifier: NCT04751487 Synced from ClinicalTrials.gov · August 06, 2026
● Study status: Completed

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

Condition: Chronic Obstructive Pulmonary Disease  ·  Sponsor: Sanofi

PhasePhase 3
Planned participants1239
Who can joinAll sexes, 40 Years to 85 Years
Healthy volunteersNo

About this study

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)…

This description comes directly from the study's public registry record.

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Locations (297)

Synexus Phoenix Central (Central Phoenix Medical Clinic)- Site Number : 8400333Phoenix, Arizona, United States
UCSF Fresno - Site Number : 8400030Fresno, California, United States
Palmtree Clinical Research Site Number : 8400184Palm Springs, California, United States
Allianz Research Institute Colorado Site Number : 8400061Denver, Colorado, United States
Helix Biomedics, LLC - Site Number : 8400049Boynton Beach, Florida, United States
Innovative Research of West Florida, Inc- Site Number : 8400041Clearwater, Florida, United States
Beautiful Minds Clinical Research Center Site Number : 8400352Cutler Bay, Florida, United States
Omega Research - Site Number : 8400031DeBary, Florida, United States
Sciences Connections, LLC Site Number : 8400045Doral, Florida, United States
North Florida/South Georgia Veterans Health System Site Number : 8400176Gainesville, Florida, United States
Finlay Medical Research- Site Number : 8400011Greenacres City, Florida, United States
Direct Helpers Medical Center Inc- Site Number : 8400065Hialeah, Florida, United States

+ 285 more locations — full list on the registry record.

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