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Clinical Trial Summary

Primary Objective: To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by - Annualized rate of acute moderate or severe COPD exacerbation (AECOPD) Secondary Objectives: To evaluate the effect of dupilumab administered every 2 weeks on - Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo - Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ) - Pre-bronchodilator FEV1 over 52 weeks compared to placebo - Lung function assessments - Moderate and severe COPD exacerbations - To evaluate safety and tolerability - To evaluate dupilumab systemic exposure and incidence of antidrug antibodies (ADA)


Clinical Trial Description

Approximately 68 weeks including a 4-week screening period, a 52-week treatment period, and 12 weeks of follow-up ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04456673
Study type Interventional
Source Sanofi
Contact
Status Active, not recruiting
Phase Phase 3
Start date July 6, 2020
Completion date May 22, 2024

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