Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation

About the trial

Sponsor

Sanofi (with Regeneron Pharmaceuticals)

Tested

Dupilumab SAR231893 (drug), Inhaled Corticosteroid (drug), Inhaled Long-Acting Beta Agonist (drug), Inhaled Long-Acting Muscarinic Antagonist (drug), Placebo (drug)

Dates

Started 2020-07-06; completion 2024-05-27

Results posted

Yes

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 exacerb…

From ClinicalTrials.gov, last updated 2025-05-29. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Sanofi US Services Inc. reported $237,496 in research payments for this study in 2025 (62 payments).

Products named: Dupixent

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.