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

• Status: Recruiting
• Trial end date: 2023-05-22

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 and 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 anti-drug antibodies (ADA)

• Phase: Phase 3

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Cholinergic Agents; Muscarinic Agonists; Muscarinic Antagonists