NCT04456673

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

A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) With Type 2 Inflammation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 935 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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)

Detailed description

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

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Dupilumab SAR231893	Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
DRUG	Inhaled Corticosteroid	Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation
DRUG	Inhaled Long-Acting Beta Agonist	Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation
DRUG	Inhaled Long-Acting Muscarinic Antagonist	Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation
DRUG	Placebo	Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Timeline

• Start date: 2020-07-06
• Primary completion: 2024-02-28
• Completion: 2024-05-27
• First posted: 2020-07-02
• Last updated: 2025-05-29
• Results posted: 2025-03-17

Locations

334 sites across 29 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czechia, France, Germany, Greece, Hungary, Latvia, Lithuania, Mexico, Netherlands, Peru, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study