NCT03930732

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: 939 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 40 Years – 80 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 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)

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: 2019-04-15
• Primary completion: 2023-02-08
• Completion: 2023-05-02
• First posted: 2019-04-29
• Last updated: 2024-02-28
• Results posted: 2024-02-28

Locations

275 sites across 24 countries: United States, Argentina, Bulgaria, Canada, Chile, China, Czechia, Denmark, Finland, Germany, Hungary, Israel, Italy, Japan, Mexico, Poland, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study