At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Dupilumab SAR231893, Inhaled Corticosteroid, and 3 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 939 participants across 275 sites in 24 countries.
Detailed 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)
Study Details
Timeline
Interventions
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation
Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation
Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous