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

Brief 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.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 924 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: April 15, 2019
Estimated Primary Completion Date: January 2022
Estimated Study Completion Date: April 2022

Arms:
- Experimental: Dupilumab
- Placebo Comparator: Placebo