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

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)

Timeline

Start

2019-04-15

Primary completion

2023-02-08

Completion

2023-05-02

Publications

• Bhatt SP, Rabe KF, Hanania NA, Vogelmeier CF, Bafadhel M, Christenson SA, Papi A, Singh D, Walsh L, Winders T, Bansal A, Robinson LB. Summary of Research: Dupilumab for Chronic Obstructive Pulmonary Disease with Type 2 Inflammation: A Pooled Analysis of Two Phase 3, Randomised, Double-Blind, Placebo-Controlled Trials. Pulm Ther. 2026 Jun 23. doi: 10.1007/s41030-026-00361-2. Online ahead of print.
• Ramakrishnan S, Petousi N, Bon J, Pavord ID, Bhatt SP, Rabe KF, Deng W, Xia C, Heble J, Soliman M, Couillard S. Win Ratio Analysis to Clarify Clinical Benefits: A Post Hoc Analysis of Phase 3 BOREAS and NOTUS (Two Pivotal Studies to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients With Moderate-to-Severe COPD With Type 2 Inflammation). Chest. 2026 Jul;170(1):76-87. doi: 10.1016/j.chest.2026.02.005. Epub 2026 Mar 5.
• Christenson SA, Hanania NA, Bhatt SP, Bafadhel M, Rabe KF, Vogelmeier CF, Papi A, Singh D, Laws E, Dakin P, Bansal A, Lu X, Bauer D, Maloney J, Robinson LB, Abdulai RM. Type 2 inflammation biomarkers and their association with response to dupilumab in COPD (BOREAS): an analysis of a randomised, placebo-controlled, phase 3 trial. Lancet Respir Med. 2025 Aug;13(8):687-697. doi: 10.1016/S2213-2600(25)00044-X. Epub 2025 Jul 9.
• Vogelmeier CF, Rabe KF, Bhatt SP, Hanania NA, Bafadhel M, Christenson SA, Papi A, Singh D, Laws E, Maloney J, Dakin P, Lu X, Bauer D, Bansal A, Robinson LB, Abdulai RM. Dupilumab reduces acute exacerbations and improves lung function in patients with COPD with type 2 inflammation irrespective of body mass index, airflow obstruction, dyspnea, and exercise capacity index scores. Respir Med. 2025 May;241:108015. doi: 10.1016/j.rmed.2025.108015. Epub 2025 Feb 28.
• Bhatt SP, Rabe KF, Hanania NA, Vogelmeier CF, Bafadhel M, Christenson SA, Papi A, Singh D, Laws E, Dakin P, Maloney J, Lu X, Bauer D, Bansal A, Abdulai RM, Robinson LB. Effect of Dupilumab on Health-Related Quality of Life and Respiratory Symptoms in Patients With COPD and Type 2 Inflammation: BOREAS and NOTUS. Chest. 2025 Jul;168(1):56-66. doi: 10.1016/j.chest.2025.01.029. Epub 2025 Jan 31.
• Bhatt SP, Rabe KF, Hanania NA, Vogelmeier CF, Bafadhel M, Christenson SA, Papi A, Singh D, Laws E, Dakin P, Maloney J, Lu X, Bauer D, Bansal A, Robinson LB, Abdulai RM. Dupilumab reduces exacerbations and improves lung function in patients with chronic obstructive pulmonary disease and emphysema: Phase 3 randomized trial (BOREAS). Respir Med. 2025 Jan;236:107846. doi: 10.1016/j.rmed.2024.107846. Epub 2024 Oct 30.
• Bhatt SP, Rabe KF, Hanania NA, Vogelmeier CF, Cole J, Bafadhel M, Christenson SA, Papi A, Singh D, Laws E, Mannent LP, Patel N, Staudinger HW, Yancopoulos GD, Mortensen ER, Akinlade B, Maloney J, Lu X, Bauer D, Bansal A, Robinson LB, Abdulai RM; BOREAS Investigators. Dupilumab for COPD with Type 2 Inflammation Indicated by Eosinophil Counts. N Engl J Med. 2023 Jul 20;389(3):205-214. doi: 10.1056/NEJMoa2303951. Epub 2023 May 21.

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