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 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)
Timeline
- Start
- 2020-07-06
- Primary completion
- 2024-02-28
- Completion
- 2024-05-27
Outcome
Met primary endpoint
registry Placebo vs Dupilumab 300 mg q2w; p = 0.0002; Risk Difference (RD) -0.435 (95% CI -0.682 to -0.188) NCT04456673 ↗
paper the rate ratio as compared with placebo was 0.66 (95% CI, 0.54 to 0.82; P<0.001). PMID 38767614 ↗
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.
- 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, Patel N, Yancopoulos GD, Akinlade B, Maloney J, Lu X, Bauer D, Bansal A, Abdulai RM, Robinson LB; NOTUS Study Investigators. Dupilumab for COPD with Blood Eosinophil Evidence of Type 2 Inflammation. N Engl J Med. 2024 Jun 27;390(24):2274-2283. doi: 10.1056/NEJMoa2401304. Epub 2024 May 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dupilumab | Monoclonal antibody | 300 mg | Subcutaneous |