Dupilumab added to usual care after a hospital stay for a COPD flare-up
Tests dupilumab in adults with COPD after a severe flare-up needing hospitalization.
Plain-language title generated from the registry record
Registry title: This After Market Study is Seeing if Dupilumab Plus Usual Standard of Care (SOC) is Better Than Usual Care Alone for Adult Participants After a Severe Chronic Obstructive Pulmonary Disease (COPD) Flare-Up Requiring Hospitalization
Key facts
- Where
- Mullica Hill, United StatesSee the site
- Phase
- Phase 4
Where in United States
- Inspira Medical Center Mullica HillMullica Hill, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Regeneron Pharmaceuticals
- Trial code
- NCT07587658EU 2025-524392-23-00
- Record updated
- 16 October 2026
- Original description
This study is researching a drug called dupilumab, referred to as "study drug". The study is focused on people diagnosed with COPD to determine if the study drug, in addition to standard of care treatment for COPD, might reduce the reoccurrence of a COPD exacerbation (a "flare-up") happening within the study treatment duration (around 90 days).Read full original descriptionShow less
A Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy of Dupilumab Added on to Standard of Care (SOC) Treatment vs SOC Treatment Following Hospitalization for a COPD Exacerbation
This study is researching a drug called dupilumab, referred to as "study drug". The study is focused on people diagnosed with COPD to determine if the study drug, in addition to standard of care treatment for COPD, might reduce the reoccurrence of a COPD exacerbation (a "flare-up") happening within the study treatment duration (around 90 days).
The study is looking at another research question:
• What side effects may happen from taking the study drug
Inclusion: Has a clinical diagnosis of COPD prior to randomization, as defined in the protocol; Hospitalized or admitted to the ED >24 hours (from time of first admission or presentation to the ED) for acute exacerbation of COPD as primary diagnosis according to the principal investigator and exacerbation is managed by Systemic Corticosteroids (SCS) ± antibiotics and other appropriate treatments as per SOC; Elevated blood eosinophil counts during the current exacerbation, as defined in the protocol. The exacerbation event starts from the day Systemic Corticosteroids (SCS) ± antibiotics are administered continuously up to the day they presented to ED/hospital.
Exclusion: Complicating pulmonary conditions during the 8 weeks prior to randomization which may confound treatment assessments, as defined in the protocol; Treatment with invasive mechanical ventilation in-hospital during the index event, as defined in the protocol; Any biologic therapy or biologic Investigational Medicinal Product (IMP) to treat type 2 inflammatory diseases within 6 months prior to the screening visit or 5 half-lives, whichever is longer, as defined in the protocol; NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply; Clinically significant pulmonary diseases other than COPD which may impair lung function and interfere with treatment assessments; Cardiac-related comorbidity, as defined in the protocol; Clinical evidence of pneumonia as the primary cause of admission in the investigator's opinion or acquired during hospital stay; Participants with clinically significant α-1 anti-trypsin deficiency which may impair lung function and interfere with treatment assessments.