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

Study of an Add-on Study Drug After a Severe COPD Flare-Up

Age
40 years or above
Gender
All
Phase
Phase 4
Participants needed
754
Find a study site near you

Study Overview

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

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Obstructive Pulmonary Disease (COPD)
  • Age: 40 years or above
  • Gender: All

Key Inclusion Criteria:

  1. Has a clinical diagnosis of COPD prior to randomization, as defined in the protocol
  2. 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
  3. 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

Key Exclusion Criteria:

  1. Clinical evidence of pneumonia as the primary cause of admission in the investigator's opinion or acquired during hospital stay
  2. Complicating pulmonary conditions during the 8 weeks prior to randomization which may confound treatment assessments, as defined in the protocol
  3. Clinically significant pulmonary diseases other than COPD which may impair lung function and interfere with treatment assessments
  4. Participants with clinically significant α-1 anti-trypsin deficiency which may impair lung function and interfere with treatment assessments
  5. Cardiac-related comorbidity, as defined in the protocol
  6. Treatment with invasive mechanical ventilation in-hospital during the index event, as defined in the protocol
  7. 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

The purpose of this research study is to learn whether adding an investigational study drug to usual standard of care treatment can lower the chance of another severe chronic obstructive pulmonary disease (COPD) flare-up in adults who were recently in the hospital or emergency department for a COPD flare-up. The study will also look at what side effects may happen with the investigational study drug.

Participants will receive either the investigational study drug plus their usual COPD care, or usual COPD care alone.

Who can participate:
Adults with COPD may be able to participate if they:

  • Have a diagnosis of COPD
  • Have been hospitalized or kept in the emergency department for more than 24 hours because of a COPD flare-up that was treated with systemic corticosteroids (strong anti-inflammatory medicines) with or without antibiotics, along with other usual care
  • Have higher levels of eosinophils (a type of white blood cell) during the current flare-up

Updated on 12 Oct 2026. Study ID: NCT07587658

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