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
EU CTIS ID: 2025-524392-23-00
What this study is testing
To evaluate the efficacy of dupilumab in reducing risk of all-cause non-elective hospital readmissions, ED visits, or deaths, and to evaluate the efficacy of dupilumab in reducing the number of moderate and/or severe COPD exacerbations.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Is ≥40 years of age, at the time of signing the informed consent.
- 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.
- NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply.
You likely can't join if
- Clinical evidence of pneumonia as the primary cause of admission in the investigator’s opinion or acquired during hospital stay
- Complicating pulmonary conditions during the 8 weeks prior to randomization which may confound treatment assessments, as defined in the protocol
- Clinically significant pulmonary diseases other than COPD which may impair lung function and interfere with treatment assessments
- Participants with clinically significant α-1 anti-trypsin deficiency which may impair lung function and interfere with treatment assessments
- Cardiac-related comorbidity, as defined in the protocol
- Treatment with invasive mechanical ventilation in-hospital during the index event, as defined in the protocol
See the full eligibility criteria
- Is ≥40 years of age, at the time of signing the informed consent.
- 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.
- NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply.
- Clinical evidence of pneumonia as the primary cause of admission in the investigator’s opinion or acquired during hospital stay
- Complicating pulmonary conditions during the 8 weeks prior to randomization which may confound treatment assessments, as defined in the protocol
- Clinically significant pulmonary diseases other than COPD which may impair lung function and interfere with treatment assessments
- Participants with clinically significant α-1 anti-trypsin deficiency which may impair lung function and interfere with treatment assessments
- Cardiac-related comorbidity, 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
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- Canada
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; Canada; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.