Dupilumab added to standard COPD care after a flare-up

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with COPD who were hospitalized or treated in the ED for a severe flare and have high eosinophil counts are randomized to receive dupilumab or placebo in addition to standard COPD care. The goal is to see if the study drug can lower the rate of recurrent exacerbations during about 90 days of treatment. The study compares dupilumab plus usual care against usual care alone and monitors safety alongside efficacy. Enrollment is at a site in Mullica Hill, New Jersey, sponsored by Regeneron with collaboration from Sanofi.

Why it matters

Who can join: the full rules

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

Where it's running

• Inspira Medical Center Mullica Hill
  Mullica Hill, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.