About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- dupilumab
- Placebo
Treatment groups
Locations
Sponsors and collaborators
Regeneron Pharmaceuticals
Lead sponsor
Sanofi
Collaborator