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

Regeneron Pharmaceuticals

Summary

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

Age range: 40+ years
Sex: All
Healthy volunteers: No

Detailed criteria

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)…

Interventions

Drug
dupilumab
Administered per the protocol
Drug
Placebo
Administered per the protocol

Location

Inspira Medical Center Mullica Hill
Mullica Hill, New Jersey

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

Summary

Eligibility

Interventions

Location

Compensation

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Details

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