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Not yet recruiting NCT07587658

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

Phase IV Interventional Chronic Obstructive Pulmonary Disease (COPD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: dupilumab, Placebo.
Who it may be relevant to
Registry conditions: Chronic Obstructive Pulmonary Disease (COPD). Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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

Interventions

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

Primary outcome measures

  • Time to first all-cause event [Time frame: Through day 90]
  • Number of moderate or severe COPD exacerbations [Time frame: Through day 90]
Secondary outcome measures (12)
  • Time to first COPD-related event [Time frame: Through day 90]
  • Time to first moderate and/or severe COPD exacerbation [Time frame: Through day 90]
  • Number of all-cause non-elective hospital readmissions [Time frame: Through day 90]
  • Number of ED visits [Time frame: Through day 90]
  • Number of COPD-related hospital readmissions [Time frame: Through day 90]
  • Number of COPD-related ED visits [Time frame: Through day 90]
  • Number of all-cause deaths [Time frame: Through day 90]
  • Number of COPD-related deaths [Time frame: Through day 90]
  • Occurrence of all-cause non-elective hospital readmissions [Time frame: Through day 60]
  • Occurrence of all-cause ED visits [Time frame: Through day 60]
  • Occurrence of all-cause deaths [Time frame: Through day 60]
  • Occurrence of COPD-related hospital readmissions [Time frame: Through day 60]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07587658 · R668-COPD-2491 · 2025-524392-23-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗