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A randomized, double blind, placebo-controlled study comparing the efficacy of dupilumab to standard of care (SOC) treatment following hospitalization for a COPD exacerbation

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524392-23-00
Enrollment
120
Registered
2026-08-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease (COPD)

Brief summary

Time to first all-cause event (all-cause event may include non-elective hospital readmission, Emergency Department (ED)/urgent care visit, or death), Number of moderate or severe COPD exacerbations

Detailed description

Time to first COPD-related event (COPD-related event may include non-elective hospital readmission, Emergency Department (ED)/urgent care visit, or death), Time to first moderate and/or severe COPD exacerbation, Number of all-cause non-elective hospital readmissions, Number of ED visits, Number of COPD-related hospital readmissions, Number of COPD-related ED visits, Number of all-cause deaths, Number of COPD-related deaths, Occurrence of all-cause non-elective hospital readmissions, ED visits, or deaths, Occurrence of COPD-related hospital readmissions, ED visits, or deaths, Change from baseline in Chronic Airways Assessment Test (CAAT) score (CAAT is a PRO measure that assesses the impact of lung disease on a person's life using an 8-item questionnaire with a 40-point scale with higher scores indicating worse disease), Change from baseline in EXAcerbation of Chronic pulmonary disease Tool (EXACT) questionnaire score (EXACT is a patient-reported daily diary that captures respiratory symptoms in COPD using a 14-item questionnaire with a 0 to 100-point scale with higher scores indicating worse disease symptoms), Occurrence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Interventions

Sponsors

Regeneron Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time to first all-cause event (all-cause event may include non-elective hospital readmission, Emergency Department (ED)/urgent care visit, or death), Number of moderate or severe COPD exacerbations

Secondary

MeasureTime frame
Time to first COPD-related event (COPD-related event may include non-elective hospital readmission, Emergency Department (ED)/urgent care visit, or death), Time to first moderate and/or severe COPD exacerbation, Number of all-cause non-elective hospital readmissions, Number of ED visits, Number of COPD-related hospital readmissions, Number of COPD-related ED visits, Number of all-cause deaths, Number of COPD-related deaths, Occurrence of all-cause non-elective hospital readmissions, ED visits, or deaths, Occurrence of COPD-related hospital readmissions, ED visits, or deaths, Change from baseline in Chronic Airways Assessment Test (CAAT) score (CAAT is a PRO measure that assesses the impact of lung disease on a person's life using an 8-item questionnaire with a 40-point scale with higher scores indicating worse disease), Change from baseline in EXAcerbation of Chronic pulmonary disease Tool (EXACT) questionnaire score (EXACT is a patient-reported daily diary that captures respiratory sy

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 15, 2026