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NCT07587658RecruitingPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 16 Oct 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
754 (estimated)
First submitted
8 May 2026
Start date
6 Oct 2026
Primary completion date
30 Jul 2028
Lead sponsor
Regeneron Pharmaceuticals
Diseases
COPD
NCT number
NCT07587658
EU CT number
2025-524392-23-00

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 754
  • From 6 Oct 2026 to the primary completion date, 30 Jul 2028
  • 14 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Complicating pulmonary conditions during the 8 weeks prior to randomization which may confound treatment assessments, 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

Other illness

  • Clinically significant pulmonary diseases other than COPD which may impair lung function and interfere with treatment assessments
  • Cardiac-related comorbidity, as defined in the protocol

Other

  • Clinical evidence of pneumonia as the primary cause of admission in the investigator's opinion or acquired during hospital stay
  • Participants with clinically significant α-1 anti-trypsin deficiency which may impair lung function and interfere with treatment assessments

Who the study is looking for

  • 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

Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
HUmani
Coordinator of this site? Confirm its status
CharleroiBelgiumNot yet recruiting
JESSA Ziekenhuis
Coordinator of this site? Confirm its status
HasseltBelgiumNot yet recruiting
UZ Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumNot yet recruiting
Emmaues
Coordinator of this site? Confirm its status
MechelenBelgiumNot yet recruiting
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Coordinator of this site? Confirm its status
YvoirBelgiumNot yet recruiting
Hospital San Pedro De Alcántara
Coordinator of this site? Confirm its status
CáceresSpainNot yet recruiting
Pectus Respiratory Health S.L.
Coordinator of this site? Confirm its status
GironaSpainNot yet recruiting
Hospital Universitario Virgen de las Nieves
Coordinator of this site? Confirm its status
GranadaSpainNot yet recruiting
Hospital Universitario Marqués de Valdecilla
Coordinator of this site? Confirm its status
SantanderSpainNot yet recruiting
Complexo Hospitalario Universitario De Santiago
Coordinator of this site? Confirm its status
Santiago de CompostelaSpainNot yet recruiting
University Hospital Of Ferrara
Coordinator of this site? Confirm its status
FerraraItalyNot yet recruiting
IRCCS Azienda Ospedaliera Metropolitana
Coordinator of this site? Confirm its status
GenoaItalyNot yet recruiting
Humanitas Mirasole S.p.A.
Coordinator of this site? Confirm its status
RozzanoItalyNot yet recruiting
Inspira Medical Center Mullica Hill
Coordinator of this site? Confirm its status
Mullica HillUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.