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
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HUmani Coordinator of this site? Confirm its status | Charleroi | Belgium | Not yet recruiting |
| JESSA Ziekenhuis Coordinator of this site? Confirm its status | Hasselt | Belgium | Not yet recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Not yet recruiting |
| Emmaues Coordinator of this site? Confirm its status | Mechelen | Belgium | Not yet recruiting |
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Coordinator of this site? Confirm its status | Yvoir | Belgium | Not yet recruiting |
| Hospital San Pedro De Alcántara Coordinator of this site? Confirm its status | Cáceres | Spain | Not yet recruiting |
| Pectus Respiratory Health S.L. Coordinator of this site? Confirm its status | Girona | Spain | Not yet recruiting |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Not yet recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Not yet recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Not yet recruiting |
| University Hospital Of Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Not yet recruiting |
| IRCCS Azienda Ospedaliera Metropolitana Coordinator of this site? Confirm its status | Genoa | Italy | Not yet recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Not yet recruiting |
| Inspira Medical Center Mullica Hill Coordinator of this site? Confirm its status | Mullica Hill | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.