What this study is
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
What's being tested
- dupilumab
Intervention · DRUG
- Placebo
Intervention · DRUG
Both interventions
Administered per the protocol
Study details
- 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
- Sponsor
- Regeneron Pharmaceuticals
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Enrolling
- 754 people
- Starts
- 2026-10-06
- Est. completion
- 2028-07-30
- Design
- Quadruple-blind, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 40 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openInspira Medical Center Mullica Hill
Mullica Hill, New Jersey, United States
Recruiting
Study team
Sponsor
Regeneron Pharmaceuticals
Study ID R668-COPD-2491
Study director
Clinical Trial Management
Regeneron Pharmaceuticals
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.