Recruiting
Phase 4

Dupilumab

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT07587658

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

dupilumab

Placebo

Study Details

Brief summary:

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study ID

NCT07587658

Start date

Oct 6, 2026

Status verified date

Oct, 2026

Completion date

Jul 30, 2028

Anticipated

Primary completion date

Jul 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

1. Has a clinical diagnosis of COPD prior to randomization, as defined in the protocol
2. 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
3. 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

Key Exclusion Criteria:

1. Clinical evidence of pneumonia as the primary cause of admission in the investigator's opinion or acquired during hospital stay
2. Complicating pulmonary conditions during the 8 weeks prior to randomization which may confound treatment assessments, as defined in the protocol
3. Clinically significant pulmonary diseases other than COPD which may impair lung function and interfere with treatment assessments
4. Participants with clinically significant α-1 anti-trypsin deficiency which may impair lung function and interfere with treatment assessments
5. Cardiac-related comorbidity, as defined in the protocol
6. Treatment with invasive mechanical ventilation in-hospital during the index event, as defined in the protocol
7. 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

Study Design

Enrollment

754 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: dupilumab

placebo comparator: Placebo

Interventions

dupilumab

Administered per the protocol

Placebo

Administered per the protocol

Primary outcome measure

  • Time to first all-cause event [ Time Frame: Through day 90 ]
  • Number of moderate or severe COPD exacerbations [ Time Frame: Through day 90 ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Inspira Medical Center Mullica Hill

Recruiting

Mullica Hill, New Jersey, United States, 08062

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Keywords

  • Moderate and/or Severe Exacerbation
  • Eosinophilic phenotype
  • Elevated blood eosinophil counts
  • Type 2 inflammation
  • dupilumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.