RecruitingPhase 4interventionalRules rewrite

Phase 4: testing dupilumab for Chronic Obstructive Pulmonary Disease (COPD)

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).

Official registry: https://clinicaltrials.gov/study/NCT07587658 · Regeneron Pharmaceuticals · enrollment listed as 754

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are dupilumab, or Placebo. The registry lists allocation as randomized. This study is researching a drug called dupilumab, referred to as "study drug".

They plan to enroll about 754 people at Mullica Hill. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: dupilumab, Placebo

Primary outcome (registry wording): Time to first all-cause event

Who it is for (from inclusion criteria)

Ages 40 Years to any
Has a clinical diagnosis of COPD prior to randomization, as defined in the protocol
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

Who the registry excludes

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

Public study contact (from the registry)

Clinical Trials Administrator

844-734-6643

clinicaltrials@regeneron.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Inspira Medical Center Mullica Hill — Mullica Hill, New Jersey (recruiting)

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FAQ about this NCT record

Is NCT07587658 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07587658?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07587658?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary