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Study of dupilumab added to standard care in adults hospitalized for COPD exacerbation to reduce readmissions, emergency visits, and death

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on adults who have been hospitalized because of a severe flare‑up of Chronic Obstructive Pulmonary Disease (COPD). The medication being tested is dupilumab, a drug given by injection under the skin. Participants will receive either the drug or a placebo, which looks the same but does not contain the active medicine.

The purpose of the study is to determine whether adding the drug to the usual treatment, called standard of care, lowers the risk of returning to the hospital, visiting the ED, or dying after the flare‑up. After discharge, participants are randomly assigned to one of the two groups and receive injections at regular intervals while researchers check in with them through clinic visits and phone calls over several months.

Researchers will track how often participants experience another worsening of symptoms, known as an exacerbation, and will record any unplanned hospital readmissions, urgent care visits, or deaths. They will also ask participants to complete simple questionnaires that measure how the lung disease affects daily life and symptom severity. Any side effects or health problems that appear during the study will be recorded and evaluated.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    After agreeing to participate, you will sign a consent form that explains the study and your rights.

  2. Step 2

    Baseline assessment

    Study staff will collect information about your health, perform basic tests, and ask you to complete two questionnaires: the chronic airways assessment test (caat) and the exacerbation of chronic pulmonary disease tool (exact). these questionnaires help measure how COPD affects your daily life.

  3. Step 3

    Randomization to treatment group

    You will be randomly assigned to receive either dupilumab or a matching placebo. both groups will continue to receive your usual standard of care for COPD.

  4. Step 4

    First study medication injection

    If assigned to the dupilumab group, you will receive a 300 mg dose of dupilumab as a subcutaneous injection (injected under the skin) using a pre‑filled syringe. if assigned to the placebo group, you will receive an injection that looks identical but contains no active drug. the exact timing of this and any future injections will follow the study schedule.

  5. Step 5

    Continuation of standard of care

    Throughout the study you will keep taking any medicines your doctor normally prescribes for COPD, such as inhalers or oral therapies.

  6. Step 6

    Regular follow‑up visits

    You will return to the study site at scheduled intervals. during each visit you may receive another injection according to the study schedule, have your health checked, and complete the caat and exact questionnaires again. the staff will also ask about any hospital readmissions, emergency department visits, or other health events.

  7. Step 7

    Monitoring for adverse events

    Any new symptoms or problems you experience will be recorded as treatment‑emergent adverse events. serious adverse events, such as hospitalization or life‑threatening conditions, will be reported immediately.

  8. Step 8

    Final assessment and study completion

    At the end of the study period, you will have a final visit where health measurements, questionnaires, and any remaining safety information are collected. after this visit, no further study procedures are required.

Who can join the trial?

5 criteria

  • Be at least 40 years old when you sign the consent form.
  • Have been diagnosed by a doctor with chronic obstructive pulmonary disease (COPD) before you join the study.
  • Have stayed in the hospital or emergency department for more than 24 hours because of a sudden worsening of your COPD, and have been treated with medicines called systemic corticosteroids (strong anti‑inflammatory drugs) with or without antibiotics (drugs that treat infection).
  • Show a higher than normal number of blood eosinophils (a type of white blood cell that can be linked to inflammation) during this current worsening episode.
  • Meet any other study rules that are described in the trial protocol.

Who cannot join the trial?

7 criteria

  • Having pneumonia (a lung infection) as the main reason for your hospital admission, or developing pneumonia while you were in the hospital.
  • Having other lung problems (pulmonary conditions) during the 8 weeks before the study that could affect the results.
  • Having other serious lung diseases besides COPD that could impair breathing or interfere with the study assessments.
  • Having a significant deficiency of α‑1 antitrypsin (a protein that protects the lungs) that could impair breathing or interfere with the study.
  • Having serious heart problems (cardiac‑related comorbidity) as defined by the study.
  • Having needed invasive mechanical ventilation (a tube placed in the airway to help you breathe) while in the hospital during the current event.
  • Having taken any biologic therapy (drugs made from living cells) for type 2 inflammatory diseases within the past 6 months, or within five drug half‑lives (the time it takes for half of the drug to leave the body), whichever is longer.
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Investigated drugs

dupilumab is a medicine given as an injection under the skin. It works by blocking specific signals in the body that cause inflammation. In this study, researchers are testing whether it can help reduce the chance of coming back to the hospital, needing an emergency‑room visit, or dying, and whether it can lower the number of moderate or severe COPD flare‑ups after a patient has been hospitalized. Standard of care (SOC) treatment refers to the usual medicines and therapies that doctors normally prescribe for COPD after a hospital stay. This can include inhaled bronchodilators, inhaled steroids, and other supportive measures that help keep breathing stable. In the trial, SOC is used as the comparison group to see how dupilumab performs against the typical treatment patients receive.

What is already known about the treatment

  • Dupixent (dupilumab)

    It is given as a 300 mg solution for injection, administered under the skin with a pre‑filled syringe. Dupilumab is an approved prescription drug that is widely studied and used for conditions such as eczema, asthma and now being tested in COPD. It works by blocking the activity of interleukin‑4 and interleukin‑13 proteins, which reduces inflammation in the airways. It belongs to the class of monoclonal antibodies that target cytokine signaling.

  • Placebo

    The placebo looks like the dupilumab injection but contains no active drug; it is given subcutaneously in the same way as the active product. Placebos are used in clinical trials to compare the effect of the real medicine and have no therapeutic effect. They contain inert ingredients and are not a treatment for any disease. They are not classified as a medication.

Investigated diseases

Chronic obstructive pulmonary disease (COPD) - It is a long‑term lung condition that causes persistent narrowing of the airways, most often due to smoking or exposure to irritating gases. The disease produces ongoing cough, excess mucus, and shortness of breath that become more noticeable over time. As the airways and air‑sacs are damaged, breathing gets harder and everyday activities may cause fatigue. Periodically, people experience flare‑ups where symptoms worsen sharply and may require urgent care. Over many years the loss of lung function usually progresses from mild to moderate and then to more severe impairment.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524392-23-00Protocol codeR668-COPD-2491Estimated enrolment750 patientsSponsorRegeneron Pharmaceuticals Inc.

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