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Study of dupilumab injections to reduce airway inflammation in adults aged 40-85 with chronic obstructive pulmonary disease

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This study focuses on patients with Chronic Obstructive Pulmonary Disease (COPD), a long-term lung condition that causes breathing difficulties. The research examines the effects of dupilumab, given as an injection under the skin, compared to a placebo. The purpose is to evaluate how this medication affects inflammation in the airways, particularly looking at mucus buildup in the lungs.

The study involves patients who have moderate to severe COPD and show specific signs of inflammation in their blood. During the study, participants receive either dupilumab (also known as SAR231893) or a matching placebo as injections under the skin for 24 weeks. The medication is provided in pre-filled syringes, and participants continue taking their regular COPD medications throughout the study.

The research uses special lung imaging techniques to examine how the treatment affects mucus in the airways. High-resolution Computed Tomography (HRCT) scans are used to look at changes in the lungs over the course of treatment. The study also monitors the safety of the treatment and any changes in breathing ability.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    You will undergo an evaluation to confirm your eligibility for the study, including verification of chronic obstructive pulmonary disease (COPD) diagnosis

    Your medical history will be reviewed, including smoking history of at least 10 pack-years

    Blood tests will be performed to check your eosinophil levels (type of white blood cells)

    A high-resolution computed tomography (HRCT) scan will be performed to assess mucus in your lungs

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either dupilumab or placebo

    The medication will be provided as an injection under the skin (subcutaneous use)

    You will continue your regular COPD medications throughout the study

  3. Step 3

    Treatment period

    The treatment period will last 24 weeks

    You will receive regular injections of either dupilumab or placebo

    Your current COPD medications will continue, including triple therapy (three different types of inhaled medications) or dual therapy if needed

  4. Step 4

    Monitoring and assessments

    Regular tests will be performed to measure your lung function

    You will undergo forced oscillation technique (FOT) tests to measure airway resistance

    Additional HRCT scans will be performed to track changes in mucus levels and airway wall thickness

    Any side effects or health changes will be monitored and recorded throughout the study

  5. Step 5

    Final evaluation

    At week 24, final assessments will be performed

    These will include HRCT scans, lung function tests, and blood tests

    The results will be compared to your initial measurements to evaluate the treatment effects

Who can join the trial?

12 criteria

  • Must be a current or former smoker with a history of smoking at least 10 pack-years (equivalent to smoking 1 pack of cigarettes per day for 10 years)
  • Must have moderate-to-severe breathing condition with specific lung function test results showing:
    • Reduced breathing capacity after using bronchodilator medication
    • Lung function between 30% and 70% of normal predicted values
    • Must have either:
      • Significant breathlessness (grade 2 or higher on breathing difficulty scale), or
      • Score of 10 or higher on COPD assessment test measuring daily symptoms
      • Must have frequent or severe episodes of symptom worsening
      • Must be using three types of inhaled medications for at least 3 months, with stable dosing for at least 1 month before study start (or two types if unable to use inhaled steroids)
      • Must have elevated levels of specific white blood cells (eosinophils) showing either:
        • 300 or more cells per microliter at screening, or
        • 150 or more cells per microliter at screening with previous history of 300 or more cells in the past year
        • Must have a mucus score of 3 or higher on medical imaging
        • Must be an adult (18 years or older)
        • Can be either male or female

Who cannot join the trial?

13 criteria

  • Previous participation in a clinical trial involving dupilumab (an injectable medication for treating certain inflammatory conditions)
  • Having any serious or active infections, including tuberculosis or hepatitis B
  • History of severe allergic reactions to injectable medications
  • Current pregnancy or breastfeeding
  • Significant liver or kidney disease
  • Active cancer or cancer treatment within the past 5 years
  • Use of other biologic medications (specialized drugs that target specific parts of the immune system) within the past 4 months
  • Uncontrolled heart disease or high blood pressure
  • History of drug or alcohol abuse within the past year
  • Mental health conditions that could interfere with study participation
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
  • Unable or unwilling to undergo required HRCT scans (detailed X-ray imaging of the chest)
  • Unable to follow study procedures or attend scheduled visits
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Investigated drugs

Dupilumab is a medication used to treat inflammation in the airways. It works by blocking certain proteins in the body that cause inflammation. In this trial, it is being studied for its effects on reducing mucus plugging in the lungs of patients with chronic obstructive pulmonary disease (COPD). The medication helps decrease inflammation in the airways and may improve breathing by reducing the amount of mucus that builds up in the lungs.

What is already known about the treatment

Dupilumab - A monoclonal antibody medication administered through subcutaneous injection that targets specific proteins involved in inflammatory responses in the body. This biologic agent is primarily used to treat various inflammatory conditions, including severe asthma, atopic dermatitis, and is being studied for chronic obstructive pulmonary disease (COPD). It works by blocking the signaling of two key proteins (interleukin-4 and interleukin-13) that contribute to inflammation in the airways and lungs, particularly affecting mucus production and airway remodeling. Dupilumab belongs to the class of biological disease-modifying drugs and has shown promising results in clinical trials for reducing inflammation and improving lung function in respiratory conditions.

Investigated diseases

Respiratory tract disease - A condition affecting the airways and other structures of the respiratory system, from the nasal passages to the lungs. It involves the accumulation of mucus in the airways, which can lead to breathing difficulties. The condition can cause changes in airway wall thickness and affect normal respiratory function. Respiratory tract disease often involves increased airway resistance and changes in lung tissue that can be observed through medical imaging. The condition may be characterized by ongoing inflammation of the respiratory passages.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521268-37-00Protocol codeLPS18583Estimated enrolment436 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).