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Study of lunsekimig versus placebo in adults with inadequately controlled eosinophilic COPD

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What is this trial about?

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

A study is being conducted in adults who have Chronic Obstructive Pulmonary Disease that is not well controlled and shows an eosinophilic phenotype, a type of inflammation involving a certain white blood cell. The investigation compares an injectable medication called lunsekimig with a placebo to determine whether the drug can lower the number of moderate to severe disease exacerbations, which are episodes when symptoms suddenly get much worse. The purpose of the study is to evaluate the drug’s ability to reduce these flare‑ups.

Participants will receive a series of injections of either the study drug or the placebo over several months, with regular clinic visits for safety checks and simple breathing tests. One key breathing test measures the amount of air expelled in the first second of a forced breath, known as Forced Expiratory Volume in 1 second, to see how lung function changes. Throughout the study, people will complete questionnaires that assess health status and symptoms, such as the SGRQ-C (a quality‑of‑life survey), the CAAT (a symptom score), and the E-RS:COPD diary (records daily breathing problems). Researchers will also monitor for any side effects, using terms like TEAEs (any undesirable effects), AESIs (specific safety concerns), and SAEs (serious problems). Blood samples will be taken to check the drug level and to look for antidrug antibodies, which are the body’s immune response to the medication.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit and eligibility confirmation

    On the first visit after joining the study, a series of assessments are performed to confirm eligibility. these include a medical history review, physical examination, and tests of lung function such as the forced expiratory volume in one second (fev1).

    Questionnaires that measure health status and symptoms, such as the st george's respiratory questionnaire for chronic respiratory disease (sgrq-c) and the chronic airways assessment test (caat), are completed.

  2. Step 2

    Randomization to study medication

    After eligibility is confirmed, the participant is randomly assigned to receive either the investigational drug lunsekimig or a matched placebo. the assignment is double‑blind, meaning neither the participant nor the study staff knows which treatment is given.

  3. Step 3

    Administration of study medication

    The participant receives an injection of the assigned product. the injection is a pre‑filled syringe containing a solution for injection. the dose listed in the protocol is 00.00 mg of lunsekimig per administration. the same procedure is used for the placebo, which contains no active substance.

    Injections are given at each scheduled study visit according to the study schedule.

  4. Step 4

    Regular follow‑up visits

    The participant attends follow‑up visits at intervals defined by the study protocol. at each visit, lung function tests, vital signs, and safety assessments are performed.

    Blood samples are collected to measure the serum concentration of lunsekimig and to check for the presence of antidrug antibodies (adas).

    The participant reports any adverse events, including serious adverse events (saes) and adverse events of special interest (aesis).

  5. Step 5

    Completion of patient‑reported outcome questionnaires

    At designated visits, the participant completes questionnaires that evaluate symptoms and health status, such as the shortness of breath questionnaire (e‑rs:coppd) and the st george's respiratory questionnaire (sgrq‑c).

    Responses are used to assess changes from baseline in scores that reflect disease impact.

  6. Step 6

    Monitoring of exacerbations

    The participant is instructed to report any worsening of respiratory symptoms that require additional treatment. these events are classified as moderate or severe copd exacerbations.

    The time to first moderate or severe exacerbation and the annualized rate of exacerbations are recorded throughout the study.

  7. Step 7

    Final study visit and study completion

    At the end of the study period, which is scheduled to conclude on 2030‑01‑22, the participant attends a final visit. final assessments include lung function testing, laboratory evaluations, and completion of all questionnaires.

    The participant receives a summary of the study procedures performed and any remaining study medication is accounted for.

Who can join the trial?

9 criteria

  • Be between 40 and 80 years old.
  • Have been told by a doctor that you have chronic obstructive pulmonary disease (COPD) for at least one year; COPD is a lung condition that makes breathing difficult.
  • After using medication that opens the airways, a lung test shows a value called post‑bronchodilator FEV1 that is at least 20% but no more than 70% of the normal amount for someone your age, and the ratio of FEV1 to FVC is less than 0.70. FEV1 is the amount of air you can force out in one second, and FVC is the total amount of air you can force out.
  • Be a former or current smoker with a history of at least 10 pack‑years (for example, one pack per day for 10 years).
  • Score 10 or higher on the Chronic Airways Assessment Test (CAAT), a questionnaire that measures how much COPD affects your daily life.
  • Have had at least two moderate or at least one severe COPD exacerbations (flare‑ups) in the past year. A moderate flare‑up usually needs extra medication, while a severe flare‑up often requires a hospital stay.
  • Have been using three inhaled medicines together (an inhaled corticosteroid, a long‑acting beta‑agonist, and a long‑acting muscarinic antagonist) for at least 12 consecutive weeks.
  • Show a blood test result with a blood eosinophil count of 150 cells per microliter or higher; eosinophils are a type of white blood cell.
  • Have a Body Mass Index (BMI) between 18 and 40 kg/m², which is a measure of body weight relative to height.

Who cannot join the trial?

9 criteria

  • Asthma, including asthma in children, or asthma‑COPD overlap syndrome (ACOS) – a condition that has features of both asthma (a lung disease that causes wheezing and shortness of breath) and COPD.
  • Any other serious lung disease that is not COPD, such as severe bronchitis or interstitial lung disease.
  • Needing long‑term supplemental oxygen at a flow greater than 4.0 L/min, or needing more than 2.0 L/min of oxygen to keep blood oxygen levels (called oxygen saturation) above 88 % while at rest.
  • Having an unstable health problem that could affect safety or the study results, such as a disease that is getting worse or changing quickly.
  • Having active tuberculosis (TB) or a TB infection that has not been fully treated – TB is a bacterial infection that mainly affects the lungs.
  • Having a current cancer or a history of cancer (referred to as malignancies).
  • Taking certain medicines at the same time, unless they have been stable for more than 6 months:
    • Long‑term macrolide antibiotics (a class of antibiotics often used for lung infections).
    • Phosphodiesterase type 3 (PDE‑3) or type 4 (PDE‑4) inhibitors – drugs that affect specific enzymes involved in inflammation.
    • Any biologic therapy (medicines made from living cells) or systemic immunosuppressant (drugs that lower the whole body’s immune response) taken within the past 4 months or within five drug half‑lives (the time it takes for half of the drug to leave the body) before screening.
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Investigated drugs

LUNSEKIMIG is an experimental medication given by injection that is being tested to see if it can help adults with chronic obstructive pulmonary disease (COPD) who still have symptoms despite their usual treatments. In this study, participants receive the drug in a pre‑filled syringe. The researchers are looking to find out whether LUNSEKIMIG can lower the number of moderate to severe COPD flare‑ups that happen over a year, especially in people whose COPD shows an eosinophilic (a type of white blood cell) pattern.

What is already known about the treatment

LUNSEKIMIG - It is supplied as a sterile solution for injection in a pre‑filled syringe and is given by a single injection under medical supervision. The product is still investigational, currently being evaluated in Phase 2b/Phase 3 trials and has not yet received regulatory approval. It is studied for adults with chronic obstructive pulmonary disease (COPD) that shows an eosinophilic pattern, with the goal of reducing moderate to severe flare‑ups. LUNSEKIMIG works by attaching to a protein that controls eosinophil activity, which helps lower airway inflammation, and it belongs to the class of biologic anti‑inflammatory monoclonal antibodies.

Investigated diseases

Chronic obstructive pulmonary disease (COPD) - A long‑term lung condition that makes it hard to move air in and out of the lungs. It usually starts with a mild cough and occasional shortness of breath, then gradually leads to more frequent breathlessness, wheezing, and coughing with mucus. Over time the airflow becomes increasingly limited, causing everyday activities to feel more difficult. Periodic worsening episodes, called exacerbations, can cause a sudden increase in symptoms and may require additional care. The disease progresses slowly, with symptoms becoming more noticeable and persistent as the lungs lose their ability to function properly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-518213-25-00Protocol codeEFC18244-THESEUSEstimated enrolment2 360 patientsSponsorSanofi-Aventis Recherche & Developpement

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