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A study to evaluate the efficacy and safety of depemokimab and salbutamol sulfate in patients with chronic obstructive pulmonary disease and type 2 inflammation.

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 is being conducted to evaluate the effectiveness and safety of depemokimab in individuals living with Chronic Obstructive Pulmonary Disease, commonly known as COPD. This condition is a long-term lung disease that makes it difficult to breathe. The study specifically focuses on patients who have type 2 inflammation, which is a specific way the body's immune system reacts and causes swelling in the airways. Participants may also use salbutamol sulfate, an inhaled medication used to help open the airways.

During the study, participants will be assigned to receive either depemokimab or a placebo through a subcutaneous injection, which is a shot given just under the skin. The study is designed so that neither the participants nor the researchers know which treatment is being administered. This approach helps ensure that the results are as accurate as possible.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study participation

    Participation begins with the administration of either the test medication or a placebo. the test medication is depemokimab, which is given as a 100 mg subcutaneous injection. a subcutaneous injection is an injection administered into the fatty tissue just under the skin. if the placebo is assigned, a sterile sodium chloride solution (salt water) is used instead.

  2. Step 2

    Ongoing treatment

    During the trial, a background medication called salbutamol is used. this is an inhalation powder taken at a dose of 800 micrograms via inhalation to help manage chronic obstructive pulmonary disease (copd), which is a lung condition that makes breathing difficult.

  3. Step 3

    Monitoring and evaluation

    The trial continues for a period of 52 weeks. during this time, the effectiveness of the treatment is monitored by tracking the rate of moderate or severe exacerbations, which are sudden worsening of lung symptoms. health changes are also measured through specific questionnaires regarding quality of life and symptom scores at the 52-week mark.

Who can join the trial?

13 criteria

  • Participants must be men or women.
  • The person must have an eosinophilic phenotype, which means their blood contains a specific type of white blood cell called an eosinophil that is present in higher amounts than normal.
  • The person must have moderate to severe Chronic Obstructive Pulmonary Disease (COPD), a long-term lung condition that makes it hard to breathe.
  • The lung condition must have been officially diagnosed for at least 1 year.
  • Lung function tests must show specific results, including a FEV1/FVC ratio (a measure of how much air you can blow out quickly compared to how much you can hold) of less than 0.70 and an FEV1 (the amount of air you can force out of your lungs in one second) that is between 30% and 80% of what is expected for a healthy person.
  • These lung measurements must be taken after using a bronchodilator, which is a medicine that helps open up the airways.
  • The person must have a high risk of exacerbations, which are sudden worsening of symptoms or "flare-ups" of the lung disease.
  • The person must have had exactly one moderate flare-up in the last 12 months.
  • The person must have additional risk factors, such as a high mMRC score or CAT score, which are tools used to measure how much shortness of breath and symptoms affect daily life.
  • The person may have chronic bronchitis, which involves long-term inflammation and mucus in the airways.
  • The person must be a current or former smoker with a history of at least 10 pack-years (a measurement calculated by multiplying the number of packs of cigarettes smoked per day by the number of years smoked).
  • The person must have been using inhaler therapy for at least 3 months, specifically using combinations of medicines like corticosteroids (to reduce swelling), LABA, or LAMA (to help relax and open the airways).
  • The person's Body Mass Index (BMI), which is a measure of body weight relative to height, must be at least 16 kg/m².

Who cannot join the trial?

10 criteria

  • People whose main lung problem is not Chronic Obstructive Pulmonary Disease, which is a long-term lung condition that makes it hard to breathe.
  • People who currently have or have previously been diagnosed with asthma, a condition where your airways swell and narrow.
  • People who had asthma as a child that did not go away before they turned 18 or has come back since then.
  • People with other significant lung diseases that the doctor decides are not caused by Chronic Obstructive Pulmonary Disease.
  • People who have had more than one moderate exacerbation, which is a sudden worsening of symptoms, or any severe exacerbation in the last 12 months.
  • People who have had pneumonia, a lung infection, a worsening of their lung condition, or a lower respiratory tract infection, which is an infection in the lungs or breathing tubes, within the 4 weeks before the first visit.
  • People who have had surgery to remove part of their lung or who plan to have lung volume reduction surgery or an endobronchial valve procedure, which are operations used to help improve breathing by changing how the lungs work.
  • People who are currently in the active stage of a pulmonary rehabilitation program, which is a supervised program of exercise and education to help people with lung disease.
  • People with chronic hypercapnia, which is a long-term buildup of too much carbon dioxide in the blood, that requires the use of machines like Bi-Level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP) to help them breathe.
  • People who need to use oxygen supplementation, which means using extra oxygen through a device, to help with their breathing.
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Investigated drugs

  • Depemokimab

    is a medication given as an injection under the skin. It is being tested to see if it can help improve the condition of people with chronic obstructive pulmonary disease (COPD) who have a specific type of inflammation in their airways.

  • Salbutamol

    is an inhaled powder used as a background treatment. It is a common medicine used to help open up the airways and make breathing easier.

What is already known about the treatment

  • Salbutamol sulfate

    This medication is an inhaled powder used to help open up the airways in people with lung conditions like asthma or COPD. It is a well-established medicine that works by relaxing the muscles around the breathing tubes to make breathing easier. It belongs to a group of drugs called short-acting beta-agonists, which act quickly to relieve symptoms.

  • Depemokimab

    This is an experimental medicine administered as a shot under the skin that is currently being studied for its ability to treat lung inflammation. It is designed to target and block specific proteins in the body that cause allergic-type swelling in the airways, particularly in patients with chronic obstructive pulmonary disease. This type of medication is classified as a monoclonal antibody, which means it is engineered to find and neutralize specific targets in the immune system.

Investigated diseases

Chronic Obstructive Pulmonary Disease - This is a long-term lung condition that causes airflow blockage and breathing difficulties. It is often characterized by persistent inflammation in the airways and lung tissue. Over time, the damage to the lungs can make it increasingly difficult to move air in and out of the body. The condition typically progresses slowly, with symptoms becoming more noticeable as the airways become more obstructed. It can involve various changes in the lungs, such as the narrowing of the small airways.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521108-23-00Protocol code224295Estimated enrolment1 196 patientsSponsorGlaxosmithkline Research & Development Limited

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).