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Study of Astegolimab Treatment in Patients with Chronic Obstructive Pulmonary Disease (COPD) to Reduce Disease Flare-ups

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What is this trial about?

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

This clinical trial focuses on patients with Chronic Obstructive Pulmonary Disease (COPD), a long-term lung condition that causes breathing difficulties and can lead to frequent chest infections. The study will test a new medication called astegolimab, which is a type of drug known as a monoclonal antibody, comparing it to a placebo. The purpose is to determine how well astegolimab works in reducing the number of moderate and severe COPD flare-ups over a one-year period.

The medication will be given as a subcutaneous injection (an injection under the skin) using a pre-filled syringe with a safety device. The treatment period will last for 52 weeks, during which participants will receive either astegolimab or a placebo. Throughout the study, doctors will monitor breathing function, quality of life, and how often COPD symptoms get worse.

The study will track several aspects of the participants' health, including changes in breathing tests, how well they feel day-to-day, and any side effects that may occur. The researchers will also measure how much of the medication stays in the body and whether the body develops any response to the treatment. This information will help determine if astegolimab is safe and effective for treating COPD.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your eligibility for the study will be evaluated based on your COPD (Chronic Obstructive Pulmonary Disease) diagnosis, which must be documented for at least 12 months

    A breathing test will be performed to measure your lung function (FEV1 test)

    Your smoking history will be reviewed - you must have a history of smoking 10 or more pack-years

    Your current COPD maintenance medications will be reviewed to confirm you have been using them for at least 12 months

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either astegolimab or a placebo

    The treatment will be given as an injection under the skin (subcutaneous injection)

    Neither you nor your doctor will know which treatment you are receiving

  3. Step 3

    52-week treatment period

    You will receive treatment for 52 weeks (one year)

    Regular assessments will include:

    Monitoring of your breathing function

    Quality of life questionnaires

    Recording of any COPD flare-ups (exacerbations)

    Regular health checks including vital signs, blood tests, and heart tests (ECG)

    Blood samples will be taken to measure medication levels and check for antibodies

  4. Step 4

    Final assessment

    At week 52, final evaluations will include:

    Breathing function test

    Quality of life assessment

    Review of any COPD flare-ups during the study period

    Final safety assessments including blood tests and heart monitoring

Who can join the trial?

12 criteria

  • You must have been diagnosed with COPD (Chronic Obstructive Pulmonary Disease) for at least 12 months
  • You must have experienced at least 2 moderate or severe COPD flare-ups (exacerbations) in the past 12 months
  • Your lung function test must show:
    • A FEV1 (amount of air you can forcefully exhale in one second) between 20% and 80% of normal predicted values
    • A ratio of FEV1/FVC (comparison of air exhaled in first second to total air exhaled) less than 0.70
    • You must have a mMRC score (scale measuring breathlessness) of 2 or higher
    • You must be either:
      • A current smoker, or
      • A former smoker who quit at least 6 months ago
      • Must have at least 10 pack-years smoking history (equivalent to smoking 20 cigarettes per day for 10 years)
      • You must have been using regular COPD maintenance medications for at least 12 months, including one of these combinations:
        • Inhaled corticosteroids (ICS) plus long-acting beta-agonist (LABA), or
        • Long-acting muscarinic antagonist (LAMA) plus LABA, or
        • All three medications (ICS plus LAMA plus LABA)
        • Both men and women may participate

Who cannot join the trial?

15 criteria

  • History of asthma or other significant respiratory conditions besides COPD
  • Active lung infection such as tuberculosis or other serious infections
  • Previous lung surgery or major chest surgery
  • Cancer diagnosis or treatment within the past 5 years
  • Serious heart conditions including heart attack in the past 6 months
  • Uncontrolled high blood pressure
  • Current participation in other clinical trials
  • Allergic reactions to similar medications in the past
  • Severe liver or kidney disease
  • Autoimmune diseases (conditions where the immune system attacks the body)
  • Regular use of oral steroids (medications like prednisone) in high doses
  • Substance abuse within the past year
  • Inability to perform required breathing tests
  • Pregnancy or breastfeeding
  • Unwillingness to use effective contraception during the study period
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Investigated drugs

Astegolimab is an investigational medication being studied for treating chronic obstructive pulmonary disease (COPD). It is designed to help reduce the frequency of moderate and severe COPD flare-ups (exacerbations). This medication aims to target specific components of the immune system that may be involved in lung inflammation and COPD symptoms. The medication is being compared to a placebo to determine how effective it is in preventing COPD exacerbations over a one-year treatment period.

What is already known about the treatment

Astegolimab - An investigational monoclonal antibody medication administered through intravenous infusion, currently being studied in Phase III clinical trials for the treatment of Chronic Obstructive Pulmonary Disease (COPD). This biological agent is designed to reduce the frequency and severity of COPD exacerbations by targeting specific inflammatory pathways involved in the disease progression. The medication belongs to the class of targeted immunotherapy drugs and represents a novel approach to treating COPD, as it aims to modify the underlying inflammatory response rather than just managing symptoms.

Investigated diseases

Chronic Obstructive Pulmonary Disease (COPD) - A progressive lung condition that makes breathing difficult due to narrowed airways and damaged lung tissue. The disease typically develops slowly over many years, causing the airways to become inflamed and the lung tissue to become damaged. Common symptoms include persistent coughing, increased mucus production, wheezing, and shortness of breath, especially during physical activity. The condition often results in repeated episodes called exacerbations, where symptoms temporarily worsen. COPD affects the lungs' ability to exchange oxygen and carbon dioxide efficiently, leading to decreased lung function over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502234-70-00Protocol codeGB44332Estimated enrolment1 198 patientsSponsorF. Hoffmann-La Roche AG

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