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Study of Tozorakimab to Reduce Lung Inflammation and Promote Healing in Patients with COPD

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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 people with COPD, a lung condition that makes breathing difficult and can cause frequent flare‑ups. The medication being tested is called tozorakimab, a drug that blocks a protein known as IL-33 which is involved in lung inflammation. Participants will receive the drug by a subcutaneous injection (a small shot under the skin) and will be compared with a group receiving a placebo, which looks the same but does not contain the active medicine.

The purpose of the trial is to see whether the drug can reduce lung inflammation and help the airways heal. Volunteers will receive regular injections over about six months and will attend several clinic visits where doctors will check their health, ask about symptoms, and collect samples. The schedule includes routine check‑ins but does not involve any invasive procedures beyond the planned assessments.

During the study, participants will undergo a few key examinations to monitor changes in the lungs. A CT scan provides a detailed picture of the chest, similar to an X‑ray but with more detail. Spirometry is a simple breathing test that measures how much air can be inhaled and exhaled. In some cases, a bronchoscopy may be performed, which uses a thin, flexible tube to look inside the airways and collect small tissue samples. Blood and other non‑invasive samples will also be taken to help understand how the drug works.

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

    Enrollment and Consent

    You join the study and sign a consent form that explains what will happen during the trial.

    The study team confirms that you meet the criteria for having chronic obstructive pulmonary disease (COPD).

  2. Step 2

    Baseline Assessments

    You undergo a series of initial tests that create a reference point for later comparison.

    These tests include a lung function test called spirometry, a chest CT scan, blood sampling, nasal brushings, sputum collection, a breath test for exhaled nitric oxide (FeNO), and a urine sample.

    You also complete questionnaires about your symptoms and quality of life, such as the CAAT, mMRC, SGRQ‑C, and a visual analogue scale for symptoms.

  3. Step 3

    Randomization

    Based on a random assignment, you receive either the study drug tozorakimab or a matching placebo.

    The assignment is made by the study system and you do not know which one you receive.

  4. Step 4

    First Injection

    You receive a subcutaneous (under the skin) injection of the assigned study medication.

    The injection is a solution for injection with a concentration of 0 mg/ml as defined in the study protocol.

  5. Step 5

    Ongoing Treatment Visits

    You return to the clinic for additional injections according to the schedule set by the study protocol.

    At each visit the staff check your safety, record any side effects, repeat the symptom questionnaires, and perform lung function tests.

    Blood, nasal, sputum, breath, and urine samples may be collected again to monitor changes.

  6. Step 6

    Week 24 Evaluation

    Approximately 24 weeks after the first injection, you undergo a comprehensive evaluation.

    This includes a repeat chest CT scan, another bronchoscopy to obtain bronchial tissue samples, follow‑up lung function tests, and the same set of questionnaires completed at baseline.

    Blood and other biological samples are taken again to assess the study’s primary and secondary outcomes.

  7. Step 7

    End of Study Visit

    You attend a final visit where the study medication is discontinued.

    The study team conducts a final safety check, collects any remaining samples, and reviews your overall experience in the trial.

Who can join the trial?

11 criteria

  • Willing and able to give written permission to join the study.
  • Score of 10 or higher on the CAAT questionnaire (a symptom survey for COPD) and a cough‑and‑sputum score of 2 or more at the first visit.
  • Women who could become pregnant and all men must agree to use a highly effective birth‑control method such as hormonal pills, condoms, or choose not to have sex.
  • Age 40 years or older but younger than 85 years.
  • Both men and women are allowed to participate.
  • Can read and understand written and spoken English (or the official language of the country where the study is done).
  • Has been told by a doctor that they have chronic obstructive airway disease (COPD) for at least one year before screening.
  • Lung test shows FEV1/FVC less than 0.7 (meaning airflow is reduced) and FEV1 (the amount of air exhaled in one second) is at least 30% of the normal predicted value and at least 1.0 L at the first visit.
  • Is a current smoker or former smoker with a history of at least 10 pack‑years (one pack per day for ten years, or an equivalent amount). Former smokers have not smoked for at least six months; current smokers are still smoking at least one cigarette per day.
  • Has been using the same inhaled COPD maintenance medicines (two or three types such as LABA, LAMA, or inhaled steroids) for at least three months before screening, and any oral COPD medicines (like macrolides or roflumilast) must also have been stable for three months.
  • Had at least one moderate or severe COPD flare (exacerbation) in the past 12 months that required treatment with oral steroids and/or antibiotics.

Who cannot join the trial?

29 criteria

  • Any unstable disorder (a health problem that is not well‑controlled, such as heart, stomach, liver, kidney, nerve, muscle, infection, hormone, blood, or mental health issues) that could make the study unsafe, affect the results, or stop you from completing the study.
  • Specific study criteria that are not disclosed publicly (referred to as Company Confidential Information, criteria 18).
  • Specific study criteria that are not disclosed publicly (Company Confidential Information, criteria 19).
  • Specific study criteria that are not disclosed publicly (Company Confidential Information, criteria 2).
  • Specific study criteria that are not disclosed publicly (Company Confidential Information, criteria 20).
  • Specific study criteria that are not disclosed publicly (Company Confidential Information, criteria 21).
  • Specific study criteria that are not disclosed publicly (Company Confidential Information, criteria 22).
  • Specific study criteria that are not disclosed publicly (Company Confidential Information, criteria 23).
  • Specific study criteria that are not disclosed publicly (Company Confidential Information, criteria 24).
  • Specific study criteria that are not disclosed publicly (Company Confidential Information, criteria 25).
  • History of any known primary immunodeficiency disorder (a condition where the immune system is weak) except a mild, symptom‑free lack of certain antibodies called IgA or IgG subclasses.
  • Current diagnosis of asthma (a lung condition that makes breathing difficult).
  • Diagnosis of HIV (human immunodeficiency virus, a virus that affects the immune system).
  • Medical history of or treatment for hepatitis B or hepatitis C (viral infections of the liver), except cured hepatitis C. This includes a positive test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti‑HBc) with a negative DNA test, and a positive hepatitis C antibody (anti‑HCV) with a negative RNA test if there is no liver scarring (cirrhosis).
  • Specific study criteria that are not disclosed publicly (Company Confidential Information, criteria 3).
  • Specific study criteria that are not disclosed publicly (Company Confidential Information, criteria 4).
  • Specific study criteria that are not disclosed publicly (Company Confidential Information, criteria 5).
  • Significant other lung diseases such as cystic fibrosis (a genetic condition that causes thick mucus in the lungs) or pulmonary fibrosis (scarring of lung tissue).
  • Specific study criteria that are not disclosed publicly (Company Confidential Information, criteria 7).
  • Specific study criteria that are not disclosed publicly (Company Confidential Information, criteria 8).
  • Any major abnormal lab test results at screening that the doctor thinks could put you at risk if you join the study.
  • Neutropenia (a low count of neutrophils, a type of white blood cell, less than 2.0 × 10⁹/L).
  • Long‑term use of oxygen therapy or non‑invasive positive pressure ventilation (NIPPV) for type 2 respiratory failure (a condition where the lungs cannot remove enough carbon dioxide). Using continuous positive airway pressure (CPAP) for sleep apnea is allowed.
  • A recent serious worsening of breathing that needed oral steroids or antibiotics for more than three days, or a respiratory infection within four weeks before screening.
  • Current cancer or cancer treated within the past five years, except for fully treated non‑invasive skin cancers (basal cell or squamous cell) or cervical carcinoma‑in‑situ treated successfully more than one year ago; also excludes suspected or unknown tumors.
  • Specific study criteria that are not disclosed publicly (Company Confidential Information, criteria 14).
  • Specific study criteria that are not disclosed publicly (Company Confidential Information, criteria 15).
  • Specific study criteria that are not disclosed publicly (Company Confidential Information, criteria 16).
  • Specific study criteria that are not disclosed publicly (Company Confidential Information, criteria 17).
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Investigated drugs

Tozorakimab is an investigational medicine that works by blocking a protein called IL‑33, which can cause inflammation in the lungs. In this study, it is given as a subcutaneous injection (a shot under the skin) in a liquid form. The trial is testing whether Tozorakimab can improve the structure of the airway lining and reduce the number of certain immune cells (eosinophils) in the bronchial tissue of people with COPD, potentially helping to lessen airway damage and inflammation.

What is already known about the treatment

Tozorakimab - Tozorakimab is given as a subcutaneous injection of a clear solution for injection. It is an experimental monoclonal antibody currently in clinical trials and not yet approved for routine use. The drug is being studied mainly for chronic obstructive pulmonary disease (COPD) where it aims to reduce airway inflammation and tissue changes. It works by binding to the protein interleukin‑33, blocking its activity and preventing the cascade that leads to eosinophil recruitment and airway remodeling; it belongs to the class of anti‑IL‑33 monoclonal antibodies.

Investigated diseases

COPD - COPD is a chronic lung condition characterized by persistent airflow limitation and inflammation of the airways. It usually develops over many years, often due to long‑term exposure to irritants such as cigarette smoke. The disease causes the airways to become narrowed and the lung tissue to lose its elasticity, leading to increasing difficulty breathing. Over time, symptoms such as cough, mucus production, and shortness of breath tend to worsen, especially during physical activity or infections.
Trial detailsLast updated 25 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522359-24-00Protocol code1066Estimated enrolment66 patients

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