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Study on Gremubamab for Patients with Bronchiectasis and Chronic Pseudomonas Aeruginosa Infection

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This clinical trial is focused on studying the effects of a treatment called Gremubamab on individuals with bronchiectasis and a chronic infection caused by a bacteria known as Pseudomonas aeruginosa. Bronchiectasis is a condition where the airways in the lungs become widened and scarred, leading to mucus build-up and frequent lung infections. The trial aims to evaluate how effective Gremubamab is in reducing the amount of Pseudomonas aeruginosa bacteria in the sputum, which is the mucus that is coughed up from the lungs, over a period of 12 weeks.

Participants in the study will receive either Gremubamab or a placebo, which is a substance with no active medication, through an intravenous infusion, meaning it is administered directly into the vein. The study will last for a total of 12 weeks, during which participants will have regular check-ups to monitor their health and the effects of the treatment. The main goal is to see if Gremubamab can help reduce the bacterial burden in the lungs, potentially leading to fewer infections and improved lung function.

The trial is designed to gather important information about the potential benefits of Gremubamab for people with bronchiectasis and chronic Pseudomonas aeruginosa infection. By participating in this study, researchers hope to find a new way to manage this challenging condition and improve the quality of life for those affected. The study will follow a structured schedule, with assessments at various points to track progress and gather data on the treatment's effectiveness.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age, clinical diagnosis of bronchiectasis, and previous test results showing Pseudomonas aeruginosa in the airways.

    Informed consent is required to participate in the study.

  2. Step 2

    Baseline assessment

    A baseline assessment is conducted to collect initial data. This includes a sputum sample to confirm the presence of Pseudomonas aeruginosa.

  3. Step 3

    Treatment administration

    The treatment involves the administration of gremubamab or a placebo.

    The medication is given as a solution for infusion through an intravenous infusion.

  4. Step 4

    Follow-up assessments

    Follow-up assessments occur at various intervals: Days 7, 14, 28, 56, 84, and 168.

    These assessments monitor the bacterial burden in sputum and other health indicators.

  5. Step 5

    Primary endpoint evaluation

    The primary endpoint is evaluated on Day 84 to assess the efficacy of gremubamab in reducing Pseudomonas aeruginosa in sputum.

  6. Step 6

    Secondary endpoint evaluation

    Secondary endpoints are evaluated from baseline to various days, including Days 28, 56, 84, and 168, to gather additional data on treatment effects.

  7. Step 7

    Completion of the study

    The study is estimated to conclude by August 30, 2024, after all assessments and data collection are completed.

Who can join the trial?

6 criteria

  • Must be between the ages of 18 and 85.
  • Have a clinical diagnosis of Bronchiectasis, which is a lung condition where the airways become widened and scarred.
  • Must be able to understand and agree to participate in the study by signing a consent form.
  • Have had a previous CT scan of the chest showing bronchiectasis in one or more parts of the lungs. A CT scan is a special type of X-ray that gives detailed pictures of the inside of the body.
  • Have had Pseudomonas aeruginosa, a type of bacteria, found in a sample from the lungs or airways at least once in the 24 months before the study starts.
  • Provide a sputum sample, which is mucus from the lungs, that tests positive for Pseudomonas aeruginosa at the screening visit and within 35 days before being randomly assigned to a study group.

Who cannot join the trial?

3 criteria

  • Patients who do not have **bronchiectasis** (a condition where the airways in the lungs are damaged and widened) and a **chronic Pseudomonas aeruginosa infection** (a long-lasting infection caused by a specific type of bacteria) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who belong to a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

Gremubamab is a medication being studied for its potential to reduce the amount of Pseudomonas aeruginosa bacteria in the sputum of patients with bronchiectasis. This trial aims to see if Gremubamab can effectively lower the bacterial burden in the lungs, which could help improve symptoms and outcomes for patients with chronic lung infections.

What is already known about the treatment

Gremubamab – Gremubamab is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials and is not yet widely available in medical practice. The main therapeutic indication for Gremubamab is the treatment of bronchiectasis with chronic Pseudomonas aeruginosa infection. At the molecular level, Gremubamab works by targeting specific components of the bacteria, reducing their presence in the lungs. It is classified as a monoclonal antibody, which is a type of medication designed to bind to specific proteins.

Investigated diseases

  • Bronchiectasis

    This is a chronic condition where the walls of the bronchi, the air passages in the lungs, become thickened from inflammation and infection. Over time, the airways lose their ability to clear out mucus, leading to frequent lung infections. Symptoms often include a persistent cough, production of large amounts of sputum, and shortness of breath. The disease can progress with repeated infections causing further damage to the airways. This can lead to a cycle of infection and inflammation, worsening lung function over time.

  • Chronic Pseudomonas aeruginosa infection

    This is a long-term infection caused by the bacterium Pseudomonas aeruginosa, commonly affecting individuals with underlying lung conditions. The bacteria can form biofilms, making them resistant to the body's immune response and difficult to eradicate. Symptoms may include persistent cough, production of greenish or yellowish sputum, and difficulty breathing. The infection can lead to chronic inflammation and damage to lung tissue. Over time, this can result in a decline in lung function and increased frequency of respiratory exacerbations.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502494-41-00Protocol code1-023-22Estimated enrolment90 patientsSponsorNHS Tayside

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).