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Efficacy and safety of galvokimig in adults with non‑cystic fibrosis bronchiectasis: a randomized, double‑blind, placebo‑controlled phase 2 trial

Verified siteInvestigational
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What is this trial about?

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

The condition being studied is non-cystic fibrosis bronchiectasis, a chronic lung problem where the airways become widened and scarred, leading to mucus buildup and repeated infections. The investigational medicine is galvokimig, given as a small injection under the skin, and it is being compared with a placebo, which looks the same but contains no active drug.

The purpose of the study is to find out if galvokimig is safe and works to delay the first pulmonary exacerbation, which is a worsening of breathing problems that may require extra treatment. Participants will receive the assigned injection once a month for a period of about 24 to 52 weeks, with regular clinic visits to check breathing health, record any side effects, and complete a survey called the Quality of life questionnaire-bronchiectasis that asks about daily symptoms. Lung function will be measured with a test known as forced expiratory volume in 1 second (FEV1), which shows how much air can be exhaled in one second and helps assess improvement.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Assessments

    After joining the study, you will undergo a series of baseline assessments to record your health status.

    These assessments include a medical history review, a lung function test called FEV1 (the amount of air you can force out of your lungs in one second), and a questionnaire that measures quality of life related to bronchiectasis.

  2. Step 2

    Randomization and First Dose

    Based on a random process, you will be assigned to receive either galvokimig or a placebo that looks like a 0.9% sodium chloride (saline) solution.

    The first dose will be given by a subcutaneous injection (an injection under the skin) according to the study protocol.

    The recorded dose for the study medication is 00 mg, administered as a solution for injection.

  3. Step 3

    Regular Dosing Schedule

    You will continue to receive the assigned injection on a regular schedule defined by the study, for a total treatment period ranging from 24 to 52 weeks.

    Each injection will be administered by study staff or, if permitted, by you at home following the same method (subcutaneous injection).

  4. Step 4

    Clinic Visits and Monitoring

    Throughout the treatment period, you will attend clinic visits at predetermined intervals (for example, at weeks 4, 12, 24, 36, and 52).

    During each visit, the study team will repeat lung function tests, review the quality of life questionnaire, and check for any adverse events (side effects).

  5. Step 5

    Reporting Pulmonary Exacerbations

    If you experience worsening respiratory symptoms that meet the study definition of a moderate or severe pulmonary exacerbation, you must report them promptly to the study team.

    These reports are essential for evaluating the primary goal of the study, which is the time to the first exacerbation.

  6. Step 6

    End‑of‑Study Assessments

    At the conclusion of the treatment period (either after 24 weeks or after 52 weeks, depending on your assigned duration), you will undergo final assessments similar to the baseline tests.

    The final visit will include lung function measurement, completion of the quality of life questionnaire, and a safety review to document any adverse events that occurred during the study.

Who can join the trial?

8 criteria

  • Be between 18 and 80 years old when you sign the consent form.
  • Have a documented diagnosis of non‑cystic fibrosis bronchiectasis (a lung condition that causes chronic cough, mucus production, and repeated infections) confirmed by a special chest scan called high‑resolution computed tomography (HRCT) that shows airway damage in at least one lung lobe.
  • Currently produce mucus (sputum) and be able to give a spontaneous sputum sample at the screening visit; if you cannot produce sputum, you will not pass screening.
  • Have had at least two moderate or severe lung flare‑ups (pulmonary exacerbations) in the past 12 months, or one severe flare‑up in the past 6 months.
  • Your lung function test after using a medicine that opens the airways (post‑bronchodilator forced expiratory volume in one second (FEV1) % predicted) must be at least 30 % of the normal value for someone of your age, sex, and size.
  • Be able to use an inhaler correctly and perform a breathing test (spirometry) according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines; if the first attempt is not adequate, you may try again once.
  • If you are male, you must agree to use contraception during the study and for at least 60 days after the last dose, and you must not donate sperm during that time.
  • If you are female, you must not be pregnant or breastfeeding, and you must either be unable to become pregnant or agree to use contraception during the study and for at least 60 days after the last dose.

Who cannot join the trial?

11 criteria

  • Any medical or mental health condition, physical exam finding, lab test result, or electrocardiogram (ECG) result that the study doctor thinks could be risky with the study drug, could affect the study results, or could make it unsafe for you to take part.
  • Having had a lung transplant in the past.
  • Having an absolute neutrophil count (ANC) lower than 1.5 × 10³ per microliter, which means a low level of a certain white blood cell that helps fight infection.
  • Having inflammatory bowel disease (IBD) yourself or a first‑degree family member with IBD, such as Crohn’s disease or ulcerative colitis. IBD is a group of conditions that cause chronic inflammation of the digestive tract.
  • Having a history of long‑lasting or repeating serious infections, or a serious infection outside the lungs (called an extrapulmonary infection) within the 6 months before the study starts.
  • Any of the following tuberculosis (TB) situations: known active TB disease; past active TB that was not fully treated and confirmed cured; hidden TB infection (latent TB) unless you have finished the recommended preventive treatment; or a high risk of catching TB.
  • Having another important lung disease besides non‑cystic fibrosis bronchiectasis, as judged by the study doctor.
  • Having an acute infection (including a lung infection) that needed antibiotics, systemic corticosteroids (steroids taken by mouth or injection), or antiviral medication within 4 weeks before screening, or during the screening period. A lung flare‑up (pulmonary exacerbation) during screening also prevents enrollment.
  • Having bronchiectasis caused by lung scarring (fibrosis), cystic fibrosis, low antibody levels (hypogammaglobulinemia), common variable immunodeficiency, or α1‑antitrypsin deficiency. These are specific conditions that can lead to bronchiectasis.
  • Having a primary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or asthma (having it as a secondary diagnosis is allowed).
  • Having significant hemoptysis—coughing up 300 mL of blood or more, or needing a blood transfusion because of coughing up blood—within 6 weeks before screening.
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Investigated drugs

Galvokimig is an experimental medicine being given as a subcutaneous injection. In this study it is tested to see if it can help adults with non‑cystic fibrosis bronchiectasis have fewer lung flare‑ups. Participants receive the drug for up to a year, and researchers compare how often they experience a worsening of breathing problems compared with those who receive a placebo.

What is already known about the treatment

  • Placebo matching Test 0.9% sodium chloride solution for injection and without active substance

    This product is a sterile salt water solution that is given by injection, usually under the skin, and contains no active drug. It is used only as a control in clinical studies and has no therapeutic effect on its own. Its purpose is to mimic the appearance and administration method of the test drug so that participants and researchers remain blinded. As a placebo, it is not a marketed medication and is described only in trial protocols and scientific reports.

  • Galvokimig

    Galvokimig is supplied as a clear solution for injection and is administered by subcutaneous (under‑the‑skin) injection. It is an investigational biologic that is currently in Phase 2 clinical trials and is not yet approved for general medical use. The drug is being studied for adults with non‑cystic fibrosis bronchiectasis, a chronic lung condition that causes repeated infections and airway damage. It works by blocking specific inflammatory signals in the body, helping to reduce lung inflammation and the risk of flare‑ups. Pharmacologically, it is classified as an experimental anti‑inflammatory biologic agent.

Investigated diseases

Non‑cystic fibrosis bronchiectasis - Non‑cystic fibrosis bronchiectasis is a condition in which the airways of the lungs become permanently widened and damaged. The widening is usually caused by repeated infections or inflammation that weaken the airway walls. As the disease progresses, mucus builds up in the enlarged airways, making it easier for bacteria to grow. This can lead to more frequent coughing, sputum production, and episodes of worsening breathing problems called exacerbations. Over time, the repeated damage can cause the lungs to become less efficient at moving air in and out. The condition is chronic, meaning it persists for a long time and may gradually worsen.
Trial detailsLast updated 12 Nov 2026
Age18+ yearsPhasePhase IITrial ID2026-525524-18-00Protocol codeNCFB01Estimated enrolment224 patientsSponsorUCB Biopharma

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