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Study of galvokimig versus placebo to assess safety and effectiveness in adults with moderate‑to‑severe chronic obstructive pulmonary disease with chronic bronchitis

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What is this trial about?

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

The study investigates adults with Chronic Obstructive Pulmonary Disease with chronic bronchitis, a condition where the airways are narrowed and produce excess mucus, leading to shortness of breath and coughing. The experimental medicine, called galvokimig, is given by a small injection under the skin, and it is compared with a placebo, which looks the same but contains no active drug. The purpose of the study is to determine whether galvokimig is safe and effective in reducing the time to the first acute exacerbation—a sudden worsening of symptoms—in this patient group.

Participants are randomly assigned to receive either the medication or the placebo for a period that can range from about six months to a year. During the study they attend regular clinic visits where basic health checks are performed, blood samples are taken, and lung function is measured using a test called forced expiratory volume in 1 second (FEV1). They also complete a health survey known as the St. George's Respiratory Questionnaire-COPD-specific version (SGRQ-C) that asks about breathlessness, activity limitation, and overall quality of life. Safety is monitored throughout, and any side effects are recorded.

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

    Randomization and Assignment

    After joining the study, you will be assigned by a computer system to receive either the investigational medicine galvokimig or a matching placebo (a saline solution without active drug). This process is called randomization and ensures that the assignment is not influenced by anyone.

    The study is double‑blind, meaning neither you nor the study staff will know which product you receive until the study is finished.

  2. Step 2

    Baseline Assessments

    Before the first dose, you will undergo a series of checks that may include breathing tests, questionnaires about your respiratory health, and a review of your medical history. These measurements provide a starting point for later comparison.

  3. Step 3

    First Dose Administration

    You will receive the first injection of the assigned product. The medication is given subcutaneously (under the skin) as a solution for injection. The exact amount of the dose is defined by the study protocol, but the label indicates a dose of 0 mg; the precise dosage will be set by the study team.

    If you are assigned to the placebo, you will receive an injection of a 0.9% sodium chloride solution that looks identical to the active product.

  4. Step 4

    Ongoing Treatment Period (24 to 52 Weeks)

    You will continue to receive the same injection regularly for a period that may last between 24 and 52 weeks, as specified by the study schedule.

    During this time you will attend scheduled clinic visits where you may receive the next dose, have your breathing function measured (e.g., forced expiratory volume in 1 second, or FEV1), and complete questionnaires such as the St. George's Respiratory Questionnaire‑COPD‑specific version (SGRQ‑C) to assess symptoms and quality of life.

    The study team will also check for any side effects or health problems that arise while you are taking the medication.

  5. Step 5

    Safety Monitoring

    At each visit you will be asked about any new symptoms or health issues. All reported problems are recorded as adverse events, and serious events are evaluated promptly.

    The study staff may perform additional tests if needed to ensure your safety.

  6. Step 6

    End‑of‑Treatment Assessment

    At the conclusion of the treatment period, you will undergo a final set of assessments similar to those performed at baseline. These include lung‑function testing, completion of the SGRQ‑C questionnaire, and a review of any adverse events that occurred during the study.

    The primary goal of the study is to determine how long it takes for the first moderate or severe worsening of COPD symptoms (acute exacerbation) to occur after you started treatment.

  7. Step 7

    Study Completion

    After the final assessments, your participation in the trial ends. The study team will analyze the collected data to evaluate the safety and effectiveness of galvokimig compared with the placebo.

Who can join the trial?

8 criteria

  • Be between 40 and 80 years old when you sign the consent form.
  • Have a doctor‑diagnosed case of moderate‑to‑severe chronic obstructive pulmonary disease (COPD) that includes chronic bronchitis (a long‑lasting cough with mucus).
  • Be using regular inhaled medicines for at least three months before screening, specifically a combination of a long‑acting beta2 agonist (LABA) and a long‑acting muscarinic antagonist (LAMA), with or without an inhaled corticosteroid (ICS).
  • Be at high risk for flare‑ups, meaning you have had at least two moderate or severe acute exacerbations (AECOPD) in the past 12 months, or one severe exacerbation in the past 6 months.
  • Score 15 or higher on the Chronic Airways Assessment Test (CAAT) when screened.
  • Show that you can use an inhaler correctly and can perform a breathing test called spirometry according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.
  • Be able to follow birth‑control rules if you are male or female: men must use contraception and avoid donating sperm for at least 60 days after the last dose; women must not be pregnant or breastfeeding and must either not be able to become pregnant or agree to use contraception for the same time period.
  • Have a history of smoking cigarettes (or having smoked) amounting to at least 10 pack‑years (for example, one pack per day for ten years).

Who cannot join the trial?

12 criteria

  • Any medical or psychiatric condition, physical exam finding, lab test result, or electrocardiogram (ECG) result that the doctor believes could be risky, could affect the study data, or could make it unsafe for the participant to take the study medication.
  • Absolute neutrophil count (ANC) lower than 1.5 × 10³ per microliter – neutrophils are a type of white blood cell that helps fight infection, and a low count means a higher risk of infection.
  • Corrected QT interval (QTc) longer than 450 milliseconds for men, longer than 470 milliseconds for women, or longer than 480 milliseconds if the person has bundle branch block – QTc is a measurement of the heart’s electrical activity on an ECG; a prolonged QTc can lead to dangerous heart rhythms. Bundle branch block is a pattern of abnormal heart electrical conduction.
  • History of chronic alcohol or drug abuse within the past 12 months.
  • History of uncompensated heart failure, fluid overload (excess fluid in the body), heart attack, new onset heart disease, or any other serious heart condition within 12 months before screening.
  • Personal or first‑degree family history of inflammatory bowel disease (IBD) – a chronic inflammation of the intestines.
  • Uncontrolled neuropsychiatric disorder, active suicidal thoughts, or any recent suicidal behavior.
  • History of chronic or recurring serious infections, or a serious infection outside the lungs within 6 months before the study start.
  • Any other important lung disease besides COPD with chronic bronchitis.
  • Hypercapnia (high carbon dioxide level in the blood) that requires use of BiPAP (a breathing machine that provides two levels of air pressure to help breathing).
  • Received a live or weakened (attenuated) vaccine within 4 weeks before screening or plans to receive such a vaccine during the study – live vaccines contain a weakened form of a virus or bacteria.
  • Safety problems with drugs that target interleukin‑13 or interleukin‑17 (proteins that help control the immune system) that caused stopping or changing treatment.
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Investigated drugs

Galvokimig is an experimental medicine given as a liquid that is injected under the skin. In this study it is being tested to see if it can help people with moderate‑to‑severe chronic obstructive pulmonary disease (COPD) who also have chronic bronchitis. The researchers want to find out whether Galvokimig can delay the first worsening of COPD symptoms, known as an acute exacerbation, compared with no active treatment. Participants will be followed for up to a year to evaluate how well the drug works and whether it is safe.

What is already known about the treatment

  • Galvokimig

    Galvokimig is given as a clear liquid that is injected under the skin (subcutaneous injection). It is still an experimental drug being studied in a Phase 2 clinical trial and is not yet approved for regular medical use. The trial is testing it for people with moderate‑to‑severe chronic obstructive pulmonary disease (COPD) that includes chronic bronchitis. It is thought to work by gently adjusting the body’s immune response to lower inflammation in the airways, and it is classified as an investigational anti‑inflammatory agent.

  • Placebo matching Test 0.9% sodium chloride solution for injection

    This placebo is a sterile salty water solution (0.9 % sodium chloride) that is also injected under the skin in the same way as the test drug. It contains no active medicine and is used only as a control in the study, so it has no therapeutic indication. Because it has no active ingredient, it does not have a mechanism of action or a pharmacological class; it simply mimics the injection process to help compare the effects of Galvokimig.

Investigated diseases

Chronic obstructive pulmonary disease with chronic bronchitis - It is a long‑term lung condition in which the airways are narrowed and inflamed, and the lungs produce excess mucus. Over time the airflow becomes more limited, making breathing harder during daily activities. Episodes of worsening symptoms, called exacerbations, can occur and may require additional care. The disease usually progresses from mild breathing difficulty to more pronounced shortness of breath and cough. Persistent mucus production contributes to frequent coughing and sputum expectoration. The condition tends to worsen gradually, especially if exposure to irritants like cigarette smoke continues.
Trial detailsLast updated 11 Nov 2026
Age18+ yearsPhasePhase IITrial ID2026-525523-25-00Protocol codeCOPD01Estimated enrolment238 patientsSponsorUCB Biopharma

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