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A study testing GSK3862995B compared to placebo for safety and effectiveness in adults aged 18 to 85 years with bronchiectasis

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 study is looking at a condition called bronchiectasis, which is a lung disease where the airways become damaged and widened, making it difficult to clear mucus and leading to repeated lung infections. People with this condition often experience frequent flare-ups of their symptoms, called exacerbations, which can include increased cough, more mucus production, and breathing difficulties. The study will test a medication called GSK3862995B, which is a biologic treatment given as an injection under the skin. Some participants will receive the actual medication while others will receive a placebo. The study will also use 5% Dextrose Injection, which is a simple sugar solution given through injection.

The purpose of the study is to evaluate how well GSK3862995B works compared with placebo in people with bronchiectasis. The study will look at whether the medication can reduce the number of times patients experience flare-ups of their condition over time. The study will also examine the safety of the medication, how the body's immune system responds to it, and how the medication moves through and is processed by the body.

During this study, participants will receive repeated doses of either GSK3862995B or placebo over a period of time. The study is designed so that neither the participants nor the doctors will know who is receiving the actual medication and who is receiving the placebo until the study is completed. Throughout the study, doctors will monitor how often participants experience flare-ups of their bronchiectasis, how long it takes before the first flare-up occurs, and how many severe flare-ups happen. The study is expected to continue until late 2027.

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

    Initial screening and consent

    Your participation begins with signing an informed consent form, which explains all requirements and restrictions of the study.

    A pregnancy test will be performed if you are a woman of childbearing potential. This test must be negative before you can receive the first dose of the study treatment.

    Your body mass index will be checked to confirm it falls within the range of 18 to 35 kilograms per square meter.

    Your age will be verified to ensure you are between 18 and 85 years old.

  2. Step 2

    Treatment phase

    You will receive either GSK3862995B or placebo during the study. A placebo is an inactive substance that looks like the real treatment but contains no active medication.

    The study treatment will be administered as a subcutaneous injection, which means it will be injected under your skin.

    The treatment involves repeat doses over the course of the study.

    The specific dosage, frequency, and exact duration of treatment administration are determined by the study protocol.

    You will be assigned to your treatment group randomly, and neither you nor your study doctor will know whether you are receiving the active medication or placebo. This is called a double-blind study design.

  3. Step 3

    Monitoring for exacerbations

    Throughout the study, your condition will be monitored to track any exacerbations. An exacerbation is a period when your bronchiectasis symptoms become worse than usual.

    The study will record the number and severity of exacerbations you experience.

    The time until your first exacerbation occurs will be documented.

    Information about severe exacerbations, which are more serious worsening episodes of your condition, will also be collected.

  4. Step 4

    Safety monitoring

    Your safety will be monitored throughout the study period.

    Any side effects or adverse reactions you experience will be recorded and evaluated.

    Your body's immune response to the treatment will be assessed. This is called immunogenicity testing.

    The study will also measure how your body processes the medication, which is known as pharmacokinetics.

  5. Step 5

    Contraception requirements

    If you are a woman of childbearing potential, you must use a highly effective contraceptive method throughout the study.

    You must not be pregnant or breastfeeding during your participation in the study.

    These requirements are in place to ensure your safety and the safety of any potential pregnancy.

  6. Step 6

    Treatment restrictions

    During the study, you should not discontinue the study treatment without discussing it with your study doctor.

    You should not change your maintenance standard of care medications without approval.

    Certain medications may be prohibited during the study, and you will be informed about these restrictions.

    Following these restrictions is important for the accuracy of the study results.

  7. Step 7

    Study completion

    The study is expected to continue until November 2027.

    Your individual participation duration will be determined by the study protocol.

    Final assessments will be conducted to evaluate the overall effect of the treatment on your condition.

Who can join the trial?

7 criteria

  • You must be between 18 and 85 years old when you sign the consent form to join the study.
  • Your BMI, which is a measure of body weight compared to height, must be between 18 and 35.
  • Both men and women can participate in this study.
  • If you are a woman who can become pregnant, you must use a highly effective birth control method during the study. Women who cannot become pregnant due to age or surgery can also participate.
  • If you are a woman who can become pregnant, you must have a negative pregnancy test within 28 days before receiving the first dose of the study treatment.
  • You must not be pregnant or breastfeeding to participate.
  • You must be able to understand and sign a consent form that explains the study requirements and agree to follow all the rules and restrictions of the study.

Who cannot join the trial?

14 criteria

  • The patient has cystic fibrosis, which is a genetic condition that causes thick mucus to build up in the lungs and other organs
  • The patient has active tuberculosis, which is a serious bacterial infection that mainly affects the lungs
  • The patient has active non-tuberculous mycobacterial infection, which is an infection caused by bacteria similar to tuberculosis but different from it
  • The patient has allergic bronchopulmonary aspergillosis, which is an allergic reaction in the lungs to a type of fungus
  • The patient has a known lung cancer or other cancer that has spread to the lungs
  • The patient has had a lung transplant, which is surgery to replace a diseased lung with a healthy lung from a donor
  • The patient has severe asthma that is not well controlled with current treatment
  • The patient has chronic obstructive pulmonary disease (COPD), which is a long-term lung disease that makes it hard to breathe
  • The patient is currently experiencing a respiratory infection that requires treatment with antibiotics
  • The patient has received immunosuppressive therapy, which are medications that weaken the immune system, within a certain time period before the study
  • The patient is pregnant or breastfeeding
  • The patient has severe liver disease or kidney disease that affects how the organs work
  • The patient has a known allergy or severe reaction to the study medication or similar medications
  • The patient is participating in another clinical trial or has recently participated in one
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Investigated drugs

  • GSK3862995B

    is an investigational medication being studied in this clinical trial. It is given to participants with bronchiectasis, which is a lung condition where the airways become damaged and widened. This medication is being tested to see if it can help improve the condition of people with bronchiectasis. Researchers want to find out if it works better than placebo and if it is safe to use.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study so researchers can compare the effects of GSK3862995B against no treatment to determine if the medication actually works.

What is already known about the treatment

GSK3862995B – GSK3862995B is an experimental medication currently being studied in Phase 2 clinical trials for the treatment of bronchiectasis, a lung condition where the airways become abnormally widened and damaged, leading to mucus buildup and repeated infections. The drug is administered as part of a research study to evaluate whether it can effectively reduce symptoms and improve lung function in patients with this condition. While the exact mechanism of action is still under investigation, the medication is being tested to determine if it can provide therapeutic benefits compared to placebo, and researchers are also studying its safety profile, how the body processes it, and whether it triggers any immune responses.

Investigated diseases

Bronchiectasis – Bronchiectasis is a long-term condition affecting the airways in the lungs. The airways become abnormally widened and damaged, losing their ability to clear mucus effectively. As mucus builds up, it creates an environment where bacteria can grow, leading to repeated lung infections. Over time, the cycle of infection and inflammation causes further damage to the airway walls. This ongoing damage makes the airways even wider and less functional. People with this condition often experience a persistent cough with mucus production and frequent chest infections.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522892-27-00Protocol code223977Estimated enrolment363 patientsSponsorGSK PLC

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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.

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