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GB-0895 for Severe Uncontrolled Asthma in Adults and Adolescents

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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 studying severe uncontrolled asthma, a form of asthma in which breathing problems and flare-ups are not well controlled with usual treatment. The study is testing GB-0895, given as a subcutaneous injection under the skin, as an extra treatment along with regular asthma care. A placebo is also used for comparison. The purpose of the study is to see whether GB-0895 can help reduce serious asthma flare-ups and whether it is safe to use over time.

Adults and adolescents in the study are assigned by chance to receive either GB-0895 or placebo, and neither the participants nor the study team knows which one is given during the study. Treatment is given over about 52 weeks, with regular study visits during that time. The study looks at how asthma changes over the year, including flare-ups, breathing, asthma symptoms, and daily life with asthma.

Some medical terms used in the study include exacerbations, which means asthma flare-ups that are bad enough to need steroid medicine or a hospital or emergency room visit, and forced expiratory volume in 1 second (FEV1), which is the amount of air that can be blown out in one second. The study also uses systemic corticosteroids, which are steroid medicines that work throughout the body.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study entry and assignment

    After joining the study, you are placed into one of two study groups by chance. The study is randomized, which means the group is chosen by a random process.

    The study is double-blind, which means you do not know which treatment you receive, and the study team does not know either during the study.

    You receive either GB-0895 or placebo. The placebo is 0.9% sodium chloride, which does not contain the study medicine.

  2. Step 2

    Study treatment period

    You receive GB-0895 as a subcutaneous injection, which means an injection under the skin, at a dose of 300 mg.

    If you are assigned to the placebo group, you receive 0.9% sodium chloride by the same type of injection.

    The treatment is given as adjunctive therapy, which means it is added to your usual asthma treatment.

    The study treatment continues for 52 weeks.

  3. Step 3

    Monitoring of asthma outcomes during the 52 weeks

    During the 52-week study period, your asthma is followed to see whether you have clinically significant exacerbations. This means asthma flare-ups that require systemic corticosteroids or lead to a hospital stay or an emergency department visit with systemic corticosteroids.

    The study also measures the number of asthma flare-ups over time.

    Your breathing is checked by measuring FEV1, which means the amount of air you can force out in one second before using a bronchodilator, at Week 52.

    Your asthma-related quality of life is measured with the AQLQ(S)12+ questionnaire at Week 52.

    Your asthma control is measured with the ACQ-6 questionnaire at Week 52.

    The time until your first clinically significant asthma flare-up is recorded from the time you are assigned to a study group.

    Your daytime asthma symptoms are recorded using the ADSD diary, which means Asthma Daytime Symptom Diary, and the weekly average score is checked at Week 52.

    Your nighttime asthma symptoms are recorded using the ANSD diary, which means Asthma Nighttime Symptom Diary, and the weekly average score is checked at Week 52.

Who can join the trial?

11 criteria

  • Be an adult or adolescent aged 12 to 80 years when the consent form is signed.
  • Have a doctor-diagnosed asthma for at least 2 years, and the diagnosis must meet accepted asthma care guidelines.
  • Be using a daily inhaled corticosteroid for at least 12 months before screening, at a medium to high dose. An inhaled corticosteroid is a medicine breathed into the lungs to reduce swelling and irritation in the airways.
  • Also be using at least one additional controller medicine for asthma for at least 3 months before screening, with no change in the inhaled steroid dose or other controller medicines for at least 3 months. A controller medicine is a regular asthma medicine used to help prevent symptoms.
  • If using ICS-formoterol as both maintenance and reliever treatment, have used it for at least 12 months before screening, with no change in the inhaled steroid dose for at least 3 months. ICS means inhaled corticosteroid, and formoterol is a long-acting medicine that helps open the airways.
  • Have had at least 2 asthma flare-ups in the past 12 months that required systemic corticosteroids despite using medium- to high-dose inhaled corticosteroids. Systemic corticosteroids are steroid medicines taken by mouth or given by injection that work through the whole body.
  • Show airflow obstruction, meaning reduced airflow in the lungs, at screening:
    • If aged 18 years or older, have a pre-bronchodilator FEV1 below 80% of the expected value. FEV1 is the amount of air a person can force out in one second.
    • If aged 12 to under 18 years, have a pre-bronchodilator FEV1 below 90% of the expected value, or have an FEV1 to FVC ratio below 0.80. FVC is the total amount of air a person can force out after taking a deep breath.
    • Have a positive bronchodilator response during screening, meaning lung function improves by at least 12% and 200 mL after using a short-acting bronchodilator medicine. A bronchodilator is a medicine that opens the airways. If this is not seen, the test may be repeated once if there was at least a 9% improvement in FEV1 after the medicine, or there must be written proof of a positive test from within the past 18 months.
    • Have an Asthma Control Questionnaire-6 score of at least 1.5 at both the screening visit and the randomization visit. This questionnaire measures how well asthma symptoms are controlled, and a higher score means worse control.
    • Weigh at least 40 kg at the screening visit.

Who cannot join the trial?

32 criteria

  • Having a clinically significant asthma flare-up within 12 weeks before screening, or during the run-in period, if it requires a change in regular asthma treatment.
  • Having another important lung disease besides asthma, such as a current infection, bronchiectasis (damaged and widened airways), pulmonary fibrosis (scarring of the lungs), allergic bronchopulmonary aspergillosis (a lung reaction to a fungus), tuberculosis, chronic obstructive pulmonary disease such as emphysema or chronic bronchitis, or a history of lung cancer.
  • Having known or suspected active tuberculosis.
  • Having an eosinophilic disease other than asthma that can raise eosinophils, which are a type of white blood cell, such as eosinophilic granulomatosis with polyangiitis or eosinophilic esophagitis.
  • Having any other illness that is not stable and could affect safety, study results, or the ability to finish the study, including problems with the heart, stomach, liver, kidneys, nerves, muscles, infections, hormones, metabolism, blood, mental health, or a major physical disability.
  • Having a clinically significant infection that needs antibiotics, antifungal medicine, antiparasitic medicine, or antiviral medicine within 14 days before joining the study or during the run-in period.
  • Having a recent acute illness that is still unresolved within 7 days before randomization, which means the day the person is assigned to a treatment group.
  • Having a current cancer or any cancer within the past 5 years, except for skin cancer removed for cure or a very early cervical cancer that was removed for cure.
  • Having a helminth infection, which means a worm parasite infection, within the past 6 months.
  • Being a current smoker, having a smoking history of 10 or more pack-years (a measure of smoking amount), or using vaping products such as e-cigarettes.
  • Being a former smoker with less than 10 pack-years or a former vaping/e-cigarette user who stopped less than 6 months before screening.
  • Having a known immunodeficiency disorder, which means a weak immune system, including a positive HIV test, or taking antiretroviral medicines, which are drugs used to treat HIV.
  • Having had major surgery within 8 weeks before screening, or having planned surgery during the study that needs general anesthesia (medicine that puts you fully asleep) or a hospital stay longer than 1 day.
  • Having used certain asthma biologic medicines before, including anti-IL-5 treatments such as mepolizumab, reslizumab, benralizumab, or depemokimab within 12 months, or other asthma monoclonal antibodies such as dupilumab or omalizumab within 4 months or 5 half-lives, whichever is longer.
  • Having ever used any anti-TSLP or anti-TSLP receptor biologic medicine, whether approved or still being studied.
  • Having taken systemic immunosuppressive or immunomodulating drugs within the last 12 weeks, such as methotrexate or cyclosporine, except for oral steroids used for asthma. A stable daily dose of prednisone 10 mg or less, or an equal dose, is allowed only if it has been unchanged for at least 3 months and is not planned to change during the study.
  • Having received an investigational medicine, meaning a medicine still being studied, within 4 months or 5 half-lives for a biologic, or within 30 days or 5 half-lives for a non-biologic medicine, before screening.
  • Having a known allergy or sensitivity to any part of the study treatment, or another drug allergy that the investigator or medical monitor thinks makes participation unsafe.
  • Having had life-threatening anaphylaxis, which is a severe and sudden allergic reaction, after any biologic treatment.
  • Being enrolled in another clinical study that involves an investigational product.
  • Having already been randomized in this study or in a previous GB-0895 study.
  • Being involved in planning or running the study, or being a site or sponsor employee, or a relative of such an employee.
  • Having any important abnormal finding on physical exam, blood pressure or other vital signs, ECG (a heart tracing test), blood tests, or urine tests that could make the study unsafe, affect the results, or prevent finishing the study.
  • Having cirrhosis (severe scarring of the liver) or another active or clinically significant liver disease, including high liver blood tests: AST, ALT, or alkaline phosphatase more than 2 times the upper limit of normal, or total bilirubin more than 1.5 times the upper limit of normal, unless the only issue is Gilbert’s syndrome with no other liver problems.
  • Having hepatitis B or hepatitis C in certain situations, including a positive hepatitis B surface antigen test, detectable hepatitis B DNA when further testing is needed, chronic hepatitis C infection, or evidence of chronic liver disease.
  • Having received immunoglobulin or any blood product within 30 days before screening.
  • Having received a live attenuated vaccine, which is a vaccine made from weakened live germs, within 30 days before randomization or at any time during the study, including follow-up.
  • Having received suplatast tosilate, a medicine that affects the immune system, within 15 days before screening.
  • Having had bronchial thermoplasty, a procedure that uses heat to treat asthma, within the last 12 months.
  • Being pregnant, breastfeeding, or planning to become pregnant during the study.
  • Being unwilling or unable to follow study rules, including poor use of regular asthma controller medicines.
  • Having a history, or suspected history, of alcohol misuse or substance abuse within the past 2 years.
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Investigated drugs

GB-0895 is the study medicine being tested in this trial. It is given as an injection under the skin and is used as an add-on treatment for people with severe asthma that is not well controlled. The goal of the study is to see whether it can help lower the number of serious asthma flare-ups over time and to check how safe it is when used along with the patient’s usual asthma treatment.

What is already known about the treatment

  • 0.9% sodium chloride

    This is a sterile salt-water solution given by injection or infusion, and in this trial it is used as a placebo, meaning it has no active drug effect. It is widely used in medicine and is well known in medical literature as a basic fluid for hydration, cleaning, and as a control treatment in studies. It does not treat asthma and has no direct effect on body receptors or disease pathways, so it is classified as a sodium chloride solution and placebo comparator.

  • GB-0895

    GB-0895 is given as a subcutaneous injection, which means it is injected under the skin. It is an investigational medicine, so its full place in medical practice is still being studied, but it is being tested for severe uncontrolled asthma as an add-on treatment to help lower the number of serious asthma attacks. Its exact molecular action is not fully established in the source data, but it is designed to act on a specific biological target involved in asthma-related inflammation, and it is classified as an experimental asthma therapy.

Investigated diseases

Severe uncontrolled asthma - A form of asthma in which the airways stay inflamed and overly sensitive, causing frequent symptoms such as wheezing, shortness of breath, chest tightness, and coughing. The condition is not well controlled even with ongoing management, so symptoms and flare-ups continue to occur. Over time, repeated flare-ups can make breathing problems more frequent and more difficult to predict. The disease may also lead to gradual changes in the airways that can make airflow more limited.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521950-41-00Protocol codeGB-0895-301Estimated enrolment786 patientsSponsorGenerate Biomedicines Inc.

sourced from the EU Clinical Trials Register and site verification

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