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Efficacy and safety of GB-0895 as adjunctive therapy in adults and adolescents with severe uncontrolled asthma (randomized, placebo‑controlled)

Fast replyInvestigationalNo placebo

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What is this trial about?

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

The study focuses on severe uncontrolled asthma, a form of asthma in which symptoms such as shortness of breath, wheezing, and frequent attacks are not well managed despite standard medicines. The investigational drug, identified as GB-0895, is given by a subcutaneous injection (a shot placed just under the skin) and is tested alongside the usual asthma treatments. Participants may receive either the active drug or a harmless saline solution called placebo for comparison.

The purpose of the study is to see whether adding GB-0895 can lower the number of serious asthma attacks over a one‑year period. Volunteers will receive the assigned injection at regular intervals for about 52 weeks and will attend routine visits where doctors will check lung function using simple breathing tests, ask about daily symptoms, and have participants fill out questionnaires that measure how asthma affects daily life and overall well‑being. Terms such as “subcutaneous” mean the medication is delivered under the skin, and “systemic corticosteroids” refer to steroid medicines taken by mouth or injection that help reduce inflammation during severe attacks.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization and first injection
After enrollment you are assigned by chance to receive either gb-0895 or a placebo injection.
The study medication is a subcutaneous injection containing 300 mg of the active substance.
The placebo is a 0.9% sodium chloride injection that looks the same as the active medication.
The injection is given under the skin during the first study visit.
Step 2
Baseline assessments
A breathing test called forced expiratory volume in 1 second is performed to measure lung function.
Questionnaires about asthma symptoms and quality of life are completed, including the asthma control questionnaire and the asthma quality of life questionnaire.
You begin a daily symptom diary in which you record asthma symptoms each day.
Step 3
Regular injection schedule
You return to the clinic for additional injections according to the study schedule.
Each visit you receive the same injection you were assigned at randomization, either gb-0895 or placebo.
The injections continue for a total period of 52 weeks.
Step 4
Periodic follow‑up assessments
At predetermined weeks (for example week 12, week 24, week 36 and week 52) you undergo repeat breathing tests and complete the same questionnaires as at baseline.
The study staff review your daily symptom diary to track changes over time.
Step 5
Monitoring for asthma worsening
If you experience a worsening of asthma that requires steroids or a visit to the emergency department, you report the event to the study team.
Such events are recorded as an exacerbation for the study analysis.
Step 6
Safety monitoring
At each clinic visit the study staff check for any side effects, measure vital signs and may collect blood samples to assess safety.
Step 7
Study completion
After 52 weeks the final assessments are performed, including the breathing test, questionnaires and review of the symptom diary.
The study ends after the final visit and no further study medication is given.

Who can join the trial?

9 criteria

Be between 12 and 80 years old when you sign the informed consent (the form that shows you agree to join the study).
Have a doctor‑confirmed diagnosis of asthma for at least 2 years that follows recognized guidelines such as the National Heart, Lung, and Blood Institute or Global Initiative for Asthma (GINA) recommendations.
Be taking a daily inhaled corticosteroid (ICS) at a medium‑to‑high dose for at least 12 months, and also be using at least one other long‑term asthma medicine (for example a LABA or LAMA) for at least 3 months, with no changes in these medicines for the past 3 months. If you use a combined inhaler that contains both an ICS and formoterol, you must have been on it for 12 months with a stable dose.
Have experienced at least two asthma flare‑ups (exacerbations) in the past 12 months that required a short course of oral systemic corticosteroid medication, even though you were already using medium‑to‑high dose inhaled steroids.
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Show reduced lung function on a breathing test called FEV1 (the amount of air you can force out in one second) before using a bronchodilator:
- For adults (18 years or older) the pre‑bronchodilator FEV1 must be less than 80% of the normal value expected for your age, height, and sex (predicted value).
- For adolescents (12 to under 18 years) either the pre‑bronchodilator FEV1 is less than 90% of predicted, or the ratio of FEV1 to forced vital capacity (FVC) is below 0.80.
- Have a positive bronchodilator responsiveness test: after inhaling a short‑acting bronchodilator (SABA), your FEV1 must increase by at least 12% and by at least 200 mL within 15–60 minutes, measured at least once during screening. If this exact increase is not seen, the test can be repeated with a lower requirement (at least 9% increase) or a documented positive test from the past 18 months can be used.
- Score 1.5 or higher on the Asthma Control Questionnaire (ACQ‑6) at both the screening visit and the randomization visit, indicating that your asthma is not well controlled.
- Weigh at least 40 kg at the screening visit.

Who cannot join the trial?

30 criteria

Had a serious asthma flare‑up that required a change in regular asthma medication within 12 weeks before the screening visit or during the run‑in period.
Has another lung disease besides asthma, such as a current infection, bronchiectasis, lung scarring (pulmonary fibrosis), fungal infection (bronchopulmonary aspergillosis), tuberculosis (TB), chronic obstructive pulmonary disease (COPD), emphysema, chronic bronchitis, or lung cancer.
Has other conditions that can raise eosinophil blood cells, for example eosinophilic granulomatosis with polyangiitis (formerly called Churg‑Strauss syndrome) or eosinophilic esophagitis.
Has any major health problem (heart, liver, kidney, brain, etc.) that is not stable and could affect safety or the study results.
Has a significant infection that needed antibiotics, antifungal, antiparasitic, or antiviral medicines within 14 days before joining the study.
Has an acute illness that has not fully resolved within 7 days before randomization.
Has a current cancer or a cancer diagnosis within the past 5 years, except for certain localized skin cancers.
Has a recent worm (helminth) infection within 6 months before the screening visit.
Is a current smoker, has smoked 10 or more pack‑years, or uses vaping/e‑cigarette products; former smokers with less than 10 pack‑years must have quit at least 6 months before screening.
Has a known immune‑system disorder, a positive HIV test, or is taking HIV medicines (antiretrovirals).
Had major surgery within 8 weeks before the screening visit or plans major surgery that requires general anesthesia or an overnight hospital stay during the study.
Used any anti‑IL‑5 medication (such as mepolizumab, reslizumab, benralizumab, depemokimab) in the past 12 months, or other asthma monoclonal antibodies (such as dupilumab, omalizumab) within 4 months or five half‑lives before screening.
Has ever taken anti‑TSLP or anti‑TSLP‑receptor biologic drugs, whether approved or experimental.
Used systemic immune‑suppressing drugs (e.g., methotrexate, cyclosporine) in the past 12 weeks, except low‑dose oral steroids for asthma that have been stable for at least 3 months.
Received an experimental biologic drug within 4 months (or five half‑lives) or an experimental non‑biologic drug within 30 days (or five half‑lives) before the screening visit.
Is allergic to any ingredient of the study medication or has a drug allergy that the investigator believes makes participation unsafe.
Has ever experienced a life‑threatening allergic reaction (anaphylaxis) to any biologic therapy.
Is already enrolled in another clinical study that uses an investigational product.
Has already been randomly assigned to this study or any previous GB‑0895 studies.
Is involved in planning or conducting the study, or is a relative of study staff or sponsor employees.
Has any significant abnormal finding on physical exam, vital signs, ECG, blood tests, or urine tests that the investigator thinks puts you at risk or could affect the study.
Has serious liver disease such as cirrhosis or liver enzyme levels more than twice the normal limit, or high bilirubin (more than 1.5 times normal) unless due to a harmless condition (Gilbert’s syndrome) with no other liver problems.
Has active hepatitis B infection (positive surface antigen) or chronic hepatitis C infection; certain past hepatitis B or C infections may be allowed only with specific test results.
Received immunoglobulin (antibody) products or blood products within 30 days before the screening visit.
Received a live‑virus vaccine (a weakened virus) within 30 days before randomization or during the study.
Received the T2 cytokine inhibitor suplatast tosilate within 15 days before the screening visit.
Had bronchial thermoplasty (a lung‑procedure) in the past 12 months.
Is pregnant, breastfeeding, or plans to become pregnant during the study.
Is unwilling or unable to follow study procedures, including regularly taking asthma controller medications.
Has a history or suspected history of alcohol misuse or drug misuse within the last 2 years.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Azienda Ospedaliero Universitaria Di Sassari
Sassari, Italy
Verified
Azienda Sanitaria Universitaria Giuliano Isontina
Trieste, Italy
Responsive
Pneumocare
Namur, Belgium

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Investigated drugs

GB-0895 is an experimental medication being tested as an additional treatment for people with severe asthma that is not well‑controlled by their usual medicines. In this study, it is given as a small injection under the skin. Researchers are looking to see if adding GB‑0895 to standard asthma therapy can lower the number of serious asthma attacks over a year compared with standard therapy alone.

What is already known about the treatment

GB-0895
GB-0895 is given as a 300 mg subcutaneous injection, meaning it is placed under the skin using a small needle. It is still an investigational drug and is currently being studied in Phase 3 trials, so it is not yet approved for general medical use. The drug is being tested to help people with severe uncontrolled asthma by reducing flare‑ups when added to their regular treatment. It works by blocking a specific protein that drives airway inflammation, and it is classified as a biologic immune‑modulating agent.
0.9% Sodium Chloride
0.9% Sodium Chloride is a sterile saline solution that can be injected under the skin or given intravenously as a control fluid. It is an approved and widely used medical product, listed in standard drug references for many purposes. In this study it serves as a placebo, providing no active treatment for asthma but helping to compare the effects of the test drug. It is classified as an isotonic saline solution, a simple electrolyte preparation.

Investigated diseases

Severe uncontrolled asthma - A chronic condition where the airways become overly sensitive and inflamed, causing recurring episodes of wheezing, shortness of breath, and coughing. Despite using high‑dose inhaled medicines, symptoms remain frequent and intense. Over time, the airway narrowing can become more pronounced, leading to increased difficulty in breathing during daily activities. Episodes may worsen suddenly, requiring additional medication or medical attention. The condition often shows a pattern of flare‑ups that can become more common if the underlying inflammation is not adequately controlled.