Phase 3 Asthma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 12 to 80 years old.
• People who have had a formal diagnosis of asthma from a doctor for at least 2 years.
• People who have been taking a medium-to-high dose inhaled corticosteroid (a type of preventer inhaler) for at least 12 months, plus at least one other asthma controller medication for at least 3 months, with no changes to those medications in the last 3 months.
• People who have had at least two asthma flare-ups in the past 12 months that required treatment with steroid tablets or injections, despite using a medium-to-high dose preventer inhaler.
• Adults aged 18 and over whose lung function test (measuring how much air can be blown out) is below 80% of the expected normal result, before taking a reliever inhaler.
• Adolescents aged 12 to under 18 whose lung function is below 90% of the expected normal result, or whose ratio of two specific lung measurements falls below a certain threshold, before taking a reliever inhaler (confirm with trial site).
• People whose airways show a meaningful improvement on a breathing test (at least 12% and 200 mL increase) after using a short-acting reliever inhaler, at least once during the screening period.
• People whose asthma symptom score (measured by a standard questionnaire called the ACQ-6) is 1.5 or above at the first screening visit.
• People who weigh at least 40 kg at the first screening visit.

Who may not be able to join:

• People who have had a significant asthma flare-up within 12 weeks before the first screening visit, or during the lead-in period, that required a change in their regular asthma medications.
• People who have another lung or breathing condition in addition to asthma, such as a current lung infection, bronchiectasis, pulmonary fibrosis, emphysema, chronic bronchitis, tuberculosis, a fungal lung infection, or a history of lung cancer.
• People who have a condition involving abnormally high levels of a type of white blood cell (eosinophils) affecting other organs, such as eosinophilic granulomatosis with polyangiitis or eosinophilic esophagitis.
• People who have an unstable or significant medical condition affecting the heart, digestive system, liver, kidneys, nervous system, muscles or joints, hormones, blood, or mental health, which the study doctor believes could affect safety or the study results.
• People who have an ongoing infection that has not cleared up and is currently being treated with antibiotics, antifungals, antiparasitic, or antiviral medications.
• People who currently have cancer, or who have had cancer within the past 5 years.
• People with a significant infection that has not fully resolved before joining the study.
• People who have had a parasitic worm infection within 6 months before the first screening visit.
• People who currently smoke, people with a smoking history of 10 or more pack-years, or people who currently use vaping products or e-cigarettes.
• Former smokers with less than 10 pack-years of smoking history, or former vapers/e-cigarette users, who have not stopped for at least 6 months before the first screening visit.
• People who have hepatitis B, hepatitis C, or HIV.
• People who have had major surgery within 8 weeks before the first screening visit, or who have surgery planned during the study that would require general anaesthesia or a hospital stay of more than one day.
• People who have used certain targeted asthma biologic medicines (specifically anti-IL-5 therapies, such as mepolizumab, reslizumab, benralizumab, or depemokimab) within the past 12 months, or other biologic medicines for asthma within 4 months or 5 half-lives of the drug.
• People who have ever used a biologic medicine that targets a protein called TSLP or its receptor, including tezepelumab, whether approved or as part of a clinical trial.
• People who have taken systemic immunosuppressant or immunomodulating medications (such as methotrexate or cyclosporine) within 12 weeks before being assigned to a treatment group.
• People who have recently taken part in another clinical trial involving a biological investigational treatment (within 4 months or 5 half-lives), or a non-biological investigational treatment (within 30 days or 5 half-lives).
• People who are known to be sensitive or allergic to any ingredient in the study treatment.
• People who have had a life-threatening allergic reaction to any biologic medicine in the past.
• People who are currently enrolled in another clinical trial that involves an investigational treatment.
• People who have previously been assigned a treatment in this study or in a previous study of the same study drug (GB-0895).
• People who have an abnormal result on a physical examination, vital signs, heart tracing (ECG), or blood and urine tests that the study doctor considers significant enough to affect safety or study results.
• People who have cirrhosis or other significant active liver disease.
• People who have received immunoglobulin or blood products within 30 days before the first screening visit.
• People who have received a live vaccine within 30 days before being assigned to a treatment group, or who would need one during the study including the follow-up period.
• People who have taken a medication called suplatast tosilate within 15 days before the first screening visit.
• People who have had a procedure called bronchial thermoplasty within the 12 months before the first screening visit.
• People who, in the study doctor's opinion, are unlikely or unable to follow the study procedures, including taking their regular asthma medications as directed.
• People who are pregnant, breastfeeding, or planning to become pregnant during the study.
• People with a history or suspected history of alcohol misuse or substance abuse within the 2 years before the first screening visit.

Important: Always verify eligibility with the trial site directly before applying.