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 confirmed asthma diagnosis from a doctor for at least 2 years.
• People who have been taking a medium-to-high dose inhaled corticosteroid (a type of inhaled asthma preventer) for at least 12 months, plus at least one other asthma controller medication for at least 3 months, with no changes to these medications in the last 3 months (confirm with trial site).
• 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 preventer inhalers.
• Adults aged 18 and over whose lung function test result (called FEV1) is below 80% of what is expected for someone of their age and size, measured before using a reliever inhaler.
• Adolescents aged 12 to under 18 whose pre-reliever lung function (FEV1) is below 90% of expected, or whose ratio of two lung function measures (FEV1:FVC) is below 0.80 (confirm with trial site).
• People whose breathing improves by at least 12% and 200 mL on a lung function test after using a short-acting reliever inhaler, at least once during the screening period.
• People whose asthma symptom questionnaire score (ACQ-6) is 1.5 or higher at the first screening visit (confirm with trial site).
• 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 in the 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, tuberculosis, emphysema, chronic bronchitis, or a history of lung cancer.
• People who have a condition involving a type of white blood cell called eosinophils affecting other parts of the body (such as eosinophilic granulomatosis with polyangiitis or eosinophilic esophagitis).
• People who have an unstable heart, digestive, liver, kidney, nerve, muscle, hormonal, blood, or psychiatric condition that the trial doctor considers could affect safety or the study results.
• People who have an ongoing infection that has not cleared up and requires antibiotic, antifungal, antiparasitic, or antiviral medication at the time of enrolling.
• People with a current cancer diagnosis, or a history of cancer within the past 5 years.
• People with a known parasitic worm (helminth) infection within 6 months before the first screening visit.
• People who currently smoke, have smoked 10 or more pack-years in their lifetime, or currently use vaping products or e-cigarettes (confirm with trial site).
• Former smokers with less than 10 pack-years of smoking history, or former vapers, 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 planned surgery requiring general anaesthesia or a hospital stay of more than one day during the study.
• People who have used certain biological asthma medicines that target a substance called IL-5 (such as mepolizumab, reslizumab, benralizumab, or depemokimab) within the past 12 months, or other biological asthma medicines within 4 months or 5 half-lives (confirm with trial site).
• People who have ever used any biological medicine that targets TSLP or the TSLP receptor, such as tezepelumab, whether approved or experimental.
• People who have used immune-suppressing or immune-modifying medications (such as methotrexate or cyclosporine) within 12 weeks before being assigned to a treatment group.
• People who have received an experimental biological medicine within 4 months or 5 half-lives, or a non-biological experimental medicine within 30 days or 5 half-lives, before the first screening visit.
• People with a known allergy or sensitivity to any ingredient in the study treatment.
• People who have had a life-threatening allergic reaction (anaphylaxis) to any biological medicine.
• People who are currently enrolled in another clinical study that involves an investigational treatment.
• People who have already been assigned to a treatment group in this study or in a previous study of the same medicine (GB-0895).
• People who have an abnormal finding on physical examination, vital signs, heart trace (ECG), or blood and urine tests that the trial doctor considers could pose a risk or affect study results.
• People who have liver cirrhosis or another active or significant 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 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 undergone a procedure called bronchial thermoplasty within the 12 months before the first screening visit.
• People who, in the trial doctor's opinion, are unlikely or unable to follow the study procedures, including taking their asthma controller 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.