Phase 2 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 75 years, male or female, who are being treated as outpatients, with a body mass index (BMI) between 18 and 30, and — for those aged 12 to 17 — a body weight of at least 30 kg.
• People who have been diagnosed with asthma according to 2025 international asthma guidelines, with a documented asthma history of at least 12 months.
• People who have been using inhaled corticosteroids (a common type of asthma preventer medication) combined with at least one other controller medication for at least 3 months before screening, with no changes to their treatment dose for at least 1 month before screening.
• People whose lung function test (called FEV₁, which measures how much air can be breathed out quickly) falls within a specific range at the screening visit — generally between 40% and 80% of the expected normal value (or up to 85% for those on a low dose of inhaled corticosteroids).
• People whose asthma symptoms score at least 1.5 on a standard asthma control questionnaire (ACQ-5) at the screening visit, indicating that asthma is not fully controlled.
• People whose airways show a meaningful improvement in the lung function test after using a reliever inhaler (salbutamol) — or who have documented evidence of this from a test done within the past 2 years.
• People whose blood test shows a certain level of allergy-related immune cells (eosinophils at 150 or more per microlitre of blood), or whose breath test shows elevated airway inflammation (FeNO of 25 ppb or higher).
• People who have had at least one severe asthma attack in the 12 months before screening (this requirement does not apply to people on a low dose of inhaled corticosteroids).
• People who fully understand what the study involves and who voluntarily agree to participate by signing a consent form before any study procedures begin.
• People whose lung function at the randomisation visit remains within the required range and has not increased by more than 20% from the screening measurement.
• People whose asthma symptom score remains at 1.5 or above on the ACQ-5 questionnaire at the randomisation visit.
• People who, during the lead-in period before the trial starts, took their required medications as directed at least 80% of the time (but not more than 120%), completed their daily diary on at least 80% of days, and have complete diary data for at least 4 of the 7 days before randomisation.

Who may not be able to join:

• People who have had a life-threatening asthma episode — such as one requiring a breathing tube, or involving dangerously high carbon dioxide levels, a breathing emergency, oxygen-related seizures, or fainting due to asthma — within the past year or during the lead-in period.
• People who had a severe asthma attack within 1 month before screening.
• People with a history of allergic reactions to biologic medicines, or a known sensitivity to any ingredient in the study drug.
• People who have used biologic medicines (such as anti-allergy or anti-inflammatory injections targeting specific immune pathways) or systemic immune-suppressing medicines (medicines that reduce the whole body's immune response) for inflammatory conditions within approximately 8 weeks or 5 half-lives before screening, whichever is the longer period.
• People who received intravenous immunoglobulin (a blood-derived immune treatment given by drip) or allergen immunotherapy (allergy desensitisation treatment) within 3 months before screening.
• People who received oral or injected corticosteroids (steroid medicines affecting the whole body), antibiotics, antifungal, antiviral, or antiparasitic medicines, certain heart/blood pressure medicines (non-selective beta-blockers), or herbal medicines with asthma effects within 1 month before screening or during the lead-in period.
• People who received a live or weakened (attenuated) vaccine within 3 months before screening, or who plan to receive one during the study.
• People who had a bronchial thermoplasty procedure (a procedure to treat severe asthma) within 12 months before screening.
• People who had major surgery within 8 weeks before screening, or who plan to have surgery requiring general anaesthesia or a hospital stay of more than 1 day during the study.
• People who, in the investigator's judgement, have a lung or breathing condition other than asthma — such as COPD, or conditions like pulmonary fibrosis, bronchiectasis, or active pneumonia — that could affect safety or the study results.
• People who have active tuberculosis, an untreated latent (dormant) tuberculosis infection, a non-tuberculosis mycobacterial infection, or a history of incompletely treated tuberculosis, based on imaging and investigator assessment.
• People with an active autoimmune disease (where the immune system attacks the body's own tissues), or an autoimmune condition requiring immune-suppressing treatment — such as rheumatoid arthritis, lupus, multiple sclerosis, or inflammatory bowel disease.
• People whose blood test shows eosinophil levels above 1,500 cells per microlitre at screening, or who have a condition known to cause abnormally high eosinophil counts in the blood (confirm with trial site).
• People with a known or suspected weakened immune system, including a history of serious, unusual, or recurring infections.
• People with a known or suspected parasitic infection, or who are considered at high risk of one in the investigator's judgement.
• People who had an active infection (such as an upper respiratory tract infection) within 1 month before screening or during the lead-in period, or who required antibiotic or antiviral treatment for an acute infection.
• People with a history of blood or lymph system cancers, or other cancers — although people who had certain localised skin cancers or cervical pre-cancers, completed curative treatment, and have had no recurrence for at least 12 months before signing the consent form may be considered eligible (confirm with trial site).
• People with other serious or poorly controlled health conditions that, in the investigator's judgement, could affect the study — including severe neurological or mental health disorders, poorly controlled diabetes or high blood pressure, major heart disease, or certain heart rhythm abnormalities.
• People who currently smoke, or who stopped smoking less than 6 months ago; or former smokers with a history of 10 or more pack-years of smoking (a measure calculated from the number of cigarettes smoked per day and the number of years of smoking).
• People whose blood tests at screening are positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or syphilis antibody — unless specific additional test results indicate the virus is not detectable in the blood (confirm with trial site).
• People with significantly reduced liver or kidney function, based on specific blood test results falling outside acceptable ranges.
• People who are pregnant or breastfeeding; people planning to become pregnant during the study or within 3 months after it ends; people of childbearing potential (male or female) who are unable to use reliable contraception from consent until 3 months after the last dose; or people with a positive pregnancy test at screening or before randomisation.
• People who participated in another clinical drug or device trial within 3 months before signing consent and received an investigational treatment, or who are still within the follow-up or washout period of another trial at the time of signing consent.
• People who donated blood, had significant blood loss, received a blood transfusion, or used blood products within 3 months before screening.
• People with known or suspected problems with following study instructions, or with a history of drug, substance, or alcohol misuse (defined as daily pure alcohol intake above 40 g for males or above 20 g for females).
• People who, in the investigator's judgement, have any condition that makes participation in this trial unsuitable.

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