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 who are willing and able to give written agreement to take part before any study procedures begin.
• People aged 12 to 80 years old at the first study visit.
• People who have a formal diagnosis of asthma from a doctor, confirmed by medical records.
• People whose breathing tests show that their airways respond to asthma medication in a specific way, or whose lung function has varied significantly over time, or who have had a positive airway challenge test within the past 12 months (confirm with trial site).
• People who are currently taking a medium or high dose of inhaled corticosteroids (a preventer inhaler) combined with a long-acting reliever inhaler (LABA), and who may also be taking up to one additional asthma controller medication such as a leukotriene receptor antagonist, a long-acting muscarinic antagonist, or theophylline.
• People who have been on their current inhaled corticosteroid and LABA treatment at a stable dose for at least 2 months before joining.
• People whose asthma symptoms are not well controlled, as measured by a standard questionnaire score of 1.5 or above at the first visit.
• People who have had at least one serious asthma flare-up in the past year that required steroid tablets or injections, or led to a hospital or emergency visit — and who have medical records confirming this.
• People who weigh at least 40 kg at the first visit.
• People of any sex, provided that women who could become pregnant agree to use a highly effective form of contraception throughout the study and for at least 8 weeks after the last dose, and have a negative pregnancy test at the first visit.

Who may not be able to join:

• People who are unable to attend all required study visits or are unwilling to follow the study's guided changes to their asthma treatment.
• People who have another significant lung condition besides asthma (such as COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, or an active lung infection), or who have ever been diagnosed with certain conditions linked to high levels of a specific type of white blood cell called eosinophils (confirm with trial site).
• People who are currently smoking, or former smokers with a history of 10 or more pack-years of smoking; former smokers with less than 10 pack-years must have stopped smoking for at least 6 months.
• People who have had a problem with alcohol or drug misuse in the 12 months before the first visit.
• People who have had a parasitic worm infection in the 24 weeks before the first visit that has not been successfully treated.
• People who have had a severe allergic reaction (anaphylaxis) to any biological medicine in the past.
• People who have a known allergy to any ingredient in the study treatment.
• People who have had a serious breathing flare-up requiring steroid treatment, or an upper or lower respiratory infection requiring antibiotics or antiviral medication, within 30 days before the first visit (a delay in joining of up to 3 months may be allowed for recovery).
• People who have a known immune system deficiency, including HIV.
• People who have had a cancer diagnosis within the past 5 years, with some specific exceptions for certain early-stage or treated cancers (confirm with trial site).
• People who have previously had a bone marrow transplant from a donor, or a whole blood transfusion within 120 days of providing a genetic sample.
• People who have an unstable medical condition in any body system — such as heart, liver, kidney, nervous system, or mental health — that in the doctor's view could affect safety, interfere with study results, or make completing the study difficult.
• People who have taken oral steroid tablets in the 4 weeks before the first visit.
• People who have used immune-suppressing medications (such as methotrexate, cyclosporine, or azathioprine) within 3 months or 5 half-lives before joining, whichever is longer.
• People who have recently received a biological medicine or an experimental non-biological treatment within specified timeframes before the first visit (confirm with trial site for exact timeframes; some exceptions apply for stable non-respiratory biologics and COVID-related treatments).
• People who have received a live vaccine within 30 days before the first dose of the study treatment.
• People who plan to take medications that are not permitted in the study, or who have not completed the required stop period for a prohibited medication.
• People who have received immunoglobulin or blood products within 30 days before giving consent to join.
• People who have had bronchial thermoplasty (a heat-based airway procedure) within 12 months before the first visit.
• People who have used traditional Chinese herbal or proprietary medicines with anti-asthma effects within 4 weeks before the first visit.
• People who are currently taking part in another clinical trial involving an experimental treatment.
• People who have significant abnormal results on physical examination, blood tests, or vital signs during the enrolment period that the study doctor considers a concern, or who have received a live vaccine within 30 days before the first visit.
• Women who are currently pregnant, breastfeeding, or lactating.
• People who are involved in planning or running this study.
• People who, in the study doctor's judgement, are unlikely to follow the study requirements.
• People who have previously been enrolled in this same trial.

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