Phase 3 Asthma Trial, Recruiting

Written by an AI model from the 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 old (male or female) who weigh at least 30 kg
• People who have been diagnosed with asthma for at least one year, with a diagnosis that meets current international asthma guidelines (2024 GINA)
• People who have been taking a medium-to-high dose of inhaled corticosteroid (a type of preventer inhaler) for at least two months before the screening visit, combined with at least one other asthma control medicine, with no changes to that treatment for at least one month before the study baseline visit
• People whose lung function test (measuring how much air can be forcefully breathed out in one second) shows a result below a certain threshold — below 80% of the expected normal value for adults, or at or below 90% for teenagers (confirm with trial site)
• People whose asthma control score (measured by a standard questionnaire called the ACQ-5) is 1.5 or higher at the screening and baseline visits, indicating poorly controlled asthma
• People who have had at least one serious asthma flare-up in the 12 months before screening that required steroid tablets or injections, or a hospital or emergency visit
• People who have had a positive breathing test (showing their airways open up meaningfully after using a bronchodilator inhaler) at some point in the 24 months before screening
• People who agree to use effective contraception from the time of signing the consent form until six months after the last dose of the study drug (applies to participants and their partners)
• People who are able to understand the study procedures, are willing to sign a consent form, and can complete study questionnaires on their own — for teenagers aged 12 to 17, a parent or guardian must also provide consent

Who may not be able to join:

• People who are known to have had an allergic reaction to the study drug or any of its ingredients
• People who have had a serious asthma flare-up requiring steroid tablets, injections, or a hospital or emergency visit within one month before screening or before the first dose
• People who have been taking steroid tablets or injections (not including steroid nose sprays, eye drops, or skin creams) in the month before screening through to the time of the first dose
• People who have received intravenous immunoglobulin therapy or allergen immunotherapy (desensitisation treatment) within one month before the first dose
• People who have had major surgery within eight weeks before screening, or who have major surgery planned during the study period
• People with a history of substance abuse or use of illegal drugs
• People who have any other health condition that the study doctor believes could affect their safety or the reliability of the trial results

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