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 18 to 75 years old at the time of signing the consent form (or the legal age of consent in the country where the study is taking place, if that differs).
• People who have been diagnosed with asthma by a doctor for at least 1 year before the screening visit.
• People who have been on a stable combination of medium- to high-dose asthma preventer inhalers (a steroid inhaler plus a long-acting reliever) for at least 12 weeks, with no change in dose or how often it is taken for at least 4 weeks before screening and between the screening and baseline visits (other controller medicines may also be included).
• People whose lung function test result (called FEV1, a measure of how much air can be breathed out) falls between 40% and 80% of what is considered normal for their age and size, measured at both the screening and baseline visits.
• People whose asthma symptom score (measured by a questionnaire called the ACQ-5) is 1.5 or higher at both the screening and baseline visits.
• People whose airway inflammation marker (called FeNO, measured in a breath test) is 25 ppb or higher at both the screening and baseline visits.
• People whose airways show a meaningful improvement in the lung function test after using a reliever inhaler (salbutamol/albuterol) at screening, meeting specific measurement thresholds (confirm with trial site).
• People whose blood test shows a high enough level of a type of immune cell called eosinophils (at least 0.30 × 10⁹ per litre) at screening.
• People who have had at least one asthma attack in the past 52 weeks that needed treatment with steroid tablets, injections, or a hospital or emergency visit.
• People who agree to follow the contraception requirements set out by the study and local regulations.
• People who are willing and able to attend all scheduled visits, follow the treatment plan, complete lab tests, fill in questionnaires, and use an electronic diary for the full duration of the study.

Who may not be able to join:

• People who have a significant lung or breathing condition other than asthma.
• People who have had an asthma attack requiring steroids, hospitalisation, or an emergency visit in the 4 weeks before the screening visit up to and including the baseline visit.
• People who have any other significant health condition or medical history that, in the investigator's opinion, could affect their safety or the study results.
• People who are pregnant or breastfeeding, or who plan to become pregnant or breastfeed during the study.
• People whose routine blood or laboratory safety test results fall outside the normal range at screening.
• People who have taken part in another clinical trial involving an experimental drug or device within 8 weeks or 5 half-lives of the study drug (whichever period is longer).
• People who have any known factor, condition, or disease that could interfere with following the treatment or affect how the results are understood.
• People who currently smoke tobacco, nicotine, or non-nicotine products, use vaping products or electronic cigarettes, or have a smoking history of 10 or more pack years; former smokers or former vapers with less than 10 pack years of smoking must have stopped for at least 26 weeks before the screening visit.
• People who are known to be sensitive or allergic to any ingredient in the study drug KT-621.
• People who are part of the research team running the trial, or their immediate family members.

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