This Phase 2b study is designed to evaluate the safety and efficacy of KT-621 in participants with uncontrolled moderate to severe eosinophilic asthma.
The main goals of this study are to investigate how effective KT-621 is at treating uncontrolled moderate to severe eosinophilic asthma, the safety and tolerability of KT-621, and how KT-621 behaves in the body.
Must be 18 years old (or the legal age of consent in the jurisdiction in which the study is taking place) to 75 years of age, inclusive, at the time of signing the ICF.
Must have a physician diagnosis of asthma for at least 1 year prior to the Screening visit.
Must be on a stable regimen of medium- to high- dose inhaled corticosteroid (ICS), in combination with a long-acting β2-agonist (LABA). The regimen may include additional controller medications used for at least 12 weeks, at a stable dose and regimen, with no change in the dose or frequency of administration for at least 4 weeks prior to the Screening visit and between the Screening and Baseline visits.
Must have a pre-bronchodilator FEV1 40 to 80% of predicted normal at the Screening and Baseline visits, prior to randomization.
Must not have any clinically significant pulmonary disease other than asthma.
Must not have had an asthma exacerbation, requiring either treatment with systemic corticosteroids (intramuscular, intravenous, or oral) and/or hospitalization or an emergency/urgent medical care visit for acute asthma worsening, at any time from 4 weeks prior to the Screening visit up to and including the Baseline visit.
Must not have any other clinically significant disease, condition, or medical history that, in the opinion of the Investigator, would interfere with participant safety, study evaluations, and/or study procedures.
Must not be pregnant or breastfeeding; must not be a woman planning to become pregnant or breastfeed during the study.
Parallel
KT-621
DrugOral drug
Placebo
Other interventionOral placebo matched to KT-621
Change from baseline in pre-bronchodilator FEV1
Change from baseline in post-bronchodilator FEV1
Change from baseline in Asthma Control Questionnaire 5-question version (ACQ-5) score
Change from baseline in Standardized Asthma Quality of Life Questionnaire [AQLQ(S)] Global Score
Incidence of treatment-emergent adverse events (TEAEs)
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