A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-ranging Study Investigating the Efficacy and Safety Profile of KT-621 Administered Orally to Adult Participants With Uncontrolled Moderate to Severe Eosinophilic Asthma
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 have an ACQ-5 score ≥ 1.5 at the Screening and Baseline visits, prior to randomization.
• Must have a FeNO level of ≥ 25 ppb at the Screening and Baseline visits.
• Must have a demonstrated evidence of reversible airway obstruction by post-bronchodilator (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL at Screening.
• Must have an absolute blood eosinophil count must be ≥ 0.30 × 10\^9/L at Screening.
• Must have a documented history of at least 1 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 within the past 52 weeks prior to Screening.
• Must agree to contraceptive requirements in compliance with the clinical study and local requirements.
• Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, other study-related procedures, and questionnaires, including completing the electronic diary (e-diary), for the duration of the study as required by the study protocol.