A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of Oral KT-621 in Adults With Uncontrolled Moderate to Severe Eosinophilic Asthma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of KT-621 in adults with uncontrolled moderate to severe eosinophilic asthma. This Phase 2b study aims to understand how well KT-621 treats this condition, how safe and tolerable it is, and how the drug behaves in the body. Participants have asthma that has been diagnosed for at least one year and meets specific lung function and inflammatory marker criteria. Participants will receive one of several doses of KT-621 or a placebo, all administered orally. The study is randomized, double-blind, and placebo-controlled, and includes multiple centers. The main treatment period lasts 12 weeks, during which doses are given to assess effects on lung function and asthma control. Safety and drug concentration in the blood will be monitored up to 16 weeks. During the study, participants will attend scheduled visits for lung function tests, asthma control questionnaires, and quality of life assessments. Blood samples will be collected to measure drug levels and eosinophil counts. Safety monitoring will track adverse events throughout the study period. The primary outcome is the change in lung function from baseline to Week 12. Participants must comply with the treatment plan and complete electronic diaries to record their symptoms and medication use.

A Study of KT-621 Administered Orally to Adult Participants With Moderate to Severe Eosinophilic Asthma