A Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long Term Safety and Tolerability of KT-621 in Participants With Asthma Previously Enrolled in a KT-621 Asthma Study

Condition studied

Uncontrolled Moderate to Severe Eosinophilic Asthma

Investigational medicinal product(s)

Every trial of KT-621 across our registers →

Eligibility

Primary endpoint

1. Incidence of treatment-emergent adverse events (TEAEs) [Time Frame: From baseline through Week 52] 2. Incidence of treatment-emergent serious adverse events (SAEs) [Time Frame: From baseline through Week 52]

Endpoint detail

1. Change from baseline in pre-bronchodilator FEV1 [Time Frame: From baseline (as assessed in the parent study) to Week 52], 2. Change from baseline in post-bronchodilator FEV1 [Time Frame: From baseline (as assessed in the parent study) to Week 52], 3. Change from baseline in Asthma Control Questionnaire 5-question version (ACQ-5) score [Time Frame: From baseline (as assessed in the parent study) to Week 52], 4. Change from baseline in Standardized Asthma Quality of Life Questionnaire [AQLQ(S)] global Score [Time Frame: From baseline (as assessed in the parent study) to Week 52], 5. Plasma concentration of KT-621 derived from plasma concentration time data [Time Frame: From baseline to Week 52]