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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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-526241-98-00
Enrollment
25
Registered
2026-09-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncontrolled Moderate to Severe Eosinophilic Asthma

Brief summary

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]

Detailed description

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]

Interventions

DRUGKT-621

Sponsors

Kymera Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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]

Secondary

MeasureTime frame
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]

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 10, 2026