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This Phase 2b open-label, long-term extension study is designed to evaluate the long-term safety and efficacy of KT-621 in participants with asthma who were previously enrolled in the parent study (KT621-AS-202) of KT-621 for asthma. The main goals of this study are to investigate the long-term safety and tolerability of KT-621, the long-term efficacy of KT-621 at treating asthma, and how KT-621 behaves in the body long-term.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KT-621 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KT-621 | Drug | Oral drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | From baseline through Week 52 | |
| Incidence of treatment-emergent serious adverse events (SAEs) | From baseline through Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in pre-bronchodilator FEV1 | From baseline (as assessed in the parent study) to Week 52 | |
| Change from baseline in post-bronchodilator FEV1 | From baseline (as assessed in the parent study) to Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kymera Medical Director | Contact | 857-285-5300 | clinicaltrials@kymeratx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kymera Investigative Site | Recruiting | Tampa | Florida | 33607 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D004194 | Disease |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Change from baseline in Asthma Control Questionnaire 5-question version (ACQ-5) score | From baseline (as assessed in the parent study) to Week 52 |
| Change from baseline in Standardized Asthma Quality of Life Questionnaire [AQLQ(S)] global Score | From baseline (as assessed in the parent study) to Week 52 |
| Plasma concentration of KT-621 derived from plasma concentration time data | From baseline to Week 52 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |