Asthma (Diagnosis)
Conditions
Keywords
KT-621, STAT6, stat6 degrader, targeted protein degrader, Phase 2, phase 2b, OLE, LTE
Brief summary
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.
Interventions
DRUGKT-621
Oral drug
Sponsors
Kymera Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have completed all visits of the parent study, per its protocol, up to the end of treatment (EoT) visit. * 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. * Must agree to contraceptive requirements in compliance with the clinical study and local requirements.
Exclusion criteria
* Must not have experienced any clinically significant change in health status during the parent study, which, in the opinion of the Investigator, would interfere with participant safety, study evaluations, or compliance with study procedures; or otherwise make the participant unsuitable for participation in this study. * Must not have developed an AE during the parent study, that in the opinion of the Investigator or of the Sponsor's Medical Monitor, could indicate that continued treatment may present an unreasonable risk for the participant. * Must not have met permanent discontinuation criteria and/or permanently discontinued study treatment for any reason during the parent study. * Must not be a member of the Sponsor or site's investigational team or their immediate family. * Must not be unsuitable to enter the study for any other reason, as judged by the Investigator, including potential risk of noncompliance to study procedures.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| 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 |
Countries
United States
Contacts
CONTACTKymera Medical Director
Outcome results
None listed