A Long-term Study of KT-621 Administered Orally to Participants With Asthma Previously Enrolled in a KT-621 Asthma Study

Official title

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

Overview

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

• Drug KT-621
  Oral drug

Primary outcome measures

• Incidence of treatment-emergent adverse events (TEAEs) [Time frame: From baseline through Week 52]
• Incidence of treatment-emergent serious adverse events (SAEs) [Time frame: From baseline through Week 52]

Secondary outcome measures (5)

• Change from baseline in pre-bronchodilator FEV1 [Time frame: From baseline (as assessed in the parent study) to Week 52]
• Change from baseline in post-bronchodilator FEV1 [Time frame: From baseline (as assessed in the parent study) to Week 52]
• 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]
• 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]
• Plasma concentration of KT-621 derived from plasma concentration time data [Time frame: From baseline to Week 52]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Kymera Investigative Site — Tampa

Identifiers

NCT: NCT07677059 · KT621-AS-203

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗