Ireland
--:--IST
Recruiting Phase 2

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

NCT07677059 · tracked via the Priya Life Science Poland tracker
Phase
Phase 2
Started
2026-06-25
Last updated
2026-10-07

Condition(s) studied

Asthma (Diagnosis)

Investigational drug(s) / intervention(s)

KT-621 →

KT-621: Oral drug

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

  • 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

Trial sites (7)

FacilityCityRegionStatus
Kymera Investigative Site Miami Florida Recruiting
Kymera Investigative Site Tampa Florida Recruiting
Kymera Investigative Site Dallas Texas Recruiting
Kymera Investigative Site Berlin Germany Recruiting
Kymera Investigative Site Poznan Poland Recruiting
Kymera Investigative Site Kamenitz Serbia Recruiting
Kymera Investigative Site Užice Serbia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07677059 on ClinicalTrials.gov ↗ ← All trials in Poland