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NCT Number: NCT07677059

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kymera Investigative Site

Tampa, Florida, 33607, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KT-621

Drug

Oral drug

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Kymera Medical Director

CONTACT

[email protected]

857-285-5300

Sponsors and collaborators

Lead sponsor

Kymera Therapeutics, Inc.

Industry

Registry information

Official study 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

Acronym: BREADTH-EXT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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