KT-621 long-term safety and efficacy in asthma patients previously in KT-621 study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label extension will follow participants who completed the parent KT-621 asthma study to assess long-term safety and tolerability of KT-621 when given orally. The study also aims to observe sustained efficacy and how the drug behaves in the body over an extended period. Participants will provide regularly scheduled assessments, lab tests, and diary entries to monitor outcomes. No control group is described, and all participants receive KT-621. Locations are limited to Kymera investigative sites in Florida and Texas.

Why it matters

Who can join: the full rules

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.

Where it's running

• Kymera Investigative Site
  Miami, Florida, United States Recruiting
• Kymera Investigative Site
  Tampa, Florida, United States Recruiting
• Kymera Investigative Site
  Dallas, Texas, United States Recruiting
• Kymera Investigative Site
  Berlin, Germany Recruiting
• Kymera Investigative Site
  Poznan, Poland Recruiting
• Kymera Investigative Site
  Kamenitz, Serbia Recruiting

Study contacts

• Study coordinator: Kymera Medical Director
• Email: clinicaltrials@kymeratx.com
• Phone: 857-285-5300

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.