RightFit
RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the long-term safety of KT-621, a medicine taken by mouth, and how well it treats asthma. It also looks at how the medicine acts in the body over time. It is for people with asthma who took part in the earlier KT-621 study, KT621-AS-202.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Completed all required visits in the earlier study through the end-of-treatment visit.
  • Willing and able to follow the study plan, including visits, treatment, lab tests, other procedures, surveys, and an electronic diary.
  • Agree to follow the study's and local birth control rules.

Who can't join

  • Had a major health change during the earlier study that the study doctor thinks could affect safety, study results, or ability to follow study rules.
  • Had a health problem during the earlier study that the study doctor or sponsor's medical reviewer thinks could make continued treatment too risky.
  • Met the rules for stopping study treatment for good, or stopped it for good for any reason, during the earlier study.
  • Are part of the sponsor's team or the study site's research team, or are an immediate family member of someone on those teams.
  • The study doctor thinks you should not join for another reason, including concern that you may not follow study procedures.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (3)

FL

TX