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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат KT-621
  Oral drug

Первичные конечные точки

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

Вторичные конечные точки (5)

• Change from baseline in pre-bronchodilator FEV1 [Срок оценки: From baseline (as assessed in the parent study) to Week 52]
• Change from baseline in post-bronchodilator FEV1 [Срок оценки: From baseline (as assessed in the parent study) to Week 52]
• Change from baseline in Asthma Control Questionnaire 5-question version (ACQ-5) score [Срок оценки: 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 [Срок оценки: From baseline (as assessed in the parent study) to Week 52]
• Plasma concentration of KT-621 derived from plasma concentration time data [Срок оценки: From baseline to Week 52]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Kymera Investigative Site — Tampa

Идентификаторы

NCT: NCT07677059 · KT621-AS-203

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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