A Study of KT-621 Administered Orally to Adult Participants With Moderate to Severe Eosinophilic Asthma

Официальное название

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-ranging Study Investigating the Efficacy and Safety Profile of KT-621 Administered Orally to Adult Participants With Uncontrolled Moderate to Severe Eosinophilic Asthma

Обзор

This Phase 2b study is designed to evaluate the safety and efficacy of KT-621 in participants with uncontrolled moderate to severe eosinophilic asthma. The main goals of this study are to investigate how effective KT-621 is at treating uncontrolled moderate to severe eosinophilic asthma, the safety and tolerability of KT-621, and how KT-621 behaves in the body.

Вмешательства

• Препарат KT-621
  Oral drug
• Другое Placebo
  Oral placebo matched to KT-621

Первичные конечные точки

• Change from baseline in pre-bronchodilator FEV1 [Срок оценки: From baseline to Week 12]

Вторичные конечные точки (6)

• Change from baseline in post-bronchodilator FEV1 [Срок оценки: From baseline to Week 12]
• Change from baseline in Asthma Control Questionnaire 5-question version (ACQ-5) score [Срок оценки: From baseline to Week 12]
• Change from baseline in Standardized Asthma Quality of Life Questionnaire [AQLQ(S)] Global Score [Срок оценки: From baseline to Week 12]
• Incidence of treatment-emergent adverse events (TEAEs) [Срок оценки: From baseline through Week 16]
• Incidence of treatment-emergent serious adverse events (SAEs) [Срок оценки: From baseline through Week 16]
• Plasma concentration of KT-621 derived from plasma concentration time data [Срок оценки: From baseline to Week 16]

Критерии участия

Критерии включения

• Must be 18 years old (or the legal age of consent in the jurisdiction in which the study is taking place) to 75 years of age, inclusive, at the time of signing the ICF.
• Must have a physician diagnosis of asthma for at least 1 year prior to the Screening visit.
• Must be on a stable regimen of medium- to high- dose inhaled corticosteroid (ICS), in combination with a long-acting β2-agonist (LABA). The regimen may include additional controller medications used for at least 12 weeks, at a stable dose and regimen, with no change in the dose or frequency of administration for at least 4 weeks prior to the Screening visit and between the Screening and Baseline visits.
• Must have a pre-bronchodilator FEV1 40 to 80% of predicted normal at the Screening and Baseline visits, prior to randomization.
• Must have an ACQ-5 score ≥ 1.5 at the Screening and Baseline visits, prior to randomization.
• Must have a FeNO level of ≥ 25 ppb at the Screening and Baseline visits.
• Must have a demonstrated evidence of reversible airway obstruction by post-bronchodilator (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL at Screening.
• Must have an absolute blood eosinophil count must be ≥ 0.30 × 10\^9/L at Screening.
• Must have a documented history of at least 1 asthma exacerbation requiring either treatment with systemic corticosteroids (intramuscular, intravenous, or oral) and/or hospitalization or an emergency/urgent medical care visit for acute asthma worsening within the past 52 weeks prior to Screening.
• Must agree to contraceptive requirements in compliance with the clinical study and local requirements.
• 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.

Критерии исключения

• Must not have any clinically significant pulmonary disease other than asthma.
• Must not have had an asthma exacerbation, requiring either treatment with systemic corticosteroids (intramuscular, intravenous, or oral) and/or hospitalization or an emergency/urgent medical care visit for acute asthma worsening, at any time from 4 weeks prior to the Screening visit up to and including the Baseline visit.
• Must not have any other clinically significant disease, condition, or medical history that, in the opinion of the Investigator, would interfere with participant safety, study evaluations, and/or study procedures.
• Must not be pregnant or breastfeeding; must not be a woman planning to become pregnant or breastfeed during the study.
• Must not have results from clinical laboratory safety tests that are outside the local reference range at Screening.
• Must not have been dosed with any investigational drug or device in a clinical study within 8 weeks or 5 half-lives (whichever is longer) of KT-621 administration.
• Must not have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results.
• Must not be a current smoker of nicotine/tobacco as well as non-nicotine products, have a smoking history of ≥ 10 pack years, or use vaping products, including electronic cigarettes. Former smokers with a smoking history of < 10 pack years and users of vaping or e-cigarette products must have stopped for at least 26 weeks prior to the Screening visit.
• Must not have a known sensitivity to any of the components of KT-621.
• Must not be a member of the investigational team or his/her immediate family.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 27 центров

• Kymera Investigative Site — Lancaster
• Kymera Investigative Site — Long Beach
• Kymera Investigative Site — Northridge
• Kymera Investigative Site — Redding
• Kymera Investigative Site — Upland
• Kymera Investigative Site — Loxahatchee Groves
• Kymera Investigative Site — Miami
• Kymera Investigative Site — Miami
• … и ещё 19 центров

Польша · 9 центров

• Kymera Investigative Site — Bialystok
• Kymera Investigative Site — Gdansk
• Kymera Investigative Site — Lodz
• Kymera Investigative Site — Poznan
• Kymera Investigative Site — Sosnowiec
• Kymera Investigative Site — Tarnów
• Kymera Investigative Site — Trzebnica
• Kymera Investigative Site — Wroclaw
• … и ещё 1 центр

Великобритания · 6 центров

• Kymera Investigative Site — Bedford
• Kymera Investigative Site — Birmingham
• Kymera Investigative Site — Bristol
• Kymera Investigative Site — Leicester
• Kymera Investigative Site — London
• Kymera Investigative Site — Wythenshawe

Испания · 5 центров

• Kymera Investigative Site — Cadiz
• Kymera Investigative Site — Jerez de la Frontera
• Kymera Investigative Site — Madrid
• Kymera Investigative Site — Mataró
• Kymera Investigative Site — Santander

Сербия · 4 центра

• Kymera Investigative Site — Belgrade
• Kymera Investigative Site — Belgrade
• Kymera Investigative Site — Kamenitz
• Kymera Investigative Site — Užice

Румыния · 3 центра

• Kymera Investigative Site — Brasov
• Kymera Investigative Site — Craiova
• Kymera Investigative Site — Timișoara

Германия · 2 центра

• Kymera Investigative Site — Berlin
• Kymera Investigative Site — Leipzig

Словакия · 2 центра

• Kymera Investigative Site — Košice
• Kymera Investigative Site — Spišská Nová Ves

Идентификаторы

NCT: NCT07323654 · KT621-AS-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗