Идёт набор NCT07301255

ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults

Фаза II С лечением Asthma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: ENV-294, Placebo.
Кому может быть актуально: Состояния в реестре: Asthma. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ENV-294 in Adult Participants With Moderate-to-Severe Asthma

Обзор

This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and potential efficacy of ENV-294 in adults with moderate to severe asthma who are receiving background treatment with inhaled corticosteroids (ICS) and long-acting beta₂-agonists (LABA). Participants will take oral ENV-294 or placebo once daily for 12 weeks. The study includes a screening period of up to 28 days before randomization to confirm eligibility. Study visits and assessments will be conducted to monitor safety, measure drug levels in the blood, and evaluate effects on asthma control and lung function.

Вмешательства

Препарат ENV-294
ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks.
Препарат Placebo
Matching oral tablet that does not contain active drug. Administered once daily by mouth for 12 weeks under the same conditions as the investigational product.

Первичные конечные точки

Incidence and Severity of Adverse Events [Срок оценки: From first dose through approximately 16 weeks]

Вторичные конечные точки (6)

Loss of Asthma Control Events [Срок оценки: Baseline to Week 12]
Time to Loss of Asthma Control [Срок оценки: Baseline to Week 12]
To assess the efficacy of ENV-294 in participants with asthma [Срок оценки: Baseline to Week 12]
To assess the efficacy of ENV-294 in participants with asthma [Срок оценки: Baseline to Week 12]
To assess the efficacy of ENV-294 in participants with asthma [Срок оценки: Baseline to Week 12]
Plasma concentration of ENV-294 [Срок оценки: Baseline to Week 12]

Критерии участия

Критерии включения

Able to read, understand, and sign an informed consent form before any study procedures
Male or female adults aged 18 to 75 years with a physician diagnosis of moderate to severe asthma for at least 12 months
Receiving stable treatment with an inhaled corticosteroid (ICS) plus a long-acting beta₂-agonist (LABA) for at least 2 months before screening
Pre-bronchodilator FEV₁ between 50% and 80% of predicted normal at screening and baseline
Demonstrated bronchodilator reversibility
ACQ-5 score ≥1.25 to ≤3.0 at screening and baseline
History of at least one asthma exacerbation in the past 12 months requiring systemic corticosteroids or hospitalization/emergency care