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Идёт набор NCT06653322

A Multi-centered，Randomized，Double-blind，Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic Asthma

Фаза III С лечением Asthma With Eosinophilic Phenotype

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: HR-1703, Placebo.
Кому может быть актуально
Состояния в реестре: Asthma With Eosinophilic Phenotype. Базовые параметры: от 12 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
Китай
Следующий шаг
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Обзор

The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype

Вмешательства

  • Препарат HR-1703
    HR-1703 will be administered by SC injection.
  • Препарат Placebo
    Matching Placebo will be administered by the SC injection.

Первичные конечные точки

  • Annualised asthma exacerbation rate，about 48weeks [Срок оценки: about 48weeks]
Вторичные конечные точки (12)
  • Mean number of days with oral corticosteroids taken for exacerbation，about 48weeks [Срок оценки: about 48weeks]
  • Frequency of exacerbations requiring hospitalisation，about 48weeks [Срок оценки: about 48weeks]
  • Time to first exacerbation requiring hospitalisation，about 48weeks [Срок оценки: about 48weeks]
  • Mean change from baseline in clinic pre- and post-BD FEV1，about 64 weeks [Срок оценки: about 64 weeks]
  • Mean change from baseline in clinic pre- and post-BD FEV1%，about 64weeks [Срок оценки: about 64weeks]
  • Mean change from baseline in clinic pre- and post-BD FVC，about 64 weeks [Срок оценки: about 64 weeks]
  • Mean change from baseline in clinic pre- and post-BD PEF，about 64 weeks [Срок оценки: about 64 weeks]
  • Mean change from baseline in FeNO，about 64weeks [Срок оценки: about 64weeks]
  • Mean change from baseline in asthma control questionnaire (ACQ-6) score，about 64 weeks [Срок оценки: about 64 weeks]
  • Mean change from baseline in ASTHMA QUALITY OF LIFE QUESTIONNAIRES (AQLQ) score，about 64weeks [Срок оценки: about 64weeks]
  • Mean change from baseline in Asthma symptom score at week 12/24/36/48/60，about 64weeks [Срок оценки: at week 12/24/36/48/60，about 64weeks]
  • Mean change from baseline in daily rescue medication use at week 12/24/36/48/60，about 64weeks [Срок оценки: at week 12/24/36/48/60，about 64weeks]

Критерии участия

Критерии включения

  • At least 12 years of age
  • A minimum weight of 40kg
  • A medical history of at least 1 year that meets the diagnosis of asthma;
  • Current treatment with medium- or high- doses of ICS for at least 6 months and using steadily at least 3 months
  • Current treatment with an additional controller medication, besides ICS, for at least 3 months and using steadily at least 1 month
  • Absolute count of blood eosinophils suggests eosinophilic asthma
  • During the screening period and baseline, pre- BD FEV1% < 80%
  • During the screening period and baseline, ACQ-6 score indicates asthma poor control
  • History of severe asthma exacerbation within the past 12 months prior to screening
  • Good compliance with eDiary completion
  • Take efficient contraceptive measures
  • Voluntarily sign the informed consent form to participate in this study

Критерии исключения

  • With other condition that could lead to elevated eosinophils
  • With Clinically significant pulmonary diseases
  • With existing immunodeficiency disease
  • With other clinically significant diseases that may affect lung function
  • With uncontrolled severe cardiovascular and cerebrovascular diseases
  • With uncontrolled hypertension and/or diabetes
  • With exacerbation, allergic rhinitis or sinusitis attacks, or clinical significant infection requiring intervention during 4 weeks prior to randomization
  • Recent major surgeries or surgical plans during the study period, or treatment measures that investigators believe may affect subject evaluation
  • Existing parasitic infections
  • Diagnosed as malignant tumor within the first 5 years of randomization
  • Significant abnormalities in screening period or baseline laboratory tests
  • Screening period or baseline ECG QTc prolongation
  • Prohibited drugs using during the pre randomization period
  • Participated in other clinical trials within 30 days prior to screening and used research drugs containing active ingredients, or was still within 5 half lives of the research drug at the time of screening
  • Smoking or quitting smoking for less than 6 months during screening, or previous smoking history ≥ 10 pack years
  • History of drug use, alcoholism, or substance abuse within the past year prior to screening
  • Allergic or intolerant to IL-5 monoclonal antibodies or other biological agents
  • Pregnant or lactating subjects
  • Other reasons why the researcher deemed it unsuitable for conducting this experiment

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • West China School of Medicine West China Hospital of Sichuan University — Чэнду

Идентификаторы

NCT: NCT06653322 · SHR-1703-302

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗