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Идёт набор NCT05979051

A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）

Фаза II / Фаза III С лечением Eosinophilic Granulomatosis With Polyangiitis

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: SHR-1703, Mepolizumab Injection.
Кому может быть актуально
Состояния в реестре: Eosinophilic Granulomatosis With Polyangiitis. Базовые параметры: от 18 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Multicenter, Single-arm/Randomized, Double-blind, Active-controlled, Parallel-group Phase 2/3 Clinical Study to Evaluate the Efficacy and Safety of SHR-1703 for Patients With EGPA

Обзор

This study is a phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.

Вмешательства

  • Препарат SHR-1703
    SHR-1703 will be administered by Subcutaneous injection in Phase 2 and Phase 3.
  • Препарат Mepolizumab Injection
    Mepolizumab Injection and Matching Placebo will be administered by Subcutaneous injection in Phase 3

Первичные конечные точки

  • Change from baseline in oral glucocorticoid dose (OCS) [Срок оценки: Up to week 12]
  • The Proportion of subjects in EGPA remission [Срок оценки: week 36 and week 48]
Вторичные конечные точки (12)
  • Change from baseline in oral glucocorticoid dose [Срок оценки: Up to week 24, week 48]
  • The proportion of subjects with OCS dosage ≤5 mg/d [Срок оценки: week 12, week 24, week 48]
  • The proportion of subjects with at least 50% reduction of OCS dosage from baseline [Срок оценки: week 12, week 24, week 48]
  • The Proportion of subjects with EULAR remission [Срок оценки: week 12, week 24, week 48]
  • The Proportion of subjects achieving EULAR remission at week 12 and week 24 of treatment and maintaining it up to week 48 [Срок оценки: week 12, week 24, week 48]
  • The Proportion of subjects with EGPA remission [Срок оценки: week 24, week 48]
  • The proportion of subjects achieving EGPA remission within 24 weeks of treatment and maintaining it up to week 48 [Срок оценки: week 24, week 48]
  • The proportion of subjects with EGPA relapse [Срок оценки: week 12, week 24, week 48]
  • The time to the first relapse of EGPA [Срок оценки: Up to week 48]
  • The proportion of subjects with Severe relapse of EGPA [Срок оценки: week 12, week 24, week 48]
  • The time of the first Severe relapse of EGPA [Срок оценки: Up to week 48]
  • Changes from baseline in Pre- and post-Bronchodilator FEV1 [Срок оценки: Up to week 48]

Критерии участия

Критерии включения

  • Male or female subjects age 18 years or older;
  • Diagnosed with EGPA for at least 6 months;
  • History of relapsing or refractory EGPA；
  • Stable dose of oral prednisone of ≥7.5 mg/day (but not >50 mg/day) for at least 4 weeks prior to randomization;
  • If receiving immunosuppressive therapy (excluding cyclophosphamide), the dosage must be stable within 4 weeks prior to randomization and during the study.

Критерии исключения

  • Subjects with other eosinophilic-related diseases;
  • Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
  • Life-threatening EGPA within 3 months prior to randomization;
  • Malignancy history within 5 years prior to randomization;
  • Immunodeficiency;
  • Uncontrolled hypertension；
  • Uncontrolled cerebrovascular and cardiovascular disease;
  • parasitic infection within 6 months prior to randomization;
  • Active infectious disease requiring clinical treatment within 4 weeks prior to randomization;
  • Subjects with a dose of oral prednisone of >50 mg/day within 4 weeks prior to randomization;
  • Oral or intravenous cyclophosphamide therapy within 4 weeks prior to randomization;
  • Intravenous or subcutaneous immunoglobulin within 12 weeks prior to randomization;
  • Biological agents or TH2 cytokine inhibitors used within 12 weeks prior to randomization or within 5 half-lives of the drug;
  • Rituximab used within 6 months prior to randomization；
  • Surgical plans that might affect the evaluation;
  • Significant laboratory abnormalities；
  • Prolonged QTc interval or other electrocardiogram abnormalities with significant safety risk at screening;
  • History of drug or substance abuse or alcohol abuse within 1 year prior to screening;
  • Subjects participated another clinical study and received active drug within 30 days or 5 half-lives of the drug prior to screening;
  • Subjects is pregnant, lactating, or planning to be pregnant;
  • Subjects have a known history of hypersensitivity or intolerance to anti-IL-5 mabs or other biological agents or previous failure of IL-5/IL-5R therapy;
  • Other conditions unsuitable for participation in the study per investigator judgement.

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
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 2 центра
  • Beijing Hospital — Пекин
  • The Second Affiliated Hospital Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT05979051 · SHR-1703-301

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗