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Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease

24 июля 2026 г. обновлено: Children's Hospital of Fudan University

Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease: An Exploratory Randomized Controlled Study

This study evaluates the efficacy and safety of the addition of Firsekibart to standard initial treatment (intravenous immunoglobulin [IVIG] plus aspirin) in children with Acute Kawasaki Disease (KD) .

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Подробное описание

This is a two-center, open-label, randomized controlled exploratory clinical trial in China. The investigators will enroll KD pediatric patients within 10 days of illness onset. Participants will be randomly assigned in a 1:2 ratio to the experimental group (receiving 3 mg/kg Firsekibart plus 2 g/kg IVIG and 30 mg/kg aspirin) or the control group (receiving 2 g/kg IVIG and 30 mg/kg aspirin). Baseline characteristics of each participant will be collected, including sex, age at onset, height, body weight, subtype of KD, fever days before initial IVIG, echocardiographic findings at enrolment, and a series of pre-IVIG laboratory tests. Two-dimensional echocardiography will be performed at admission, 2 weeks, 1 month, 3 months, and 6 months after illness onset to assess the coronary artery lesions. This study aims to determine the therapeutic potential of standard therapy combined with Firsekibart in the acute phase of KD for reducing the incidence of coronary artery lesions (CAL) , decreasing IVIG resistance, and improving inflammation control.

Тип исследования

Интервенционный

Регистрация (Оцененный)

90

Фаза

  • Фаза 2
  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Fang Liu, MD
  • Номер телефона: +86 021-64932800
  • Электронная почта: liufang@fudan.edu.cn

Учебное резервное копирование контактов

  • Имя: Lan He, MD
  • Номер телефона: +8602164932026
  • Электронная почта: helan0361@163.com

Места учебы

  • Китай
    • Jiangxi
      • Nanchang, Jiangxi, Китай, 330006
        • Jiangxi Provincial Children's Hospital
        • Контакт:
          • Xiaohui Liu, MD
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Китай, 201102
        • Children's Hospital of Fudan University
        • Контакт:
          • Fang Liu, MD

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Ребенок

Принимает здоровых добровольцев

Нет

Описание

Inclusion Criteria:

  1. Meeting diagnostic criteria for Kawasaki disease (KD) released by American Heart Association (AHA) in 2024
  2. Diagnosed before the tenth day of illness (with the first day of illness defined as the first day of fever)
  3. Not treated with IVIG yet
  4. Age >28 days，<18 years

Exclusion Criteria:

  1. Receiving steroids or other immunosuppressive agents in the previous 30 days;
  2. With a previous history of KD;
  3. Afebrile before enrolment;
  4. Contraindications for subcutaneous injection, including severe local skin infection, ulceration, etc;
  5. Known hypersensitivity to immunoglobulins, Firsekibart, or any of the excipients;
  6. With suspected infectious diseases including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella and influenza, etc;
  7. With serious immune diseases, such as immunodeficiency, or chromosomal abnormalities;
  8. With severe hepatic dysfunction (ALT > 3 times the upper limit of normal) prior to treatment
  9. Unwillingness to provide written informed consent;
  10. Unlikely to complete at least 3 months of follow-up;
  11. Any other conditions deemed unsuitable for enrolment by investigators.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: standard treatment group

【Standard treatment follow the 2024 AHA Guidelines of Kawasaki Disease】

  1. IVIG 2g/kg once, given over 8 to 12 hours;
  2. Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 3 days and C-reactive protein (CRP) is normal. Aspirin will be continued for at least 6 weeks after illness onset.

Participants with persistent or recurrent fever (temperature of ≥38°C ) 36 hours after completion of the first IVIG infusion are defined as having resistance to IVIG and will receive rescue therapy. The rescue therapy will be chosen on the basis of participant's condition and the physician's experience.

Participants intolerant to aspirin may receive oral clopidogrel as an alternative.
Лекарство: Aspirin
Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 3 days and CRP is normal. Aspirin will be continued for at least 6 weeks after onset of illness.
Другие имена:
  • Ацетилсалициловая кислота
Лекарство: IVIG
IVIG 2g/kg once, given over 8 to 12 hours, with the maximum dose of 60g.
Другие имена:
  • Внутривенные иммуноглобулины человека
Экспериментальный: Firsekibart + standard treatment group
  1. Firsekibart 3 mg/kg by a single subcutaneous injection prior to IVIG infusion. After a 30-minute observation period confirming the absence of adverse reactions, the IVIG infusion is initiated.
  2. IVIG 2g/kg once, given over 8 to 12 hours;
  3. Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 3 days and CRP is normal. Aspirin will be continued for at least 6 weeks after onset of illness.

【Standard treatment also follow the 2024 AHA Guidelines of Kawasaki Disease】

Discomfort occurring during the observation period after Firsekibart will be treated symptomatically, and standard treatment will subsequently be provided as needed based on the participant's condition and the physician's experience.

In the event of a Grade ≥3 allergic reaction, epinephrine will be administered as needed.

Management of IVIG resistance, aspirin intolerance will be the same as in the control group.
Лекарство: Aspirin
Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 3 days and CRP is normal. Aspirin will be continued for at least 6 weeks after onset of illness.
Другие имена:
  • Ацетилсалициловая кислота
Лекарство: Firsekibart
Firsekibart 3 mg/kg by a single subcutaneous injection prior to IVIG infusion. After a 30-minute observation period confirming the absence of adverse reactions, the IVIG infusion is initiated.
Другие имена:
  • Interleukin (IL)-1β receptor antagonist
Лекарство: IVIG
IVIG 2g/kg once, given over 8 to 12 hours, with the maximum dose of 60g.
Другие имена:
  • Внутривенные иммуноглобулины человека

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Occurrence of coronary artery lesions (CAL) at one month of illness
Временное ограничение: from admission to 1 month of illness onset
Two-dimensional echocardiography will be performed to evaluate CAL at 1 month of illness. Measurements for each patient include the diameter of the left main coronary artery (LMCA), the left anterior descending artery (LAD), the left circumflex coronary artery (LCX), and the proximal and middle segments of the right coronary artery (RCA). Z score of each coronary artery will be calculated (Journal of the American Society of Echocardiography, 2011, 24(1).). CAL is defined as z≥2.5 of any coronary artery of LMCA, LAD, LCX, and the proximal and middle segment of the RCA.
from admission to 1 month of illness onset
Occurrence of the need for rescue therapy
Временное ограничение: from admission to discharge (about 2 weeks of illness onset)
Temperature will be measured every 6 hours a day during hospitalization. Participants who have recurrent or persistent fever (temperature ≥38°C) after 36 hours of completion of initial IVIG infusion will be given rescue therapy.
from admission to discharge (about 2 weeks of illness onset)

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Duration of fever (hours) after initiation of initial IVIG infusion
Временное ограничение: from initiation of the initial IVIG infusion to the first recorded afebrile status (up to 60 hours after the infusion of IVIG)
Temperature will be measured every 6 hours a day during hospitalization. Participants with temperature <37.5℃ for more than 24 hours are considered afebrile. Record the time of the initiation of IVIG infusion and the time of the body temperature first becoming normal.
from initiation of the initial IVIG infusion to the first recorded afebrile status (up to 60 hours after the infusion of IVIG)
Occurrence of coronary artery lesions (CAL) at 2 weeks of illness
Временное ограничение: from admission to 2 weeks of illness onset
Two-dimensional echocardiography will be performed to evaluate CAL at 2 weeks of illness. The measurement of each patient included the diameter of the left main coronary artery (LMCA), the left anterior descending artery (LAD), the left circumflex coronary artery (LCX), and the proximal and middle segments of the right coronary artery (RCA). Z score of each coronary artery will be calculated (Journal of the American Society of Echocardiography, 2011, 24(1).). CAL is defined as z≥2.5 of any coronary artery of LMCA, LAD, LCX, and the proximal and middle segment of the RCA.
from admission to 2 weeks of illness onset
Occurrence of coronary artery lesions (CAL) at 3 months of illness
Временное ограничение: from admission to 3 months of illness onset
Two-dimensional echocardiography will be performed to evaluate CAL at 3 months of illness. Measurements for each patient include the diameter of the left main coronary artery (LMCA), the left anterior descending artery (LAD), the left circumflex coronary artery (LCX), and the proximal and middle segments of the right coronary artery (RCA). Z score of each coronary artery will be calculated (Journal of the American Society of Echocardiography, 2011, 24(1).). CAL is defined as z≥2.5 of any coronary artery of LMCA, LAD, LCX, and the proximal and middle segment of the RCA.
from admission to 3 months of illness onset
Occurrence of medium-to-giant coronary artery aneurysms (CAAs)
Временное ограничение: from admission to 6 months of illness onset
This is a repeatedly measured binary variable. CAL classification is based on the maximum Z score according to the 2024 American Heart Association guideline. Medium CAAs is defined as a maximum Z score ≥5 to <10, and all internal diameters <8 mm; large or giant CAAs defined as a maximum Z score ≥10, or any internal diameter ≥8 mm.
from admission to 6 months of illness onset
Changes in z scores of LAD
Временное ограничение: from admission to 6 months of illness onset
This is a repeated measurement. The internal diameter of LAD will be measured by echocardiography at five time points: at enrolment, at 2 weeks, 1 month, 3 months and 6 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter (Journal of the American Society of Echocardiography, 2011, 24(1).).
from admission to 6 months of illness onset
Changes in z scores of LMCA
Временное ограничение: from admission to 6 months of illness onset
This is a repeated measurement. The internal diameter of LMCA will be measured by echocardiography at five time points: at enrolment, at 2 weeks, 1 month, 3 months and 6 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter (Journal of the American Society of Echocardiography, 2011, 24(1).).
from admission to 6 months of illness onset
Changes in z scores of LCX
Временное ограничение: from admission to 6 months of illness onset
This is a repeated measurement. The internal diameter of LCX will be measured by echocardiography at five time points: at enrolment, at 2 weeks, 1 month, 3 months and 6 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter (Journal of the American Society of Echocardiography, 2011, 24(1).).
from admission to 6 months of illness onset
Changes in z scores of the proximal segment of RCA
Временное ограничение: from admission to 6 months of illness onset
This is a repeated measurement. The internal diameter of the proximal segment of RCA will be measured by echocardiography at five time points: at enrolment, at 2 weeks, 1 month, 3 months and 6 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter (Journal of the American Society of Echocardiography, 2011, 24(1).).
from admission to 6 months of illness onset
Changes in z scores of the middle segment of RCA
Временное ограничение: from admission to 6 months of illness onset
This is a repeated measurement. The internal diameter of the middle segment of RCA will be measured by echocardiography at five time points: at enrolment, at 2 weeks, 1 month, 3 months and 6 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter (Journal of the American Society of Echocardiography, 2011, 24(1).).
from admission to 6 months of illness onset
Occurrence of CAL regression
Временное ограничение: from admission to 6 months of illness onset
CAL regression is defined as Z score <2.5 in any coronary artery (LMCA, LAD, LCX, and the proximal and middle segments of the RCA), with no stenotic or occlusive lesions present.The internal diameter of the coronary artery will be measured by echocardiography at five time points: at enrolment, at 2 weeks, 1 month, 3 months and 6 months after illness onset. Z score will be calculated based on the height, weight and coronary artery diameter (Journal of the American Society of Echocardiography, 2011, 24(1).).
from admission to 6 months of illness onset
Occurrence of CAL progression
Временное ограничение: from admission to 6 months of illness onset
CAL progression is defined as an increment in the Z score >1 from admission in any coronary artery (LMCA, LAD, LCX, proximal and middle segments of RCA) at any given time point within 6 months of illness onset. The outcome will be assessed in all participants and those with CAL at baseline.
from admission to 6 months of illness onset
Occurrence of adverse events
Временное ограничение: from admission to 6 months of illness onset
This is a composite outcome, including (a) clinical adverse events (death, severe infection, allergic reactions, heart failure, and thrombosis); (b) laboratory abnormalities (neutropenia, defined as <1.5×10⁹/L; thrombocytopenia, defined as <100×10⁹/L; newly developed ALT abnormality after medication, or further elevation of abnormal baseline ALT); (c) infectious events (occurrence of bacterial/viral infections); and (d) injection-site allergic reactions (redness and swelling at the injection site, rash, and anaphylactic shock) , etc.
from admission to 6 months of illness onset
Change in serum C-reactive protein (CRP) concentration
Временное ограничение: from admission to 1 month of illness onset
Serum CRP levels will be measured at three time points: at enrolment, 72 hours after completion of the initial IVIG infusion, and 1 month of illness onset.
from admission to 1 month of illness onset
Change in Serum Amyloid A (SAA) concentration
Временное ограничение: from admission to 1 month of illness onset
SAA levels will be measured at three time points: at enrolment, 72 hours after completion of the initial IVIG infusion, and 1 month of illness onset.
from admission to 1 month of illness onset
Change in serum interleukin (IL)-1β concentration
Временное ограничение: from admission to 72 hours after completion of the initial IVIG infusion
Serum IL-1β levels will be measured at two time points: at enrolment, 72 hours after completion of the initial IVIG infusion.
from admission to 72 hours after completion of the initial IVIG infusion

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Children's Hospital of Fudan University

Соавторы

Jiangxi Province Children's Hospital

Следователи

  • Директор по исследованиям: Fang Liu, MD, Children's Hospital of Fudan University

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 августа 2026 г.

Первичное завершение (Оцененный)

1 сентября 2027 г.

Завершение исследования (Оцененный)

1 февраля 2028 г.

Даты регистрации исследования

Первый отправленный

26 июня 2026 г.

Впервые представлено, что соответствует критериям контроля качества

6 июля 2026 г.

Первый опубликованный (Действительный)

7 июля 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

27 июля 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

24 июля 2026 г.

Последняя проверка

1 июля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 2026-244

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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