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

2026年7月24日 更新者：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) .

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

90

阶段

  • 阶段2
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：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.
药品：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.
其他名称：
  • 乙酰水杨酸
药品：IVIG
IVIG 2g/kg once, given over 8 to 12 hours, with the maximum dose of 60g.
其他名称：
  • 静脉注射免疫球蛋白，人
实验性的：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.
药品：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.
其他名称：
  • 乙酰水杨酸
药品：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.
其他名称：
  • Interleukin (IL)-1β receptor antagonist
药品：IVIG
IVIG 2g/kg once, given over 8 to 12 hours, with the maximum dose of 60g.
其他名称：
  • 静脉注射免疫球蛋白，人

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Occurrence of coronary artery lesions (CAL) at one month of illness
大体时间：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
大体时间：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)

次要结果测量

结果测量
措施说明
大体时间
Duration of fever (hours) after initiation of initial IVIG infusion
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Children's Hospital of Fudan University

合作者

Jiangxi Province Children's Hospital

调查人员

  • 研究主任：Fang Liu, MD、Children's Hospital of Fudan University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2027年9月1日

研究完成 (估计的)

2028年2月1日

研究注册日期

首次提交

2026年6月26日

首先提交符合 QC 标准的

2026年7月6日

首次发布 (实际的)

2026年7月7日

研究记录更新

最后更新发布 (实际的)

2026年7月27日

上次提交的符合 QC 标准的更新

2026年7月24日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2026-244

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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