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

Официальное название

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

Обзор

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) .

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.

Вмешательства

• Препарат IVIG
  IVIG 2g/kg once, given over 8 to 12 hours, with the maximum dose of 60g.
• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Occurrence of coronary artery lesions (CAL) at one month of illness [Срок оценки: from admission to 1 month of illness onset]
• Occurrence of the need for rescue therapy [Срок оценки: from admission to discharge (about 2 weeks of illness onset)]

Вторичные конечные точки (12)

• Duration of fever (hours) after initiation of initial IVIG infusion [Срок оценки: from initiation of the initial IVIG infusion to the first recorded afebrile status (up to 60 hours after the infusion of IVIG)]
• Change in serum C-reactive protein (CRP) concentration [Срок оценки: from admission to 1 month of illness onset]
• Change in Serum Amyloid A (SAA) concentration [Срок оценки: from admission to 1 month of illness onset]
• Change in serum interleukin (IL)-1β concentration [Срок оценки: from admission to 72 hours after completion of the initial IVIG infusion]
• Occurrence of coronary artery lesions (CAL) at 2 weeks of illness [Срок оценки: from admission to 2 weeks of illness onset]
• Occurrence of coronary artery lesions (CAL) at 3 months of illness [Срок оценки: from admission to 3 months of illness onset]
• Occurrence of medium-to-giant coronary artery aneurysms (CAAs) [Срок оценки: from admission to 6 months of illness onset]
• Changes in z scores of LAD [Срок оценки: from admission to 6 months of illness onset]
• Changes in z scores of LMCA [Срок оценки: from admission to 6 months of illness onset]
• Changes in z scores of LCX [Срок оценки: from admission to 6 months of illness onset]
• Changes in z scores of the proximal segment of RCA [Срок оценки: from admission to 6 months of illness onset]
• Changes in z scores of the middle segment of RCA [Срок оценки: from admission to 6 months of illness onset]

Критерии участия

Критерии включения

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

Критерии исключения

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

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

• Jiangxi Provincial Children's Hospital — Nanchang
• Children's Hospital of Fudan University — Шанхай

Идентификаторы

NCT: NCT07686770 · 2026-244

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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