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

24 de julho de 2026 atualizado por: 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) .

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

90

Estágio

  • Fase 2
  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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.
Medicamento: 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.
Outros nomes:
  • Ácido acetilsalicílico
Medicamento: IVIG
IVIG 2g/kg once, given over 8 to 12 hours, with the maximum dose of 60g.
Outros nomes:
  • Imunoglobulinas Intravenosas Humanas
Experimental: 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.
Medicamento: 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.
Outros nomes:
  • Ácido acetilsalicílico
Medicamento: 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.
Outros nomes:
  • Interleukin (IL)-1β receptor antagonist
Medicamento: IVIG
IVIG 2g/kg once, given over 8 to 12 hours, with the maximum dose of 60g.
Outros nomes:
  • Imunoglobulinas Intravenosas Humanas

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Occurrence of coronary artery lesions (CAL) at one month of illness
Prazo: 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
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Duration of fever (hours) after initiation of initial IVIG infusion
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Children's Hospital of Fudan University

Colaboradores

Jiangxi Province Children's Hospital

Investigadores

  • Diretor de estudo: Fang Liu, MD, Children's Hospital of Fudan University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de agosto de 2026

Conclusão Primária (Estimado)

1 de setembro de 2027

Conclusão do estudo (Estimado)

1 de fevereiro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

26 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de julho de 2026

Primeira postagem (Real)

7 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2026-244

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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