IVIG: IVIG 2g/kg once, given over 8 to 12 hours, with the maximum dose of 60g.
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.
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.
Study summary
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) .
Eligibility
Sex
ALL
Min age
29 Days
Max age
17 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Occurrence of coronary artery lesions (CAL) at one month of illness — 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.
Occurrence of the need for rescue therapy — 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.
Trial sites (2)
Facility
City
Region
Status
Jiangxi Provincial Children's Hospital
Nanchang
Jiangxi
Children's Hospital of Fudan University
Shanghai
Shanghai Municipality
More Children's Hospital of Fudan University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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