About this trial
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 criteria
Qualifiers
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
Disqualifiers
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;
Trial design
Treatments tested in this trial
- IVIG
- Aspirin
- Firsekibart
Treatment groups
Sponsors and collaborators
Children's Hospital of Fudan University
Lead sponsor
Jiangxi Province Children's Hospital
Collaborator