Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease
Starting soon · Phase 2/Phase 3
Conditions studied: Kawasaki Disease
In brief
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) .
Key facts
- Study ID
- NCT07686770
- Run by
- Children's Hospital of Fudan University
- People needed
- 90
- Starts
- 2026-08-01
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2026-07-27
Who can join
Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Jiangxi Provincial Children's Hospital — Nanchang, Jiangxi, China
- Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China
Full record on ClinicalTrials.gov
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