Not Yet RecruitingPhase 2/3

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

China90 participantsStarted 2026-08-01

Plain-language 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) .

Who can participate

Age range

29 Days – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Occurrence of coronary artery lesions (CAL) at one month of illness

Timeframe: from admission to 1 month of illness onset

Occurrence of the need for rescue therapy

Timeframe: from admission to discharge (about 2 weeks of illness onset)

Trial details

NCT IDNCT07686770

SponsorChildren's Hospital of Fudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-01

Contact for this trial

Fang Liu, MD

+86 021-64932800 liufang@fudan.edu.cn

View on ClinicalTrials.gov More Kawasaki Disease trials