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

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age29-17
SponsorChildren's Hospital of Fudan University

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

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Children's Hospital of Fudan University

Lead sponsor

Jiangxi Province Children's Hospital

Collaborator