Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IVIG, Aspirin, Firsekibart.
- Who it may be relevant to
- Registry conditions: Kawasaki Disease. Basic parameters: 29 Days — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease: An Exploratory Randomized Controlled Study
Overview
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) .
Detailed description
This is a two-center, open-label, randomized controlled exploratory clinical trial in China. The investigators will enroll KD pediatric patients within 10 days of illness onset. Participants will be randomly assigned in a 1:2 ratio to the experimental group (receiving 3 mg/kg Firsekibart plus 2 g/kg IVIG and 30 mg/kg aspirin) or the control group (receiving 2 g/kg IVIG and 30 mg/kg aspirin). Baseline characteristics of each participant will be collected, including sex, age at onset, height, body weight, subtype of KD, fever days before initial IVIG, echocardiographic findings at enrolment, and a series of pre-IVIG laboratory tests. Two-dimensional echocardiography will be performed at admission, 2 weeks, 1 month, 3 months, and 6 months after illness onset to assess the coronary artery lesions. This study aims to determine the therapeutic potential of standard therapy combined with Firsekibart in the acute phase of KD for reducing the incidence of coronary artery lesions (CAL) , decreasing IVIG resistance, and improving inflammation control.
Interventions
- Drug IVIG
IVIG 2g/kg once, given over 8 to 12 hours, with the maximum dose of 60g. - Drug 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. - Drug 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.
Primary outcome measures
- Occurrence of coronary artery lesions (CAL) at one month of illness [Time frame: from admission to 1 month of illness onset]
- Occurrence of the need for rescue therapy [Time frame: from admission to discharge (about 2 weeks of illness onset)]
Secondary outcome measures (12)
- Duration of fever (hours) after initiation of initial IVIG infusion [Time frame: from initiation of the initial IVIG infusion to the first recorded afebrile status (up to 60 hours after the infusion of IVIG)]
- Change in serum C-reactive protein (CRP) concentration [Time frame: from admission to 1 month of illness onset]
- Change in Serum Amyloid A (SAA) concentration [Time frame: from admission to 1 month of illness onset]
- Change in serum interleukin (IL)-1β concentration [Time frame: from admission to 72 hours after completion of the initial IVIG infusion]
- Occurrence of coronary artery lesions (CAL) at 2 weeks of illness [Time frame: from admission to 2 weeks of illness onset]
- Occurrence of coronary artery lesions (CAL) at 3 months of illness [Time frame: from admission to 3 months of illness onset]
- Occurrence of medium-to-giant coronary artery aneurysms (CAAs) [Time frame: from admission to 6 months of illness onset]
- Changes in z scores of LAD [Time frame: from admission to 6 months of illness onset]
- Changes in z scores of LMCA [Time frame: from admission to 6 months of illness onset]
- Changes in z scores of LCX [Time frame: from admission to 6 months of illness onset]
- Changes in z scores of the proximal segment of RCA [Time frame: from admission to 6 months of illness onset]
- Changes in z scores of the middle segment of RCA [Time frame: from admission to 6 months of illness onset]
Eligibility criteria
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;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Jiangxi Provincial Children's Hospital — Nanchang
- Children's Hospital of Fudan University — Shanghai
Identifiers
NCT: NCT07686770 · 2026-244