Kawasaki disease
Conditions
Interventions
Observation Group:1. Firsekibart (3 mg/kg, single subcutaneous injection) plus IVIG (2 g/kg, single intravenous infusion over 8–12 hours
may be extended to 24 hours if severe adverse reactions occur) plus Aspirin (initial dose 30–50 mg/kg/day, divided into 3 oral doses
after fever resolution for >=48 hours, reduce to 3–5 mg/kg/day as a single daily dose)
2.Aspirin Duration: KD patients without CAA: 6–8 weeks
KD patients with CAA: continue until coronary artery abnormalities resolve
Control Group:1.IVIG (2 g/kg, single intravenous infusion over 8–12 hours
Sponsors
Children's Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
0.5 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Criteria for Complete KD (Kawasaki Disease) Diagnosis. Fever for at least 4 days (day of fever onset = day 1 of fever) + at least 4 of the following 5 principal clinical features (not required to occur simultaneously): 1.1 Polymorphous rash; 1.2 Bilateral, non-exudative bulbar conjunctival injection; 1.3Oral changes: dry, red, cracked lips, strawberry tongue, or erythema of the oropharyngeal mucosa, or any combination thereof; 1.4Erythema of the palms and soles, often accompanied by swelling, followed by desquamation in the subacute phase; 1.5 Cervical lymphadenopathy, usually unilateral, >=1.5 cm in diameter;The illness cannot be explained by any other known disease process. 2. Criteria for Incomplete KD Diagnosis:Prolonged fever of unknown origin with 2–3 principal clinical features, or unexplained fever lasting >=7 days in infants (day 1 = day of fever onset), plus at least one 2.1 CRP >=30 mg/L and/or ESR>=40 mm/h; 2.2 Three or more of the following: 2.2.1Anemia; 2.2.2Platelets >=450,000/mm^3; 2.2.3 Albumin =15,000/mm^3; 2.2.6Urine WBC >=10/hpf; 2.3LAD or RCA Z-score >=2.5; 2.4 Presence of >=3 features including decreased left ventricular function, mitral regurgitation, pericardial effusion, or LAD or RCA Z-score between 2 and 2.5. 3. Age 6 months to 18 years, any sex, disease onset =38°C) at admission. 4. Plus at least one of the following high-risk conditions: 4.1High risk for IVIG resistance predicted by Kobayashi score >=5; 4.2Involvement of major organs. 5. Written informed consent obtained from the legal guardian, and ability to complete the full follow-up as required. 6. No severe local skin infection, ulceration, or other contraindications to subcutaneous injection.
Exclusion criteria
Exclusion criteria: 1. Prior or current treatment with IVIG, corticosteroids, biologics, or any immunosuppressive agents; 2. Allergy to immunoglobulins, aspirin, Voxinkibart (or the investigational product), or any of its excipients; 3. Known immunodeficiency, malignancy, active tuberculosis, or active hepatitis B/hepatitis C/HIV infection; 4. Concurrent severe cardiac dysfunction (LVEF = 10); 5. History of coronary artery aneurysms or severe cardiovascular disease (e.g., congenital heart disease, cardiomyopathy); 6. Concurrent participation in another interventional clinical trial. 7. Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the defervescence rate within 36 hours post-treatment between vixarelimab + IVIG + aspirin versus IVIG + aspirin in high-risk Kawasaki disease, defined as axillary temperature = 24 hours.;To compare the cumulative incidence of coronary artery Z-score >= 2.5 or development of coronary artery aneurysm (CAA) by Day 50 post-treatment between vixarelimab + IVIG + aspirin versus IVIG + aspirin in high-risk KD patients.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in inflammatory markers including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and other relevant parameters.;Coronary Artery Outcomes Change in maximum coronary artery Z-score at Days 7, 21, 50 and 90 Number of new-onset coronary artery aneurysm (CAA) cases;IVIG Resistance: To compare the rate of IVIG resistance between the two treatment groups from 36 hours to 7 days post-treatment, defined as temperature>= 38.0°C.;Safety Assessments: Documentation of adverse events (AEs) and serious adverse events (SAEs).; | — |
Countries
China
Contacts
Public ContactHaiguo Yu
Children's Hospital of Nanjing Medical University
Outcome results
None listed