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Immunoglobulin Plus Firsekibart in Kawasaki Disease
NCT07686770Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Nov 2026
- Primary completion
- Sep 2027
- Countries
- 1
- Sponsor
- Children's Hospital of Fudan University
- Drugs
- genakumab
- Conditions
- Kawasaki disease (KD)
01
Overview
Phase 3, randomised, open-label trial of genakumab in Kawasaki disease (KD) (2 arms), sponsored by Children's Hospital of Fudan University. Primary endpoints: Occurrence of coronary artery lesions at 1 month and Occurrence of the need for rescue therapy at 2 weeks. Planned start Nov 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
standard treatment group
IVIG 2g/kg once + Aspirin 30 mg/kg/day then 3-5 mg/kg/day
Firsekibart + standard treatment group
Firsekibart 3 mg/kg SC once + IVIG 2g/kg once + Aspirin 30 mg/kg/day then 3-5 mg/kg/day
03
Who it enrols
Pediatric patients (>28 days, <18 years) diagnosed with Kawasaki disease within 10 days of illness onset, not yet treated with IVIG, excluding those with recent steroid/immunosuppressive use, previous KD history, or severe hepatic dysfunction.
04
Endpoints
Primary
Occurrence of coronary artery lesions
Occurrence of the need for rescue therapy
Secondary
Duration of fever
Change in serum C-reactive protein concentration
Change in Serum Amyloid A concentration
Change in serum interleukin-1β concentration
Occurrence of coronary artery lesions at 2 weeks
Occurrence of coronary artery lesions at 3 months
Occurrence of medium-to-giant coronary artery aneurysms
Changes in z scores of LAD
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