drugset / Trial / NCT07686770
Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease
Phase 2/3
Not yet recruiting
90 enrolled
Children's Hospital of Fudan University
Jiangxi Province Children's Hospital · collab
RandomizedParallel-groupSingle-blindTreatment
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) .
Timeline
- Start
- 2026-08-01
- Primary completion
- 2027-09-01
- Completion
- 2028-02-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Firsekibart | Protein / enzyme biologic | 3 mg/kg | Subcutaneous |
| Background | Aspirin | Small molecule | 3 mg/kg | Oral |
| Background | Aspirin | Small molecule | 5 mg/kg | Oral |
| Background | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 2 g/kg | Intravenous |