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

NCT07686770 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-07-27

No results posted yet for this study

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) .

Conditions

  • Kawasaki Disease

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.

Sponsors & Collaborators

  • Jiangxi Province Children's Hospital

    collaborator OTHER

  • Children's Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Fang Liu, MD · Children's Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
29 Days
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-09-01
Completion
2028-02-01

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07686770 on ClinicalTrials.gov