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

Condition(s) studied

Investigational drug(s) / intervention(s)

IVIG: IVIG 2g/kg once, given over 8 to 12 hours, with the maximum dose of 60g.

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.

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.

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) .

Eligibility

Primary outcome measure(s)

• Occurrence of coronary artery lesions (CAL) at one month of illness — from admission to 1 month of illness onset
  Two-dimensional echocardiography will be performed to evaluate CAL at 1 month of illness. Measurements for each patient include the diameter of the left main coronary artery (LMCA), the left anterior descending artery (LAD), the left circumflex coronary artery (LCX), and the proximal and middle segments of the right coronary artery (RCA). Z score of each coronary artery will be calculated (Journal of the American Society of Echocardiography, 2011, 24(1).). CAL is defined as z≥2.5 of any coronary artery of LMCA, LAD, LCX, and the proximal and middle segment of the RCA.
• Occurrence of the need for rescue therapy — from admission to discharge (about 2 weeks of illness onset)
  Temperature will be measured every 6 hours a day during hospitalization. Participants who have recurrent or persistent fever (temperature ≥38°C) after 36 hours of completion of initial IVIG infusion will be given rescue therapy.

Trial sites (2)

More Children's Hospital of Fudan University trials in China

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