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NCT Number: NCT07686770

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

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) .

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Key information

Conditions

Kawasaki Disease Cardiovascular Diseases Hemic and Lymphatic Diseases Lymphatic Diseases Mucocutaneous Lymph Node Syndrome Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis

Age range

29 day–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Jiangxi Provincial Children's Hospital, Nanchang, Jiangxi, China

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About this study

This is a two-center, open-label, randomized controlled exploratory clinical trial in China. The investigators will enroll KD pediatric patients within 10 days of illness onset. Participants will be randomly assigned in a 1:2 ratio to the experimental group (receiving 3 mg/kg Firsekibart plus 2 g/kg IVIG and 30 mg/kg aspirin) or the control group (receiving 2 g/kg IVIG and 30 mg/kg aspirin). Baseline characteristics of each participant will be collected, including sex, age at onset, height, body weight, subtype of KD, fever days before initial IVIG, echocardiographic findings at enrolment, and a series of pre-IVIG laboratory tests. Two-dimensional echocardiography will be performed at admission, 2 weeks, 1 month, 3 months, and 6 months after illness onset to assess the coronary artery lesions. This study aims to determine the therapeutic potential of standard therapy combined with Firsekibart in the acute phase of KD for reducing the incidence of coronary artery lesions (CAL) , decreasing IVIG resistance, and improving inflammation control.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meeting diagnostic criteria for Kawasaki disease (KD) released by American Heart Association (AHA) in 2024
  • Diagnosed before the tenth day of illness (with the first day of illness defined as the first day of fever)
  • Not treated with IVIG yet
  • Age >28 days，<18 years

Exclusion criteria

  • Receiving steroids or other immunosuppressive agents in the previous 30 days;
  • With a previous history of KD;
  • Afebrile before enrolment;
  • Contraindications for subcutaneous injection, including severe local skin infection, ulceration, etc;
  • Known hypersensitivity to immunoglobulins, Firsekibart, or any of the excipients;
  • With suspected infectious diseases including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella and influenza, etc;
  • With serious immune diseases, such as immunodeficiency, or chromosomal abnormalities;
  • With severe hepatic dysfunction (ALT > 3 times the upper limit of normal) prior to treatment
  • Unwillingness to provide written informed consent;
  • Unlikely to complete at least 3 months of follow-up;
  • Any other conditions deemed unsuitable for enrolment by investigators.

Treatment and study plan

IVIG

Drug

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

Other names: Intravenous Immunoglobulins, Human

Aspirin

Drug

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.

Other names: Acetylsalicylic acid

Firsekibart

Drug

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.

Other names: Interleukin (IL)-1β receptor antagonist

Primary outcomes

  1. Occurrence of coronary artery lesions (CAL) at one month of illness

    Time frame: 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.

  2. Occurrence of the need for rescue therapy

    Time frame: 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.

Secondary outcomes

  1. Duration of fever (hours) after initiation of initial IVIG infusion

    Time frame: from initiation of the initial IVIG infusion to the first recorded afebrile status (up to 60 hours after the infusion of IVIG)

    Temperature will be measured every 6 hours a day during hospitalization. Participants with temperature <37.5℃ for more than 24 hours are considered afebrile. Record the time of the initiation of IVIG infusion and the time of the body temperature first becoming normal.

  2. Change in serum C-reactive protein (CRP) concentration

    Time frame: from admission to 1 month of illness onset

    Serum CRP levels will be measured at three time points: at enrolment, 72 hours after completion of the initial IVIG infusion, and 1 month of illness onset.

  3. Change in Serum Amyloid A (SAA) concentration

    Time frame: from admission to 1 month of illness onset

    SAA levels will be measured at three time points: at enrolment, 72 hours after completion of the initial IVIG infusion, and 1 month of illness onset.

  4. Change in serum interleukin (IL)-1β concentration

    Time frame: from admission to 72 hours after completion of the initial IVIG infusion

    Serum IL-1β levels will be measured at two time points: at enrolment, 72 hours after completion of the initial IVIG infusion.

  5. Occurrence of coronary artery lesions (CAL) at 2 weeks of illness

    Time frame: from admission to 2 weeks of illness onset

    Two-dimensional echocardiography will be performed to evaluate CAL at 2 weeks of illness. The measurement of each patient included 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.

  6. Occurrence of coronary artery lesions (CAL) at 3 months of illness

    Time frame: from admission to 3 months of illness onset

    Two-dimensional echocardiography will be performed to evaluate CAL at 3 months 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.

  7. Occurrence of medium-to-giant coronary artery aneurysms (CAAs)

    Time frame: from admission to 6 months of illness onset

    This is a repeatedly measured binary variable. CAL classification is based on the maximum Z score according to the 2024 American Heart Association guideline. Medium CAAs is defined as a maximum Z score ≥5 to <10, and all internal diameters <8 mm; large or giant CAAs defined as a maximum Z score ≥10, or any internal diameter ≥8 mm.

  8. Changes in z scores of LAD

    Time frame: from admission to 6 months of illness onset

    This is a repeated measurement. The internal diameter of LAD will be measured by echocardiography at five time points: at enrolment, at 2 weeks, 1 month, 3 months and 6 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter (Journal of the American Society of Echocardiography, 2011, 24(1).).

  9. Changes in z scores of LMCA

    Time frame: from admission to 6 months of illness onset

    This is a repeated measurement. The internal diameter of LMCA will be measured by echocardiography at five time points: at enrolment, at 2 weeks, 1 month, 3 months and 6 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter (Journal of the American Society of Echocardiography, 2011, 24(1).).

  10. Changes in z scores of LCX

    Time frame: from admission to 6 months of illness onset

    This is a repeated measurement. The internal diameter of LCX will be measured by echocardiography at five time points: at enrolment, at 2 weeks, 1 month, 3 months and 6 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter (Journal of the American Society of Echocardiography, 2011, 24(1).).

  11. Changes in z scores of the proximal segment of RCA

    Time frame: from admission to 6 months of illness onset

    This is a repeated measurement. The internal diameter of the proximal segment of RCA will be measured by echocardiography at five time points: at enrolment, at 2 weeks, 1 month, 3 months and 6 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter (Journal of the American Society of Echocardiography, 2011, 24(1).).

  12. Changes in z scores of the middle segment of RCA

    Time frame: from admission to 6 months of illness onset

    This is a repeated measurement. The internal diameter of the middle segment of RCA will be measured by echocardiography at five time points: at enrolment, at 2 weeks, 1 month, 3 months and 6 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter (Journal of the American Society of Echocardiography, 2011, 24(1).).

  13. Occurrence of CAL regression

    Time frame: from admission to 6 months of illness onset

    CAL regression is defined as Z score <2.5 in any coronary artery (LMCA, LAD, LCX, and the proximal and middle segments of the RCA), with no stenotic or occlusive lesions present.The internal diameter of the coronary artery will be measured by echocardiography at five time points: at enrolment, at 2 weeks, 1 month, 3 months and 6 months after illness onset. Z score will be calculated based on the height, weight and coronary artery diameter (Journal of the American Society of Echocardiography, 2011, 24(1).).

  14. Occurrence of CAL progression

    Time frame: from admission to 6 months of illness onset

    CAL progression is defined as an increment in the Z score >1 from admission in any coronary artery (LMCA, LAD, LCX, proximal and middle segments of RCA) at any given time point within 6 months of illness onset. The outcome will be assessed in all participants and those with CAL at baseline.

  15. Occurrence of adverse events

    Time frame: from admission to 6 months of illness onset

    This is a composite outcome, including (a) clinical adverse events (death, severe infection, allergic reactions, heart failure, and thrombosis); (b) laboratory abnormalities (neutropenia, defined as <1.5×10⁹/L; thrombocytopenia, defined as <100×10⁹/L; newly developed ALT abnormality after medication, or further elevation of abnormal baseline ALT); (c) infectious events (occurrence of bacterial/viral infections); and (d) injection-site allergic reactions (redness and swelling at the injection site, rash, and anaphylactic shock) , etc.

Study contacts

Contact information is provided by the study sponsor or research team.

Fang Liu, MD

CONTACT

[email protected]

+86 021-64932800

Lan He, MD

CONTACT

[email protected]

+8602164932026

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

  • Jiangxi Province Children's Hospital

Registry information

Official study title

Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease: An Exploratory Randomized Controlled Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 7, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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