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

24. Juli 2026 aktualisiert von: Children's Hospital of Fudan University

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

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) .

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

90

Phase

  • Phase 2
  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Jiangxi Provincial Children's Hospital
        • Kontakt:
          • Xiaohui Liu, MD
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201102
        • Children's Hospital of Fudan University
        • Kontakt:
          • Fang Liu, MD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

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

Exclusion Criteria:

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: standard treatment group

【Standard treatment follow the 2024 AHA Guidelines of Kawasaki Disease】

  1. IVIG 2g/kg once, given over 8 to 12 hours;
  2. 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 C-reactive protein (CRP) is normal. Aspirin will be continued for at least 6 weeks after illness onset.

Participants with persistent or recurrent fever (temperature of ≥38°C ) 36 hours after completion of the first IVIG infusion are defined as having resistance to IVIG and will receive rescue therapy. The rescue therapy will be chosen on the basis of participant's condition and the physician's experience.

Participants intolerant to aspirin may receive oral clopidogrel as an alternative.
Arzneimittel: 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.
Andere Namen:
  • Acetylsalicylsäure
Arzneimittel: IVIG
IVIG 2g/kg once, given over 8 to 12 hours, with the maximum dose of 60g.
Andere Namen:
  • Intravenöse Immunglobuline, Mensch
Experimental: Firsekibart + standard treatment group
  1. 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.
  2. IVIG 2g/kg once, given over 8 to 12 hours;
  3. 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.

【Standard treatment also follow the 2024 AHA Guidelines of Kawasaki Disease】

Discomfort occurring during the observation period after Firsekibart will be treated symptomatically, and standard treatment will subsequently be provided as needed based on the participant's condition and the physician's experience.

In the event of a Grade ≥3 allergic reaction, epinephrine will be administered as needed.

Management of IVIG resistance, aspirin intolerance will be the same as in the control group.
Arzneimittel: 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.
Andere Namen:
  • Acetylsalicylsäure
Arzneimittel: 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.
Andere Namen:
  • Interleukin (IL)-1β receptor antagonist
Arzneimittel: IVIG
IVIG 2g/kg once, given over 8 to 12 hours, with the maximum dose of 60g.
Andere Namen:
  • Intravenöse Immunglobuline, Mensch

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Occurrence of coronary artery lesions (CAL) at one month of illness
Zeitfenster: 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.
from admission to 1 month of illness onset
Occurrence of the need for rescue therapy
Zeitfenster: 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.
from admission to discharge (about 2 weeks of illness onset)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Duration of fever (hours) after initiation of initial IVIG infusion
Zeitfenster: 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.
from initiation of the initial IVIG infusion to the first recorded afebrile status (up to 60 hours after the infusion of IVIG)
Occurrence of coronary artery lesions (CAL) at 2 weeks of illness
Zeitfenster: 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.
from admission to 2 weeks of illness onset
Occurrence of coronary artery lesions (CAL) at 3 months of illness
Zeitfenster: 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.
from admission to 3 months of illness onset
Occurrence of medium-to-giant coronary artery aneurysms (CAAs)
Zeitfenster: 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.
from admission to 6 months of illness onset
Changes in z scores of LAD
Zeitfenster: 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).).
from admission to 6 months of illness onset
Changes in z scores of LMCA
Zeitfenster: 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).).
from admission to 6 months of illness onset
Changes in z scores of LCX
Zeitfenster: 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).).
from admission to 6 months of illness onset
Changes in z scores of the proximal segment of RCA
Zeitfenster: 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).).
from admission to 6 months of illness onset
Changes in z scores of the middle segment of RCA
Zeitfenster: 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).).
from admission to 6 months of illness onset
Occurrence of CAL regression
Zeitfenster: 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).).
from admission to 6 months of illness onset
Occurrence of CAL progression
Zeitfenster: 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.
from admission to 6 months of illness onset
Occurrence of adverse events
Zeitfenster: 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.
from admission to 6 months of illness onset
Change in serum C-reactive protein (CRP) concentration
Zeitfenster: 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.
from admission to 1 month of illness onset
Change in Serum Amyloid A (SAA) concentration
Zeitfenster: 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.
from admission to 1 month of illness onset
Change in serum interleukin (IL)-1β concentration
Zeitfenster: 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.
from admission to 72 hours after completion of the initial IVIG infusion

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Children's Hospital of Fudan University

Mitarbeiter

Jiangxi Province Children's Hospital

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

1. September 2027

Studienabschluss (Geschätzt)

1. Februar 2028

Studienanmeldedaten

Zuerst eingereicht

26. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. Juli 2026

Zuerst gepostet (Tatsächlich)

7. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

27. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2026-244

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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