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

NCT07686770 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2026-244
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Kawasaki Disease; Firsekibart; Coronary Artery Lesion; IVIG-resistant

Outcome Measures

Primary Outcomes (2)

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

  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

  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)

Secondary Outcomes (15)

• Duration of fever (hours) after initiation of initial IVIG infusion

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

• Change in serum C-reactive protein (CRP) concentration

  from admission to 1 month of illness onset

• Change in Serum Amyloid A (SAA) concentration

  from admission to 1 month of illness onset

• Change in serum interleukin (IL)-1β concentration

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

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

  from admission to 2 weeks of illness onset

Study Arms (2)

standard treatment group

ACTIVE COMPARATOR

【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.

Drug: IVIG; Drug: Aspirin

Firsekibart + standard treatment group

EXPERIMENTAL

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.

Drug: IVIG; Drug: Aspirin; Drug: Firsekibart

Interventions

IVIG DRUG

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

Also known as: Intravenous Immunoglobulins, Human

Firsekibart + standard treatment group; standard treatment group

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.

Also known as: Acetylsalicylic acid

Firsekibart + standard treatment group; standard treatment group

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.

Also known as: Interleukin (IL)-1β receptor antagonist

Firsekibart + standard treatment group

Eligibility Criteria

• Age: 29 Days - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangxi Province Children's Hospital: collaborator
• Children's Hospital of Fudan University: lead

Study Sites (2)

Jiangxi Provincial Children's Hospital

Nanchang, Jiangxi, 330006, China

Location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Interventions

Immunoglobulins, Intravenous; Aspirin; Interleukins

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors

Study Officials

• Fang Liu, MD

  Children's Hospital of Fudan University

  STUDY DIRECTOR

Central Study Contacts

Fang Liu, MD

CONTACT

+86 021-64932800; liufang@fudan.edu.cn

Lan He, MD

CONTACT

+8602164932026; helan0361@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and physicians will not be masked to the assignment. Outcome assessors (i.e., echocardiographers) and statisticians will be unaware of the assignments throughout the trial until completion of the statistical analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:2 (experimental group: control group)

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 7, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)