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New drug combo aims to shield Children's hearts from kawasaki disease

NCT ID NCT07686770

Disease control Sponsor: Children's Hospital of Fudan University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 28, 2026 · Updated 5 times

Summary

This study tests whether adding a drug called firsekibart to the standard treatment (IVIG and aspirin) can better prevent coronary artery damage in children with Kawasaki disease. Kawasaki disease causes inflammation in blood vessels, especially those supplying the heart, and can lead to serious heart problems. The trial will enroll 90 children diagnosed within 10 days of fever onset and compare outcomes like coronary artery lesions and fever duration between the two treatment groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
firsekibart (an IL-1β receptor antagonist) plus intravenous immunoglobulin (IVIG) and aspirin
What this could lead to
If successful, this combination could reduce the risk of lasting heart damage in children with Kawasaki disease.
What could go wrong
This is an early exploratory trial with only 90 children, so results may not be conclusive. Adding a new drug also carries unknown side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

29 days to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Kawasaki disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kawasaki disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's Hospital of Fudan University

    Shanghai, Shanghai Municipality, 201102, China

  • Jiangxi Provincial Children's Hospital

    Nanchang, Jiangxi, 330006, China

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