Could a common arthritis drug save Children's hearts?
NCT ID NCT07371689
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 3 trial tests whether the anti-inflammatory drug anakinra can help children with acute myocarditis (heart inflammation) recover heart function faster. About 110 children in intensive care will receive either anakinra or a placebo for 7 days, alongside standard care. The main goal is to see if more children achieve normal heart function within 3 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anakinra (Kineret), an anti-inflammatory drug
- What this could lead to
- If it works, this could provide a new treatment to quickly restore heart function in children with severe heart inflammation.
- What could go wrong
- This is an early-stage Phase 3 trial with only 110 participants. The drug may not improve recovery more than standard care, and side effects like infections are possible.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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3 months to 18 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Children from ≥ 3 months to \< 18 years of age * Hospitalized in the Intensive Care Unit (ICU) for acute myocarditis defined as : - a reduced left ventricle ejection fraction below 50% and - troponin T rise (\>1.5x normal range), Signed informed consent by legal representative and patient according to the legislation. Exclusion Criteria: * Children weighing less than 5 Kgs * Known anterior cardiomyopathy or operated cardiopathy * Neutropenia (\< 1,5 × 10\^9 /L). * Known hypersensitivity to Anakinra or any of its excipients (citric acid anhydrous, sodium chloride, disodium EDTA dihydrate, polysorbate 80, E. coli derived proteins) * Administration of a live vaccine in the 4 weeks prior to inclusion * Hepatitis B infection, defined as positive HBsAg and/or detectable HBV DNA (PCR). Patients with increased risk of Tuberculosis (TB) infection * Recent tuberculosis infection or with active TB * Close contact with a patient with TB * Patients recently arrived less than 3 months from a country with high prevalence of TB * A chest radiograph suggestive of TB * Patients with overt concomitant bacterial infection * Patients previously treated with another biotherapy * Patients with any type of immunodeficiency or cancer * Anti TNF-α within the past 14 days * Malignancy or history of malignancy or any comorbidity limiting survival or conditions predicting inability to complete the study Ongoing or recent use of any other medication Known inhibitors/inducers of cytochrome P450 * Pregnancy or breastfeeding * No affiliation to the Social Security * Current enrollment in another clinical trial * Inability of the legal representative (and the patient, when applicable) to understand the national language (French)
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Bicêtre Hospital - APHP, Pediatric intensive care unit
Le Kremlin-Bicêtre, France, 94275, France