PEDIATRIC ACUTE MYOCARDITISPhase 3ANAPEMNCT07371689
ANAKINRA IN THE TREATMENT OF PEDIATRIC ACUTE MYOCARDITIS
A Phase 3 study testing Anakinra, KINERET® in people with PEDIATRIC ACUTE MYOCARDITIS, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Double blind RCT aiming to compare the efficacy of Anakinra vs placebo, on top of the standard of care, on restoration of myocardial function at 3 days following treatment initiation, in children admitted for acute myocarditis in intensive care units. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- PEDIATRIC ACUTE MYOCARDITIS
- What is being tested?
- Anakinra, KINERET®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2026to Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Bicêtre Hospital - APHP, Pediatric intensive care unit
Le Kremlin-Bicêtre, France, 94275
Ramy CHARBEL, Study Principal Investigator, 01 45 21 32 05, ramy.charbel@aphp.fr
About this study
Double blind RCT aiming to compare the efficacy of Anakinra vs placebo, on top of the standard of care, on restoration of myocardial function at 3 days following treatment initiation, in children admitted for acute myocarditis in intensive care units.
Read the detailed description
Activation of the inflammasome is increasingly recognized in the pathogenesis of acute myocarditis. We hypothesize that by blocking inflammasome using anakinra, we interfere with the key mechanism driving myocardial inflammation and fibrosis, allowing for restauration of myocardial function compared to standard of care alone. Children from ≥ 3 months to < 18 years of age hospitalized in the Intensive Care Unit for acute myocarditis defined as a reduced left ventricle ejection fraction below 50% and troponin T rise (>1.5x normal range) will be randomized to either receive SC Anakinra or Placebo in addition to standard of care treatment. Primary endpoint: Proportion of children with recovered left ventricle ejection fraction (LVEF ≥ 50%) measured by echocardiography at 3 days after treatment initiation.
Secondary endpoints:
- Proportion of children with recovered left ventricle ejection fraction (LVEF ≥ 50%) measured by echocardiography at 7 and 28 days after treatment initiation. Patients who die or undergo heart transplant within the first 7 and 28 days after treatment initiation respectively will be considered as a failure (i.e, LVEF < 50%). Patients who still require ECMO at 7 and 28 days after treatment initiation respectively will also be considered as failure (i.e., LVEF < 50%).
- Time to recovery of normal left ventricular ejection fraction (LVEF ≥ 50%) within the first 3 days after treatment initiation
- Proportion of children requiring ECMO within the first 3 days after treatment initiation
- Proportion of children who undergo heart transplant within 6 months after treatment initiation
- Time to all-cause death within 6 months after treatment initiation
- Time to cardiovascular-related death within 6 months after treatment initiation
- Proportion of children with drug-related side effects (hypersensitivity, neutropenia, drug-related liver enzymes elevation…)
- a- NT proBNP at inclusion and at 24 hours, 48 hours, 72 hours following treatment initiation - Troponin T at inclusion and at 24 hours, 48 hours, 72 hours following treatment initiation - Proportion of children with ventricular tachycardia assessed by EKG at inclusion and at 24 hours, 48 hours, 72 hours following treatment initiation - b - NT proBNP at 7 days following treatment initiation - Troponin T at 7 days following treatment initiation - Proportion of children with ventricular tachycardia assessed by EKG at 7 days following treatment initiation - Proportion of children with fibrosis on cardiac MRI according to modified Lake Louise criteria at 6 months following treatment initiation - Proportion of children with dilated cardiomyopathy on cardiac echocardiography (Left ventricular end diastolic diameter ˃ 2 SD with altered systolic function <50%) at 3 and 6 months following treatment initiation - Proportion of children with ventricular arrhythmia at 6 months following treatment initiation.
- Conditions
- PEDIATRIC ACUTE MYOCARDITIS
- Being tested
- Anakinra, KINERET®
- Keywords
- Myocarditis, Anakinra, Anti-IL1, Inflammation, Pediatric
- Medical subject headings
- Myocarditis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anakinra, KINERET®Drug
Patients will be randomized to receive Anakinra 4mg/Kg (maximum 100 mg) subcutaneously once a day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Anakinra | Experimental | Anakinra, KINERET, solution for injection in pre-filled syringe. Posology for clinical trial: 4 mg/Kg (maximum 100 mg) once daily subcutaneously for 7 days. Receives: Drug: Anakinra, KINERET® |
| Placebo | Placebo comparator | Placebo of Anakinra, solution of NaCl 0.9% Posology for clinical trial: 4 mg/Kg (maximum 100 mg) once daily subcutaneously for 7 days. Receives: Drug: Anakinra, KINERET® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children with recovered left ventricle ejection fraction ≥ 50% measured by echocardiography at 3 days after treatment initiation.
Main objective: To compare the efficacy of Anakinra vs placebo, on top of the standard of care, on restoration of myocardial function at 3 days following treatment initiation, in children admitted for acute myocarditis in intensive care units. Primary endpoint: Proportion of children with recovered left ventricle ejection fraction (LVEF ≥ 50%) measured by echocardiography at 3 days after treatment initiation. Patients who die within the first 3 days after treatment initiation or patients who still require ECMO at 3 days after treatment initiation will be considered as a failure.
Measured: 3 days
Secondary outcomes (9)
Proportion of children with recovered left ventricle ejection fraction ≥ 50% measured by echocardiography at 7 and 28 days after treatment initiation. Patients who die or undergo heart transplant within the first 7 and 28 days after treatment initiation
Measured: 7 and 28 days
Time to recovery of normal left ventricular ejection fraction (LVEF ≥ 50%) within the first 3 days after treatment initiation
Measured: 3 days
Proportion of children requiring ECMO within the first 3 days after treatment initiation
Measured: 3 days
Proportion of children who undergo heart transplant within 6 months after treatment initiation
Measured: 6 months
Time to all-cause death within 6 months after treatment initiation
Measured: 6 months
Time to cardiovascular-related death within 6 months after treatment initiation
Measured: 6 months
Proportion of children with drug-related side effects (hypersensitivity, neutropenia, drug-related liver enzymes elevation…)
Measured: 6 months
following treatment initiation-TroponinT at inclusion and at24 hours,48 hours,72 hours following treatment initiation-Proportion of children with ventricular tachycardia assessed by EKG at inclusion and at 24hours,48hours,72hours following treatment init
Measured: 24,48,72 hours
NTproBNP at7days, Troponin T at7days,Proportion of children with ventricular tachycardia assessed by EKG at7days, Proportion of children with fibros on cardiac MRI at6months,Proportion of children with dilated cardiomyopathy,with ventricular arrhythmia
Measured: 7 days - 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PEDIATRIC ACUTE MYOCARDITISStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a superiority, national multicentre phase III double-blind randomized placebo-controlled trial to demonstrate the efficacy of Anakinra vs placebo as an add-on curative treatment on top of standard of care of acute myocarditis in children. Diagnosis of myocarditis is confirmed, in addition to troponin T rise (\*1.5 Normal range), by an echocardiogram performed during the first 24H of suspicion. Patients will be randomized to receive Anakinra 4mg/Kg (maximum 100 mg) or placebo subcutaneously once a day for 7 days, in addition to standard care: ACE and/or Beta-blocker. Randomization 1:1 will be conducted centrally with the use of an Interactive WEB Randomisation system (IWRS). Patients who have failed at 3 days of treatment will be treated at the clinicians' discretion and can receive anakinra. Discharge will be left to the physician decision, based on the normalization of systolic function and troponin T, and lack of complication defined by heart failure, ventricular ta
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371689
- Sponsor's protocol ID
- APHP230825
- Other IDs
- 2025-521478-32-00, 2025
- Acronym
- ANAPEM
- Status last verified
- Oct 2025
- First submitted
- 19 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANAKINRA IN THE TREATMENT OF PEDIATRIC ACUTE MYOCARDITIS
- ClinicalTrials.gov ID
- NCT07371689
- Acronym / sponsor ID
- ANAPEM / APHP230825
- Conditions
- PEDIATRIC ACUTE MYOCARDITIS
- Keywords
- Myocarditis, Anakinra, Anti-IL1, Inflammation, Pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double blind RCT aiming to compare the efficacy of Anakinra vs placebo, on top of the standard of care, on restoration of myocardial function at 3 days following treatment initiation, in children admitted for acute myocarditis in intensive care units.
Detailed description
Activation of the inflammasome is increasingly recognized in the pathogenesis of acute myocarditis. We hypothesize that by blocking inflammasome using anakinra, we interfere with the key mechanism driving myocardial inflammation and fibrosis, allowing for restauration of myocardial function compared to standard of care alone. Children from ≥ 3 months to < 18 years of age hospitalized in the Intensive Care Unit for acute myocarditis defined as a reduced left ventricle ejection fraction below 50% and troponin T rise (>1.5x normal range) will be randomized to either receive SC Anakinra or Placebo in addition to standard of care treatment. Primary endpoint: Proportion of children with recovered left ventricle ejection fraction (LVEF ≥ 50%) measured by echocardiography at 3 days after treatment initiation.
Secondary endpoints:
- Proportion of children with recovered left ventricle ejection fraction (LVEF ≥ 50%) measured by echocardiography at 7 and 28 days after treatment initiation. Patients who die or undergo heart transplant within the first 7 and 28 days after treatment initiation respectively will be considered as a failure (i.e, LVEF < 50%). Patients who still require ECMO at 7 and 28 days after treatment initiation respectively will also be considered as failure (i.e., LVEF < 50%).
- Time to recovery of normal left ventricular ejection fraction (LVEF ≥ 50%) within the first 3 days after treatment initiation
- Proportion of children requiring ECMO within the first 3 days after treatment initiation
- Proportion of children who undergo heart transplant within 6 months after treatment initiation
- Time to all-cause death within 6 months after treatment initiation
- Time to cardiovascular-related death within 6 months after treatment initiation
- Proportion of children with drug-related side effects (hypersensitivity, neutropenia, drug-related liver enzymes elevation…)
- a- NT proBNP at inclusion and at 24 hours, 48 hours, 72 hours following treatment initiation - Troponin T at inclusion and at 24 hours, 48 hours, 72 hours following treatment initiation - Proportion of children with ventricular tachycardia assessed by EKG at inclusion and at 24 hours, 48 hours, 72 hours following treatment initiation - b - NT proBNP at 7 days following treatment initiation - Troponin T at 7 days following treatment initiation - Proportion of children with ventricular tachycardia assessed by EKG at 7 days following treatment initiation - Proportion of children with fibrosis on cardiac MRI according to modified Lake Louise criteria at 6 months following treatment initiation - Proportion of children with dilated cardiomyopathy on cardiac echocardiography (Left ventricular end diastolic diameter ˃ 2 SD with altered systolic function <50%) at 3 and 6 months following treatment initiation - Proportion of children with ventricular arrhythmia at 6 months following treatment initiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a superiority, national multicentre phase III double-blind randomized placebo-controlled trial to demonstrate the efficacy of Anakinra vs placebo as an add-on curative treatment on top of standard of care of acute myocarditis in children. Diagnosis of myocarditis is confirmed, in addition to troponin T rise (*1.5 Normal range), by an echocardiogram performed during the first 24H of suspicion. Patients will be randomized to receive Anakinra 4mg/Kg (maximum 100 mg) or placebo subcutaneously once a day for 7 days, in addition to standard care: ACE and/or Beta-blocker. Randomization 1:1 will be conducted centrally with the use of an Interactive WEB Randomisation system (IWRS). Patients who have failed at 3 days of treatment will be treated at the clinicians' discretion and can receive anakinra. Discharge will be left to the physician decision, based on the normalization of systolic function and troponin T, and lack of complication defined by heart failure, ventricular ta
| Arm | Type | Receives |
|---|---|---|
| Anakinra | Experimental | Drug: Anakinra, KINERET®Anakinra, KINERET, solution for injection in pre-filled syringe. Posology for clinical trial: 4 mg/Kg (maximum 100 mg) once daily subcutaneously for 7 days. |
| Placebo | Placebo comparator | Drug: Anakinra, KINERET®Placebo of Anakinra, solution of NaCl 0.9% Posology for clinical trial: 4 mg/Kg (maximum 100 mg) once daily subcutaneously for 7 days. |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anakinra, KINERET®Patients will be randomized to receive Anakinra 4mg/Kg (maximum 100 mg) subcutaneously once a day for 7 days | Drug | Anakinra, Placebo |
Primary outcome
Proportion of children with recovered left ventricle ejection fraction ≥ 50% measured by echocardiography at 3 days after treatment initiation.
Time frame: 3 days
Main objective: To compare the efficacy of Anakinra vs placebo, on top of the standard of care, on restoration of myocardial function at 3 days following treatment initiation, in children admitted for acute myocarditis in intensive care units. Primary endpoint: Proportion of children with recovered left ventricle ejection fraction (LVEF ≥ 50%) measured by echocardiography at 3 days after treatment initiation. Patients who die within the first 3 days after treatment initiation or patients who still require ECMO at 3 days after treatment initiation will be considered as a failure.
9 secondary outcomes
Proportion of children with recovered left ventricle ejection fraction ≥ 50% measured by echocardiography at 7 and 28 days after treatment initiation. Patients who die or undergo heart transplant within the first 7 and 28 days after treatment initiation
Time frame: 7 and 28 days
Time to recovery of normal left ventricular ejection fraction (LVEF ≥ 50%) within the first 3 days after treatment initiation
Time frame: 3 days
Proportion of children requiring ECMO within the first 3 days after treatment initiation
Time frame: 3 days
Proportion of children who undergo heart transplant within 6 months after treatment initiation
Time frame: 6 months
Time to all-cause death within 6 months after treatment initiation
Time frame: 6 months
Time to cardiovascular-related death within 6 months after treatment initiation
Time frame: 6 months
Proportion of children with drug-related side effects (hypersensitivity, neutropenia, drug-related liver enzymes elevation…)
Time frame: 6 months
following treatment initiation-TroponinT at inclusion and at24 hours,48 hours,72 hours following treatment initiation-Proportion of children with ventricular tachycardia assessed by EKG at inclusion and at 24hours,48hours,72hours following treatment init
Time frame: 24,48,72 hours
NTproBNP at7days, Troponin T at7days,Proportion of children with ventricular tachycardia assessed by EKG at7days, Proportion of children with fibros on cardiac MRI at6months,Proportion of children with dilated cardiomyopathy,with ventricular arrhythmia
Time frame: 7 days - 3 and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anakinra, KINERET® in people with PEDIATRIC ACUTE MYOCARDITIS, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ramy CHARBEL, Study Principal Investigator (01 45 21 32 05, ramy.charbel@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of children with recovered left ventricle ejection fraction ≥ 50% measured by echocardiography at 3 days after treatment initiation. (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.