ANAKINRA IN THE TREATMENT OF PEDIATRIC ACUTE MYOCARDITIS

NCT07371689 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: APHP2308252025-521478-32-00
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PEDIATRIC ACUTE MYOCARDITIS

Keywords

Myocarditis; Anakinra; Anti-IL1; Inflammation; Pediatric

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  7 and 28 days

• Time to recovery of normal left ventricular ejection fraction (LVEF ≥ 50%) within the first 3 days after treatment initiation

  3 days

• Proportion of children requiring ECMO within the first 3 days after treatment initiation

  3 days

• Proportion of children who undergo heart transplant within 6 months after treatment initiation

  6 months

• Time to all-cause death within 6 months after treatment initiation

  6 months

Study Arms (2)

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.

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.

Drug: Anakinra, KINERET®

Interventions

Anakinra, KINERET® DRUG

Patients will be randomized to receive Anakinra 4mg/Kg (maximum 100 mg) subcutaneously once a day for 7 days

Anakinra; Placebo

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Bicêtre Hospital - APHP, Pediatric intensive care unit

Le Kremlin-Bicêtre, France, 94275, France

Location

MeSH Terms

Conditions

Myocarditis; Inflammation

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Central Study Contacts

Ramy CHARBEL, Study Principal Investigator

CONTACT

01 45 21 32 05; ramy.charbel@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 28, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 28, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)