Optimising anakinra dose and route for very premature infants
Official title: Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants
Run by Monash Medical Centre · NCT07254000 · Data updated 2026-11-12
This trial will test different doses and ways of giving the drug anakinra to very premature infants to find the safest dosing that reaches target blood levels.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 24 Weeks to 29 Weeks |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | Monash Medical Centre Academic / other |
| Locations | 2 sites (Clayton, Victoria and 1 other locations) |
| Status | Recruiting |
| Started | June 27, 2025 |
| Main results expected | June 2026 |
| Study ends | December 2026 |
| Registry record updated | November 28, 2025 |
| Trial ID | NCT07254000 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are infants born at 24+0 to 28+6 weeks' gestation who are cared for at a participating hospital, whose legal representatives can consent, and who do not have excluded congenital or severe perinatal conditions.
✕Probably not a fit
Infants with major genetic syndromes, severe cardiac defects, congenital diaphragmatic hernia, intrauterine stroke, imminent plan for comfort/palliative care, or those born outside the recruiting institutions are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
AP2 is a phase 2, randomized, three-arm, parallel-group, dose-ranging trial enrolling infants born between 24+0 and 28+6 weeks' gestation to determine optimal intravenous anakinra dosing. The protocol includes a subcutaneous pharmacokinetic sub-study in week 3 to compare route of administration. Key outcomes are pharmacokinetics (linearity and target concentration attainment), feasibility, safety, and exploratory dose–exposure–response analyses using biomarkers and early efficacy endpoints. Infants with major congenital anomalies, significant pre-/perinatal compromise, or born outside participating centers are excluded.
Why it matters
Potential benefit: If successful, this approach could reduce inflammation-driven lung and brain injury in extremely premature infants and lower later rates of chronic lung disease and neurodevelopmental disability.
How similar studies have gone: A prior phase I/IIa trial showed intravenous anakinra was feasible in 24–27+6 week infants with no acute safety signals and confirmed pharmacokinetic predictions, so this builds on promising early data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Born between 24+0 and 28+6 weeks of gestation Exclusion Criteria: * Inability of the legal representatives to consent, * Genetic syndromes, * Severe cardiac anomalies, * Substantial pre-/perinatal compromise, * Congenital diaphragmatic hernia, * Intrauterine stroke, * Conditions that could confound trial results * Imminent death or plan for comfort / palliative care * Infants born outside the recruiting institutions
Where it's running
-
Monash Children's Hospital
Clayton, Victoria, Australia Recruiting -
Starship Children's Hospital
Grafton, Auckland, New Zealand Not yet recruiting
Study contacts
- Principal investigator: Marcel F Nold, Prof — Monash Health/ Monash University/ Hudson Institute of Medical Research
- Study coordinator: Marcel F Nold, Prof
- Email: marcel.nold@monash.edu
- Phone: +61385723936
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.