Optimising anakinra dose and route for very premature infants
Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants
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 |
| Enrollment | 24 (estimated) |
| Ages | 24 Weeks to 29 Weeks |
| Sex | All |
| Sponsor | Monash Medical Centre Academic / other |
| Locations | 2 sites (Clayton, Victoria and 1 other locations) |
| Trial ID | NCT07254000 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Clayton, Victoria and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.