Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants

Recruiting now · Phase 2

Conditions studied: Premature Infants, Very Premature Infants, Inflammation

In brief

A phase 2 randomised, three-arm, parallel-group, dose-ranging trial to determine safety, efficacy and optimal dosing of intravenous anakinra in premature neonates, with subcutaneous pharmacokinetic sub-study.

Key facts

Study ID

NCT07254000

Run by

Monash Medical Centre

People needed

24

Starts

2025-06-27

Expected to finish

2026-12-01

Last updated by the study team

2025-11-28

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Born between 24+0 and 28+6 weeks of gestation

You may not qualify if…

• 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 is running

• Monash Children's Hospital — Clayton, Victoria, Australia (enrolling)
• Starship Children's Hospital — Grafton, Auckland, New Zealand

Full record on ClinicalTrials.gov

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