Clinical Trial

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

Study acronym: AP2
Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated November 28, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Trial Details
NCT Number NCT07254000
Lead Sponsor Monash Medical Centre
Collaborators: Monash University, Hudson Institute of Medical Research, Liggins Institute, Starship Children's Hospital of New Zealand
Conditions Premature Infants, Very Premature Infants, Inflammation
Enrollment 24 participants
Start Date 2025-06-27
Primary Completion 2026-06 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-11-28