drugset / Trial / NCT07254000
Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants
Phase 2
Recruiting
24 enrolled
Monash Medical Centre
Hudson Institute of Medical Research · collabLiggins Institute · collabMonash University · collabStarship Children's Hospital of New Zealand · collab
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2025-06-27
- Primary completion
- 2026-06
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Anakinra | Protein / enzyme biologic | — | Intravenous |