Trial Profile

Randomized, Double-Blind Parallel-Group, Adaptive, Three-Arm, Phase 2b/3 Multicenter Study to Evaluate the Efficacy and Safety of Zelpultide Alfa in Preventing Bronchopulmonary Dysplasia (BPD) in High-Risk Preterm Neonates Compared to Standard of Care (SOC)

Status: Active, no longer recruiting

Phase of Trial: Phase II/III

Latest Information Update: 06 Oct 2025

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At a glance

08 Sep 2025 Number of treatment arms are increased from 2 to 3 by the addition of Experimental: Zelpultide alfa 6 mg/kg plus standard of care arm.
08 Sep 2025 Planned number of patients changed from 316 to 366.
08 Sep 2025 Planned End Date changed from 30 Jul 2029 to 28 Feb 2030.

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