Study of Zelpultide Alfa to Reduce Bronchopulmonary Dysplasia in Extremely Premature Babies Phase 2b3 Randomized, Double-Blind, Placebo-Controlled Trial

What this Trial Is About

Researchers are studying whether an investigational drug called Zelpultide Alfa can reduce the occurrence of Bronchopulmonary Dysplasia BPD in extremely premature babies. This randomized, double-blind, placebo-controlled phase 2b3 study has an adaptive design and includes two parts Part 1 for dose selection and exploratory safety and efficacy, and Part 2 for confirmatory evaluation of the selected dose. Participants will receive up to 7 doses of Zelpultide Alfa or a placebo air-sham administered intratracheally at 24-hour intervals while still intubated, alongside standard care. In Part 1, babies are randomized to either 4 mgkg Zelpultide Alfa, 6 mgkg Zelpultide Alfa, or placebo, and after evaluating safety and efficacy, the selected dose moves to Part 2. In Part 2, babies are randomized to receive the chosen dose plus standard care or placebo plus standard care. During the study, babies will be closely monitored for safety and efficacy outcomes, including the incidence of grade 2 or 3 BPD or death by 36 weeks post menstrual age. Researchers will assess ventilator-free days, oxygen use, extubation rate, hospitalizations, and adverse events. The study results will help determine if Zelpultide Alfa added to standard care helps prevent BPD in high-risk preterm neonates. Participation lasts until at least 36 weeks post menstrual age with follow-up assessments for up to 24 months corrected age.

Efficacy and Safety of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD)