AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingPhase 2, Phase 3Ages 0 Minutes - 96 HoursAllAirway Therapeutics, Inc.
💬

In plain words

What the trial is, and whether it could suit you

This is a randomized, parallel-group, double-blind, placebo-controlled multicenter phase 2b/3 study with an adaptive seamless design. The goal fo this study is to determine if an investigational drug, Zelpultide Alfa, can reduce the occurrence of Bronchopulmonary Dysplasia (BPD) in extremely premature babies. The study comprises 2 parts: * Part 1: Phase 2b, dose selection and exploratory efficacy and safety. * Part 2: Phase 3, confirmatory efficacy and safety. In Part 1, the study subjects will be randomized with a 1:1:1 allocation ratio to either : 1. Standard of care + zelpultide alfa 4 mg/kg or, 2. Standard of care + zelpultide alfa 6 mg/kg or, 3. Standard of care + placebo (air-sham). In Part 1, all three arms will be evaluated descriptively to support dose selection based on safety, tolerability, and exploratory efficacy signals. Upon completion of Part 1, the DSMC will recomm

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Born between gestational age (GA) 22 0/7 to 27 6/7 weeks, inclusive. 2. Received at least 1 dose of SOC-indicated animal-derived pulmonary surfactant treatment after birth. 3. Intubated and on invasive mechanical ventilation per SOC. 4. Able to receive the first dose of zelpultide alfa or air-sham at least 15 min after the surfactant administration but within 96 h of birth and within 48 h from the start of invasive mechanical ventilation. Subjects extubated and re-intubated after their pulmonary surfactant dose(s) are eligible as long as the inclusion criteria are met. 5. Informed consent and personal information authorization form signed by the subject's parent(s) or legal guardian(s). Exclusion Criteria: 1. Birth weight \< 400 g or \> 1,500 g. 2. Major apparent congenital abnormalities impacting cardio and pulmonary function identified before randomization, such as, but not limited to: * Clinically relevant Potter-like syndrome and any pulmonary congenital anomalies, * Clinically relevant congenital diaphragmatic hernia, * Omphalocele or gastroschisis, esophageal atresia, * Known or suspected cyanotic congenital heart disease (ie, tetralogy of fallot, transposition of the great arteries, etc). 3. Active do no resuscitate (DNR) order in place. 4. History of allergy or sensitivity to any surfactant or any component of zelpultide alfa. 5. Concurrent enrollment in any clinical study that utilizes treatments (investigational medical products or devices) outside of SOC or participation in studies within the last 30 days (or 5 half-lives of an IMP) prior to birth (for the mother) or up to week 36 PMA. 6. Any condition or situation that, in the Investigator's judgement, puts the neonate at significant risk, could confound the study results, or may interfere significantly with the neonate's participation in the study.
💊

What it tests

  • Air-sham
  • Zelpultide alfa
📍

Where

49 sites
Clínica y Maternidad Suizo Argentina
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Hospital Sanatorio de la Trinidad San Isidro
Buenos Aires, Argentina
Hospital Universitario Austral
Buenos Aires, Argentina
ZAS Middelheim
Antwerp, Belgium
UZ Leuven
Leuven, Belgium
CHU de Liege - Hospital de la Citadelle
Liège, Belgium
Clinique CHC MontLégia
Liège, Belgium

…and 41 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy