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Efficacy and Safety of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD)
Sponsor: Airway Therapeutics, Inc.
Summary
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 recommend which Phase 2b dose ("selected dose") to progress into Part 2 to the Study Steering Committee, which will decide the dose for Part 2 (Phase 3). A sample size reassessment will be performed after Part 1 completion. In Part 2, the selected dose of zelpultide alfa will be compared against placebo (air-sham) in a confirmatory analysis on the primary and key secondary endpoints. The study subjects will be randomized with a 1:1 allocation ratio to either: 1. Standard of care + zelpultide alfa (selected dose from Part 1), or 2. Standard of care + placebo (air-sham). The main objective in part 2 is to compare the efficacy of zelpultide alfa added to standard of care versus standard of care plus placebo (air-sham) in terms of incidence of grade 2 and grade 3 bronchopulmonary dysplasia (BPD) and death in neonates at high risk for developing BPD. In both parts, treatment will be administered intratracheally. Participants will receive up to 7 administrations of zelpultide alfa at (4mg/kg or 6 mg/kg) or air-sham in 24 h intervals while the subjects are still intubated per standard of care.
Official title: 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)
Key Details
Gender
All
Age Range
0 Minutes - 96 Hours
Study Type
INTERVENTIONAL
Enrollment
366
Start Date
2025-02-03
Completion Date
2030-04-30
Last Updated
2026-05-22
Healthy Volunteers
No
Conditions
Interventions
Air-sham
Room air for intratracheal administration
Zelpultide alfa
Reconstituted Zelpultide alfa for intratracheal administration
Locations (50)
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
Cliniques Universitaires Saint-Luc
Brussels, Belgium
UZ Leuven
Leuven, Belgium
CHU de Liege - Hospital de la Citadelle
Liège, Belgium
Clinique CHC MontLégia
Liège, Belgium
CHU Lille - Hôpital Jeanne de Flandre
Lille, France
CHRU Nancy
Nancy, France
CHU Nice
Nice, France
AP-HP CHU Robert-Debré - Hôpitaux de Paris
Paris, France
AP-HP Paris Saclay University - Hôpitaux Antoine-Béclère
Paris, France
AP-HP Paris Saclay University Bicêtre Hospital
Paris, France
AP-HP University Hospital Cochin - Port Royal
Paris, France
Hôpital de Poissy Saint-Germain-en-Laye
Poissy, France
Medical Faculty of TU Dresden
Dresden, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
University Children's Hospital Regensburg (KUNO)
Regensburg, Germany
Bnai Zion Medical Center
Haifa, Israel
Rambam Medical Center
Haifa, Israel
Haddasah medical center
Jerusalem, Israel
Shaare-Zedek Medical Center
Jerusalem, Israel
Ziv Medical Center
Safed, Israel
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
Bologna, Italy
Istituto Giannina Gaslini
Genova, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Ospedale dei Bambini "V. Buzzi"
Milan, Italy
Università degli Studi di Napoli Federico II
Naples, Italy
Azienda Ospedale Università di Padova
Padova, Italy
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
University Hospital in Krakow
Krakow, Poland
Polish Mother's Memorial Hospital - Research Institute in Lodz
Lodz, Poland
Gynecological Obstetric Clinical Hospital of Poznan University of Medical Sciences
Poznan, Poland
University Clinical Hospital No. 2 PUM
Szczecin, Poland
University Hospital Wroclaw
Wroclaw, Poland
Hospital General Universitario de Alicante Dr. Balmis
Alicante, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Sant Joan de Déu
Barcelona, Spain
Hospital Universitario Cruces - OSI Ezkerraldea-Enkarterri-Cruces
Bilbao, Spain
Hospital Universitario Puerta del Mar
Cadiz, Spain
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Regional Universitario de Málaga
Málaga, Spain
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Spain
Hospital Universitari i Politècnic La Fe
Valencia, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain