RECRUITING Phase 2 / Phase 3 ClinicalTrials.gov

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

Sponsor: Airway Therapeutics, Inc. • ClinicalTrials.gov ID: NCT06897839

Registry updated: 2026-10-09

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Description

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.

Interventions

Air-sham (Other)
Room air for intratracheal administration
Zelpultide alfa (Drug)
Reconstituted Zelpultide alfa for intratracheal administration

Eligibility criteria

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.

Conditions

Bronchopulmonary Dysplasia

Locations

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
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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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