Efficacy and Safety of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD)
NCT ID: NCT06897839
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
366 participants
INTERVENTIONAL
2025-02-03
2030-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Zelpultide alfa 4 mg/kg plus standard of care
In addition to the preterm neonate standard of care, the subjects randomized to this treatment arm will receive up to 7 administrations of zelpultide alfa at 4 mg/kg (birth weight) in 24 h intervals while the subjects are still intubated.
Zelpultide alfa
Reconstituted Zelpultide alfa for intratracheal administration
Placebo (air-sham) plus standard of care
In addition to the preterm neonate standard of care, approximately 1 mL of air drawn into a dosing syringe will be administered up to 7 times to neonate subjects randomized to the control (placebo) arm, following the same means and intervals as in the treatment arm.
Air-sham
Room air for intratracheal administration
Zelpultide alfa 6 mg/kg plus standard of care
In addition to the preterm neonate standard of care, the subjects randomized to this treatment arm will receive up to 7 administrations of zelpultide alfa at 6 mg/kg (birth weight) in 24 h intervals while the subjects are still intubated.
Zelpultide alfa
Reconstituted Zelpultide alfa for intratracheal administration
Interventions
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Air-sham
Room air for intratracheal administration
Zelpultide alfa
Reconstituted Zelpultide alfa for intratracheal administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
5. Informed consent and personal information authorization form signed by the subject's parent(s) or legal guardian(s).
Exclusion Criteria
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.
0 Minutes
96 Hours
ALL
No
Sponsors
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Airway Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Bnai Zion Medical Center
Haifa, , Israel
Shaare-Zedek Medical Center
Jerusalem, , Israel
Ziv Medical Center
Safed, , Israel
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
Bologna, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Ospedale dei Bambini "V. Buzzi"
Milan, , Italy
Azienda Ospedale Università di Padova
Padua, , Italy
Hospital General Universitario de Alicante Dr. Balmis
Alicante, , Spain
Hospital de la Santa Creu i Sant Pau
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
Countries
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Central Contacts
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Facility Contacts
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Ayala Gover
Role: primary
Yair Kasirer
Role: primary
Polina Gurevich
Role: primary
Other Identifiers
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2024-513420-41-00
Identifier Type: CTIS
Identifier Source: secondary_id
ZEL-003
Identifier Type: -
Identifier Source: org_study_id