Bronchopulmonary DysplasiaPhase 2/3ZELANCT06897839
Efficacy and Safety of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD)
A Phase 2/3 study testing Zelpultide alfa in people with Bronchopulmonary Dysplasia, run by Airway Therapeutics, Inc. at 49 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 minutes to 96 hours
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Zelpultide alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 366 participants
- Where
- 49 sitesin 8 countries
- Study dates
- 3 Feb 2025to 30 Apr 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 minutes to 96 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Born between gestational age (GA) 22 0/7 to 27 6/7 weeks, inclusive.
- Received at least 1 dose of SOC-indicated animal-derived pulmonary surfactant treatment after birth.
- Intubated and on invasive mechanical ventilation per SOC.
- 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.
- Informed consent and personal information authorization form signed by the subject's parent(s) or legal guardian(s).
Who cannot join
- Birth weight < 400 g or > 1,500 g.
- 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).
Show all 10Show fewer
- Active do no resuscitate (DNR) order in place.
- History of allergy or sensitivity to any surfactant or any component of zelpultide alfa.
- 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.
- 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.
Trial locations and contacts
49 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
49 sites in 8 countries
Spain13 sites, 13 recruiting
- Recruiting
Hospital General Universitario de Alicante Dr. Balmis
Alicante
- Recruiting
Hospital Clínic de Barcelona
Barcelona
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona
- Recruiting
Hospital Sant Joan de Déu
Barcelona
- Recruiting
Hospital Universitario Cruces - OSI Ezkerraldea-Enkarterri-Cruces
Bilbao
- Recruiting
Hospital Universitario Puerta del Mar
Cadiz
- Recruiting
Hospital Universitari Arnau de Vilanova de Lleida
Lleida
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid
- Recruiting
Hospital Universitario La Paz
Madrid
- Recruiting
Hospital Regional Universitario de Málaga
Málaga
- Recruiting
Hospital Clínico Universitario de Santiago
Santiago de Compostela
- Recruiting
Hospital Universitari i Politècnic La Fe
Valencia
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza
France8 sites, 8 recruiting
- Recruiting
CHU Lille - Hôpital Jeanne de Flandre
Lille
- Recruiting
CHRU Nancy
Nancy
- Recruiting
CHU Nice
Nice
- Recruiting
AP-HP CHU Robert-Debré - Hôpitaux de Paris
Paris
- Recruiting
AP-HP Paris Saclay University - Hôpitaux Antoine-Béclère
Paris
- Recruiting
AP-HP Paris Saclay University Bicêtre Hospital
Paris
- Recruiting
AP-HP University Hospital Cochin - Port Royal
Paris
- Recruiting
Hôpital de Poissy Saint-Germain-en-Laye
Poissy
Italy6 sites, 6 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
Bologna
- Recruiting
Istituto Giannina Gaslini
Genova
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
- Recruiting
Ospedale dei Bambini "V. Buzzi"
Milan
- Recruiting
Università degli Studi di Napoli Federico II
Naples
- Recruiting
Azienda Ospedale Università di Padova
Padova
Poland6 sites, 6 recruiting
- Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk
- Recruiting
University Hospital in Krakow
Krakow
- Recruiting
Polish Mother's Memorial Hospital - Research Institute in Lodz
Lodz
- Recruiting
Gynecological Obstetric Clinical Hospital of Poznan University of Medical Sciences
Poznan
- Recruiting
University Clinical Hospital No. 2 PUM
Szczecin
- Recruiting
University Hospital Wroclaw
Wroclaw
Israel5 sites, 5 recruiting
- Recruiting
Bnai Zion Medical Center
Haifa
- Recruiting
Rambam Medical Center
Haifa
- Recruiting
Haddasah medical center
Jerusalem
- Recruiting
Shaare-Zedek Medical Center
Jerusalem
- Recruiting
Ziv Medical Center
Safed
Argentina4 sites, 4 recruiting
- Recruiting
Clínica y Maternidad Suizo Argentina
Buenos Aires
- Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires
- Recruiting
Hospital Sanatorio de la Trinidad San Isidro
Buenos Aires
- Recruiting
Hospital Universitario Austral
Buenos Aires
Belgium4 sites, 4 recruiting
- Recruiting
ZAS Middelheim
Antwerp
- Recruiting
UZ Leuven
Leuven
- Recruiting
CHU de Liege - Hospital de la Citadelle
Liège
- Recruiting
Clinique CHC MontLégia
Liège
Germany3 sites, 3 recruiting
- Not yet recruiting
Medical Faculty of TU Dresden
Dresden
- Not yet recruiting
Universitätsklinikum Freiburg
Freiburg im Breisgau
- Recruiting
University Children's Hospital Regensburg (KUNO)
Regensburg
About this study
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)
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.
Read more
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 :
- Standard of care + zelpultide alfa 4 mg/kg or,
- Standard of care + zelpultide alfa 6 mg/kg or,
- 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:
- Standard of care + zelpultide alfa (selected dose from Part 1), or
- 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.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- Air-sham, Zelpultide alfa
- Keywords
- BPD, Zelpultide alfa, AT-100
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air-shamOther
Room air for intratracheal administration
Zelpultide alfaDrug
Also called AT-100, rhSP-D
Reconstituted Zelpultide alfa for intratracheal administration
| Study group | Role | What they receive |
|---|---|---|
| Zelpultide alfa 4 mg/kg plus standard of care | Experimental | 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. Receives: Drug: Zelpultide alfa |
| Placebo (air-sham) plus standard of care | Sham comparator | 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. Receives: Other: Air-sham |
| Zelpultide alfa 6 mg/kg plus standard of care | Experimental | 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. Receives: Drug: Zelpultide alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade 2 or grade 3 Bronchopulmonary Dysplasia (BPD) or death
BPD is defined and graded based on the classification according to Jensen et al., 2019 (2019 PMID: 30995069)
Measured: Week 36 Post Menstrual Age (PMA)
Secondary outcomes (23)
Ventilator-free days
A ventilator-free day is defined as a natural calendar day without being on invasive mechanical ventilation (ie, invasive ventilation via ETT or tracheostomy); tracheostomy will be treated as all invasive ventilation.
Measured: From birth to 36 weeks Post Menstrual Age (PMA)
Incidence of grade 2 or grade 3 Bronchopulmonary Dysplasia (BPD)
Measured: Week 36 Post Menstrual Age (PMA)
Incidence of death
Measured: Week 36 Post Menstrual Age (PMA)
Incidence of grade 2 or grade 3 Bronchopulmonary Dysplasia (BPD) or death assessed on 3 consecutive days at week 36 PMA
BPD is defined and graded based on the classification according to Jensen et al., 2019 (2019 PMID: 30995069)
Measured: Week 36 Post Menstrual Age (PMA)
The proportion of subjects with no Bronchopulmonary Dysplasia (BPD), grade 1, grade 2, or grade 3 BPD
BPD is defined and graded based on the classification according to Jensen et al., 2019 (2019 PMID: 30995069)
Measured: Week 36 Post Menstrual Age (PMA)
The proportion of subjects with no Bronchopulmonary Dysplasia (BPD), grade 1, grade 2, or grade 3 BPD assessed on 3 consecutive days at week 36 PMA
BPD is defined and graded based on the classification according to Jensen et al., 2019 (2019 PMID: 30995069)
Measured: Week 36 Post Menstrual Age (PMA)
Ventilator-free days
A ventilator-free day is defined as a natural calendar day without being on invasive mechanical ventilation (ie, invasive ventilation via ETT or tracheostomy); tracheostomy will be treated as all invasive ventilation.
Measured: From birth to day 28 of life
Total average days on supplemental oxygen
Measured: From birth to 36 Weeks Post Menstrual Age (PMA)
Total average days on continuous positive airway pressure (CPAP) or high flow nasal cannula (HFNC)
Measured: From birth to week 36 Post Menstrual Age (PMA)
Extubation rate
Measured: Study Day 7
Average preductal oxygen saturation measured by oxygen saturation to fraction of inspired oxygen ratio (SF)
Measured: From Study Days 1 to 7
Average preductal oxygen saturation measured by oxygen saturation index (OSI)
Measured: From Study Days 1 to 7
Incidence of grade 2 or grade 3 Bronchopulmonary Dysplasia (BPD) or death
BPD is defined and graded based on the classification according to Jensen et al., 2019 (2019 PMID: 30995069)
Measured: Week 40 Post Menstrual Age (PMA)
Incidence of grade 2 or grade 3 Bronchopulmonary Dysplasia (BPD)
BPD is defined and graded based on the classification according to Jensen et al., 2019 (2019 PMID: 30995069)
Measured: Week 40 Post Menstrual Age (PMA)
The proportion of subjects with no Bronchopulmonary Dysplasia (BPD), grade 1, grade 2, or grade 3 BPD
BPD is defined and graded based on the classification according to Jensen et al., 2019 (2019 PMID: 30995069)
Measured: Week 40 Post Menstrual Age (PMA)
Incidence of grade 2 or grade 3 Bronchopulmonary Dysplasia (BPD) or death after excluding subjects with death at ≤ 14 days postnatal age
BPD is defined and graded based on the classification according to Jensen et al., 2019 (2019 PMID: 30995069)
Measured: Week 36 and week 40 Post Menstrual Age (PMA)
Ventilator-free days
A ventilator-free day is defined as a natural calendar day without being on invasive mechanical ventilation (ie, invasive ventilation via ETT or tracheostomy); tracheostomy will be treated as all invasive ventilation.
Measured: From birth to week 40 Post Menstrual Age (PMA)
Survival at 6, 12 and 24 months corrected age
Measured: 6, 12 and 24 month corrected age
Average number of hospitalizations and days in hospital
Measured: 6 and 12 months corrected age
Incidence of chronic respiratory morbidity
Measured: 12 month corrected age
Incidence of neurodevelopmental disability among survivors
Measured: 24 months corrected age
Severity and frequency of treatment-emergent adverse events (TEAEs) or treatment-emergent serious adverse events (TESAEs)
Measured: From start of treatment through week 36 Post Menstrual Age (PMA) or hospital discharge, whichever comes first
Immunogenicity analysis
Determination of anti-SP-D antibodies in blood at day 28 of life compared to baseline), assessed in a subset of 60 patients
Measured: Day 28 of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start3 Feb 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Airway Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897839
- Sponsor's protocol ID
- ZEL-003
- Other IDs
- 2024-513420-41-00
- Acronym
- ZELA
- Status last verified
- Dec 2025
- First submitted
- 20 Feb 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06897839
- Acronym / sponsor ID
- ZELA / ZEL-003
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- BPD, Zelpultide alfa, AT-100
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 366 participants (estimated)
- Lead sponsor
- Airway Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- Standard of care + zelpultide alfa 4 mg/kg or,
- Standard of care + zelpultide alfa 6 mg/kg or,
- 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:
- Standard of care + zelpultide alfa (selected dose from Part 1), or
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zelpultide alfa 4 mg/kg plus standard of care | Experimental | Drug: Zelpultide alfaIn 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. |
| Placebo (air-sham) plus standard of care | Sham comparator | Other: Air-shamIn 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. |
| Zelpultide alfa 6 mg/kg plus standard of care | Experimental | Drug: Zelpultide alfaIn 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. |
Who may qualify
- Ages
- 0 minutes to 96 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Born between gestational age (GA) 22 0/7 to 27 6/7 weeks, inclusive.
- Received at least 1 dose of SOC-indicated animal-derived pulmonary surfactant treatment after birth.
- Intubated and on invasive mechanical ventilation per SOC.
- 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.
- Informed consent and personal information authorization form signed by the subject's parent(s) or legal guardian(s).
Key exclusion criteria (10 listed)
- Birth weight < 400 g or > 1,500 g.
- Major apparent congenital abnormalities impacting cardio and pulmonary function identified before randomization, such as, but not limited to:
- Active do no resuscitate (DNR) order in place.
- History of allergy or sensitivity to any surfactant or any component of zelpultide alfa.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air-shamRoom air for intratracheal administration | Other | Placebo (air-sham) plus standard of care |
| Zelpultide alfaAlso: AT-100, rhSP-DReconstituted Zelpultide alfa for intratracheal administration | Drug | Zelpultide alfa 4 mg/kg plus standard of care, Zelpultide alfa 6 mg/kg plus standard of care |
Primary outcome
Incidence of grade 2 or grade 3 Bronchopulmonary Dysplasia (BPD) or death
Time frame: Week 36 Post Menstrual Age (PMA)
BPD is defined and graded based on the classification according to Jensen et al., 2019 (2019 PMID: 30995069)
23 secondary outcomes
Ventilator-free days
Time frame: From birth to 36 weeks Post Menstrual Age (PMA)
Incidence of grade 2 or grade 3 Bronchopulmonary Dysplasia (BPD)
Time frame: Week 36 Post Menstrual Age (PMA)
Incidence of death
Time frame: Week 36 Post Menstrual Age (PMA)
Incidence of grade 2 or grade 3 Bronchopulmonary Dysplasia (BPD) or death assessed on 3 consecutive days at week 36 PMA
Time frame: Week 36 Post Menstrual Age (PMA)
The proportion of subjects with no Bronchopulmonary Dysplasia (BPD), grade 1, grade 2, or grade 3 BPD
Time frame: Week 36 Post Menstrual Age (PMA)
The proportion of subjects with no Bronchopulmonary Dysplasia (BPD), grade 1, grade 2, or grade 3 BPD assessed on 3 consecutive days at week 36 PMA
Time frame: Week 36 Post Menstrual Age (PMA)
Ventilator-free days
Time frame: From birth to day 28 of life
Total average days on supplemental oxygen
Time frame: From birth to 36 Weeks Post Menstrual Age (PMA)
Total average days on continuous positive airway pressure (CPAP) or high flow nasal cannula (HFNC)
Time frame: From birth to week 36 Post Menstrual Age (PMA)
Extubation rate
Time frame: Study Day 7
Average preductal oxygen saturation measured by oxygen saturation to fraction of inspired oxygen ratio (SF)
Time frame: From Study Days 1 to 7
Average preductal oxygen saturation measured by oxygen saturation index (OSI)
Time frame: From Study Days 1 to 7
Incidence of grade 2 or grade 3 Bronchopulmonary Dysplasia (BPD) or death
Time frame: Week 40 Post Menstrual Age (PMA)
Incidence of grade 2 or grade 3 Bronchopulmonary Dysplasia (BPD)
Time frame: Week 40 Post Menstrual Age (PMA)
The proportion of subjects with no Bronchopulmonary Dysplasia (BPD), grade 1, grade 2, or grade 3 BPD
Time frame: Week 40 Post Menstrual Age (PMA)
Incidence of grade 2 or grade 3 Bronchopulmonary Dysplasia (BPD) or death after excluding subjects with death at ≤ 14 days postnatal age
Time frame: Week 36 and week 40 Post Menstrual Age (PMA)
Ventilator-free days
Time frame: From birth to week 40 Post Menstrual Age (PMA)
Survival at 6, 12 and 24 months corrected age
Time frame: 6, 12 and 24 month corrected age
Average number of hospitalizations and days in hospital
Time frame: 6 and 12 months corrected age
Incidence of chronic respiratory morbidity
Time frame: 12 month corrected age
Incidence of neurodevelopmental disability among survivors
Time frame: 24 months corrected age
Severity and frequency of treatment-emergent adverse events (TEAEs) or treatment-emergent serious adverse events (TESAEs)
Time frame: From start of treatment through week 36 Post Menstrual Age (PMA) or hospital discharge, whichever comes first
Immunogenicity analysis
Time frame: Day 28 of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
49 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Zelpultide alfa in people with Bronchopulmonary Dysplasia, run by Airway Therapeutics, Inc. at 49 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Spain, France, Italy, Poland, Israel and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alan Wolk (513-770-9630, info@airwaytherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade 2 or grade 3 Bronchopulmonary Dysplasia (BPD) or death (time frame: Week 36 Post Menstrual Age (PMA)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.