Actively Recruiting
Randomized, Double-Blind, Adaptive Phase 2b/3 Study of Zelpultide Alfa to Prevent Bronchopulmonary Dysplasia in High-Risk Preterm Neonates
Led by Airway Therapeutics, Inc. · Updated on 2026-06-03
366
Participants Needed
50
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying if an investigational drug called Zelpultide Alfa can reduce the risk of Bronchopulmonary Dysplasia (BPD) in extremely premature babies. This is a randomized, double-blind, placebo-controlled, multicenter phase 2b/3 trial with an adaptive design to evaluate the drug's safety and effectiveness in this vulnerable population. The study includes two parts: the first part focuses on selecting the best dose and exploring initial effects, while the second part confirms the chosen dose's impact on BPD and death rates. In Part 1, participants are randomly assigned to receive either Zelpultide Alfa at 4 mg/kg, 6 mg/kg, or a placebo (air-sham), all along with standard care. Treatment is given intratracheally up to seven times at 24-hour intervals while the babies are still intubated. After deciding on the best dose from Part 1, Part 2 compares the selected Zelpultide Alfa dose with placebo, again alongside standard care, using a 1:1 random assignment. The main goal in Part 2 is to confirm whether adding Zelpultide Alfa reduces the incidence of moderate to severe BPD or death. Participants will be closely monitored with various safety and efficacy assessments throughout the study. Researchers will measure outcomes like the occurrence of grade 2 or 3 BPD or death by 36 weeks post menstrual age, days without ventilator support, oxygen use, and hospitalization rates up to 24 months corrected age. The study also tracks adverse events and immune responses. Participation involves receiving study treatments while intubated and attending follow-up evaluations to assess the drug's effects and safety over time.
CONDITIONS
Brief Title
Efficacy and Safety of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Born between gestational age 22 0/7 to 27 6/7 weeks, inclusive
- Received at least one dose of animal-derived pulmonary surfactant treatment after birth
- Intubated and on invasive mechanical ventilation as part of standard care
- Able to receive first dose of study drug or placebo at least 15 minutes after surfactant administration but within 96 hours of birth and 48 hours from start of ventilation
- Informed consent signed by parent(s) or legal guardian(s)
You will not qualify if you...
- Birth weight less than 400 grams or greater than 1,500 grams
- Major congenital abnormalities impacting heart or lung function such as Potter-like syndrome, diaphragmatic hernia, omphalocele, gastroschisis, esophageal atresia, or cyanotic congenital heart disease
- Active do not resuscitate (DNR) order in place
- History of allergy or sensitivity to surfactant or study drug components
- Participation in other clinical studies with investigational treatments within 30 days before birth or up to 36 weeks post menstrual age
- Any condition judged by investigator to put neonate at significant risk or interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days
Participants receive up to 7 administrations of Zelpultide alfa or placebo via intratracheal administration at 24-hour intervals while intubated, alongside standard of care.
Up to 7 dosing visits (in-person) during intubation
Duration - Up to 24 months corrected age
Participants are monitored for safety, lung function, and developmental outcomes through 36 weeks post menstrual age and up to 24 months corrected age.
Multiple follow-up visits including assessments at 36 and 40 weeks post menstrual age, and at 6, 12, and 24 months corrected age
Trial Site Locations
Total: 50 locations
1
Clínica y Maternidad Suizo Argentina
Buenos Aires, Argentina
Actively Recruiting
2
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Actively Recruiting
3
Hospital Sanatorio de la Trinidad San Isidro
Buenos Aires, Argentina
Not Yet Recruiting
4
Hospital Universitario Austral
Buenos Aires, Argentina
Actively Recruiting
5
ZAS Middelheim
Antwerp, Belgium
Not Yet Recruiting
6
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Not Yet Recruiting
7
UZ Leuven
Leuven, Belgium
Not Yet Recruiting
8
CHU de Liege - Hospital de la Citadelle
Liège, Belgium
Not Yet Recruiting
9
Clinique CHC MontLégia
Liège, Belgium
Actively Recruiting
10
CHU Lille - Hôpital Jeanne de Flandre
Lille, France
Actively Recruiting
11
CHRU Nancy
Nancy, France
Actively Recruiting
12
CHU Nice
Nice, France
Not Yet Recruiting
13
AP-HP CHU Robert-Debré - Hôpitaux de Paris
Paris, France
Actively Recruiting
14
AP-HP Paris Saclay University - Hôpitaux Antoine-Béclère
Paris, France
Actively Recruiting
15
AP-HP Paris Saclay University Bicêtre Hospital
Paris, France
Actively Recruiting
16
AP-HP University Hospital Cochin - Port Royal
Paris, France
Actively Recruiting
17
Hôpital de Poissy Saint-Germain-en-Laye
Poissy, France
Actively Recruiting
18
Medical Faculty of TU Dresden
Dresden, Germany
Not Yet Recruiting
19
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Not Yet Recruiting
20
University Children's Hospital Regensburg (KUNO)
Regensburg, Germany
Actively Recruiting
21
Bnai Zion Medical Center
Haifa, Israel
Not Yet Recruiting
22
Rambam Medical Center
Haifa, Israel
Actively Recruiting
23
Haddasah medical center
Jerusalem, Israel
Not Yet Recruiting
24
Shaare-Zedek Medical Center
Jerusalem, Israel
Actively Recruiting
25
Ziv Medical Center
Safed, Israel
Actively Recruiting
26
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
Bologna, Italy
Actively Recruiting
27
Istituto Giannina Gaslini
Genova, Italy
Not Yet Recruiting
28
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Actively Recruiting
29
Ospedale dei Bambini "V. Buzzi"
Milan, Italy
Actively Recruiting
30
Università degli Studi di Napoli Federico II
Naples, Italy
Actively Recruiting
31
Azienda Ospedale Università di Padova
Padova, Italy
Actively Recruiting
32
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Not Yet Recruiting
33
University Hospital in Krakow
Krakow, Poland
Not Yet Recruiting
34
Polish Mother's Memorial Hospital - Research Institute in Lodz
Lodz, Poland
Not Yet Recruiting
35
Gynecological Obstetric Clinical Hospital of Poznan University of Medical Sciences
Poznan, Poland
Actively Recruiting
36
University Clinical Hospital No. 2 PUM
Szczecin, Poland
Not Yet Recruiting
37
University Hospital Wroclaw
Wroclaw, Poland
Actively Recruiting
38
Hospital General Universitario de Alicante Dr. Balmis
Alicante, Spain
Actively Recruiting
39
Hospital Clínic de Barcelona
Barcelona, Spain
Actively Recruiting
40
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Actively Recruiting
41
Hospital Sant Joan de Déu
Barcelona, Spain
Actively Recruiting
42
Hospital Universitario Cruces - OSI Ezkerraldea-Enkarterri-Cruces
Bilbao, Spain
Actively Recruiting
43
Hospital Universitario Puerta del Mar
Cadiz, Spain
Actively Recruiting
44
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, Spain
Actively Recruiting
45
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Not Yet Recruiting
46
Hospital Universitario La Paz
Madrid, Spain
Actively Recruiting
47
Hospital Regional Universitario de Málaga
Málaga, Spain
Actively Recruiting
48
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Spain
Actively Recruiting
49
Hospital Universitari i Politècnic La Fe
Valencia, Spain
Actively Recruiting
50
Hospital Universitario Miguel Servet
Zaragoza, Spain
Actively Recruiting
Research Team
A
Alan Wolk
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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