Status:
RECRUITING
Efficacy and Safety of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD)
Lead Sponsor:
Airway Therapeutics, Inc.
Conditions:
Bronchopulmonary Dysplasia
Eligibility:
All Genders
Up to 96 years
Phase:
PHASE2
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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).
- 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.
Key Trial Info
Start Date :
February 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2030
Estimated Enrollment :
366 Patients enrolled
Trial Details
Trial ID
NCT06897839
Start Date
February 3 2025
End Date
April 30 2030
Last Update
December 16 2025
Active Locations (18)
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1
Bnai Zion Medical Center
Haifa, Israel
2
Shaare-Zedek Medical Center
Jerusalem, Israel
3
Ziv Medical Center
Safed, Israel
4
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
Bologna, Italy