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Zelpultide Alfa to reduce bronchopulmonary dysplasia risk in extremely premature babies

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)

PHASE2; PHASE3 · Airway Therapeutics, Inc. · NCT06897839

This trial will try Zelpultide Alfa in extremely premature infants on ventilators to see if it lowers their chance of developing bronchopulmonary dysplasia.

Quick facts

PhasePHASE2; PHASE3
Study typeInterventional
Enrollment366 (estimated)
Ages0 Minutes to 96 Hours
SexAll
SponsorAirway Therapeutics, Inc. (industry)
Locations50 sites (Buenos Aires and 49 other locations)
Trial IDNCT06897839 on ClinicalTrials.gov

What this trial studies

This is a randomized, parallel-group, double-blind, placebo-controlled adaptive seamless Phase 2b/3 trial testing Zelpultide Alfa versus an air-sham in extremely preterm infants. Part 1 (Phase 2b) compares two doses (4 mg/kg and 6 mg/kg) against placebo to select a dose based on safety, tolerability, and exploratory efficacy signals, and an independent DSMC will recommend the selected dose. Part 2 (Phase 3) will enroll infants using the selected dose to confirm efficacy and safety versus placebo. Eligible infants are those born at 22 0/7 to 27 6/7 weeks who received surfactant and are intubated and receiving invasive mechanical ventilation within the specified enrollment window.

Who should consider this trial

Good fit: Infants born at 22 0/7 to 27 6/7 weeks who received at least one dose of animal-derived surfactant, are intubated on invasive mechanical ventilation within the enrollment window, and whose parent or guardian consents.

Not a fit: Infants with birth weight under 400 g or over 1,500 g, major congenital cardiopulmonary abnormalities, or other exclusion criteria are unlikely to be eligible or to benefit from this intervention.

Why it matters

Potential benefit: If effective, Zelpultide Alfa could reduce the occurrence of bronchopulmonary dysplasia and its long-term respiratory complications in extremely preterm infants.

How similar studies have performed: This therapeutic approach is relatively novel in this population; related biologic and anti-inflammatory strategies for preventing BPD have shown mixed results and no established agent yet prevents BPD reliably.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Buenos Aires and 49 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Bronchopulmonary Dysplasia, BPD, Zelpultide alfa, AT-100

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.