Zelpultide Alfa to reduce bronchopulmonary dysplasia risk in extremely premature babies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Clínica y Maternidad Suizo Argentina
  Buenos Aires, Argentina Recruiting
• Hospital Italiano de Buenos Aires
  Buenos Aires, Argentina Recruiting
• Hospital Sanatorio de la Trinidad San Isidro
  Buenos Aires, Argentina Recruiting
• Hospital Universitario Austral
  Buenos Aires, Argentina Recruiting
• ZAS Middelheim
  Antwerp, Belgium Recruiting
• UZ Leuven
  Leuven, Belgium Recruiting

Study contacts

• Study coordinator: Alan Wolk
• Email: info@airwaytherapeutics.com
• Phone: 513-770-9630

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.