Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Respiratory Distress Syndrome, Pre-term Infants

In brief

This is a 2-part, prospective, randomized, blinded, sham-controlled, multi-center study comparing preterm subjects with RDS who are treated with APC-0101 and nCPAP/NIV to subjects treated with nCPAP/NIV alone (Sham). In Part 1, subjects will be followed until they reach 40 weeks post-menstrual age (PMA) or are discharged from the NICU, whichever comes first. In Part 2, subjects will undergo post-term follow-up through 24 months corrected age.

Key facts

Study ID

NCT06776783

Run by

Aerogen Pharma Limited

People needed

520

Starts

2025-09-24

Expected to finish

2029-05-01

Last updated by the study team

2026-08-06

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inborn at the study site's hospital (i.e., not transferred from another hospital following delivery)
• Gestational age at birth of 26 through 33 weeks PMA
• Birth weight appropriate for gestational age (AGA, weight 3rd to 97th percentile on Fenton Growth Curve)
• Birth weight ≤ 2000 grams
• Post-natal age 1 to 24 hours at randomization
• On nCPAP or NIV for at least 30 minutes with RSS = 1.4 - 2.0 to maintain SpO2 90-95% at randomization. RSS is calculated as (nCPAP cm H2O) × (FiO2) or as (NIV mean airway pressure cm H2O) × (FiO2).
• FiO2 ≥ 0.24 at randomization
• nCPAP or mPaw ≥ 6 cm H2O at randomization
• Chest radiograph (CXR) or lung ultrasound compatible with RDS prior to randomization

You may not qualify if…

• On SiPAP®, RAM® cannula, or high flow nasal cannula (HFNC) (> 2 liters per minute [LPM]) at the time of randomization
• Prior instillation of surfactant
• Premature rupture of membranes (PROM) occurring > 14 days before birth
• Significant congenital/chromosomal anomaly (e.g., Pierre Robin syndrome, clinically significant congenital heart disease, or trisomy)
• Pneumothorax
• Other etiologies of respiratory distress
• Enrollment in another interventional study with similar efficacy endpoints
• Apgar score at 5 min of 0-3
• Prior cardiopulmonary resuscitation (CPR) or epinephrine
• Base Deficit > 15 mEq/L on most recent arterial blood gas (not capillary blood gas, venous blood gas, or cord gas) prior to randomization. Note that arterial blood gas is not required prior to randomization.
• Partial pressure of carbon dioxide (PaCO2) > 65 mmHg on most recent arterial blood gas (not capillary blood gas, venous blood gas, or cord gas) prior to randomization.
• Triplet or higher order multiple birth

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (enrolling)
• Jacobs Medical Center — La Jolla, California, United States (enrolling)
• UF Health Jacksonville — Jacksonville, Florida, United States (enrolling)
• Advent Health — Orlando, Florida, United States (enrolling)
• Memorial Hospital of South Bend — South Bend, Indiana, United States (enrolling)
• Goryeb Children's Hospital — Morristown, New Jersey, United States (enrolling)
• The Trustees of Columbia University in the City of New York — New York, New York, United States (enrolling)
• Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• Maria Farreri Children's Hospital — Valhalla, New York, United States (enrolling)
• Christus Children's Hospital — San Antonio, Texas, United States (enrolling)
• University of Virginia School of Medicine — Charlottesville, Virginia, United States (enrolling)
• WVU Medicine Children's Hospital — Morgantown, West Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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