Condition: Bronchopulmonary Dysplasia · Sponsor: Airway Therapeutics, Inc.
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, Zelpultide Alfa, can reduce the occurrence of Bronchopulmonary Dysplasia (BPD) in extremely premature babies. The study comprises 2 parts: * Part 1: Phase 2b, dose selection and exploratory efficacy and safety. * Part 2: Phase 3, confirmatory efficacy and safety. In Part 1, the study subjects will be randomized with a 1:1:1 allocation ratio to either : 1. Standard of care + zelpultide alfa 4 mg/kg or, 2. Standard of care + zelpultide alfa 6 mg/kg or, 3. Standard of care + placebo (air-sham). In Part 1, all three arms will be evaluated descriptively to support dose selection based on safety, tolerability, and exploratory efficacy signals. Upon completion of Part 1, the DSMC will recommend which Phase 2b dose ("selected dose") to progress into Part 2 to the Study Steering Committee, which will decide the dose for Part 2 (Phase 3). A sample size reassessment will be performed after Part 1 completion. In Part 2, the selected dose of zelpultide alfa will be compared against placebo (air-sham) in a confirmatory analysis on the primary and key secondary endpoints. The study subjects will be randomized with a 1:1 allocation ratio to either: 1. Standard of care + zelpultide alfa (selected dose from Part 1), or 2. Standard of care + placebo (air-sham). The main objective in part 2…
This description comes directly from the study's public registry record.
Alan Wolk · 513-770-9630 · info@airwaytherapeutics.com
Always discuss trial participation with your own doctor first.
| 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 |
| Cliniques Universitaires Saint-Luc | Brussels, Belgium | Not Yet Recruiting |
| UZ Leuven | Leuven, Belgium | Recruiting |
| CHU de Liege - Hospital de la Citadelle | Liège, Belgium | Recruiting |
| Clinique CHC MontLégia | Liège, Belgium | Recruiting |
| CHU Lille - Hôpital Jeanne de Flandre | Lille, France | Recruiting |
| CHRU Nancy | Nancy, France | Recruiting |
| CHU Nice | Nice, France | Recruiting |
+ 38 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06897839