drugset / Trial / NCT06431776

Inhaled Molgramostim in Pediatric Participants With Autoimmune Pulmonary Alveolar Proteinosis (aPAP).

NCT06431776

Phase 3 Recruiting 5 enrolled Savara Inc.
NaSingle-groupOpen-labelTreatment

Summary

The goal of this open-label study is to study molgramostim as a treatment for autoimmune pulmonary alveolar proteinosis (aPAP) in pediatric patients between age 6 and 18. The main questions it aims to answer are: The effect of molgramostim on breathing tests and activity in pediatric patients with aPAP and the safety of molgramostim in pediatric patients with aPAP. This is an open-label study: all participants will receive treatment with molgramostim. Patients will: * Take molgramostim once daily via nebulizer every day for 12 months. * Visit the clinic approximately every 12 weeks for checkups and tests. * Keep a diary of any oxygen use.

Timeline

Start
2025-10-22
Primary completion
2027-06
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Molgramostim Protein / enzyme biologic 300 ug Inhaled