NCT03482752

Safety Extension Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis

An Open-label, Non-controlled, Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis Patients

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Savara Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

SAV006-03 is an open-label extension study for participants who had completed the IMPALA study. At the baseline visit, eligible participants may continue or re-start treatment with 300 µg inhaled molgramostim (recombinant human Granulocyte-Macrophage Colony Stimulating Factor; GM-CSF) administered intermittently in cycles of seven days molgramostim, administered once daily, and seven days off treatment. Participants will be treated with inhaled molgramostim for up to 36 months. During the trial, whole lung lavage will be applied as rescue therapy.

Conditions

• Autoimmune Pulmonary Alveolar Proteinosis

Interventions

Type	Name	Description
DRUG	Molgramostim	300 µg inhaled molgramostim in cycles of once daily administration for 7 days, then 7 days off treatment.

Timeline

• Start date: 2018-04-16
• Primary completion: 2021-01-14
• Completion: 2021-01-14
• First posted: 2018-03-29
• Last updated: 2024-07-03
• Results posted: 2024-07-03

Locations

13 sites across 10 countries: Denmark, France, Germany, Greece, Israel, Italy, Netherlands, Russia, Turkey (Türkiye), United Kingdom