CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 164 enrolled
Drug / intervention
Molgramostim +2 moredrug
Likely dose
Molgramostim 300 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04544293
NCT04544293Phase 3Active
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A Randomized, Double-blind, Placebo-controlled Clinical Trial of Once-daily Inhaled Molgramostim Nebulizer Solution in Adult Subjects With Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

Savara Inc.·interventional·Posted Sep 10, 2020·Updated Aug 7, 2025

In Brief

A Phase 3 clinical trial evaluating Molgramostim, Placebo, and 1 other intervention for Autoimmune Pulmonary Alveolar Proteinosis. Active but no longer recruiting, targeting 164 participants across 54 sites in 18 countries.

Detailed Summary

160 subjects with autoimmune pulmonary alveolar proteinosis (aPAP) will be randomized to receive once daily treatment with inhaled molgramostim (MOL) or placebo (PBO) for 48 weeks. Subjects completing the 48-week placebo-controlled period will receive open-label treatment with once daily inhaled molgramostim for 96 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutoimmune Pulmonary Alveolar Proteinosis
CountriesAustralia, Belgium, Canada, France, Germany, Greece, Ireland, Italy, Japan, Netherlands, Poland, Portugal, Romania, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3Active
2021202220232024202520262027
First PostedSep 10, 2020
Enrollment StartMay 19, 2021
Primary CompletionNov 30, 2023
Study CompletionMay 30, 2027
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 5.8 years ago

Interventions

Molgramostimdrug

Molgramostim 300 µg nebulizer solution

Placebodrug

Matching placebo nebulizer solution

Molgramostim Open-labeldrug

Molgramostim 300 µg nebulizer solution