Clinical Trial of Inhaled Molgramostim Nebulizer Solution in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
← catalyst calendarSponsored by Savara Inc. (industry) · SVRA — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
164actual
Sites
54
Countries
Australia, Belgium, Canada +15
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-05-19 | actual | When the study began enrolling |
| Primary completion | 2023-11-30 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-05-30 | estimated | The whole study's end, after follow-up |
| First posted | 2020-09-10 | actual | When this record first appeared on the registry |
| Results posted | 2025-08-07 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-08-07 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Autoimmune Pulmonary Alveolar Proteinosis
Interventions
- Drug: Molgramostim — also filed as Recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF)
- Drug: Placebo — also filed as Placebo nebulizer
- Drug: Molgramostim Open-label — also filed as Recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF)
Primary outcome
what the primary-completion date above is the date OFChange From Baseline in Percent (%) Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Adjusted for Hemoglobin Concentration to Week 24
measured From Baseline to Week 24
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-10-09 · 4.3 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-04-24 · 4.6 MB · SAP_001.pdf
Publications
- PMID 40834301 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
Permalink · SVRA's whole pipeline · Catalyst calendar · Every registered study · What changed