A randomized, double-blind, placebo-controlled clinical trial of once-daily inhaled molgramostim nebulizer solution in adult subjects with autoimmune pulmonary alveolar proteinosis (aPAP)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511052-41-00

Acronym

SAV00605

Enrollment

Registered

2024-10-29

Start date

2021-05-10

Completion date

Unknown

Last updated

2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Pulmonary Alveolar Proteinosis

Brief summary

Change in % predicted DLCO from baseline to Week 24

Detailed description

Change in % predicted DLCO from baseline to Week 48, Change in SGRQ Total from baseline to Week 24, Change in SGRQ Activity from baseline to Week 24, Change in EC (expressed as peak METs) from baseline to Week 24, Change in SGRQ Total from baseline to Week 48, Change in SGRQ Activity from baseline to Week 48, Change in EC (expressed as peak METs) from baseline to Week 48

Interventions

DRUGPlacebo nebulizer solution

DRUGMolgradex

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in % predicted DLCO from baseline to Week 24	—

Secondary

Measure	Time frame
Change in % predicted DLCO from baseline to Week 48, Change in SGRQ Total from baseline to Week 24, Change in SGRQ Activity from baseline to Week 24, Change in EC (expressed as peak METs) from baseline to Week 24, Change in SGRQ Total from baseline to Week 48, Change in SGRQ Activity from baseline to Week 48, Change in EC (expressed as peak METs) from baseline to Week 48	—

Countries

Belgium, France, Germany, Ireland, Italy, Poland, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026