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NCT04544293 · ClinicalTrials.gov registry record · Phase 3
Clinical Trial of Inhaled Molgramostim Nebulizer Solution in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
A Phase 3 study of Autoimmune Pulmonary Alveolar Proteinosis, sponsored by Savara.
- Active
- Registry status
- Phase 3
- Development phase
- 164
- Enrollment target
- 20
- Study locations
NCT04544293: Active Phase 3 study of Autoimmune Pulmonary Alveolar Proteinosis, sponsored by Savara.
NCT04544293 is a Phase 3 study of Autoimmune Pulmonary Alveolar Proteinosis that is active but no longer recruiting, run by Savara. The registered enrollment target is 164 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04544293, a Phase 3 study of Autoimmune Pulmonary Alveolar Proteinosis, is active but no longer recruiting, sponsored by Savara.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 164 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
As a measure of pulmonary gas transfer, a standardized lung function test, DLCO, was conducted. The single-breath DLCO test was performed in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines for DLCO testing. Results reported as % predicted DLCO adjusted for hemoglobin concentration (%predicted DLCOadj).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Molgramostim
- DRUG Molgramostim Open-label
Study Locations (20)
North Carolina
- Duke University Medical Center - Durham
- Wake Med Health & Hospital - Raleigh
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Cleveland Clinic - Cleveland
Pennsylvania
- University of Pennsylvania Perelman School of Medicine - Pulmonology - Philadelphia
- University of Pittsburgh - Pittsburgh
New South Wales
- Royal Prince Alfred Hospital - Camperdown
- Westmead Hospital - Westmead
Arkansas
- University Of Arkansas For Medical Services - Little Rock
California
- UCLA David Geffen School of Medicine - Los Angeles
Colorado
- National Jewish Health - Denver
Connecticut
- Yale University - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2021-05-19 |
| Est. Completion | 2027-05-30 |
| Phase | Phase 3 |
What the registry record for NCT04544293 still lists
NCT04544293 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Autoimmune Pulmonary Alveolar Proteinosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04544293 names 20 study sites across 16 states, led by North Carolina, Ohio, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04544293 about?
NCT04544293 is a clinical study titled "Clinical Trial of Inhaled Molgramostim Nebulizer Solution in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)". 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 mol...
What is the current status of trial NCT04544293?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 164 participants. The study started on 2021-05-19. Estimated completion is 2027-05-30.
What conditions does trial NCT04544293 study?
This clinical trial studies the following conditions: Autoimmune Pulmonary Alveolar Proteinosis.
What interventions are being tested in trial NCT04544293?
The interventions under investigation include: Placebo (DRUG), Molgramostim (DRUG), Molgramostim Open-label (DRUG).
Who is sponsoring clinical trial NCT04544293?
This trial is sponsored by Savara, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04544293 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autoimmune Pulmonary Alveolar Proteinosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04544293's enrollment target sits among peer trials
164 1470th of 2000 higher than 530 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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