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Clinical Trial of Inhaled Molgramostim Nebulizer Solution in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

Study acronym: IMPALA-2
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Site details revised at 10 of 54 sitesv26
  2. Results first posted: Aug 7, 2025
    • Secondary endpoints revised (13)
    v25
  3. Start date: May 10, 2021 to May 19, 2021
    • Secondary endpoints revised (13)
    v24
  4. Primary endpoint revisedv23 Show 8 more changesShow less
    • Enrollment target: estimated 160 to confirmed 164
    • Study completion date: Nov 30, 2024 to May 30, 2027
    • Interventions: Molgramostim (Drug), Placebo (Drug) to Molgramostim (Drug), Molgramostim Open-label (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints revised (13)
    • Site details revised at 10 of 54 sites
    • Study arms: 2 to 3
    • Study description expanded, about 4 words
  5. Re-verified, no change to tracked fieldsv22
Show 20 earlier versionsHide 20 earlier versions
  1. Primary completion date changed from estimate of Jun 2024 to Nov 30, 2023
    • Study completion date: Jun 2025 to Nov 30, 2024
    • Site details revised at 10 of 54 sites
    v21
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study description revised
    • Site details revised at 54 of 54 sites
    v20
  3. Site contacts updated at 1 of 54 sitesv19
  4. Study sites: 55 to 54v18
  5. Site details revised at 3 of 55 sitesv17
  6. Study sites: 54 to 55v16
  7. Re-verified, no change to tracked fieldsv15
  8. Site details revised at 2 of 54 sitesv14
  9. Study sites revised (54)v13
  10. Study sites: 55 to 54v12
  11. Study sites revised (55)v11
  12. Study sites: 54 to 55v10
  13. Site details revised at 9 of 54 sitesv9
  14. Study sites: 53 to 54
    • Eligibility criteria expanded, about 3 words
    v8
  15. Study sites: 50 to 53v7
  16. Study sites: 17 to 50v6
  17. Primary endpoint revisedv5 Show 5 more changesShow less
    • Study sites: 4 to 17
    • Start date changed from estimate of Jul 2021 to May 10, 2021
    • Eligibility criteria expanded, about 60 words
    • Secondary endpoints: 3 to 13
    • Study description shortened, about 31 words
  18. Primary completion date: Nov 2023 to Jun 2024
    • Start date: May 18, 2021 to Jul 2021
    • Study sites: 1 to 4
    • Study completion date: Nov 2024 to Jun 2025
    v4
  19. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 2021 to May 18, 2021
    v3
  20. Start date: Jan 1, 2021 to Feb 2021
    • Primary completion date: Nov 1, 2023 to Nov 2023
    • Study completion date: Nov 1, 2024 to Nov 2024
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04544293
Lead Sponsor Savara Inc.
Conditions
(from sponsor)		 Autoimmune Pulmonary Alveolar Proteinosis
Related terms Pulmonary Alveolar Proteinosis, Acquired
Enrollment 164 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov