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An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)

Study acronym: SAIL
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 72 → 85 locations Eligibility criteria expanded, about 7 words · Secondary endpoints: details revised at 1 of 3 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 1 of 3 entries
  2. Trial sites expanded: 68 → 72 locationsv13
  3. Trial sites expanded: 54 → 68 locationsv12
  4. Study sites: 52 to 54v11
  5. Trial sites expanded: 44 → 52 locations Study description shortened, about 15 wordsv10 Show 1 more changeShow less
    • Study description shortened, about 15 words

    See this version in full on ClinicalTrials.gov ↗

Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 37 to 44v9
  2. Study sites: 30 to 37 Study description expanded, about 105 wordsv8 Show 1 more changeShow less
    • Study description expanded, about 105 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 26 to 30v7
  4. Study sites: 23 to 26v6
  5. Study sites: 19 to 23v5
  6. Study sites: 11 to 19v4
  7. Study sites: 12 to 11v3
  8. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 12 · Start date changed from estimate of Apr 30, 2025 to Apr 17, 2025 · Eligibility criteria expanded, about 18 wordsv2 Show 3 more changesShow less
    • Study sites: 1 to 12
    • Start date changed from estimate of Apr 30, 2025 to Apr 17, 2025
    • Eligibility criteria expanded, about 18 words

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is an open-label extension study for participants who were previously enrolled in and completed an Avalyn Pharma Sponsored study with an inhaled antifibrotic, such as AP01. Eligible participants will have their final dose of drug at the end of study visit from the lead-in study and first AP-LTE-008 study visit on the same day.
Trial Details
NCT Number NCT06951217
Lead Sponsor Avalyn Pharma Inc.
Conditions Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
Enrollment 340 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov