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AURORANCT06736990

A Phase 2 Study of CAL101 in Patients With Idiopathic Pulmonary Fibrosis

StatusActive, Not Recruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

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Record History

All 20 versions: 17 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Primary completion moved earlier from Aug 2027 to Nov 2026
    • Study completion moved earlier from Nov 2027 to Feb 2027
    • Site details revised at 54 of 54 sites
    v20
  2. Site details revised at 3 of 54 sitesv19
  3. Site details revised at 2 of 54 sitesv17
  4. Site details revised at 1 of 54 sitesv16
  5. Site details revised at 2 of 54 sitesv15
Show 11 earlier versionsHide 11 earlier versions
  1. Site details revised at 2 of 54 sitesv14
  2. Eligibility criteria expanded, about 27 words
    • Site details revised at 2 of 54 sites
    • Study description expanded, about 4 words
    v13
  3. Site details revised at 4 of 54 sitesv12
  4. Site details revised at 4 of 54 sitesv11
  5. Study sites: 47 to 54v10
  6. Study sites: 43 to 47v9
  7. Site details revised at 5 of 43 sitesv8
  8. Study sites: 20 to 43v7
  9. Study sites: 1 to 20v6
  10. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of May 2025 to Jun 20, 2025
    v5
  11. Study title shortened, about 6 wordsv2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Change from baseline in forced vital capacity (FVC) compared to placebo
Timeframe: 28 weeks

Arms and interventions

CAL101Experimental
PlaceboPlacebo comparator

Drugs: CAL101, Placebo

Sites

54 sites in 11 countries

United Kingdom 9, United States 9, Italy 7, France 5, South Korea 5, Romania 4, Spain 4, Denmark 3, Norway 3, Turkey (Türkiye) 3, Netherlands 2