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A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF)

StatusCompleted
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 56 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Trial completed Site details revised at 4 of 26 sites · Eligibility criteria shortened, about 5 words Show 2 more changesShow less
    • Site details revised at 4 of 26 sites
    • Eligibility criteria shortened, about 5 words
  2. Re-verified, no change to tracked fieldsv55
  3. Enrollment reduced: 39 → 26 participants Trial status changed: Recruiting → Active, Not Recruiting · Trial sites reduced: 43 → 26 locations · Primary completion moved earlier from Dec 23, 2026 to Apr 21, 2026 · 1 morev54 Show 4 more changesShow less
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Trial sites reduced: 43 → 26 locations
    • Primary completion moved earlier from Dec 23, 2026 to Apr 21, 2026
    • Completion moved earlier from May 12, 2027 to Sep 9, 2026
  4. Eligibility criteria revisedv53 See this version in full on ClinicalTrials.gov ↗
  5. Site details revised at 2 of 43 sitesv52
Show 45 earlier versionsHide 45 earlier versions
  1. Site details revised at 2 of 43 sitesv51
  2. Site details revised at 2 of 43 sitesv50
  3. Study sites: 42 to 43v49
  4. Site details revised at 2 of 42 sitesv48
  5. Site details revised at 4 of 42 sitesv47
  6. Site details revised at 1 of 42 sitesv46
  7. Site details revised at 2 of 42 sitesv45
  8. Site details revised at 3 of 42 sitesv44
  9. Site details revised at 5 of 42 sitesv43
  10. Site details revised at 3 of 42 sitesv42
  11. Study sites revised (42)v41 See this version in full on ClinicalTrials.gov ↗
  12. Site details revised at 1 of 42 sitesv40
  13. Trial status: Suspended to Recruiting Study sites: 41 to 42v39 Show 1 more changeShow less
    • Study sites: 41 to 42
  14. Enrollment target: 33 to 39 Primary completion date: May 12, 2027 to Dec 23, 2026 · Secondary endpoints: 1 to 2 · Study arms: 3 to 4v38 Show 3 more changesShow less
    • Primary completion date: May 12, 2027 to Dec 23, 2026
    • Secondary endpoints: 1 to 2
    • Study arms: 3 to 4

    See this version in full on ClinicalTrials.gov ↗

  15. Trial status: Recruiting to Suspended Sponsor's reason: The study was paused due to sponsor decision. Primary and study completion dates: Mar 31, 2025 to May 12, 2027 · Site details revised at 41 of 41 sitesv37 Show 2 more changesShow less
    • Primary and study completion dates: Mar 31, 2025 to May 12, 2027
    • Site details revised at 41 of 41 sites
  16. Study sites: 40 to 41v36
  17. Site details revised at 5 of 40 sitesv35
  18. Study sites: 39 to 40 Primary and study completion dates: Mar 2025 to Mar 31, 2025v34 Show 1 more changeShow less
    • Primary and study completion dates: Mar 2025 to Mar 31, 2025
  19. Study sites: 38 to 39v33
  20. Site details revised at 5 of 38 sitesv32
  21. Site details revised at 1 of 38 sitesv31
  22. Study sites: 31 to 38v30
  23. Enrollment target: 36 to 33 Secondary endpoints: 2 to 1 · Site details revised at 1 of 31 sitesv29 Show 2 more changesShow less
    • Secondary endpoints: 2 to 1
    • Site details revised at 1 of 31 sites

    See this version in full on ClinicalTrials.gov ↗

  24. Study sites revised (31)v28 See this version in full on ClinicalTrials.gov ↗
  25. Study sites: 30 to 31v27
  26. Study sites: 29 to 30v26
  27. Re-verified, no change to tracked fieldsv25
  28. Study sites: 28 to 29v24
  29. Study sites: 27 to 28v23
  30. Phase: Phase 1 to Phase 1/2 Enrollment target: 9 to 36 · Primary and study completion dates: Jan 2024 to Mar 2025 · Interventions: VX-522 mRNA therapy (Drug) to IVA (Drug), VX-522 mRNA therapy (Drug) · 1 morev22 Show 4 more changesShow less
    • Enrollment target: 9 to 36
    • Primary and study completion dates: Jan 2024 to Mar 2025
    • Interventions: VX-522 mRNA therapy (Drug) to IVA (Drug), VX-522 mRNA therapy (Drug)
    • Study arms: 1 to 3
  31. Study sites: 26 to 27v21
  32. Study sites: 25 to 26v20
  33. Study sites: 21 to 25v19
  34. Study sites: 20 to 21v18
  35. Study sites: 19 to 20v17
  36. Study sites: 16 to 19v16
  37. Study sites: 15 to 16v15
  38. Study sites: 13 to 15v14
  39. Study sites: 10 to 13v13
  40. Study sites: 9 to 10v12
  41. Study sites: 8 to 9v11
  42. Study sites: 7 to 8v10
  43. Study sites: 6 to 7v9
  44. Study sites: 5 to 6v8
  45. Study sites: 4 to 5v7
  • 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.
The purpose of this study is to evaluate the safety, and tolerability and efficacy of VX-522 in participants 18 years of age and older with cystic fibrosis and a cystic fibrosis transmembrane conductance regulator (CFTR) genotype not responsive to CFTR modulator therapy.
Trial Details
NCT Number NCT05668741
Lead Sponsor Vertex Pharmaceuticals Incorporated
Collaborators: Moderna, Inc
Conditions Cystic Fibrosis
Enrollment 26 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov