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FUSION: A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in Amyotrophic Lateral Sclerosis Participants With Fused in Sarcoma Mutations (FUS-ALS)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Jun 2026 to Jun 17, 2026v42
  2. Secondary endpoints revised (7)v41 See this version in full on ClinicalTrials.gov ↗
  3. Re-verified, no change to tracked fieldsv40
  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 95 to confirmed 89 · Site details revised at 25 of 25 sitesv39 Show 2 more changesShow less
    • Enrollment target: estimated 95 to confirmed 89
    • Site details revised at 25 of 25 sites
  5. Study sites: 24 to 25v38
Show 36 earlier versionsHide 36 earlier versions
  1. Study sites: 23 to 24v37
  2. Study sites: 22 to 23v36
  3. Study sites: 20 to 22v35
  4. Secondary endpoints revised (7)v34 See this version in full on ClinicalTrials.gov ↗
  5. Enrollment target: 77 to 95 Study sites: 19 to 20 · Eligibility criteria expanded, about 39 words · Secondary endpoints: 6 to 7 · 2 morev33 Show 5 more changesShow less
    • Study sites: 19 to 20
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: 6 to 7
    • Study description shortened, about 7 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites: 18 to 19v32
  7. Study sites: 17 to 18v31
  8. Study sites: 14 to 17v30
  9. Primary completion date: Jun 2025 to Jun 2026 Completion date: Sep 2025 to Mar 2028 · Study description expanded, about 46 wordsv29 Show 2 more changesShow less
    • Completion date: Sep 2025 to Mar 2028
    • Study description expanded, about 46 words

    See this version in full on ClinicalTrials.gov ↗

  10. Study sites: 13 to 14v28
  11. Study sites: 12 to 13v27
  12. Site details revised at 1 of 12 sitesv26
  13. Study sites: 11 to 12v25
  14. Study sites: 13 to 11v24
  15. Study sites: 12 to 13v23
  16. Primary completion date: Mar 2024 to Jun 2025 Study sites: 11 to 12 · Completion date: Mar 2024 to Sep 2025v22 Show 2 more changesShow less
    • Study sites: 11 to 12
    • Completion date: Mar 2024 to Sep 2025
  17. Site details revised at 2 of 11 sitesv21
  18. Study sites: 10 to 11v20
  19. Primary endpoint revised Enrollment target: 64 to 77 · Study sites: 9 to 10 · Eligibility criteria shortened, about 49 words · 2 morev19 Show 5 more changesShow less
    • Enrollment target: 64 to 77
    • Study sites: 9 to 10
    • Eligibility criteria shortened, about 49 words
    • Secondary endpoints: 7 to 6
    • Study description shortened, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  20. Site contacts updated at 1 of 9 sitesv18
  21. Study sites: 8 to 9v17
  22. Site contacts updated at 1 of 8 sitesv16
  23. Site contacts updated at 2 of 8 sitesv15
  24. Study sites: 6 to 8v14
  25. Study sites: 5 to 6v13
  26. Re-verified, no change to tracked fieldsv12
  27. Study sites: 4 to 5v11
  28. Study sites: 3 to 4 Start date changed from estimate of Jul 2021 to Jun 14, 2021v10 Show 1 more changeShow less
    • Start date changed from estimate of Jul 2021 to Jun 14, 2021
  29. Start date: Jun 2021 to Jul 2021v9
  30. Study sites: 2 to 3v8
  31. Study sites: 1 to 2v7
  32. Start date: May 2021 to Jun 2021v6
  33. Primary endpoint revised Start date: Apr 2021 to May 2021 · Eligibility criteria expanded, about 160 words · Secondary endpoints: 6 to 7 · 1 morev5 Show 4 more changesShow less
    • Start date: Apr 2021 to May 2021
    • Eligibility criteria expanded, about 160 words
    • Secondary endpoints: 6 to 7
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  34. Re-verified, no change to tracked fieldsv4
  35. Trial status: Not Yet Recruiting to Recruitingv3
  36. Start date: Mar 2021 to Apr 2021v2
  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.
Ionis Pharmaceuticals
32 trials monitored
See 2 trials at risk
ALS
387 trials monitored
See 18 trials at risk
The primary purpose of this study is to evaluate the efficacy of ION363 on clinical function and survival in carriers of fused in sarcoma mutations with amyotrophic lateral sclerosis (FUS-ALS).
Trial Details
NCT Number NCT04768972
Lead Sponsor Ionis Pharmaceuticals, Inc.
Conditions Amyotrophic Lateral Sclerosis
Enrollment 89 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov