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Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ION464 Administered to Adults With Multiple System Atrophy (HORIZON)

Study acronym: HORIZON
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 14 to 15v32
  2. Site details revised at 1 of 14 sitesv31
  3. 2 versions Re-verified since Dec 5, 2025, no change to tracked fieldsv29-v30
  4. Study sites: 11 to 14v28
  5. Study sites: 12 to 11v27
Show 25 earlier versionsHide 25 earlier versions
  1. Study sites: 11 to 12v26
  2. Primary completion date: Nov 2023 to Sep 2027 Completion date: Dec 2025 to Sep 2027 · Eligibility criteria expanded, about 3 wordsv25 Show 2 more changesShow less
    • Completion date: Dec 2025 to Sep 2027
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 10 to 11v24
  4. Study sites revised (10)v23 See this version in full on ClinicalTrials.gov ↗
  5. Study sites: 9 to 10v22
  6. Study sites: 11 to 9v21
  7. Site details revised at 1 of 11 sitesv20
  8. Study sites: 12 to 11v19
  9. Study sites: 11 to 12v18
  10. Study sites: 10 to 11v17
  11. Study sites: 9 to 10v16
  12. Site details revised at 1 of 9 sitesv15
  13. Re-verified, no change to tracked fieldsv14
  14. Trial status: Active, Not Recruiting to Recruiting Start date: Jul 7, 2020 to Jul 21, 2022 · Study sites: 8 to 9v13 Show 2 more changesShow less
    • Start date: Jul 7, 2020 to Jul 21, 2022
    • Study sites: 8 to 9
  15. Lead sponsor: Biogen to Ionis Pharmaceuticals, Inc. Primary completion date: Jul 13, 2022 to Nov 2023 · Enrollment target: 34 to 40 · Completion date: Jul 13, 2022 to Dec 2025 · 6 morev12 Show 9 more changesShow less
    • Primary completion date: Jul 13, 2022 to Nov 2023
    • Enrollment target: 34 to 40
    • Completion date: Jul 13, 2022 to Dec 2025
    • Interventions: BIIB101 (Drug), Placebo (Drug) to ION464 (Drug), Placebo (Drug)
    • Secondary endpoints: 4 to 5
    • Study description expanded, about 98 words
    • Study arms: 3 to 4
    • Eligibility criteria shortened, about 3 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  16. Trial status: Recruiting to Active, Not Recruiting Site details revised at 8 of 8 sitesv11 Show 1 more changeShow less
    • Site details revised at 8 of 8 sites
  17. Re-verified, no change to tracked fieldsv10
  18. Study sites: 6 to 8v9
  19. Study sites: 4 to 6v8
  20. Study sites: 3 to 4v7
  21. Study sites: 2 to 3v6
  22. Study sites: 1 to 2 Start date changed from estimate of Jul 20, 2020 to Jul 7, 2020v5 Show 1 more changeShow less
    • Start date changed from estimate of Jul 20, 2020 to Jul 7, 2020
  23. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v4 Show 1 more changeShow less
    • Study sites: 0 to 1
  24. Study sites: 10 to 0v3
  25. Study sites: 0 to 10v2
  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.
The primary objectives are to evaluate the safety and tolerability of multiple doses of ION464 administered via intrathecal (IT) injection (Part 1) and to evaluate the long-term safety and tolerability of ION464 (Part 2) in participants with multiple system atrophy (MSA). The secondary objectives are to evaluate the pharmacodynamic (PD) effect of ION464 on the level of a potential biomarker of target engagement (Parts 1 and 2) and to evaluate the pharmacokinetic (PK) profile of ION464 in serum (Part 1).
Trial Details
NCT Number NCT04165486
Lead Sponsor Ionis Pharmaceuticals, Inc.
Conditions Multiple System Atrophy
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov