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A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT)

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 25 to 26
    • Eligibility criteria expanded, about 24 words
  2. Study sites: 24 to 25v42
  3. Re-verified, no change to tracked fieldsv41
  4. Study sites: 29 to 24v40
  5. 3 versions Re-verified since Sep 9, 2025, no change to tracked fieldsv37-v39
Show 35 earlier versionsHide 35 earlier versions
  1. Primary and study completion dates: Jan 31, 2026 to Oct 31, 2027v36 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 80 to confirmed 86
    • Eligibility criteria expanded, about 172 words
    • Secondary endpoints revised (5)
    • Site details revised at 29 of 29 sites
  2. Study sites: 28 to 29v35
  3. Study sites: 27 to 28v34
  4. Study sites: 24 to 27v33
  5. Study sites: 23 to 24v32
  6. Study sites: 22 to 23v31
  7. Study sites: 21 to 22v30
  8. Study sites: 20 to 21v29
  9. Site contacts updated at 1 of 20 sitesv28
  10. Study sites: 19 to 20v27
  11. Site contacts updated at 1 of 19 sitesv26
  12. Study sites: 17 to 19v25
  13. Study sites: 16 to 17v24
  14. Study sites: 15 to 16v23
  15. Study sites: 14 to 15v22
  16. Eligibility criteria expanded, about 4 wordsv21
  17. Study sites: 13 to 14v20
  18. Study sites: 11 to 13v19
  19. Primary and study completion dates: Oct 31, 2026 to Jan 31, 2026v18
  20. Site contacts updated at 1 of 11 sitesv17
  21. Primary and study completion dates: Jan 31, 2026 to Oct 31, 2026
    • Study sites: 10 to 11
    • Eligibility criteria expanded, about 57 words
    • Study title expanded, about 1 word
    v16
  22. Study sites: 9 to 10v15
  23. Study sites: 7 to 9v14
  24. Study sites: 6 to 7v13
  25. Study sites: 4 to 6v12
  26. Study sites: 3 to 4v11
  27. Study sites: 2 to 3v10
  28. Primary and study completion dates: Aug 31, 2024 to Jan 31, 2026v9
  29. Enrollment target: 50 to 80v8 Show 5 more changesShow less
    • Primary endpoints: 4 to 2
    • Study sites: 1 to 2
    • Eligibility criteria expanded, about 185 words
    • Secondary endpoints revised (5)
    • Study title revised
  30. Start date changed from estimate of Feb 28, 2022 to Feb 14, 2022v7
  31. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v6
  32. Start date: Nov 30, 2021 to Feb 28, 2022v5
  33. Start date: Aug 31, 2021 to Nov 30, 2021
    • Primary endpoints: 5 to 4
    v4
  34. Start date: Mar 31, 2021 to Aug 31, 2021v3 Show 4 more changesShow less
    • Primary endpoints revised (5)
    • Primary and study completion dates: Mar 31, 2024 to Aug 31, 2024
    • Secondary endpoints revised (5)
    • Eligibility criteria shortened, about 2 words
  35. Primary endpoints: 8 to 5
    • Secondary endpoints: 31 to 5
    • Eligibility criteria expanded, about 3 words
    v2
  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.
A Global Phase III multicenter, randomized, assessor-blinded, active-controlled designed to evaluate safety and efficacy of study drug for the treatment of the MPS II.
Trial Details
NCT Number NCT04573023
Lead Sponsor JCR Pharmaceuticals Co., Ltd.
Conditions
(from sponsor)		 Mucopolysaccharidosis II
Related terms Mucopolysaccharidosis II
Enrollment 86 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov