Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05199688 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study to Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, and Pharmacodynamics of Satralizumab in Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)

Study acronym: SAkuraSun
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 4 of 4 changed
See other at-risk trials from Roche/Genentech

Record History

The 50 most recent of 59 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Study sites: 13 to 14 Show 1 more changeShow less
    • Study sites: 13 to 14
  2. Site details revised at 2 of 13 sitesv58
  3. Re-verified, no change to tracked fieldsv57
  4. Site details revised at 1 of 13 sitesv56
  5. Start date changed from estimate of Apr 30, 2026 to May 6, 2026v55
Show 45 earlier versionsHide 45 earlier versions
  1. Start date: Mar 31, 2026 to Apr 30, 2026 Study sites: 12 to 13v54 Show 1 more changeShow less
    • Study sites: 12 to 13
  2. Re-verified, no change to tracked fieldsv53
  3. Start date: Dec 31, 2025 to Mar 31, 2026 Study sites: 10 to 12v52 Show 1 more changeShow less
    • Study sites: 10 to 12
  4. 3 versions Re-verified since Nov 18, 2025, no change to tracked fieldsv49-v51
  5. Start date: Sep 30, 2025 to Dec 31, 2025 Study sites: 9 to 10v48 Show 1 more changeShow less
    • Study sites: 9 to 10
  6. Study sites: 8 to 9 Primary completion date: Dec 16, 2026 to Mar 31, 2027 · Completion date: Dec 14, 2029 to Sep 12, 2029v47 Show 2 more changesShow less
    • Primary completion date: Dec 16, 2026 to Mar 31, 2027
    • Completion date: Dec 14, 2029 to Sep 12, 2029
  7. 2 versions Re-verified since Jul 25, 2025, no change to tracked fieldsv45-v46
  8. Start date: Jun 30, 2025 to Sep 30, 2025v44
  9. Primary completion date: Mar 31, 2027 to Dec 16, 2026 Completion date: Sep 12, 2029 to Dec 14, 2029v43 Show 1 more changeShow less
    • Completion date: Sep 12, 2029 to Dec 14, 2029
  10. Re-verified, no change to tracked fieldsv42
  11. Start date: Mar 31, 2025 to Jun 30, 2025v41
  12. 2 versions Re-verified since Feb 3, 2025, no change to tracked fieldsv39-v40
  13. Site details revised at 1 of 8 sitesv38
  14. 2 versions Re-verified since Nov 2, 2024, no change to tracked fieldsv36-v37
  15. Start date: Sep 30, 2024 to Mar 31, 2025v35
  16. Re-verified, no change to tracked fieldsv34
  17. Start date: Jul 31, 2024 to Sep 30, 2024v33
  18. Start date: Jun 28, 2024 to Jul 31, 2024v32
  19. 2 versions Re-verified since May 9, 2024, no change to tracked fieldsv30-v31
  20. Primary completion date: Feb 28, 2027 to Mar 31, 2027 Completion date: Feb 28, 2027 to Sep 12, 2029 · Start date: Sep 30, 2024 to Jun 28, 2024v29 Show 2 more changesShow less
    • Completion date: Feb 28, 2027 to Sep 12, 2029
    • Start date: Sep 30, 2024 to Jun 28, 2024
  21. 4 versions Re-verified since Dec 25, 2023, no change to tracked fieldsv25-v28
  22. Primary completion date: Sep 9, 2024 to Feb 28, 2027 Start date: Oct 31, 2023 to Sep 30, 2024v24 Show 1 more changeShow less
    • Start date: Oct 31, 2023 to Sep 30, 2024
  23. Start date: Sep 30, 2023 to Oct 31, 2023v23
  24. Re-verified, no change to tracked fieldsv22
  25. Study sites: 7 to 8v21
  26. Start date: Jun 30, 2023 to Sep 30, 2023 Study sites: 6 to 7v20 Show 1 more changeShow less
    • Study sites: 6 to 7
  27. Study sites: 4 to 6v19
  28. Study sites: 3 to 4v18
  29. Start date: Feb 28, 2023 to Jun 30, 2023v17
  30. Start date: Jan 30, 2023 to Feb 28, 2023v16
  31. Re-verified, no change to tracked fieldsv15
  32. Study sites: 2 to 3 Start date: Feb 28, 2023 to Jan 30, 2023v14 Show 1 more changeShow less
    • Start date: Feb 28, 2023 to Jan 30, 2023
  33. Start date: Nov 30, 2022 to Feb 28, 2023v13
  34. Start date: Oct 30, 2022 to Nov 30, 2022v12
  35. Start date: Sep 30, 2022 to Oct 30, 2022v11
  36. Re-verified, no change to tracked fieldsv10
  • 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.
Roche/Genentech
366 trials monitored
See 33 trials at risk
This study will primarily evaluate the pharmacokinetics of satralizumab in pediatric patients aged 2-11 years with anti-aquaporin-4 (AQP4) antibody seropositive neuromyelitis optica spectrum disorder (NMOSD). Efficacy, safety, tolerability, and pharmacodynamics will be evaluated in a descriptive manner, given the small number of patients who will be enrolled in this study.
Trial Details
NCT Number NCT05199688
Lead Sponsor Hoffmann-La Roche
Conditions Neuromyelitis Optica Spectrum Disorder, NMOSD
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov