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A Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Satralizumab in Participants With Anti-N-methyl-D-aspartic Acid Receptor (NMDAR) or Anti-leucine-rich Glioma-inactivated 1 (LGI1) Encephalitis

Study acronym: Cielo
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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

  1. Trial sites reduced: 77 → 56 locations Eligibility criteria expanded, about 42 words · Secondary endpoints: details revised at 1 of 11 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 42 words
    • Secondary endpoints: details revised at 1 of 11 entries
  2. Trial status changed: Recruiting → Active, Not Recruiting Trial sites reduced: 93 → 77 locations · Enrollment target: estimated 120 to confirmed 122v55 Show 2 more changesShow less
    • Trial sites reduced: 93 → 77 locations
    • Enrollment target: estimated 120 to confirmed 122
  3. Site details revised at 26 of 93 sitesv54
  4. Enrollment reduced: 152 → 120 participants Completion moved earlier from Dec 14, 2029 to Dec 14, 2028 · Secondary endpoints: details revised at 2 of 11 entries · Site details revised at 3 of 93 sites · 1 morev53 Show 4 more changesShow less
    • Completion moved earlier from Dec 14, 2029 to Dec 14, 2028
    • Secondary endpoints: details revised at 2 of 11 entries
    • Site details revised at 3 of 93 sites
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  5. Site details revised at 2 of 93 sitesv52
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 92 to 93v51
  2. Site details revised at 2 of 92 sitesv50
  3. Study sites: 89 to 92v49
  4. Study sites: 88 to 89v48
  5. Site details revised at 2 of 88 sitesv47
  6. Study sites: 87 to 88v46
  7. Study sites: 83 to 87v45
  8. Site details revised at 2 of 83 sitesv44
  9. Re-verified, no change to tracked fieldsv43
  10. Site details revised at 1 of 83 sitesv42
  11. Study sites: 82 to 83 Primary completion date: Jun 23, 2026 to Dec 16, 2026 · Completion date: Dec 7, 2028 to Dec 14, 2029v41 Show 2 more changesShow less
    • Primary completion date: Jun 23, 2026 to Dec 16, 2026
    • Completion date: Dec 7, 2028 to Dec 14, 2029
  12. Study sites: 81 to 82v40
  13. Re-verified, no change to tracked fieldsv39
  14. Site details revised at 1 of 81 sitesv38
  15. Study Status, Contacts/Locations, IPDSharingv37
  16. Re-verified, no change to tracked fieldsv36
  17. Study Status, Contacts/Locationsv35
  18. Study sites: 79 to 81v34
  19. 2 versions Re-verified since Oct 25, 2024, no change to tracked fieldsv32-v33
  20. Study sites: 78 to 79v31
  21. Site details revised at 5 of 78 sitesv30
  22. Primary completion date: Jun 23, 2025 to Jun 23, 2026 Study sites: 77 to 78 · Completion date: Dec 7, 2027 to Dec 7, 2028v29 Show 2 more changesShow less
    • Study sites: 77 to 78
    • Completion date: Dec 7, 2027 to Dec 7, 2028
  23. Study sites: 76 to 77v28
  24. Study sites: 74 to 76v27
  25. Study sites revised (74)v26 See this version in full on ClinicalTrials.gov ↗
  26. Study sites: 72 to 74v25
  27. Study sites: 70 to 72v24
  28. Study sites: 69 to 70v23
  29. Study sites: 65 to 69v22
  30. Study sites: 64 to 65v21
  31. Study sites: 62 to 64v20
  32. Study sites: 60 to 62v19
  33. Site details revised at 1 of 60 sitesv18
  34. Study sites: 58 to 60v17
  35. Study sites: 56 to 58v16
  36. Site details revised at 1 of 56 sitesv15
  37. Study sites: 55 to 56v14
  38. Study sites: 49 to 55v13
  39. Study sites: 45 to 49v12
  40. Study sites: 39 to 45v11
  41. Study sites: 21 to 39v10
  42. Study sites: 15 to 21v9
  43. Study sites: 9 to 15v8
  44. Study sites: 6 to 9v7
  • 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
The purpose of this study is to assess the efficacy, safety, PK, and PD of satralizumab in participants with NMDAR and LGI1 encephalitis.
Trial Details
NCT Number NCT05503264
Lead Sponsor Hoffmann-La Roche
Collaborators: Chugai Pharmaceutical
Conditions NMDAR Autoimmune Encephalitis, LGI1 Autoimmune Encephalitis
Enrollment 122 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov