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Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).

Study acronym: SIRIUS-SLE LTE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 years 11 months later Apr 8, 2030 → Apr 3, 2034
See other at-risk trials from Novartis

Record History

  1. Primary completion pushed from Apr 8, 2030 to Apr 3, 2034 Primary endpoints: details revised at 1 of 1 entry · Trial sites expanded: 143 → 162 locations · Completion pushed from Apr 5, 2032 to Oct 2, 2034 · 3 more Show 6 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Trial sites expanded: 143 → 162 locations
    • Completion pushed from Apr 5, 2032 to Oct 2, 2034
    • Eligibility criteria shortened, about 65 words
    • Secondary endpoints: 4 to 7
    • Study description expanded, about 67 words
  2. Trial sites expanded: 127 → 143 locationsv32
  3. Study sites: 113 to 127 Primary completion date: Apr 19, 2030 to Apr 8, 2030 · Completion date: Apr 16, 2032 to Apr 5, 2032v31 Show 2 more changesShow less
    • Primary completion date: Apr 19, 2030 to Apr 8, 2030
    • Completion date: Apr 16, 2032 to Apr 5, 2032
  4. Study sites: 109 to 113v30
  5. Study sites: 103 to 109v29
Show 27 earlier versionsHide 27 earlier versions
  1. Study sites: 100 to 103v28
  2. Study sites: 79 to 100v27
  3. Study sites: 71 to 79 Primary completion date: Dec 25, 2029 to Apr 19, 2030 · Completion date: Dec 23, 2031 to Apr 16, 2032v26 Show 2 more changesShow less
    • Primary completion date: Dec 25, 2029 to Apr 19, 2030
    • Completion date: Dec 23, 2031 to Apr 16, 2032
  4. Study sites: 70 to 71v25
  5. Study sites: 62 to 70v24
  6. Study sites: 48 to 62v23
  7. Study sites: 42 to 48v22
  8. Study sites: 35 to 42v21
  9. Study sites: 22 to 35v20
  10. Study sites: 21 to 22v19
  11. Study sites: 18 to 21v18
  12. Study sites: 17 to 18v17
  13. Study sites: 15 to 17v16
  14. Study sites: 14 to 15v15
  15. Study sites: 12 to 14v14
  16. Study sites: 11 to 12v13
  17. Study sites: 10 to 11v12
  18. Re-verified, no change to tracked fieldsv11
  19. Study sites: 8 to 10v10
  20. Study sites: 7 to 8v9
  21. Study sites: 5 to 7v8
  22. Study sites: 4 to 5v7
  23. Study sites: 3 to 4v6
  24. Study sites: 1 to 3v5
  25. Study sites: 2 to 1v4
  26. Study sites: 1 to 2v3
  27. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Dec 9, 2031 to Dec 25, 2029 · Study sites: 0 to 1 · Completion date: Dec 9, 2031 to Dec 23, 2031 · 1 morev2 Show 4 more changesShow less
    • Primary completion date: Dec 9, 2031 to Dec 25, 2029
    • Study sites: 0 to 1
    • Completion date: Dec 9, 2031 to Dec 23, 2031
    • Start date: May 17, 2024 to May 21, 2024
  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.
Novartis
555 trials monitored
See 31 trials at risk
Lupus (SLE)
651 trials monitored
See 25 trials at risk
The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).
Trial Details
NCT Number NCT06133972
Lead Sponsor Novartis Pharmaceuticals
Conditions Systemic Lupus Erythematosus
Enrollment 550 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov