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Secukinumab Open Label Roll-over Extension Protocol

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 63 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Study sites: 168 to 169
  2. Study sites: 167 to 168v62
  3. Study sites: 166 to 167v61
  4. Study sites: 167 to 166v60
  5. Site details revised at 25 of 167 sitesv59
Show 45 earlier versionsHide 45 earlier versions
  1. Enrollment target: 715 to 1000 Site details revised at 66 of 167 sitesv58 Show 1 more changeShow less
    • Site details revised at 66 of 167 sites
  2. Study sites: 166 to 167v57
  3. Study sites revised (166)v56 See this version in full on ClinicalTrials.gov ↗
  4. Study sites: 167 to 166v55
  5. Site details revised at 9 of 167 sitesv54
  6. Study sites: 164 to 167v53
  7. Study sites: 162 to 164v52
  8. Primary completion date: Dec 29, 2027 to Jan 29, 2030 Study sites: 161 to 162 · Completion date: Feb 29, 2028 to Apr 4, 2030v51 Show 2 more changesShow less
    • Study sites: 161 to 162
    • Completion date: Feb 29, 2028 to Apr 4, 2030
  9. Study sites: 160 to 161v50
  10. Study sites: 155 to 160v49
  11. Study sites: 157 to 155 Primary completion date: Nov 30, 2027 to Dec 29, 2027v48 Show 1 more changeShow less
    • Primary completion date: Nov 30, 2027 to Dec 29, 2027
  12. Site details revised at 13 of 157 sitesv47
  13. Study sites revised (157)v46 See this version in full on ClinicalTrials.gov ↗
  14. Study sites: 156 to 157v45
  15. Site details revised at 5 of 156 sitesv44
  16. Study sites: 154 to 156v43
  17. Study sites: 153 to 154v42
  18. Study sites: 152 to 153v41
  19. Study sites: 151 to 152v40
  20. Study sites: 150 to 151v39
  21. Site details revised at 2 of 150 sitesv38
  22. Study sites: 149 to 150v37
  23. Site details revised at 1 of 149 sitesv36
  24. Study sites: 148 to 149v35
  25. Primary completion date: Oct 30, 2026 to Nov 30, 2027 Study sites: 146 to 148 · Completion date: Oct 18, 2027 to Feb 29, 2028v34 Show 2 more changesShow less
    • Study sites: 146 to 148
    • Completion date: Oct 18, 2027 to Feb 29, 2028
  26. Study sites revised (146)v33 See this version in full on ClinicalTrials.gov ↗
  27. Study sites: 145 to 146v32
  28. Site details revised at 2 of 145 sitesv31
  29. Site details revised at 3 of 145 sitesv30
  30. Completion date: May 4, 2027 to Oct 18, 2027 Site details revised at 1 of 145 sitesv29 Show 1 more changeShow less
    • Site details revised at 1 of 145 sites
  31. Completion date: Jan 5, 2027 to May 4, 2027 Site details revised at 2 of 145 sitesv28 Show 1 more changeShow less
    • Site details revised at 2 of 145 sites
  32. Site details revised at 1 of 145 sitesv27
  33. Study sites: 144 to 145v26
  34. Study sites: 143 to 144v25
  35. Study sites: 142 to 143v24
  36. Study sites: 139 to 142v23
  37. Study sites: 138 to 139v22
  38. Study sites: 137 to 138v21
  39. Site details revised at 1 of 137 sitesv20
  40. Study sites: 136 to 137v19
  41. Site details revised at 2 of 136 sitesv18
  42. Study sites: 135 to 136v17
  43. Site details revised at 1 of 135 sitesv16
  44. Study sites: 134 to 135v15
  45. Study sites: 133 to 134v14
  • 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
The purpose of this study is to assess long term safety in participants who have completed a Novartis trial with secukinumab, have been judged by the investigator to benefit from continued treatment with secukinumab, and are unable to obtain the marketed secukinumab formulation.
Trial Details
NCT Number NCT04638647
Lead Sponsor Novartis Pharmaceuticals
Conditions Autoimmunity, Inflammation
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov