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A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS)

Study acronym: SKYPS
StatusRecruiting
PhasePhase 2
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 82 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 32 → 37 locations
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 4 of 11 entries
  2. Study sites: 31 to 32v81
  3. Primary completion pushed from Apr 1, 2026 to Mar 1, 2028
    • Study completion pushed from Feb 19, 2029 to Jan 17, 2031
    • Site details revised at 2 of 31 sites
    v80
  4. Study sites: 29 to 31v79
  5. Study sites: 28 to 29v78
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 30 to 28v77
  2. Study sites: 29 to 30v76
  3. Study sites: 27 to 29v75
  4. Enrollment target: 72 to 51v74
  5. Study sites: 28 to 27v73
  6. Site details revised at 11 of 28 sitesv72
  7. Site details revised at 1 of 28 sitesv71
  8. Study sites: 29 to 28v70
  9. Site details revised at 1 of 29 sitesv69
  10. Primary completion date: Nov 29, 2024 to Apr 1, 2026
    • Study completion date: Apr 2027 to Feb 19, 2029
    v68
  11. Site details revised at 1 of 29 sitesv67
  12. Site details revised at 1 of 29 sitesv66
  13. Study sites: 30 to 29v65
  14. Primary completion date: Jan 2023 to Nov 29, 2024v64
  15. Re-verified, no change to tracked fieldsv63
  16. Site details revised at 1 of 30 sitesv62
  17. Site details revised at 1 of 30 sitesv61
  18. Site details revised at 1 of 30 sitesv60
  19. Site details revised at 3 of 30 sitesv59
  20. Site details revised at 2 of 30 sitesv58
  21. Study sites: 29 to 30v57
  22. Study sites: 28 to 29v56
  23. 2 versions Re-verified since Nov 3, 2021, no change to tracked fieldsv54-v55
  24. Study sites: 31 to 28v53
  25. Re-verified, no change to tracked fieldsv52
  26. Study sites: 30 to 31v51
  27. Primary completion date: Apr 2022 to Jan 2023
    • Study completion date: Feb 2025 to Apr 2027
    v50
  28. Primary completion date: May 2025 to Apr 2022
    • Study completion date: Apr 2028 to Feb 2025
    v49
  29. Primary completion date: Jun 2022 to May 2025
    • Study completion date: Mar 2025 to Apr 2028
    v48
  30. Study sites: 32 to 30v47
  31. Re-verified, no change to tracked fieldsv46
  32. Study sites: 33 to 32v45
  33. Re-verified, no change to tracked fieldsv44
  34. Study completion date: May 2025 to Mar 2025v43
  35. Study sites: 34 to 33v42
  36. Study sites revised (34)v41
  37. Primary completion date: Oct 2019 to Jun 2022
    • Study completion date: Jan 2024 to May 2025
    v40
  38. Study sites: 35 to 34v39
  39. Study sites: 37 to 35v38
  40. Study completion date: Dec 20, 2023 to Jan 2024v37
  41. Study Identification, Study Statusv36
  42. Re-verified, no change to tracked fieldsv35
  43. Study sites: 38 to 37v34
  44. Study sites: 37 to 38v33
  • 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.
Sanofi
284 trials monitored
See 12 trials at risk
Primary Objective: To describe the pharmacokinetic (PK) profile of sarilumab in patients aged 1-17 years with Systemic Juvenile Idiopathic Arthritis (sJIA) in order to identify the dose and regimen for adequate treatment of this population. Secondary Objective: To describe the pharmacodynamics (PD) profile, the efficacy, and the long term safety of sarilumab in patients with sJIA.
Trial Details
NCT Number NCT02991469
Lead Sponsor Sanofi
Collaborators: Regeneron Pharmaceuticals
Conditions
(from sponsor)		 Juvenile Idiopathic Arthritis
Related terms Arthritis, Juvenile
Enrollment 51 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov