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A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

Study acronym: POETYK SLE-1
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 71 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Dec 17, 2025 to Oct 19, 2026 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 490 to confirmed 516 · Study sites: 222 to 197 · 2 morev71 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 490 to confirmed 516
    • Study sites: 222 to 197
    • Completion date: Dec 17, 2027 to Nov 13, 2028
    • Secondary endpoints revised (15)

    See this version in full on ClinicalTrials.gov ↗

  2. Site details revised at 3 of 222 sitesv70
  3. Study sites revised (222)v69 See this version in full on ClinicalTrials.gov ↗
  4. Study sites revised (222)v68 See this version in full on ClinicalTrials.gov ↗
  5. Study sites revised (222)v67 See this version in full on ClinicalTrials.gov ↗
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites revised (222)v66 See this version in full on ClinicalTrials.gov ↗
  2. Study sites: 221 to 222v65
  3. Study sites: 215 to 221v64
  4. Study sites: 213 to 215v63
  5. Study sites: 211 to 213v62
  6. Study sites: 210 to 211v61
  7. Study sites revised (210)v60 See this version in full on ClinicalTrials.gov ↗
  8. Study sites revised (210)v59 See this version in full on ClinicalTrials.gov ↗
  9. Study sites revised (210)v58 See this version in full on ClinicalTrials.gov ↗
  10. Study sites: 207 to 210v57
  11. Study sites: 200 to 207v56
  12. Study sites: 199 to 200v55
  13. Study sites revised (199)v54 See this version in full on ClinicalTrials.gov ↗
  14. Study sites revised (199)v53 See this version in full on ClinicalTrials.gov ↗
  15. Study sites revised (199)v52 See this version in full on ClinicalTrials.gov ↗
  16. Study sites: 198 to 199v51
  17. Study sites revised (198)v50 See this version in full on ClinicalTrials.gov ↗
  18. Study sites revised (198)v49 See this version in full on ClinicalTrials.gov ↗
  19. Study sites revised (198)v48 See this version in full on ClinicalTrials.gov ↗
  20. Study sites revised (198)v47 See this version in full on ClinicalTrials.gov ↗
  21. Study sites revised (198)v46 See this version in full on ClinicalTrials.gov ↗
  22. Study sites: 197 to 198v45
  23. Study sites: 196 to 197v44
  24. Study sites revised (196)v43 See this version in full on ClinicalTrials.gov ↗
  25. Study sites: 195 to 196v42
  26. Study sites revised (195)v41 See this version in full on ClinicalTrials.gov ↗
  27. Study sites: 194 to 195v40
  28. Study sites: 193 to 194v39
  29. Study sites: 187 to 193v38
  30. Study sites: 186 to 187v37
  31. Study sites: 185 to 186 Eligibility criteria expanded, about 1 wordv36 Show 1 more changeShow less
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  32. Study sites revised (185)v35 See this version in full on ClinicalTrials.gov ↗
  33. Study sites revised (185)v34 See this version in full on ClinicalTrials.gov ↗
  34. Study sites: 183 to 185v33
  35. Study sites: 182 to 183v32
  36. Study sites: 178 to 182v31
  37. Study sites: 179 to 178v30
  38. Study sites: 187 to 179v29
  39. Study sites: 184 to 187v28
  40. Study sites revised (184)v27 See this version in full on ClinicalTrials.gov ↗
  41. Site details revised at 1 of 184 sitesv26
  42. Site details revised at 1 of 184 sitesv25
  43. Site details revised at 2 of 184 sitesv24
  44. Study sites revised (184)v23 See this version in full on ClinicalTrials.gov ↗
  45. Study sites: 182 to 184v22
  • 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.
The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.
Trial Details
NCT Number NCT05617677
Lead Sponsor Bristol-Myers Squibb
Conditions Systemic Lupus Erythematosus
Enrollment 516 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov