A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

StatusActive, Not Recruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary completion moved at least 35 days later Sep 5, 2024 → Oct 10, 2024
See other at-risk trials from Bristol-Myers Squibb

Record History

The 50 most recent of 73 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Sep 5, 2024 to Oct 10, 2024
  2. Study completion date: Jun 10, 2027 to Jun 3, 2027
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 58 of 58 entries
  3. Site details revised at 1 of 183 sitesv71
  4. Results first posted: Oct 24, 2025
    • Secondary endpoints: details revised at 2 of 58 entries
    v70
  5. Secondary endpoints: 56 to 58v69
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 186 to 183v68
  2. Enrollment target: estimated 650 to confirmed 670
    • Primary completion date changed from estimate of Sep 3, 2024 to Sep 5, 2024
    • Study completion date: May 12, 2027 to Jun 10, 2027
    v67
  3. Study sites: 187 to 186v66
  4. Study sites: 186 to 187v65
  5. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 200 to 186
    v64
  6. Study sites: 199 to 200v63
  7. Study sites revised (199)v62
  8. Study sites: 195 to 199v61
  9. Study sites: 194 to 195
    • Eligibility criteria revised
    v60
  10. Study sites: 193 to 194v59
  11. Study sites revised (193)v58
  12. Study sites: 192 to 193v57
  13. Study sites revised (192)v56
  14. Study sites: 190 to 192v55
  15. Site details revised at 1 of 190 sitesv54
  16. Study sites revised (190)v53
  17. Study sites: 180 to 190v52
  18. Site details revised at 1 of 180 sitesv51
  19. Study sites: 177 to 180v50
  20. Study sites: 173 to 177v49
  21. Study sites: 171 to 173v48
  22. Study sites: 170 to 171v47
  23. Study sites: 167 to 170v46
  24. Study sites: 158 to 167v45
  25. Study sites: 157 to 158v44
  26. Study sites: 151 to 157v43
  27. Study sites revised (151)v42
  28. Site details revised at 1 of 151 sitesv41
  29. Study sites revised (151)v40
  30. Primary completion date: Jan 16, 2024 to Sep 3, 2024
    • Study sites: 144 to 151
    • Study completion date: Oct 13, 2026 to May 12, 2027
    v39
  31. Study sites: 143 to 144v38
  32. Study sites: 137 to 143v37
  33. Study sites: 133 to 137v36
  34. Study sites: 131 to 133v35
  35. Study sites: 128 to 131v34
  36. Study sites: 124 to 128v33
  37. Study sites: 123 to 124v32
  38. Study sites: 122 to 123v31
  39. Study sites revised (122)v30
  40. Study sites: 121 to 122v29
  41. Site details revised at 11 of 121 sitesv28
  42. Study sites revised (121)v27
  43. Study sites revised (121)v26
  44. Study sites: 122 to 121v25
  45. Study sites revised (122)v24
  • 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 efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheumatic drugs. The long term extension period will provide additional long-term efficacy and safety information.
Trial Details
NCT Number NCT04908202
Lead Sponsor Bristol-Myers Squibb
Conditions
(from sponsor)		 Psoriatic Arthritis
Related terms Arthritis, Psoriatic, Joint Diseases
Enrollment 670 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov