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POETYK SjS-1NCT05946941

A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome

StatusActive, Not Recruiting
PhasePhase 3
Primary completion (estimated)
Track this trial

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Record History

The 50 most recent of 69 versions: 49 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 756 to confirmed 774
    • Study sites: 229 to 199
    v68
  2. Site details revised at 3 of 229 sitesv67
  3. Site details revised at 4 of 229 sitesv66
  4. Site details revised at 6 of 229 sitesv65
  5. Site details revised at 1 of 229 sitesv64
Show 44 earlier versionsHide 44 earlier versions
  1. Site details revised at 2 of 229 sitesv63
  2. Study sites revised (229)v62
  3. Study sites revised (229)v61
  4. Study sites revised (229)v60
  5. Study sites revised (229)v59
  6. Study sites revised (229)v58
  7. Study sites revised (229)v57
  8. Study sites revised (229)v56
  9. Study sites revised (229)v55
  10. Study sites revised (229)v54
  11. Study sites revised (229)v53
  12. Study sites revised (229)v52
  13. Study sites: 228 to 229v51
  14. Study sites: 226 to 228v50
  15. Study sites: 225 to 226v49
  16. Study sites: 223 to 225v48
  17. Eligibility criteria expanded, about 10 words
    • Secondary endpoints: 18 to 19
    • Study sites revised (223)
    v47
  18. Study sites revised (223)v46
  19. Study sites revised (223)v45
  20. Study sites revised (223)v44
  21. Study sites revised (223)v43
  22. Study sites revised (223)v42
  23. Study sites revised (223)v41
  24. Study sites: 222 to 223v40
  25. Study sites revised (222)v39
  26. Study sites revised (222)v38
  27. Study sites revised (222)v37
  28. Study sites: 221 to 222v36
  29. Study sites revised (221)v35
  30. Study sites revised (221)v34
  31. Study sites revised (221)v33
  32. Study sites revised (221)v32
  33. Study sites revised (221)v31
  34. Study sites revised (221)v30
  35. Study sites revised (221)v29
  36. Study sites revised (221)v28
  37. Study sites revised (221)v27
  38. Study sites revised (221)v26
  39. Study sites revised (221)v25
  40. Study sites: 218 to 221v24
  41. Study sites: 82 to 218v23
  42. Study sites: 78 to 82v22
  43. Study sites: 76 to 78v21
  44. Study sites: 72 to 76v20
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52
Timeframe: Baseline, Week 52

Secondary (19)

Change from baseline in European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Week 52
Number of participants with decrease in ESSPRI ≥ 1 or 15% from baseline at Week 52
Number of participants with decrease in ESSDAI ≥ 3 points from baseline at Week 52
Number of participants with ESSDAI < 5 at Week 52
Change from baseline in ESSDAI at Week 24
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Change from baseline in stimulated whole salivary flow (SWSF) at Week 52
Change from baseline in physician global assessment (PhGA) at Week 52
Change from baseline in functional assessment of chronic illness therapy (FACIT)-fatigue at Week 52
Change from baseline in ocular dryness numeric rating scale (NRS) at Week 52
Change from baseline in oral dryness NRS at Week 52
Change from baseline in joint/ muscle pain NRS at Week 52
Number of participants with an increase of Schirmer's test ≥ 5 mm if abnormal baseline or no change of Schirmer's test to abnormal if baseline is normal
Number of participants with adverse events (AEs)
Number of participants with serious AEs (SAEs)
Number of participants with AEs leading to discontinuation of treatment and study discontinuation
Number of participants with AEs of special interest (AESIs)
Number of participants with clinical laboratory abnormalities
Number of participants with electrocardiogram (ECG) abnormalities
Number of participants with vital sign abnormalities

Arms and interventions

Deucravacitinib, Dose 1Experimental
Deucravacitinib, Dose 2Experimental
Placebo, followed by Deucravacitinib Dose 1 or Dose 2Placebo comparator

Drugs: Deucravacitinib

Other: Placebo

Sites

199 sites in 33 countries

China 28, United States 28, Japan 26, Poland 12, Argentina 8, France 8, Brazil 6, Chile 6, Germany 6, Italy 6, Spain 6, Taiwan 5, Canada 4, Mexico 4, South Korea 4, Turkey (Türkiye) 4, United Kingdom 4, Colombia 3, Finland 3, Peru 3, Romania 3, Austria 2, Bulgaria 2, Greece 2, Hungary 2, Israel 2, Netherlands 2, Portugal 2, Puerto Rico 2, Sweden 2, Switzerland 2, Australia 1, Belgium 1