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A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State

StatusActive, Not Recruiting
PhasePhase 3
SponsorAmgen
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 435 to confirmed 434 · Study sites: 209 to 194 · Primary completion date: Sep 2, 2026 to Oct 22, 2026 · 1 morev50 Show 4 more changesShow less
    • Enrollment target: estimated 435 to confirmed 434
    • Study sites: 209 to 194
    • Primary completion date: Sep 2, 2026 to Oct 22, 2026
    • Completion date: Nov 3, 2026 to Dec 17, 2026
  2. Study sites: 207 to 209v49
  3. Study sites revised (207)v48 See this version in full on ClinicalTrials.gov ↗
  4. Study sites: 205 to 207v47
  5. Study sites: 204 to 205v46
Show 44 earlier versionsHide 44 earlier versions
  1. Study sites: 203 to 204v45
  2. Study sites revised (203)v44 See this version in full on ClinicalTrials.gov ↗
  3. Study sites revised (203)v43 See this version in full on ClinicalTrials.gov ↗
  4. Study sites: 202 to 203v42
  5. Study sites: 199 to 202v41
  6. Study sites: 196 to 199 Primary completion date: Nov 3, 2026 to Sep 2, 2026v40 Show 1 more changeShow less
    • Primary completion date: Nov 3, 2026 to Sep 2, 2026
  7. Study sites: 197 to 196 Primary and study completion dates: Aug 3, 2026 to Nov 3, 2026v39 Show 1 more changeShow less
    • Primary and study completion dates: Aug 3, 2026 to Nov 3, 2026
  8. Re-verified, no change to tracked fieldsv38
  9. Study sites: 196 to 197v37
  10. Study sites: 194 to 196v36
  11. Study sites: 193 to 194v35
  12. Study sites: 191 to 193v34
  13. Re-verified, no change to tracked fieldsv33
  14. Study sites: 186 to 191v32
  15. Study sites: 184 to 186 Eligibility criteria expanded, about 393 wordsv31 Show 1 more changeShow less
    • Eligibility criteria expanded, about 393 words

    See this version in full on ClinicalTrials.gov ↗

  16. Study sites: 183 to 184 Eligibility criteria shortened, about 393 wordsv30 Show 1 more changeShow less
    • Eligibility criteria shortened, about 393 words

    See this version in full on ClinicalTrials.gov ↗

  17. Study sites: 182 to 183 Eligibility criteria expanded, about 393 wordsv29 Show 1 more changeShow less
    • Eligibility criteria expanded, about 393 words

    See this version in full on ClinicalTrials.gov ↗

  18. Study sites: 175 to 182 Eligibility criteria shortened, about 393 wordsv28 Show 1 more changeShow less
    • Eligibility criteria shortened, about 393 words

    See this version in full on ClinicalTrials.gov ↗

  19. Eligibility criteria expanded, about 393 wordsv27 See this version in full on ClinicalTrials.gov ↗
  20. Study sites: 169 to 175 Primary and study completion dates: Jul 27, 2026 to Aug 3, 2026 · Eligibility criteria shortened, about 393 wordsv26 Show 2 more changesShow less
    • Primary and study completion dates: Jul 27, 2026 to Aug 3, 2026
    • Eligibility criteria shortened, about 393 words

    See this version in full on ClinicalTrials.gov ↗

  21. Study sites: 130 to 169 Primary and study completion dates: May 1, 2026 to Jul 27, 2026 · Start date: Mar 11, 2024 to Apr 8, 2024v25 Show 2 more changesShow less
    • Primary and study completion dates: May 1, 2026 to Jul 27, 2026
    • Start date: Mar 11, 2024 to Apr 8, 2024
  22. Study sites: 116 to 130v24
  23. Study sites: 93 to 116v23
  24. Study sites: 86 to 93v22
  25. Study sites: 79 to 86v21
  26. Study sites: 76 to 79v20
  27. Study sites: 70 to 76v19
  28. Study sites: 69 to 70v18
  29. Study sites: 66 to 69v17
  30. Study sites: 55 to 66v16
  31. Study sites: 47 to 55v15
  32. Study sites: 27 to 47v14
  33. Site details revised at 1 of 27 sitesv13
  34. Study sites: 31 to 27v12
  35. Study sites: 24 to 31v11
  36. Study sites: 22 to 24v10
  37. Site details revised at 2 of 22 sitesv9
  38. Study sites: 19 to 22v8
  39. Study sites: 16 to 19v7
  40. Study sites: 15 to 16v6
  41. Study sites: 6 to 15 Primary completion date: Mar 2026 to May 1, 2026 · Completion date: May 2026 to May 1, 2026v5 Show 2 more changesShow less
    • Primary completion date: Mar 2026 to May 1, 2026
    • Completion date: May 2026 to May 1, 2026
  42. Lead sponsor: Horizon Pharma Ireland, Ltd., Dublin Ireland to Amgen Study description expanded, about 5 wordsv4 Show 1 more changeShow less
    • Study description expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  43. Study sites: 4 to 6v3
  44. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 4 · Start date changed from estimate of Feb 2024 to Mar 11, 2024v2 Show 2 more changesShow less
    • Study sites: 0 to 4
    • Start date changed from estimate of Feb 2024 to Mar 11, 2024
  1. Study First Submitted
  • 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.
Amgen
168 trials monitored
See 11 trials at risk
Primary Objective: To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state Secondary Objectives: 1. To evaluate the effect of dazodalibep on patient-reported outcomes (PROs) in participants with SS. 2. To evaluate the effect of dazodalibep on measures of systemic activity, PROs, and salivary flow in participants with SS 3. To evaluate the safety and tolerability of multiple doses of dazodalibep in participants with SS
Trial Details
NCT Number NCT06245408
Lead Sponsor Amgen
Conditions Sjögren's Syndrome (SS)
Enrollment 434 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov