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Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 58 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC Completion pushed from Jul 11, 2028 to Nov 27, 2028 · Eligibility criteria expanded, about 12 words · Secondary endpoints: details revised at 9 of 29 entries · 1 more Show 4 more changesShow less
    • Completion pushed from Jul 11, 2028 to Nov 27, 2028
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 9 of 29 entries
    • Site details revised at 5 of 120 sites
  2. Study sites: 119 to 120v57
  3. Completion moved earlier from Jun 18, 2029 to Jul 11, 2028 Study sites: 118 to 119v56 Show 1 more changeShow less
    • Study sites: 118 to 119
  4. Trial sites expanded: 115 → 118 locationsv55
  5. Study sites: 113 to 115v54
  6. Trial sites expanded: 108 → 113 locationsv53
  7. Trial sites expanded: 103 → 108 locations Completion pushed from Jul 11, 2028 to Jun 18, 2029v52 Show 1 more changeShow less
    • Completion pushed from Jul 11, 2028 to Jun 18, 2029
  8. Re-verified, no change to tracked fieldsv51
  9. Completion date: Sep 30, 2028 to Jul 11, 2028v50
  10. Study sites: 99 to 103v49
  11. Study sites: 97 to 99v48
  12. Study sites: 95 to 97v47
  13. Site details revised at 1 of 95 sitesv46
  14. Study sites: 94 to 95v45
  15. Study sites: 92 to 94v44
  16. Study sites: 90 to 92v43
  17. Study sites: 89 to 90v42
  18. Study sites: 88 to 89v41
  19. Study sites: 83 to 88v40
  20. Study sites: 80 to 83v39
  21. Re-verified, no change to tracked fieldsv38
  22. Study sites: 78 to 80 Eligibility criteria expanded, about 28 wordsv37 Show 1 more changeShow less
    • Eligibility criteria expanded, about 28 words

    See this version in full on ClinicalTrials.gov ↗

  23. Study sites: 77 to 78v36
  24. Re-verified, no change to tracked fieldsv35
  25. Study sites: 73 to 77v34
  26. Re-verified, no change to tracked fieldsv33
  27. Study sites: 72 to 73v32
  28. Site details revised at 2 of 72 sitesv31
  29. Study sites: 71 to 72v30
  30. Study sites: 70 to 71v29
  31. Study sites: 66 to 70v28
  32. Study sites: 62 to 66v27
  33. Study sites: 61 to 62v26
  34. Study sites: 57 to 61v25
  35. Study sites: 50 to 57v24
  36. Study sites: 49 to 50v23
  37. Enrollment target: 300 to 201 Study sites: 43 to 49v22 Show 1 more changeShow less
    • Study sites: 43 to 49
  38. Study sites: 40 to 43v21
  39. Study sites: 37 to 40v20
  40. Study sites: 32 to 37v19
  41. Study sites: 31 to 32v18
  42. Study sites: 29 to 31v17
  43. Study sites: 25 to 29v16
  44. Primary completion date: May 11, 2026 to May 14, 2027 Study sites: 23 to 25v15 Show 1 more changeShow less
    • Study sites: 23 to 25
  45. Study sites: 20 to 23v14
  46. Re-verified, no change to tracked fieldsv13
  47. Study sites: 130 to 20v12
  48. Re-verified, no change to tracked fieldsv11
  49. Study sites: 136 to 130v10
  50. Site details revised at 4 of 136 sitesv9
  • 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 main purpose of this study is to evaluate the safety and efficacy of nipocalimab compared to placebo in delaying relapse in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) who initially respond to nipocalimab in Stage A.
Trial Details
NCT Number NCT05327114
Lead Sponsor Janssen Research & Development, LLC
Conditions Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Enrollment 201 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov