A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)

Study acronym: UNIFI Jr
StatusCompleted
PhasePhase 3
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 66 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Results posted: Oct 20, 2026 Show 5 more changesShow less
    • Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC
    • Primary endpoints revised (9)
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: 14 to 13
    • Site details revised at 7 of 58 sites
  2. Re-verified, no change to tracked fieldsv65
  3. Trial status: Active, Not Recruiting to Completed
    • Primary completion date changed from estimate of Jul 24, 2025 to May 8, 2025
    • Study completion date changed from estimate of Nov 7, 2025 to Jun 5, 2025
    v64
  4. 6 versions Re-verified since Feb 7, 2025, no change to tracked fieldsv58-v63
  5. Study sites revised (58)v57
Show 40 earlier versionsHide 40 earlier versions
  1. Enrollment target: 113 to 112v56
  2. 2 versions Re-verified since Dec 4, 2024, no change to tracked fieldsv54-v55
  3. Study sites revised (58)v53
  4. 3 versions Re-verified since Aug 14, 2024, no change to tracked fieldsv50-v52
  5. Study sites revised (58)v49
  6. Site details revised at 1 of 58 sitesv48
  7. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 110 to confirmed 113
    • Site details revised at 58 of 58 sites
    v47
  8. Study sites revised (58)v46
  9. Study sites revised (58)v45
  10. Enrollment target: 100 to 110
    • Study sites revised (58)
    v44
  11. Study sites: 57 to 58v43
  12. 2 versions Re-verified since Dec 5, 2023, no change to tracked fieldsv41-v42
  13. Study completion date: Jul 25, 2025 to Nov 7, 2025
    • Site details revised at 1 of 57 sites
    v40
  14. Re-verified, no change to tracked fieldsv39
  15. Study sites: 56 to 57v38
  16. Study sites: 54 to 56v37
  17. Study sites: 52 to 54v36
  18. Study sites: 50 to 52v35
  19. Site details revised at 1 of 50 sitesv34
  20. Re-verified, no change to tracked fieldsv33
  21. Study sites: 49 to 50v32
  22. Study sites: 69 to 49v31
  23. 2 versions Re-verified since Jan 31, 2023, no change to tracked fieldsv29-v30
  24. Study sites: 63 to 69
    • Study completion date: Jul 24, 2025 to Jul 25, 2025
    v28
  25. Study sites revised (63)v27
  26. Re-verified, no change to tracked fieldsv26
  27. Site details revised at 2 of 63 sitesv25
  28. Study sites: 61 to 63v24
  29. Site details revised at 5 of 61 sitesv23
  30. Site details revised at 7 of 61 sitesv22
  31. Enrollment target: 90 to 100
    • Study sites: 60 to 61
    • Secondary endpoints: 11 to 14
    • Eligibility criteria shortened, about 1 word
    v21
  32. Study sites: 61 to 60v20
  33. Study sites: 59 to 61v19
  34. Re-verified, no change to tracked fieldsv18
  35. Site details revised at 2 of 59 sitesv17
  • 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: a) the efficacy of ustekinumab dosing in inducing clinical remission, b) safety profile of ustekinumab, and c) ustekinumab exposure (pharmacokinetics \[PK\]) in pediatric participants with moderately to severely active UC.
Trial Details
NCT Number NCT04630028
Lead Sponsor Janssen Research & Development, LLC
Conditions
(from sponsor)		 Colitis, Ulcerative
Related terms Colitis, Ulcerative
Enrollment 112 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov