Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease

Study acronym: U-EMPOWER
StatusActive, Not Recruiting
PhasePhase 3
SponsorAbbVie
Started

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Trial flagged as At Risk
Primary completion moved at least 3 years 6 months later Jun 2027 → Jan 2031
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Record History

The 50 most recent of 70 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jun 2027 to Jan 2031 Show 7 more changesShow less
    • Primary endpoints: details revised at 1 of 3 entries
    • Enrollment closed, study ongoing
    • Study completion moved earlier from Dec 2034 to Jan 2031
    • Enrollment target: estimated 110 to confirmed 111
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 4 of 7 entries
    • Study sites revised (85)
  2. Study sites revised (85)v69
  3. Site details revised at 1 of 85 sitesv68
  4. Study sites: 84 to 85v67
  5. Study sites: 83 to 84v66
  6. Primary completion moved earlier from Feb 2031 to Jun 2027v65
  7. Primary completion pushed from Jun 2027 to Feb 2031
    • Start date: Jul 26, 2024 to Aug 8, 2024
    • Eligibility criteria expanded, about 14 words
    v64
  8. Site details revised at 1 of 83 sitesv63
  9. Study sites: 81 to 83v62
  10. Eligibility criteria expanded, about 3 wordsv61
  11. Study sites: 80 to 81v60
  12. Study sites revised (80)v59
  13. Study sites: 79 to 80v58
  14. Study sites: 78 to 79v57
  15. Study sites: 77 to 78v56
  16. Study sites: 75 to 77v55
  17. Re-verified, no change to tracked fieldsv54
  18. Study sites revised (75)v53
  19. Study sites: 74 to 75v52
  20. Re-verified, no change to tracked fieldsv51
  21. Study sites: 73 to 74v50
  22. Study sites: 72 to 73v49
  23. Study sites: 71 to 72v48
  24. Study sites: 70 to 71v47
  25. Study sites: 68 to 70v46
  26. Study sites: 65 to 68v45
  27. Study sites: 64 to 65v44
  28. Study sites: 63 to 64v43
  29. Study sites: 62 to 63v42
  30. Study sites: 60 to 62v41
  31. Study sites: 59 to 60v40
  32. Study sites: 58 to 59v39
  33. Study sites: 55 to 58v38
  34. Study sites: 54 to 55v37
  35. Re-verified, no change to tracked fieldsv36
  36. Study sites: 53 to 54v35
  37. Study sites: 52 to 53v34
  38. Study sites: 51 to 52v33
  39. Study sites: 50 to 51v32
  40. Study sites: 48 to 50v31
  41. Study sites: 47 to 48v30
  42. Study sites: 44 to 47v29
  43. Study sites: 43 to 44v28
  44. Study sites revised (43)v27
  45. Study sites: 42 to 43
    • Primary completion date: Jun 15, 2027 to Jun 2027
    • Study completion date: Dec 20, 2034 to Dec 2034
    v26
  46. Study sites: 40 to 42v25
  47. Study sites: 39 to 40v24
  48. Re-verified, no change to tracked fieldsv23
  49. Study sites: 38 to 39v22
  50. Study sites: 37 to 38v21
  • 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.
AbbVie
349 trials monitored
See 27 trials at risk
Crohn's Disease
643 trials monitored
See 36 trials at risk
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective oral Upadacitinib is in treating moderately to severely active Crohn's Disease in pediatric participants aged 2 to 18 years old who have had inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy. Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active CD and is being developed for moderate- to severely active CD in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: a 12-week open-label induction phase which means that the study doctor and participants know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 52-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given (UPA Dose B or Dose C). Period 2 is a 156-week open-label extension of Period 1. Approximately 110 pediatric participants with moderate to severely active CD will be enrolled at approximately 92 sites worldwide. Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will have a safety follow up for 30 days after discontinuation from any time point within the study. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Trial Details
NCT Number NCT06332534
Lead Sponsor AbbVie
Conditions
(from sponsor)		 Crohn's Disease
Related terms Crohn Disease
Enrollment 111 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov