A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata

Study acronym: Up-AA
StatusRecruiting
PhasePhase 3
SponsorAbbVie
Started

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Record History

The 50 most recent of 136 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Trial sites reduced: 283 → 272 locations
    • Study sites revised (272)
  2. Primary endpoints: details revised at 1 of 2 entries Show 4 more changesShow less
    • Study sites: 283 to 272
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints revised (16)
    • Publications: details revised at 1 of 1 entry
  3. Study sites: 282 to 283v134
  4. Study sites revised (282)v133
  5. Study sites: 281 to 282v132
  6. Study sites: 280 to 281v131
  7. Trial sites expanded: 275 → 280 locationsv130
  8. Trial sites expanded: 271 → 274 locationsv129
  9. Study sites: 271 to 274v128
  10. Study sites: 269 to 271v127
  11. Study sites: 268 to 269v126
  12. Primary and study completion pushed from Jan 2028 to Apr 2030
    • Study sites: 267 to 268
    v125
  13. Study sites revised (267)v124
  14. Study sites revised (267)v123
  15. Study sites revised (267)v122
  16. Study sites revised (267)v121
  17. Site details revised at 1 of 267 sitesv120
  18. Re-verified, no change to tracked fieldsv119
  19. Site details revised at 3 of 267 sitesv118
  20. Site details revised at 1 of 267 sitesv117
  21. Site details revised at 2 of 267 sitesv116
  22. Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 1399 to 1500
    • Study sites revised (267)
    v115
  23. Study sites revised (267)v114
  24. Eligibility criteria expanded, about 25 words
    • Study sites revised (267)
    • Study arms: 17 to 23
    v113
  25. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1500 to confirmed 1399
    • Site details revised at 267 of 267 sites
    v112
  26. Site details revised at 20 of 267 sitesv111
  27. Study sites revised (267)v110
  28. Site details revised at 12 of 267 sitesv109
  29. Site details revised at 13 of 267 sitesv108
  30. Study sites revised (267)v107
  31. Site details revised at 1 of 267 sitesv106
  32. Site details revised at 4 of 267 sitesv105
  33. Site details revised at 1 of 267 sitesv104
  34. Site details revised at 2 of 267 sitesv103
  35. Site details revised at 1 of 267 sitesv102
  36. Study sites revised (267)v101
  37. Study sites: 244 to 267
    • Primary and study completion dates: Jan 3, 2028 to Jan 2028
    v100
  38. Site contacts updated at 1 of 244 sitesv99
  39. Study sites: 239 to 244v98
  40. Site details revised at 25 of 239 sitesv97
  41. Study sites: 228 to 239v96
  42. Study sites: 226 to 228v95
  43. Site details revised at 1 of 226 sitesv94
  44. Study sites: 224 to 226v93
  45. Study sites: 221 to 224v92
  46. Study sites: 220 to 221v91
  47. Study sites: 217 to 220v90
  48. Study sites: 214 to 217v89
  49. Study sites: 213 to 214v88
  50. Study sites: 211 to 213v87
  • 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
Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the head and face, but hair loss can happen on any part of the body. The purpose of this study is to assess how safe, effective, and tolerable upadacitinib is in adolescent and adult participants with severe AA. Upadacitinib is an approved drug being investigated for the treatment of AA. In Study 1 and Study 2 and Study 4 Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. In Study 1 and Study 2 and Study 4 Period B, participants originally randomized to upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will either remain on placebo in Period B, or be randomized in 1 of 2 groups, based off of their Severity of Alopecia Tool (SALT) score. Participants who complete Study 1, Study 2 or Study 4, can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. Around 1500 participants with severe AA will be enrolled in the study at approximately 280 sites worldwide. Participants will receive oral tablets of either upadacitinib or placebo once daily for up to 160 weeks with the potential of being re-randomized into a different treatment group at Weeks 24 and 52. Participants will be followed up for up to 30 days after last study drug dose. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular 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 NCT06012240
Lead Sponsor AbbVie
Conditions
(from sponsor)		 Alopecia Areata
Related terms Alopecia Areata
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov