A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab

Study acronym: Switch-Up
StatusActive, Not Recruiting
PhasePhase 3
SponsorAbbVie
Started

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Trial flagged as At Risk
Primary completion moved at least 2 months later Aug 2026 → Nov 2026
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Record History

The 50 most recent of 124 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Enrollment closed, study ongoing Show 6 more changesShow less
    • Primary completion pushed from Aug 2026 to Nov 2026
    • Study completion pushed from Mar 2027 to May 2027
    • Enrollment target: estimated 200 to confirmed 184
    • Study sites: 128 to 129
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: details revised at 3 of 3 entries
  2. Minor Study sites: 127 to 128v123
  3. Minor Study sites revised (127)v122
  4. Minor Study sites: 126 to 127v121
  5. Minor Study sites: 124 to 126v120
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  1. Minor Study sites: 123 to 124v119
  2. Minor Study sites: 121 to 123v118
  1. Minor Trial sites expanded: 118 → 121 locations
    • Site details revised at 1 of 121 sites
    v117
  2. Minor Study sites: 118 to 121v116
  3. Minor Site details revised at 1 of 118 sitesv115
  4. Minor Study sites: 117 to 118
    • Start date: Jun 12, 2024 to Jun 14, 2024
    v114
  5. Minor Re-verified, no change to tracked fieldsv113
  6. Minor Study sites: 116 to 117v112
  7. Minor Study sites: 114 to 116v111
  8. Minor Study sites: 111 to 114v110
  9. Minor Study sites: 108 to 111v109
  10. Minor Study sites: 107 to 108v108
  11. Minor Re-verified, no change to tracked fieldsv107
  12. Minor Study sites: 106 to 107v106
  13. Minor Study sites: 105 to 106v105
  14. Minor 2 versions Re-verified since Feb 19, 2026, no change to tracked fieldsv103-v104
  15. Minor Study sites: 104 to 105v102
  16. Minor Site details revised at 1 of 104 sitesv101
  17. Minor Study sites: 103 to 104v100
  18. Minor 2 versions Re-verified since Jan 22, 2026, no change to tracked fieldsv98-v99
  19. Minor Site details revised at 1 of 103 sitesv97
  20. Minor Study sites: 102 to 103v96
  21. Minor Re-verified, no change to tracked fieldsv95
  22. Minor Study sites: 101 to 102v94
  23. Minor Study sites: 100 to 101v93
  24. Minor Re-verified, no change to tracked fieldsv92
  25. Minor Study sites: 99 to 100v91
  26. Minor Site details revised at 1 of 99 sitesv90
  27. Minor Study sites: 98 to 99v89
  28. Minor Study sites: 97 to 98v88
  29. Minor Re-verified, no change to tracked fieldsv87
  30. Minor Study sites: 96 to 97v86
  31. Notable Enrollment target: 300 to 200v85 Show 4 more changesShow less
    • Primary endpoint revised
    • Interventions: Dupilumab Dose A (Drug), Upadacitinib Dose A (Drug), Upadacitinib Dose B (Drug) to Dupilumab 300mg Dose (Drug), Upadacitinib 15mg Dose (Drug), Upadacitinib 30mg Dose (Drug)
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoints revised (3)
  32. Minor Site details revised at 2 of 96 sitesv84
  33. Minor Re-verified, no change to tracked fieldsv83
  34. Minor Site details revised at 1 of 96 sitesv82
  35. Minor Re-verified, no change to tracked fieldsv81
  36. Notable Primary completion date: Aug 2025 to Aug 2026
    • Study sites: 95 to 96
    • Study completion date: Mar 2026 to Mar 2027
    v80
  37. Minor Site details revised at 2 of 95 sitesv79
  38. Minor Study sites: 94 to 95v78
  39. Minor Study sites revised (94)v77
  40. Minor Site details revised at 1 of 94 sitesv76
  41. Minor Study sites: 93 to 94v75
  • 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.
349 trials monitored
See 27 trials at risk
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study aims to provide data on the efficacy and safety of upadacitinib at different doses in adult participants with moderate to severe AD. Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis (AD). This study is conducted in 2 periods. During Period 1, participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib 15mg or dupilumab 300mg. Based on the participants response to upadacitinib 15mg, they may have their dose increased to upadacitinib 30mg after 2 weeks. In Period 2, participants that completed Period 1 will either remain on their assigned dose or be reassigned to a different dose based on their Eczema Area and Severity Index (EASI) response. Approximately 200 adult participants ages 18 to less than 64 with moderate to severe AD who are current users of dupilumab and had a history of inadequate response to dupilumab will be enrolled at up to 130 sites worldwide. The study is comprised of a 35-day Screening Period, an 8-week Open-Label Period 1 and a 24-week Open-Label Period 2 for participants that completed Period 1. Participants will receive upadacitinib oral tablets once daily or dupilumab subcutaneous (SC) injection every other week for 32 weeks and followed for 30 days. 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 NCT06389136
Lead Sponsor AbbVie
Conditions
(from sponsor)
Atopic Dermatitis
Related terms Dermatitis, Atopic
Enrollment 184 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov