MinorEnrollment closed, study ongoingShow 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
MinorStudy sites: 127 to 128v123
MinorStudy sites revised (127)v122
MinorStudy sites: 126 to 127v121
MinorStudy sites: 124 to 126v120
Show 2 earlier versionsHide 2 earlier versions
MinorStudy sites: 123 to 124v119
MinorStudy sites: 121 to 123v118
MinorTrial sites expanded: 118 → 121 locations
Site details revised at 1 of 121 sites
v117
MinorStudy sites: 118 to 121v116
MinorSite details revised at 1 of 118 sitesv115
MinorStudy sites: 117 to 118
Start date: Jun 12, 2024 to Jun 14, 2024
v114
MinorRe-verified, no change to tracked fieldsv113
MinorStudy sites: 116 to 117v112
MinorStudy sites: 114 to 116v111
MinorStudy sites: 111 to 114v110
MinorStudy sites: 108 to 111v109
MinorStudy sites: 107 to 108v108
MinorRe-verified, no change to tracked fieldsv107
MinorStudy sites: 106 to 107v106
MinorStudy sites: 105 to 106v105
Minor2 versionsRe-verified since Feb 19, 2026, no change to tracked fieldsv103-v104
MinorStudy sites: 104 to 105v102
MinorSite details revised at 1 of 104 sitesv101
MinorStudy sites: 103 to 104v100
Minor2 versionsRe-verified since Jan 22, 2026, no change to tracked fieldsv98-v99
MinorSite details revised at 1 of 103 sitesv97
MinorStudy sites: 102 to 103v96
MinorRe-verified, no change to tracked fieldsv95
MinorStudy sites: 101 to 102v94
MinorStudy sites: 100 to 101v93
MinorRe-verified, no change to tracked fieldsv92
MinorStudy sites: 99 to 100v91
MinorSite details revised at 1 of 99 sitesv90
MinorStudy sites: 98 to 99v89
MinorStudy sites: 97 to 98v88
MinorRe-verified, no change to tracked fieldsv87
MinorStudy sites: 96 to 97v86
NotableEnrollment target: 300 to 200v85Show 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)
MinorSite details revised at 2 of 96 sitesv84
MinorRe-verified, no change to tracked fieldsv83
MinorSite details revised at 1 of 96 sitesv82
MinorRe-verified, no change to tracked fieldsv81
NotablePrimary completion date: Aug 2025 to Aug 2026
Study sites: 95 to 96
Study completion date: Mar 2026 to Mar 2027
v80
MinorSite details revised at 2 of 95 sitesv79
MinorStudy sites: 94 to 95v78
MinorStudy sites revised (94)v77
MinorSite details revised at 1 of 94 sitesv76
MinorStudy 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.
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.