A Phase 3 interventional study of Upadacitinib 15mg Dose and Dupilumab 300mg Dose in Atopic Dermatitis, sponsored by AbbVie. Recruiting at 128 sites in 9 countries. Open to participants aged 18 Years to 63 Years. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's planned enrollment of 200 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participant meets all the following disease activity criteria at Baseline Visit:
Exclusion Criteria:
Meeting any of the following conditions at Baseline:
At Baseline any of the following medical diseases or disorders:
Participants randomly assigned to receive Upadacitinib 15mg tablet once per day. Based on clinical response, participants randomized to Upadacitinib 15mg may have their dose increased to Upadacitinib 30mg starting at Week 2.
Drug: Upadacitinib 15mg Dose · Drug: Upadacitinib 30mg Dose
Participants randomly assigned to receive Dupilumab 300mg SC injection once every other week for 8 weeks.
Drug: Dupilumab 300mg Dose
Participants that were receiving Upadacitinib 15mg or 30mg and completed Period 1, will be allocated or continue to receive oral doses of Upadacitinib 30mg in Period 2 with a clinical response of \< EASI 75 at Week 8
Drug: Upadacitinib 30mg Dose
Participants that were receiving Upadacitinib 15mg or 30mg and completed Period 1, will continue to receive the same oral doses of Upadacitinib in Period 2 with a clinical response of ≥ EASI 75 at Week 8
Drug: Upadacitinib 15mg Dose · Drug: Upadacitinib 30mg Dose
Participants that were receiving Dupilumab 300mg and completed Period 1, will continue to receive Dupilumab 300mg SC injection in Period 2 with a clinical response of ≥ EASI 75 at Week 8
Drug: Dupilumab 300mg Dose
Participants that were receiving Dupilumab 300mg SC injections and completed Period 1, will receive oral doses of Upadacitinib 15mg in Period 2 with a clinical response of \< EASI 75 at Week 8
Drug: Upadacitinib 15mg Dose
Oral tablet
Also known as: ABT-494, RINVOQ
Subcutaneous (SC) injection
Oral tablet
Also known as: ABT-494, RINVOQ
Participants who achieve at least a 90% reduction in Eczema Area and Severity Index from Baseline (EASI 90)
The EASI is a validated measure used to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points.
Time frame: At Week 8
Percentage of participants who achieve a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1)
Worst Pruritus NRS (WP-NRS) is a validated single self-reported measure where patients rate the worst level of itching they have experienced over the past 24 hours on a scale from 0 (no itching) to 10 (worst itching imaginable)
Time frame: At Week 8
Participants who simultaneous achieve at least a 90% reduction in Eczema Area and Severity Index from Baseline (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1)
The EASI is a validated measure used to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Worst Pruritus NRS (WP-NRS) is a validated single self-reported measure where patients rate the worst level of itching they have experienced over the past 24 hours on a scale from 0 (no itching) to 10 (worst itching imaginable)
Time frame: At Week 8
Percentage of participants achieving worst pruritus numerical rating scale (WP-NRS) 0/1
Worst Pruritus NRS (WP-NRS) is a validated single self-reported measure where patients rate the worst level of itching they have experienced over the past 24 hours on a scale from 0 (no itching) to 10 (worst itching imaginable)
Time frame: At Week 4
Showing the first 100 of 128 sites across 9 countries.
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Sap
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