Adults 18 to 64, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Achieving ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 24Primary· Baseline and Week 24
The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) are assessed for severity 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
Group
Value
95% CI
UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period
74.6
64.5 – 84.8
UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period
48.1
39.6 – 56.6
UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period
68.5
60.5 – 76.4
UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period
29.3
19.4 – 39.1
Percentage of Participants Achieving ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24Secondary· Baseline and Week 24
The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) are assessed for severity 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
Group
Value
95% CI
UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period
97.2
93.3 – 100.0
UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period
69.2
61.3 – 77.0
UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period
88.5
83.0 – 94.0
UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period
52.4
41.6 – 63.2
Percentage of Participants Achieving a 100% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 100) at Week 24Secondary· Baseline and Week 24
The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) are assessed for severity 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
Group
Value
95% CI
UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period
33.8
22.8 – 44.8
UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period
7.5
3.0 – 12.0
UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period
21.5
14.5 – 28.6
UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period
3.7
0.0 – 7.7
Percentage of Participants Achieving ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 12Secondary· Baseline and Week 12
The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) are assessed for severity 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
Group
Value
95% CI
UPA 15 mg Double-Blind Treatment Period
64.4
58.1 – 70.7
UPA 30 mg Double-Blind Treatment Period
79.3
74.0 – 84.6
Percentage of Participants Achieving ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 12Secondary· Baseline and Week 12
The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) are assessed for severity 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
Group
Value
95% CI
UPA 15 mg Double-Blind Treatment Period
33.8
27.6 – 40.0
UPA 30 mg Double-Blind Treatment Period
59.9
53.5 – 66.3
Percentage of Participants Achieving a 100% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 100) at Week 12Secondary· Baseline and Week 12
The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) are assessed for severity 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
Group
Value
95% CI
UPA 15 mg Double-Blind Treatment Period
7.7
4.2 – 11.2
UPA 30 mg Double-Blind Treatment Period
15.9
11.1 – 20.6
Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 12 Among Those With WP-NRS > 1 at BaselineSecondary· Baseline and Week 12
The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) assessed for severity 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%),
Group
Value
95% CI
UPA 15 mg Double-Blind Treatment Period
18.0
12.5 – 23.6
UPA 30 mg Double-Blind Treatment Period
32.5
25.9 – 39.1
Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 24 Among Those With WP-NRS > 1 at BaselineSecondary· Baseline and Week 24
The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) assessed for severity 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%),
Group
Value
95% CI
UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period
38.5
25.2 – 51.7
UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period
20.7
12.0 – 29.5
UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period
35.0
25.7 – 44.3
UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period
20.3
10.1 – 30.6
Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1 at Week 12Secondary· At Week 12
vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis \[no erythema, no induration/papulation, no lichenification, no oozing/crusting\] Post-inflammatory hyperpigmentation and/or hypopigmentation may be present) to 4 - Severe (marked erythema \[deep or bright red\], marked induration/papulation, and/or marked lichenification).
Group
Value
95% CI
UPA 15 mg Double-Blind Treatment Period
29.7
23.7 – 35.7
UPA 30 mg Double-Blind Treatment Period
51.5
45.0 – 58.0
Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1 at Week 24Secondary· At Week 24
vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis \[no erythema, no induration/papulation, no lichenification, no oozing/crusting\] Post-inflammatory hyperpigmentation and/or hypopigmentation may be present) to 4 - Severe (marked erythema \[deep or bright red\], marked induration/papulation, and/or marked lichenification).
Group
Value
95% CI
UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period
63.4
52.2 – 74.6
UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period
40.6
32.3 – 48.9
UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period
52.3
43.7 – 60.9
UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period
29.3
19.4 – 39.1
Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥4 at Week 12 Among Those With Baseline WP-NRS ≥4Secondary· Baseline and Week 12
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Group
Value
95% CI
UPA 15 mg Double-Blind Treatment Period
53.3
46.0 – 60.5
UPA 30 mg Double-Blind Treatment Period
67.7
61.1 – 74.3
Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥4 at Week 24 Among Those With Baseline WP-NRS ≥4Secondary· Baseline and Week 24
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Group
Value
95% CI
UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period
73.1
61.0 – 85.1
UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period
57.3
46.6 – 68.0
UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period
67.0
57.8 – 76.2
UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period
60.0
47.6 – 72.4
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
UPA 15 mg Double-Blind Treatment Period
Serious: 8/229 (3%)
Deaths: 0/229
UPA 30 mg Double-Blind Treatment Period
Serious: 0/232 (0%)
Deaths: 0/232
UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period
Serious: 1/72 (1%)
Deaths: 0/72
UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period
Serious: 1/144 (1%)
Deaths: 0/144
UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period
Serious: 1/133 (1%)
Deaths: 0/133
UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period
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 evaluates the dosing flexibility of upadacitinib in adult participants with moderate to severe AD. Adverse events and change in the disease activity will be assessed.
Upadacitinib is an approved drug for the treatment of moderate to severe/active immune-mediated inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis (UC), Crohn's Disease (CD), and AD. The study is comprised of a 35-day Screening Period, a 12-week double-blind period and a 12-week single-blind period. During the double-blind period, participants are placed in 1 of 2 groups, called treatment arms and will be randomized in a 1:1 ratio to receive upadacitinib. At 12 weeks during the single blind period, participants will be blinded to the upadacitinib dose based on their EASI response and reassigned to in 1 of 4 arms. After the last study visit, there is a 30-day follow-up visit. Approximately 454 adult participants ages 18 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 160 sites worldwide.
The study is comprised of a 12-week double-blind period, followed by a 12-week single-blind period. Participants will receive upadacitinib oral tablets once daily for up to 24 weeks.
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 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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07502339 — Upadacitinib in Patients Hospitalized With Acute Severe Ulcerative Colitis
· Phase 4
· not yet recruiting
NCT07492251 — Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Ran
· Phase 2
· not yet recruiting
NCT06016517 — Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis
· not yet recruiting
NCT07546097 — Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis（U
· Phase 4
· recruiting
NCT07510191 — TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response
· Phase 4
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 29 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05507580.