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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000434-42 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UPA 15 mg Double-Blind Treatment Period | Experimental | Participants received 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Double-Blind Treatment Period. |
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| UPA 30 mg Double-Blind Treatment Period | Experimental | Participants received 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Double-Blind Treatment Period. |
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| UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period | Experimental | At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
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| UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period | Experimental | At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a < 90% reduction in the Eczema Area and Severity Index (EASI) (< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
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| UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upadacitinib | Drug | Oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at 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%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at 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%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). |
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Inclusion Criteria:
Exclusion Criteria:
Participants with current or past history of infection including:
Evidence of Hepatitis B virus (HBV) or Hepatitis C virus (HCV).
Any of the following medical diseases or disorders:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Momentum Clinical Research /ID# 254028 | Darlinghurst | New South Wales | 2010 | Australia | ||
| Premier Specialist /ID# 246150 |
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| Label | URL |
|---|---|
| Related Info | View source |
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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.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
The study comprised of a 35-day Screening Period, a 12-week Double-Blind Treatment Period and a 12-week Single-Blind Treatment Period. During the Single-Blind Period, participants were blinded to the upadacitinib dose and Eczema Area and Severity Index (EASI) score evaluations.
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| ID | Title | Description |
|---|---|---|
| FG000 | UPA 15 mg Double-Blind Treatment Period | Participants received 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Double-Blind Treatment Period. |
| FG001 | UPA 30 mg Double-Blind Treatment Period |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind Treatment Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 21, 2023 | Jun 30, 2025 |
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| Experimental |
At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
|
| UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period | Experimental | At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a < 90% reduction in the Eczema Area and Severity Index (EASI) (< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
|
|
| Baseline and Week 24 |
| Percentage of Participants Achieving a 100% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 100) at 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%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). | Baseline and Week 24 |
| Percentage of Participants Achieving ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at 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%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). | Baseline and Week 12 |
| Percentage of Participants Achieving ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at 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%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). | Baseline and Week 12 |
| Percentage of Participants Achieving a 100% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 100) at 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%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). | Baseline and Week 12 |
| 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 Baseline | 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%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). 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). | Baseline and Week 12 |
| 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 Baseline | 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%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). 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). | Baseline and Week 24 |
| Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1 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). | At Week 12 |
| Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1 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). | At Week 24 |
| 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 ≥4 | 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). | Baseline and Week 12 |
| 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 ≥4 | 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). | Baseline and Week 24 |
| Percentage of Participants Achieving Worst Pruritus Numerical Rating Scale (WP-NRS) of 0 or 1 at Week 12 Among Those With Baseline WP-NRS >1 | 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). | Baseline and Week 12 |
| Percentage of Participants Achieving Worst Pruritus Numerical Rating Scale (WP-NRS) of 0 or 1 at Week 24 Among Those With Baseline WP-NRS >1 | 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). | Baseline and Week 24 |
| Percentage of Participants Achieving Improvement (Reduction) in Dermatology Life Quality Index (DLQI) ≥4 at Week 12 Among Those With Baseline DLQI ≥4 | DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of atopic dermatitis (AD) disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of participant's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. | Baseline and Week 12 |
| Percentage of Participants Achieving Improvement (Reduction) in Dermatology Life Quality Index (DLQI) ≥4 at Week 24 Among Those With Baseline DLQI ≥4 | DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of atopic dermatitis (AD) disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of participant's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. | Baseline and Week 24 |
| Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) of 0 or 1 At Week 12 Among Those With Baseline DLQI >1 | DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of atopic dermatitis (AD) disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of participant's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. | Baseline and Week 12 |
| Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) of 0 or 1 At Week 24 Among Those With Baseline DLQI >1 | DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of atopic dermatitis (AD) disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of participant's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. | Baseline and Week 24 |
| Kogarah |
| New South Wales |
| 2217 |
| Australia |
| Veracity Clinical Research /ID# 246154 | Woolloongabba | Queensland | 4102 | Australia |
| North Eastern Health Specialists /ID# 246153 | Campbelltown | South Australia | 5074 | Australia |
| Skin Health Institute Inc /ID# 246146 | Carlton | Victoria | 3053 | Australia |
| Cliniques Universitaires UCL Saint-Luc /ID# 245842 | Woluwe-Saint-Lambert | Brussels Capital | 1200 | Belgium |
| Grand Hôpital De Charleroi - Notre Dame /ID# 245837 | Charleroi | Hainaut | 6000 | Belgium |
| AZ Sint-Lucas /ID# 253708 | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| Dermatologie Maldegem /ID# 245840 | Maldegem | Oost-Vlaanderen | 9990 | Belgium |
| CHU de Liege /ID# 245839 | Liège | 4000 | Belgium |
| UMHAT Alexandrovska EAD /ID# 246594 | Sofiya | Sofia | 1431 | Bulgaria |
| Medical center Cordis /ID# 253310 | Pleven | 5800 | Bulgaria |
| Acibadem City Clinic Tokuda University Hospital EAD /ID# 246395 | Sofia | 1407 | Bulgaria |
| Ambulatory for Specialized Medical Care for skin and venereal diseases /ID# 247027 | Sofia | 1407 | Bulgaria |
| Medical Center Euroderma /ID# 246736 | Sofia | 1606 | Bulgaria |
| Medical center EuroHealth /ID# 246305 | Sofia | 1606 | Bulgaria |
| Dermatology Research Institute - Blackfoot Trail /ID# 246703 | Calgary | Alberta | T2J 7E1 | Canada |
| Beacon Dermatology Inc /ID# 246705 | Calgary | Alberta | T3A 2N1 | Canada |
| Rejuvenation Dermatology - Edmonton Downtown /ID# 256790 | Edmonton | Alberta | T5J 3S9 | Canada |
| Alberta DermaSurgery Centre /ID# 247286 | Edmonton | Alberta | T6G 1C3 | Canada |
| Dr. Chih-ho Hong Medical Inc. /ID# 246700 | Surrey | British Columbia | V3R 6A7 | Canada |
| Lynde Institute for Dermatology /ID# 246699 | Markham | Ontario | L3P 1X2 | Canada |
| SKiN Centre for Dermatology /ID# 246702 | Peterborough | Ontario | K9J 5K2 | Canada |
| Private Practice - Dr. Kim Papp Clinical Research /ID# 246698 | Waterloo | Ontario | N2J 1C4 | Canada |
| Beijing Friendship Hospital /ID# 247719 | Beijing | Beijing Municipality | 100032 | China |
| Peking University Third Hospital /ID# 247842 | Beijing | Beijing Municipality | 100191 | China |
| Dermatology Hospital of Southern Medical University /ID# 247951 | Guangzhou | Guangdong | 510091 | China |
| The First Hospital of China Medical University /ID# 247686 | Shenyang | Liaoning | 110001 | China |
| Huashan Hospital, Fudan University /ID# 247680 | Shanghai | Shanghai Municipality | 200040 | China |
| Dermatologische Gemeinschaftspraxis Mahlow /ID# 245629 | Blankenfelde-Mahlow | Brandenburg | 15831 | Germany |
| Klinikum Darmstadt /ID# 247028 | Darmstadt | Hesse | 64283 | Germany |
| Universitaetsklinikum Frankfurt /ID# 245627 | Frankfurt am Main | Hesse | 60590 | Germany |
| Fachklinik Bad Bentheim /ID# 245634 | Bad Bentheim | Lower Saxony | 48455 | Germany |
| Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 245636 | Bramsche | Lower Saxony | 49565 | Germany |
| Universitaetsklinikum Muenster /ID# 245623 | Münster | North Rhine-Westphalia | 48149 | Germany |
| Universitaetsklinikum Carl Gustav Carus Dresden /ID# 248413 | Dresden | Saxony | 01307 | Germany |
| Elbe Klinikum Buxtehude /ID# 245626 | Buxtehude | 21614 | Germany |
| Derma Study Center Friedrichshafen GmbH /ID# 245640 | Friedrichshafen | 88045 | Germany |
| Universitaetsklinikum Halle (Saale) /ID# 245637 | Halle | 06120 | Germany |
| Dermatologikum Hamburg /ID# 245635 | Hamburg | 20354 | Germany |
| Dermatologie Quist-BAG Dres. med. Quist PartG /ID# 245628 | Mainz | 55128 | Germany |
| Gyongyosi Bugat Pal Korhaz /ID# 246422 | Gyöngyös | Heves County | 3200 | Hungary |
| Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 246428 | Kaposvár | Somogy County | 7400 | Hungary |
| Clinexpert Kft /ID# 246427 | Budapest | 1033 | Hungary |
| DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 246426 | Debrecen | 4031 | Hungary |
| IRCCS Istituto Clinico Humanitas /ID# 246630 | Rozzano | Lombardy | 20089 | Italy |
| Duplicate_Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 254355 | Ancona | 60126 | Italy |
| Duplicate_ASST Spedali civili di Brescia /ID# 246631 | Brescia | 25123 | Italy |
| Universita degli Studi Gabriele dAnnunzio /ID# 246629 | Chieti | 66100 | Italy |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 246634 | Milan | 20122 | Italy |
| Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 246632 | Perugia | 06156 | Italy |
| Miyata Dermatology Clinic /ID# 255491 | Matsudo-Shi | Chiba | 271-0092 | Japan |
| Fukuoka University Hospital /ID# 255182 | Fukuoka | Fukuoka | 814-0180 | Japan |
| Takagi Dermatological Clinic /ID# 255181 | Obihiro-shi | Hokkaido | 080-0013 | Japan |
| Nomura Dermatology Clinic /ID# 255534 | Yokohama | Kanagawa | 221-0825 | Japan |
| Tohoku University Hospital /ID# 255183 | Sendai | Miyagi | 9808574 | Japan |
| Maruyama Dermatology Clinic /ID# 255441 | Koto-ku | Tokyo | 136-0074 | Japan |
| Amphia Ziekenhuis /ID# 246397 | Breda | North Brabant | 4818 CK | Netherlands |
| Amsterdam UMC, locatie AMC /ID# 245673 | Amsterdam | North Holland | 1105 AZ | Netherlands |
| Greenlane Clinical Centre /ID# 246556 | Epsom | Auckland | 1051 | New Zealand |
| Clinical Trials New Zealand /ID# 246557 | Hamilton | Waikato Region | 3204 | New Zealand |
| Aotearoa Clinical Trials /ID# 246559 | Auckland | 1640 | New Zealand |
| Duplicate_Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus /ID# 253508 | Poznan | Greater Poland Voivodeship | 60-693 | Poland |
| Specjalistyczna Przychodnia Lekarska Alergo-Med sp. z o.o. /ID# 253846 | Poznan | Greater Poland Voivodeship | 61-578 | Poland |
| Oftalmika sp. z o.o. /ID# 253429 | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-631 | Poland |
| MICS Centrum Medyczne Torun /ID# 245749 | Torun | Kuyavian-Pomeranian Voivodeship | 87-100 | Poland |
| Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 245836 | Krakow | Lesser Poland Voivodeship | 31-011 | Poland |
| CenterMed Krakow Sp. z o.o. /ID# 253940 | Krakow | Lesser Poland Voivodeship | 31-530 | Poland |
| Klinika Ambroziak Sp. z o.o. /ID# 245748 | Warsaw | Masovian Voivodeship | 02-953 | Poland |
| Royalderm Agnieszka Nawrocka /ID# 245746 | Warsaw | Masovian Voivodeship | 02-962 | Poland |
| Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 245741 | Gdansk | Pomeranian Voivodeship | 80-546 | Poland |
| Centrum Medyczne Pratia Gdynia /ID# 245835 | Gdynia | Pomeranian Voivodeship | 81-338 | Poland |
| Silmedic Sp. z o.o. /ID# 253863 | Katowice | Silesian Voivodeship | 40-282 | Poland |
| Dermed Centrum Medyczne Sp. z o.o /ID# 246329 | Lodz | Łódź Voivodeship | 90-265 | Poland |
| Santa Sp. z o.o. Santa Familia Centrum Badan, Profilaktyki i Leczenia /ID# 253872 | Lodz | Łódź Voivodeship | 90-302 | Poland |
| Centro Hospitalar de Lisboa Central /ID# 246247 | Lisbon | 1169-050 | Portugal |
| Hospital CUF Descobertas /ID# 245702 | Lisbon | 1998-018 | Portugal |
| Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 245701 | Porto | 4099-001 | Portugal |
| Centro Hospitalar Universitario de Sao Joao, EPE /ID# 245704 | Porto | 4200-319 | Portugal |
| Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 247515 | Bratislava | 811 09 | Slovakia |
| BeneDerma s.r.o. /ID# 247513 | Bratislava | 841 04 | Slovakia |
| Univerzitna nemocnica Martin /ID# 246948 | Martin | Žilina Region | 036 01 | Slovakia |
| Korea University Ansan Hospital /ID# 245653 | Ansan-si | Gyeonggido | 15355 | South Korea |
| Soon Chun Hyang University Hospital Bucheon /ID# 245654 | Bucheon-si | Gyeonggido | 14584 | South Korea |
| Ajou University Hospital /ID# 245652 | Suwon | Gyeonggido | 16499 | South Korea |
| Chungang University Hospital /ID# 245655 | Dongjak-gu | Seoul Teugbyeolsi | 06973 | South Korea |
| Seoul National University Hospital /ID# 245651 | Seoul | Seoul Teugbyeolsi | 03080 | South Korea |
| Konkuk University Medical Center /ID# 245657 | Seoul | Seoul Teugbyeolsi | 05030 | South Korea |
| Hospital Universitario Germans Trias i Pujol /ID# 246320 | Badalona | Barcelona | 08916 | Spain |
| Hospital Universitari de Bellvitge /ID# 246326 | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Universitario Puerta de Hierro - Majadahonda /ID# 253820 | Majadahonda | Madrid | 28222 | Spain |
| Hospital General Universitario de Alicante Doctor Balmis /ID# 246270 | Alicante | 03010 | Spain |
| Hospital Universitario Infanta Leonor /ID# 246272 | Madrid | 28031 | Spain |
| Hospital Universitario Ramon y Cajal /ID# 246273 | Madrid | 28034 | Spain |
| Complejo Hospitalario Universitario de Pontevedra /ID# 246323 | Pontevedra | 36071 | Spain |
| Hospital Universitario Virgen del Rocio /ID# 253822 | Seville | 41013 | Spain |
| Kaohsiung Chang Gung Memorial Hospital /ID# 245710 | Kaohsiung City | Kaohsiung | 833 | Taiwan |
| National Taiwan University Hospital /ID# 245711 | Taipei City | Taipei | 100 | Taiwan |
| Chung Shan Medical University Hospital /ID# 245707 | Taichung | 40201 | Taiwan |
| Mackay Memorial Hospital /ID# 245713 | Taipei | 104 | Taiwan |
| Taipei Municipal Wan Fang Hospital /ID# 245712 | Taipei | 116 | Taiwan |
| Linkou Chang Gung Memorial Hospital /ID# 245709 | Taoyuan City | 333 | Taiwan |
| University Hospital Southampton NHS Foundation Trust /ID# 246393 | Southampton | Hampshire | SO16 6YD | United Kingdom |
| NHS Greater Glasgow and Clyde /ID# 246253 | Glasgow | Scotland | G12 0XH | United Kingdom |
| Leeds Teaching Hospitals NHS Trust /ID# 246241 | Leeds | West Yorkshire | LS9 7TF | United Kingdom |
| NHS Lothian /ID# 246245 | Edinburgh | EH3 9HE | United Kingdom |
Participants received 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Double-Blind Treatment Period.
| FG002 | UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
| FG003 | UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a < 90% reduction in the Eczema Area and Severity Index (EASI) (< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
| FG004 | UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
| FG005 | UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a < 90% reduction in the Eczema Area and Severity Index (EASI) (< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Single-Blind Treatment Period |
|
|
ITT_1 Population: all participants who were randomized in the Double-Blind Treatment Period
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | UPA 15 mg Double-Blind Treatment Period | Participants received 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Double-Blind Treatment Period. |
| BG001 | UPA 30 mg Double-Blind Treatment Period | Participants received 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Double-Blind Treatment Period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at 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%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). | Intent-to-Treat (ITT_2) Population: all participants who were allocated to an assigned dose at Week 12 for the Single-Blind Treatment Period; participants with available data, as observed analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 24 |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at 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%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). | Intent-to-Treat (ITT_2) Population: all participants who were allocated to an assigned dose at Week 12 for the Single-Blind Treatment Period; participants with available data, as observed analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a 100% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 100) at 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%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). | Intent-to-Treat (ITT_2) Population: all participants who were allocated to an assigned dose at Week 12 for the Single-Blind Treatment Period; participants with available data, as observed analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at 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%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). | Intent-to-Treat (ITT_1) Population: all participants who were randomized in the Double-Blind Treatment Period; participants with available data, as observed analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at 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%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). | Intent-to-Treat (ITT_1) Population: all participants who were randomized in the Double-Blind Treatment Period; participants with available data, as observed analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a 100% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 100) at 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%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). | Intent-to-Treat (ITT_1) Population: all participants who were randomized in the Double-Blind Treatment Period; participants with available data, as observed analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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 Baseline | 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%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). 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). | Intent-to-Treat (ITT_1) Population: all participants who were randomized in the Double-Blind Treatment Period; participants with available data, as observed analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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 Baseline | 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%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). 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). | Intent-to-Treat (ITT_2) Population: all participants who were allocated to an assigned dose at Week 12 for the Single-Blind Treatment Period; participants with available data, as observed analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1 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). | Intent-to-Treat (ITT_1) Population: all participants who were randomized in the Double-Blind Treatment Period; participants with available data, as observed analysis | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1 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). | Intent-to-Treat (ITT_2) Population: all participants who were allocated to an assigned dose at Week 12 for the Single-Blind Treatment Period; participants with available data, as observed analysis | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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 ≥4 | 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). | Intent-to-Treat (ITT_1) Population: all participants who were randomized in the Double-Blind Treatment Period; participants with available data, as observed analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 12 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 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 ≥4 | 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). | Intent-to-Treat (ITT_2) Population: all participants who were allocated to an assigned dose at Week 12 for the Single-Blind Treatment Period; participants with available data, as observed analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Worst Pruritus Numerical Rating Scale (WP-NRS) of 0 or 1 at Week 12 Among Those With Baseline WP-NRS >1 | 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). | Intent-to-Treat (ITT_1) Population: all participants who were randomized in the Double-Blind Treatment Period; participants with available data, as observed analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 12 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Worst Pruritus Numerical Rating Scale (WP-NRS) of 0 or 1 at Week 24 Among Those With Baseline WP-NRS >1 | 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). | Intent-to-Treat (ITT_2) Population: all participants who were allocated to an assigned dose at Week 12 for the Single-Blind Treatment Period; participants with available data, as observed analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Improvement (Reduction) in Dermatology Life Quality Index (DLQI) ≥4 at Week 12 Among Those With Baseline DLQI ≥4 | DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of atopic dermatitis (AD) disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of participant's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. | Intent-to-Treat (ITT_1) Population: all participants who were randomized in the Double-Blind Treatment Period; participants with available data, as observed analysis | Posted | Number | 97.5% Confidence Interval | percentage of participants | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Improvement (Reduction) in Dermatology Life Quality Index (DLQI) ≥4 at Week 24 Among Those With Baseline DLQI ≥4 | DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of atopic dermatitis (AD) disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of participant's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. | Intent-to-Treat (ITT_2) Population: all participants who were allocated to an assigned dose at Week 12 for the Single-Blind Treatment Period; participants with available data, as observed analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) of 0 or 1 At Week 12 Among Those With Baseline DLQI >1 | DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of atopic dermatitis (AD) disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of participant's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. | Intent-to-Treat (ITT_1) Population: all participants who were randomized in the Double-Blind Treatment Period; participants with available data, as observed analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) of 0 or 1 At Week 24 Among Those With Baseline DLQI >1 | DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of atopic dermatitis (AD) disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of participant's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. | Intent-to-Treat (ITT_2) Population: all participants who were allocated to an assigned dose at Week 12 for the Single-Blind Treatment Period; participants with available data, as observed analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 24 |
|
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.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | UPA 15 mg Double-Blind Treatment Period | Participants received 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Double-Blind Treatment Period. | 0 | 229 | 8 | 229 | 41 | 229 |
| EG001 | UPA 30 mg Double-Blind Treatment Period | Participants received 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Double-Blind Treatment Period. | 0 | 232 | 0 | 232 | 67 | 232 |
| EG002 | UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. | 0 | 72 | 1 | 72 | 17 | 72 |
| EG003 | UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a < 90% reduction in the Eczema Area and Severity Index (EASI) (< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. | 0 | 144 | 1 | 144 | 38 | 144 |
| EG004 | UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. | 0 | 133 | 1 | 133 | 39 | 133 |
| EG005 | UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a < 90% reduction in the Eczema Area and Severity Index (EASI) (< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. | 0 | 91 | 0 | 91 | 33 | 91 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| TOXIC NODULAR GOITRE | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| EPIDIDYMITIS | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| HAND FRACTURE | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| DERMATITIS ATOPIC | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| DERMATITIS EXFOLIATIVE GENERALISED | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| ORAL HERPES | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| ACNE | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| DERMATITIS ATOPIC | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 27, 2024 | Jun 30, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613732 | upadacitinib |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
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| Other, not specified |
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| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a < 90% reduction in the Eczema Area and Severity Index (EASI) (< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
| OG002 | UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
| OG003 | UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a < 90% reduction in the Eczema Area and Severity Index (EASI) (< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
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At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a < 90% reduction in the Eczema Area and Severity Index (EASI) (< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
| OG002 | UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
| OG003 | UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a < 90% reduction in the Eczema Area and Severity Index (EASI) (< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
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| OG001 | UPA 30 mg Double-Blind Treatment Period | Participants received 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Double-Blind Treatment Period. |
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| OG001 | UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a < 90% reduction in the Eczema Area and Severity Index (EASI) (< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
| OG002 | UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
| OG003 | UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a < 90% reduction in the Eczema Area and Severity Index (EASI) (< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
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| Units | Counts |
|---|---|
| Participants |
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At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a < 90% reduction in the Eczema Area and Severity Index (EASI) (< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.
| OG002 | UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥90% reduction in the Eczema Area and Severity Index (EASI) (≥EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
| OG003 | UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a < 90% reduction in the Eczema Area and Severity Index (EASI) (< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
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| Participants |
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| OG002 | UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
| OG003 | UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a < 90% reduction in the Eczema Area and Severity Index (EASI) (< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
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| OG002 | UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
| OG003 | UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a < 90% reduction in the Eczema Area and Severity Index (EASI) (< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
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| Units | Counts |
|---|---|
| Participants |
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|
At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a < 90% reduction in the Eczema Area and Severity Index (EASI) (< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
| OG002 | UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
| OG003 | UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a < 90% reduction in the Eczema Area and Severity Index (EASI) (< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
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| Units | Counts |
|---|---|
| Participants |
|
|
At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a < 90% reduction in the Eczema Area and Severity Index (EASI) (< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
| OG002 | UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
| OG003 | UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period | At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a < 90% reduction in the Eczema Area and Severity Index (EASI) (< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. |
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