A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic Dermatitis (Flex-Up)

A Phase 3b/4 Randomized, Blinded, Treat-to-Target and Dose-Flexibility Study of Upadacitinib in Adult Subjects With Moderate to Severe Atopic Dermatitis

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Upadacitinib

• Study Type: Interventional
• Enrollment (Actual): 461
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Momentum Clinical Research /ID# 254028
    • Kogarah, New South Wales, Australia, 2217
      • Premier Specialist /ID# 246150
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Veracity Clinical Research /ID# 246154
  • South Australia
    • Campbelltown, South Australia, Australia, 5074
      • North Eastern Health Specialists /ID# 246153
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Skin Health Institute Inc /ID# 246146
• Belgium
  • Liege, Belgium, 4000
    • CHU de Liege /ID# 245839
  • Bruxelles-Capitale
    • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
      • Cliniques Universitaires UCL Saint-Luc /ID# 245842
  • Hainaut
    • Charleroi, Hainaut, Belgium, 6000
      • Grand Hôpital De Charleroi - Notre Dame /ID# 245837
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • AZ Sint-Lucas /ID# 253708
    • Maldegem, Oost-Vlaanderen, Belgium, 9990
      • Dermatologie Maldegem /ID# 245840
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Medical center Cordis /ID# 253310
  • Sofia, Bulgaria, 1407
    • Acibadem City Clinic Tokuda University Hospital EAD /ID# 246395
  • Sofia, Bulgaria, 1407
    • Ambulatory for Specialized Medical Care for skin and venereal diseases /ID# 247027
  • Sofia, Bulgaria, 1606
    • Medical center EuroHealth /ID# 246305
  • Sofiya, Bulgaria, 1606
    • Medical Center Euroderma /ID# 246736
  • Sofia
    • Sofiya, Sofia, Bulgaria, 1431
      • UMHAT Alexandrovska EAD /ID# 246594
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Dermatology Research Institute - Blackfoot Trail /ID# 246703
    • Calgary, Alberta, Canada, T3A 2N1
      • Beacon Dermatology Inc /ID# 246705
    • Edmonton, Alberta, Canada, T6G 1C3
      • Alberta DermaSurgery Centre /ID# 247286
    • Edmonton, Alberta, Canada, T5J 3S9
      • Rejuvenation Dermatology - Edmonton Downtown /ID# 256790
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dr. Chih-ho Hong Medical Inc. /ID# 246700
  • Ontario
    • Markham, Ontario, Canada, L3P 1X2
      • Lynde Institute for Dermatology /ID# 246699
    • Peterborough, Ontario, Canada, K9J 5K2
      • SKiN Centre for Dermatology /ID# 246702
    • Waterloo, Ontario, Canada, N2J 1C4
      • Private Practice - Dr. Kim Papp Clinical Research /ID# 246698
• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital /ID# 247842
    • Beijing, Beijing, China, 100032
      • Beijing Friendship Hospital /ID# 247719
  • Guangdong
    • Guangzhou, Guangdong, China, 510091
      • Dermatology Hospital of Southern Medical University /ID# 247951
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • The First Hospital of China Medical University /ID# 247686
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Huashan Hospital, Fudan University /ID# 247680
• Germany
  • Buxtehude, Germany, 21614
    • Elbe Klinikum Buxtehude /ID# 245626
  • Friedrichshafen, Germany, 88045
    • Derma Study Center Friedrichshafen GmbH /ID# 245640
  • Halle (Saale), Germany, 06120
    • Universitaetsklinikum Halle (Saale) /ID# 245637
  • Hamburg, Germany, 20354
    • Dermatologikum Hamburg /ID# 245635
  • Mainz, Germany, 55128
    • Dermatologie Quist-BAG Dres. med. Quist PartG /ID# 245628
  • Brandenburg
    • Blankenfelde-Mahlow, Brandenburg, Germany, 15831
      • Dermatologische Gemeinschaftspraxis Mahlow /ID# 245629
  • Hessen
    • Darmstadt, Hessen, Germany, 64283
      • Klinikum Darmstadt /ID# 247028
    • Frankfurt am Main, Hessen, Germany, 60590
      • Universitaetsklinikum Frankfurt /ID# 245627
  • Niedersachsen
    • Bad Bentheim, Niedersachsen, Germany, 48455
      • Fachklinik Bad Bentheim /ID# 245634
    • Bramsche, Niedersachsen, Germany, 49565
      • Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 245636
  • Nordrhein-Westfalen
    • Muenster, Nordrhein-Westfalen, Germany, 48149
      • Universitaetsklinikum Muenster /ID# 245623
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
      • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 248413
• Hungary
  • Budapest, Hungary, 1033
    • Clinexpert Kft /ID# 246427
  • Debrecen, Hungary, 4031
    • DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 246426
  • Heves
    • Gyongyos, Heves, Hungary, 3200
      • Gyongyosi Bugat Pal Korhaz /ID# 246422
  • Somogy
    • Kaposvár, Somogy, Hungary, 7400
      • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 246428
• Italy
  • Ancona, Italy, 60126
    • Duplicate_Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 254355
  • Brescia, Italy, 25123
    • Duplicate_ASST Spedali civili di Brescia /ID# 246631
  • Chieti, Italy, 66100
    • Universita degli Studi Gabriele dAnnunzio /ID# 246629
  • Milano, Italy, 20122
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 246634
  • Perugia, Italy, 06156
    • Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 246632
  • Lombardia
    • Rozzano, Lombardia, Italy, 20089
      • IRCCS Istituto Clinico Humanitas /ID# 246630
• Japan
  • Chiba
    • Matsudo-Shi, Chiba, Japan, 271-0092
      • Miyata Dermatology Clinic /ID# 255491
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 814-0180
      • Fukuoka University Hospital /ID# 255182
  • Hokkaido
    • Obihiro-shi, Hokkaido, Japan, 080-0013
      • Takagi Dermatological Clinic /ID# 255181
  • Kanagawa
    • Yokohama-shi, Kanagawa, Japan, 221-0825
      • Nomura Dermatology Clinic /ID# 255534
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 9808574
      • Tohoku University Hospital /ID# 255183
  • Tokyo
    • Koto-ku, Tokyo, Japan, 136-0074
      • Maruyama Dermatology Clinic /ID# 255441
• Korea, Republic of
  • Gyeonggido
    • Ansan-si, Gyeonggido, Korea, Republic of, 15355
      • Korea University Ansan Hospital /ID# 245653
    • Bucheon-si, Gyeonggido, Korea, Republic of, 14584
      • Soon Chun Hyang University Hospital Bucheon /ID# 245654
    • Suwon-si, Gyeonggido, Korea, Republic of, 16499
      • Ajou University Hospital /ID# 245652
  • Seoul Teugbyeolsi
    • Dongjak-gu, Seoul Teugbyeolsi, Korea, Republic of, 06973
      • Chungang University Hospital /ID# 245655
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05030
      • Konkuk University Medical Center /ID# 245657
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
      • Seoul National University Hospital /ID# 245651
• Netherlands
  • Noord-Brabant
    • Breda, Noord-Brabant, Netherlands, 4818 CK
      • Amphia Ziekenhuis /ID# 246397
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      • Amsterdam UMC, locatie AMC /ID# 245673
• New Zealand
  • Auckland, New Zealand, 1640
    • Aotearoa Clinical Trials /ID# 246559
  • Auckland
    • Epsom, Auckland, New Zealand, 1051
      • Greenlane Clinical Centre /ID# 246556
  • Waikato
    • Hamilton, Waikato, New Zealand, 3204
      • Clinical Trials New Zealand /ID# 246557
• Poland
  • Kujawsko-pomorskie
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-631
      • Oftalmika sp. z o.o. /ID# 253429
    • Torun, Kujawsko-pomorskie, Poland, 87-100
      • MICS Centrum Medyczne Torun /ID# 245749
  • Lodzkie
    • Lodz, Lodzkie, Poland, 90-265
      • Dermed Centrum Medyczne Sp. z o.o /ID# 246329
    • Lodz, Lodzkie, Poland, 90-302
      • Santa Sp. z o.o. Santa Familia Centrum Badan, Profilaktyki i Leczenia /ID# 253872
  • Malopolskie
    • Krakow, Malopolskie, Poland, 31-011
      • Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 245836
    • Krakow, Malopolskie, Poland, 31-530
      • CenterMed Krakow Sp. z o.o. /ID# 253940
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 02-962
      • Royalderm Agnieszka Nawrocka /ID# 245746
    • Warszawa, Mazowieckie, Poland, 02-953
      • Klinika Ambroziak Sp. z o.o. /ID# 245748
  • Pomorskie
    • Gdansk, Pomorskie, Poland, 80-546
      • Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 245741
    • Gdynia, Pomorskie, Poland, 81-338
      • Centrum Medyczne Pratia Gdynia /ID# 245835
  • Slaskie
    • Katowice, Slaskie, Poland, 40-282
      • Silmedic Sp. z o.o. /ID# 253863
  • Wielkopolskie
    • Poznan, Wielkopolskie, Poland, 61-578
      • Specjalistyczna Przychodnia Lekarska Alergo-Med sp. z o.o. /ID# 253846
    • Poznań, Wielkopolskie, Poland, 60-693
      • Duplicate_Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus /ID# 253508
• Portugal
  • Lisboa, Portugal, 1998-018
    • Hospital CUF Descobertas /ID# 245702
  • Lisbon, Portugal, 1169-050
    • Centro Hospitalar de Lisboa Central /ID# 246247
  • Porto, Portugal, 4099-001
    • Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 245701
  • Porto, Portugal, 4200-319
    • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 245704
• Slovakia
  • Bratislava, Slovakia, 811 09
    • Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 247515
  • Bratislava, Slovakia, 841 04
    • BeneDerma s.r.o. /ID# 247513
  • Zilinsky Kraj
    • Martin, Zilinsky Kraj, Slovakia, 036 01
      • Univerzitna nemocnica Martin /ID# 246948
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante Doctor Balmis /ID# 246270
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor /ID# 246272
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal /ID# 246273
  • Pontevedra, Spain, 36071
    • Complejo Hospitalario Universitario de Pontevedra /ID# 246323
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio /ID# 253822
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitario Germans Trias i Pujol /ID# 246320
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitari de Bellvitge /ID# 246326
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 253820
• Taiwan
  • Taichung, Taiwan, 40201
    • Chung Shan Medical University Hospital /ID# 245707
  • Taipei, Taiwan, 116
    • Taipei Municipal Wan Fang Hospital /ID# 245712
  • Taipei City, Taiwan, 104
    • Mackay Memorial Hospital /ID# 245713
  • Taoyuan City, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital /ID# 245709
  • Kaohsiung
    • Kaohsiung City, Kaohsiung, Taiwan, 833
      • Kaohsiung Chang Gung Memorial Hospital /ID# 245710
  • Taipei
    • Taipei City, Taipei, Taiwan, 100
      • National Taiwan University Hospital /ID# 245711
• United Kingdom
  • Edinburgh, United Kingdom, EH3 9HE
    • NHS Lothian /ID# 246245
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • University Hospital Southampton NHS Foundation Trust /ID# 246393
  • Scotland
    • Glasgow, Scotland, United Kingdom, G12 0XH
      • NHS Greater Glasgow and Clyde /ID# 246253
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS9 7TF
      • Leeds Teaching Hospitals NHS Trust /ID# 246241

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline and participant meets Hanifin and Rajka criteria.
• Eczema Area and Severity Index (EASI) score >= 16, vIGA-AD score >= 3 and >= 10% Body Surface Area (BSA) of AD involvement at the Baseline Visit.
• Baseline weekly average of daily Worst Pruritus NRS >= 4.
• Candidate for systemic treatment defined as prior use of systemic treatment for AD, OR previous inadequate response to TCS, TCI or PDE-4 inhibitors, OR for whom topical treatments are otherwise medically inadvisable.

Exclusion Criteria:

• Participants with current or past history of infection including:

  • Two or more episodes of herpes zoster, or one or more episodes of disseminated herpes zoster;
  • One or more episodes of disseminated herpes simplex (including eczema herpeticum);
  • Human immunodeficiency virus (HIV) infection defined as confirmed positive anti-HIV antibody (HIV Ab) test;
  • Active tuberculosis (TB) or meet TB exclusionary parameters (protocol specified requirements for TB testing);
  • Japan only: Positive result of beta-D-glucan (screening for Pneumocystis jirovecii infection) or two consecutive indeterminate results of beta-D-glucan during the Screening Period;
  • Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to the Baseline Visit;
  • Chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, makes the participant an unsuitable candidate for the study;
  • COVID-19 infection: In participants who tested positive for COVID, at least 5 days must have passed since a COVID-19 positive test result for study entry of asymptomatic participants. Participants with mild/moderate COVID-19 infection can be enrolled if fever is resolved without use of antipyretics for 24 hours and other symptoms improved, or if 5 days have passed since the COVID-19 positive test result (whichever comes last). Participants may be rescreened if judged to be in good general health, as determined by the investigator based upon the medical history and physical examination.
• Evidence of Hepatitis B virus (HBV) or Hepatitis C virus (HCV).

• Any of the following medical diseases or disorders:

  • Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, and aorto-coronary bypass surgery;
  • History of an organ transplant which requires continued immunosuppression;
  • History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class;
  • History of gastrointestinal perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for gastrointestinal perforation per investigator judgment;
  • Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery; participants with a history of gastric banding/segmentation are not excluded;
  • History of malignancy except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Upadacitinib; Oral tablet; Other Names: RINVOQ; ABT-494
Experimental: 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.	Drug: Upadacitinib; Oral tablet; Other Names: RINVOQ; ABT-494
Experimental: 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.	Drug: Upadacitinib; Oral tablet; Other Names: RINVOQ; ABT-494
Experimental: 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.	Drug: Upadacitinib; Oral tablet; Other Names: RINVOQ; ABT-494
Experimental: 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.	Drug: Upadacitinib; Oral tablet; Other Names: RINVOQ; ABT-494
Experimental: 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.	Drug: Upadacitinib; Oral tablet; Other Names: RINVOQ; ABT-494

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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%).	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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related info

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2023
• Primary Completion (Actual): July 11, 2024
• Study Completion (Actual): August 15, 2024

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Upadacitinib; Atopic Dermatitis (AD); RINVOQ
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema; Janus Kinase Inhibitors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Protein Kinase Inhibitors; Upadacitinib
• Other Study ID Numbers: M22-000; 2022-000434-42 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes