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

NCT05507580 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: M22-0002022-000434-42
• Study Type: interventional
• Target: 461
• Locations: 18 countries
• Sites: 106

Brief Summary

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.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis (AD); Upadacitinib; RINVOQ

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Percentage of Participants Achieving ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24

  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

  Baseline and Week 24

• Percentage of Participants Achieving ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 12

  Baseline and Week 12

• Percentage of Participants Achieving ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 12

  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

  Baseline and Week 12

Study Arms (6)

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.

Drug: Upadacitinib

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.

Drug: Upadacitinib

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.

Drug: Upadacitinib

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.

Drug: Upadacitinib

UPA 30 mg Double-Blind Treatment Period --> UPA 15 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 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.

Drug: Upadacitinib

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.

Drug: Upadacitinib

Interventions

Upadacitinib DRUG

Oral tablet

Also known as: RINVOQ, ABT-494

UPA 15 mg Double-Blind Treatment Period; UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period; UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period; UPA 30 mg Double-Blind Treatment Period; UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period; UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• AbbVie: lead

Study Sites (106)

Momentum Clinical Research /ID# 254028

Darlinghurst, New South Wales, 2010, Australia

Location

Premier Specialist /ID# 246150

Kogarah, New South Wales, 2217, Australia

Location

Veracity Clinical Research /ID# 246154

Woolloongabba, Queensland, 4102, Australia

Location

North Eastern Health Specialists /ID# 246153

Campbelltown, South Australia, 5074, Australia

Location

Skin Health Institute Inc /ID# 246146

Carlton, Victoria, 3053, Australia

Location

Cliniques Universitaires UCL Saint-Luc /ID# 245842

Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

Location

Grand Hôpital De Charleroi - Notre Dame /ID# 245837

Charleroi, Hainaut, 6000, Belgium

Location

AZ Sint-Lucas /ID# 253708

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Dermatologie Maldegem /ID# 245840

Maldegem, Oost-Vlaanderen, 9990, Belgium

Location

CHU de Liege /ID# 245839

Liège, 4000, Belgium

Location

UMHAT Alexandrovska EAD /ID# 246594

Sofiya, Sofia, 1431, Bulgaria

Location

Medical center Cordis /ID# 253310

Pleven, 5800, Bulgaria

Location

Acibadem City Clinic Tokuda University Hospital EAD /ID# 246395

Sofia, 1407, Bulgaria

Location

Ambulatory for Specialized Medical Care for skin and venereal diseases /ID# 247027

Sofia, 1407, Bulgaria

Location

Medical Center Euroderma /ID# 246736

Sofia, 1606, Bulgaria

Location

Medical center EuroHealth /ID# 246305

Sofia, 1606, Bulgaria

Location

Dermatology Research Institute - Blackfoot Trail /ID# 246703

Calgary, Alberta, T2J 7E1, Canada

Location

Beacon Dermatology Inc /ID# 246705

Calgary, Alberta, T3A 2N1, Canada

Location

Rejuvenation Dermatology - Edmonton Downtown /ID# 256790

Edmonton, Alberta, T5J 3S9, Canada

Location

Alberta DermaSurgery Centre /ID# 247286

Edmonton, Alberta, T6G 1C3, Canada

Location

Dr. Chih-ho Hong Medical Inc. /ID# 246700

Surrey, British Columbia, V3R 6A7, Canada

Location

Lynde Institute for Dermatology /ID# 246699

Markham, Ontario, L3P 1X2, Canada

Location

SKiN Centre for Dermatology /ID# 246702

Peterborough, Ontario, K9J 5K2, Canada

Location

Private Practice - Dr. Kim Papp Clinical Research /ID# 246698

Waterloo, Ontario, N2J 1C4, Canada

Location

Beijing Friendship Hospital /ID# 247719

Beijing, Beijing Municipality, 100032, China

Location

Peking University Third Hospital /ID# 247842

Beijing, Beijing Municipality, 100191, China

Location

Dermatology Hospital of Southern Medical University /ID# 247951

Guangzhou, Guangdong, 510091, China

Location

The First Hospital of China Medical University /ID# 247686

Shenyang, Liaoning, 110001, China

Location

Huashan Hospital, Fudan University /ID# 247680

Shanghai, Shanghai Municipality, 200040, China

Location

Dermatologische Gemeinschaftspraxis Mahlow /ID# 245629

Blankenfelde-Mahlow, Brandenburg, 15831, Germany

Location

Klinikum Darmstadt /ID# 247028

Darmstadt, Hesse, 64283, Germany

Location

Universitaetsklinikum Frankfurt /ID# 245627

Frankfurt am Main, Hesse, 60590, Germany

Location

Fachklinik Bad Bentheim /ID# 245634

Bad Bentheim, Lower Saxony, 48455, Germany

Location

Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 245636

Bramsche, Lower Saxony, 49565, Germany

Location

Universitaetsklinikum Muenster /ID# 245623

Münster, North Rhine-Westphalia, 48149, Germany

Location

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 248413

Dresden, Saxony, 01307, Germany

Location

Elbe Klinikum Buxtehude /ID# 245626

Buxtehude, 21614, Germany

Location

Derma Study Center Friedrichshafen GmbH /ID# 245640

Friedrichshafen, 88045, Germany

Location

Universitaetsklinikum Halle (Saale) /ID# 245637

Halle, 06120, Germany

Location

Dermatologikum Hamburg /ID# 245635

Hamburg, 20354, Germany

Location

Dermatologie Quist-BAG Dres. med. Quist PartG /ID# 245628

Mainz, 55128, Germany

Location

Gyongyosi Bugat Pal Korhaz /ID# 246422

Gyöngyös, Heves County, 3200, Hungary

Location

Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 246428

Kaposvár, Somogy County, 7400, Hungary

Location

Clinexpert Kft /ID# 246427

Budapest, 1033, Hungary

Location

DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 246426

Debrecen, 4031, Hungary

Location

IRCCS Istituto Clinico Humanitas /ID# 246630

Rozzano, Lombardy, 20089, Italy

Location

Duplicate_Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 254355

Ancona, 60126, Italy

Location

Duplicate_ASST Spedali civili di Brescia /ID# 246631

Brescia, 25123, Italy

Location

Universita degli Studi Gabriele dAnnunzio /ID# 246629

Chieti, 66100, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 246634

Milan, 20122, Italy

Location

Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 246632

Perugia, 06156, Italy

Location

Miyata Dermatology Clinic /ID# 255491

Matsudo-Shi, Chiba, 271-0092, Japan

Location

Fukuoka University Hospital /ID# 255182

Fukuoka, Fukuoka, 814-0180, Japan

Location

Takagi Dermatological Clinic /ID# 255181

Obihiro-shi, Hokkaido, 080-0013, Japan

Location

Nomura Dermatology Clinic /ID# 255534

Yokohama, Kanagawa, 221-0825, Japan

Location

Tohoku University Hospital /ID# 255183

Sendai, Miyagi, 9808574, Japan

Location

Maruyama Dermatology Clinic /ID# 255441

Koto-ku, Tokyo, 136-0074, Japan

Location

Amphia Ziekenhuis /ID# 246397

Breda, North Brabant, 4818 CK, Netherlands

Location

Amsterdam UMC, locatie AMC /ID# 245673

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Greenlane Clinical Centre /ID# 246556

Epsom, Auckland, 1051, New Zealand

Location

Clinical Trials New Zealand /ID# 246557

Hamilton, Waikato Region, 3204, New Zealand

Location

Aotearoa Clinical Trials /ID# 246559

Auckland, 1640, New Zealand

Location

Duplicate_Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus /ID# 253508

Poznan, Greater Poland Voivodeship, 60-693, Poland

Location

Specjalistyczna Przychodnia Lekarska Alergo-Med sp. z o.o. /ID# 253846

Poznan, Greater Poland Voivodeship, 61-578, Poland

Location

Oftalmika sp. z o.o. /ID# 253429

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-631, Poland

Location

MICS Centrum Medyczne Torun /ID# 245749

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

Location

Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 245836

Krakow, Lesser Poland Voivodeship, 31-011, Poland

Location

CenterMed Krakow Sp. z o.o. /ID# 253940

Krakow, Lesser Poland Voivodeship, 31-530, Poland

Location

Klinika Ambroziak Sp. z o.o. /ID# 245748

Warsaw, Masovian Voivodeship, 02-953, Poland

Location

Royalderm Agnieszka Nawrocka /ID# 245746

Warsaw, Masovian Voivodeship, 02-962, Poland

Location

Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 245741

Gdansk, Pomeranian Voivodeship, 80-546, Poland

Location

Centrum Medyczne Pratia Gdynia /ID# 245835

Gdynia, Pomeranian Voivodeship, 81-338, Poland

Location

Silmedic Sp. z o.o. /ID# 253863

Katowice, Silesian Voivodeship, 40-282, Poland

Location

Dermed Centrum Medyczne Sp. z o.o /ID# 246329

Lodz, Łódź Voivodeship, 90-265, Poland

Location

Santa Sp. z o.o. Santa Familia Centrum Badan, Profilaktyki i Leczenia /ID# 253872

Lodz, Łódź Voivodeship, 90-302, Poland

Location

Centro Hospitalar de Lisboa Central /ID# 246247

Lisbon, 1169-050, Portugal

Location

Hospital CUF Descobertas /ID# 245702

Lisbon, 1998-018, Portugal

Location

Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 245701

Porto, 4099-001, Portugal

Location

Centro Hospitalar Universitario de Sao Joao, EPE /ID# 245704

Porto, 4200-319, Portugal

Location

Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 247515

Bratislava, 811 09, Slovakia

Location

BeneDerma s.r.o. /ID# 247513

Bratislava, 841 04, Slovakia

Location

Univerzitna nemocnica Martin /ID# 246948

Martin, Žilina Region, 036 01, Slovakia

Location

Korea University Ansan Hospital /ID# 245653

Ansan-si, Gyeonggido, 15355, South Korea

Location

Soon Chun Hyang University Hospital Bucheon /ID# 245654

Bucheon-si, Gyeonggido, 14584, South Korea

Location

Ajou University Hospital /ID# 245652

Suwon, Gyeonggido, 16499, South Korea

Location

Chungang University Hospital /ID# 245655

Dongjak-gu, Seoul Teugbyeolsi, 06973, South Korea

Location

Seoul National University Hospital /ID# 245651

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Konkuk University Medical Center /ID# 245657

Seoul, Seoul Teugbyeolsi, 05030, South Korea

Location

Hospital Universitario Germans Trias i Pujol /ID# 246320

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitari de Bellvitge /ID# 246326

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario Puerta de Hierro - Majadahonda /ID# 253820

Majadahonda, Madrid, 28222, Spain

Location

Hospital General Universitario de Alicante Doctor Balmis /ID# 246270

Alicante, 03010, Spain

Location

Hospital Universitario Infanta Leonor /ID# 246272

Madrid, 28031, Spain

Location

Hospital Universitario Ramon y Cajal /ID# 246273

Madrid, 28034, Spain

Location

Complejo Hospitalario Universitario de Pontevedra /ID# 246323

Pontevedra, 36071, Spain

Location

Hospital Universitario Virgen del Rocio /ID# 253822

Seville, 41013, Spain

Location

Kaohsiung Chang Gung Memorial Hospital /ID# 245710

Kaohsiung City, Kaohsiung, 833, Taiwan

Location

National Taiwan University Hospital /ID# 245711

Taipei City, Taipei, 100, Taiwan

Location

Chung Shan Medical University Hospital /ID# 245707

Taichung, 40201, Taiwan

Location

Mackay Memorial Hospital /ID# 245713

Taipei, 104, Taiwan

Location

Taipei Municipal Wan Fang Hospital /ID# 245712

Taipei, 116, Taiwan

Location

Linkou Chang Gung Memorial Hospital /ID# 245709

Taoyuan, 333, Taiwan

Location

University Hospital Southampton NHS Foundation Trust /ID# 246393

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

NHS Greater Glasgow and Clyde /ID# 246253

Glasgow, Scotland, G12 0XH, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust /ID# 246241

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Location

NHS Lothian /ID# 246245

Edinburgh, EH3 9HE, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 19, 2022
• Study Start: May 29, 2023
• Primary Completion: July 11, 2024
• Study Completion: August 15, 2024
• Last Updated: July 29, 2025
• Results First Posted: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

BE (5); DE (12); PL (13); IT (6); ES (8); GB (4); PT (4); HU (4); AU (5); KR (6); NZ (3); BU (6); TW (6); JP (6); NL (2); CN (5); CA (8); SL (3)