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

NCT ID: NCT05507580

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 461 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-29
• Study Completion Date: 2024-08-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Upadacitinib

Intervention Type: DRUG

Oral tablet

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.

Group Type: EXPERIMENTAL

Upadacitinib

Intervention Type: DRUG

Oral tablet

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.

Group Type: EXPERIMENTAL

Upadacitinib

Intervention Type: DRUG

Oral tablet

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.

Group Type: EXPERIMENTAL

Upadacitinib

Intervention Type: DRUG

Oral tablet

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.

Group Type: EXPERIMENTAL

Upadacitinib

Intervention Type: DRUG

Oral tablet

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.

Group Type: EXPERIMENTAL

Upadacitinib

Intervention Type: DRUG

Oral tablet

Interventions

Upadacitinib

Oral tablet

Intervention Type: DRUG

Other Intervention Names

RINVOQ; ABT-494

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Momentum Clinical Research /ID# 254028

Darlinghurst, New South Wales, Australia

Premier Specialist /ID# 246150

Kogarah, New South Wales, Australia

Veracity Clinical Research /ID# 246154

Woolloongabba, Queensland, Australia

North Eastern Health Specialists /ID# 246153

Campbelltown, South Australia, Australia

Skin Health Institute Inc /ID# 246146

Carlton, Victoria, Australia

Cliniques Universitaires UCL Saint-Luc /ID# 245842

Woluwe-Saint-Lambert, Brussels Capital, Belgium

Grand Hôpital De Charleroi - Notre Dame /ID# 245837

Charleroi, Hainaut, Belgium

AZ Sint-Lucas /ID# 253708

Ghent, Oost-Vlaanderen, Belgium

Dermatologie Maldegem /ID# 245840

Maldegem, Oost-Vlaanderen, Belgium

CHU de Liege /ID# 245839

Liège, , Belgium

UMHAT Alexandrovska EAD /ID# 246594

Sofiya, Sofia, Bulgaria

Medical center Cordis /ID# 253310

Pleven, , Bulgaria

Acibadem City Clinic Tokuda University Hospital EAD /ID# 246395

Sofia, , Bulgaria

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

Sofia, , Bulgaria

Medical Center Euroderma /ID# 246736

Sofia, , Bulgaria

Medical center EuroHealth /ID# 246305

Sofia, , Bulgaria

Dermatology Research Institute - Blackfoot Trail /ID# 246703

Calgary, Alberta, Canada

Beacon Dermatology Inc /ID# 246705

Calgary, Alberta, Canada

Rejuvenation Dermatology - Edmonton Downtown /ID# 256790

Edmonton, Alberta, Canada

Alberta DermaSurgery Centre /ID# 247286

Edmonton, Alberta, Canada

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

Surrey, British Columbia, Canada

Lynde Institute for Dermatology /ID# 246699

Markham, Ontario, Canada

SKiN Centre for Dermatology /ID# 246702

Peterborough, Ontario, Canada

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

Waterloo, Ontario, Canada

Beijing Friendship Hospital /ID# 247719

Beijing, Beijing Municipality, China

Peking University Third Hospital /ID# 247842

Beijing, Beijing Municipality, China

Dermatology Hospital of Southern Medical University /ID# 247951

Guangzhou, Guangdong, China

The First Hospital of China Medical University /ID# 247686

Shenyang, Liaoning, China

Huashan Hospital, Fudan University /ID# 247680

Shanghai, Shanghai Municipality, China

Dermatologische Gemeinschaftspraxis Mahlow /ID# 245629

Blankenfelde-Mahlow, Brandenburg, Germany

Klinikum Darmstadt /ID# 247028

Darmstadt, Hesse, Germany

Universitaetsklinikum Frankfurt /ID# 245627

Frankfurt am Main, Hesse, Germany

Fachklinik Bad Bentheim /ID# 245634

Bad Bentheim, Lower Saxony, Germany

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

Bramsche, Lower Saxony, Germany

Universitaetsklinikum Muenster /ID# 245623

Münster, North Rhine-Westphalia, Germany

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 248413

Dresden, Saxony, Germany

Elbe Klinikum Buxtehude /ID# 245626

Buxtehude, , Germany

Derma Study Center Friedrichshafen GmbH /ID# 245640

Friedrichshafen, , Germany

Universitaetsklinikum Halle (Saale) /ID# 245637

Halle, , Germany

Dermatologikum Hamburg /ID# 245635

Hamburg, , Germany

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

Mainz, , Germany

Gyongyosi Bugat Pal Korhaz /ID# 246422

Gyöngyös, Heves County, Hungary

Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 246428

Kaposvár, Somogy County, Hungary

Clinexpert Kft /ID# 246427

Budapest, , Hungary

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

Debrecen, , Hungary

IRCCS Istituto Clinico Humanitas /ID# 246630

Rozzano, Lombardy, Italy

Duplicate_Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 254355

Ancona, , Italy

Duplicate_ASST Spedali civili di Brescia /ID# 246631

Brescia, , Italy

Universita degli Studi Gabriele dAnnunzio /ID# 246629

Chieti, , Italy

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

Milan, , Italy

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

Perugia, , Italy

Miyata Dermatology Clinic /ID# 255491

Matsudo-Shi, Chiba, Japan

Fukuoka University Hospital /ID# 255182

Fukuoka, Fukuoka, Japan

Takagi Dermatological Clinic /ID# 255181

Obihiro-shi, Hokkaido, Japan

Nomura Dermatology Clinic /ID# 255534

Yokohama, Kanagawa, Japan

Tohoku University Hospital /ID# 255183

Sendai, Miyagi, Japan

Maruyama Dermatology Clinic /ID# 255441

Koto-ku, Tokyo, Japan

Amphia Ziekenhuis /ID# 246397

Breda, North Brabant, Netherlands

Amsterdam UMC, locatie AMC /ID# 245673

Amsterdam, North Holland, Netherlands

Greenlane Clinical Centre /ID# 246556

Epsom, Auckland, New Zealand

Clinical Trials New Zealand /ID# 246557

Hamilton, Waikato Region, New Zealand

Aotearoa Clinical Trials /ID# 246559

Auckland, , New Zealand

Duplicate_Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus /ID# 253508

Poznan, Greater Poland Voivodeship, Poland

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

Poznan, Greater Poland Voivodeship, Poland

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

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

MICS Centrum Medyczne Torun /ID# 245749

Torun, Kuyavian-Pomeranian Voivodeship, Poland

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

Krakow, Lesser Poland Voivodeship, Poland

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

Krakow, Lesser Poland Voivodeship, Poland

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

Warsaw, Masovian Voivodeship, Poland

Royalderm Agnieszka Nawrocka /ID# 245746

Warsaw, Masovian Voivodeship, Poland

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

Gdansk, Pomeranian Voivodeship, Poland

Centrum Medyczne Pratia Gdynia /ID# 245835

Gdynia, Pomeranian Voivodeship, Poland

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

Katowice, Silesian Voivodeship, Poland

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

Lodz, Łódź Voivodeship, Poland

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

Lodz, Łódź Voivodeship, Poland

Centro Hospitalar de Lisboa Central /ID# 246247

Lisbon, , Portugal

Hospital CUF Descobertas /ID# 245702

Lisbon, , Portugal

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

Porto, , Portugal

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

Porto, , Portugal

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

Bratislava, , Slovakia

BeneDerma s.r.o. /ID# 247513

Bratislava, , Slovakia

Univerzitna nemocnica Martin /ID# 246948

Martin, Žilina Region, Slovakia

Korea University Ansan Hospital /ID# 245653

Ansan-si, Gyeonggido, South Korea

Soon Chun Hyang University Hospital Bucheon /ID# 245654

Bucheon-si, Gyeonggido, South Korea

Ajou University Hospital /ID# 245652

Suwon, Gyeonggido, South Korea

Chungang University Hospital /ID# 245655

Dongjak-gu, Seoul Teugbyeolsi, South Korea

Seoul National University Hospital /ID# 245651

Seoul, Seoul Teugbyeolsi, South Korea

Konkuk University Medical Center /ID# 245657

Seoul, Seoul Teugbyeolsi, South Korea

Hospital Universitario Germans Trias i Pujol /ID# 246320

Badalona, Barcelona, Spain

Hospital Universitari de Bellvitge /ID# 246326

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Puerta de Hierro - Majadahonda /ID# 253820

Majadahonda, Madrid, Spain

Hospital General Universitario de Alicante Doctor Balmis /ID# 246270

Alicante, , Spain

Hospital Universitario Infanta Leonor /ID# 246272

Madrid, , Spain

Hospital Universitario Ramon y Cajal /ID# 246273

Madrid, , Spain

Complejo Hospitalario Universitario de Pontevedra /ID# 246323

Pontevedra, , Spain

Hospital Universitario Virgen del Rocio /ID# 253822

Seville, , Spain

Kaohsiung Chang Gung Memorial Hospital /ID# 245710

Kaohsiung City, Kaohsiung, Taiwan

National Taiwan University Hospital /ID# 245711

Taipei City, Taipei, Taiwan

Chung Shan Medical University Hospital /ID# 245707

Taichung, , Taiwan

Mackay Memorial Hospital /ID# 245713

Taipei, , Taiwan

Taipei Municipal Wan Fang Hospital /ID# 245712

Taipei, , Taiwan

Linkou Chang Gung Memorial Hospital /ID# 245709

Taoyuan, , Taiwan

University Hospital Southampton NHS Foundation Trust /ID# 246393

Southampton, Hampshire, United Kingdom

NHS Greater Glasgow and Clyde /ID# 246253

Glasgow, Scotland, United Kingdom

Leeds Teaching Hospitals NHS Trust /ID# 246241

Leeds, West Yorkshire, United Kingdom

NHS Lothian /ID# 246245

Edinburgh, , United Kingdom

Countries

Australia; Belgium; Bulgaria; Canada; China; Germany; Hungary; Italy; Japan; Netherlands; New Zealand; Poland; Portugal; Slovakia; South Korea; Spain; Taiwan; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.rxabbvie.com/

Related Info

Other Identifiers

2022-000434-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M22-000

Identifier Type: -

Identifier Source: org_study_id