NCT03569293

Brief Summary

The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
912

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2018

Longer than P75 for phase_3

Geographic Reach
25 countries

180 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 13, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2021

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 3, 2022

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
Last Updated

October 24, 2025

Status Verified

October 1, 2025

Enrollment Period

2.4 years

First QC Date

June 14, 2018

Results QC Date

January 3, 2022

Last Update Submit

October 22, 2025

Conditions

Keywords

Atopic DermatitisUpadacitinib

Outcome Measures

Primary Outcomes (2)

  • Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16

    EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

    Baseline and Week 16

  • Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16

    The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale: * 0 - Clear: No inflammatory signs of AD; * 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification; * 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting; * 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present; * 4 - Severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present.

    Baseline and Week 16

Secondary Outcomes (44)

  • Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16

    Baseline (last available rolling average before the first dose of study drug) and Week 16

  • Main Study: Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16

    Baseline and Week 16

  • Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4

    Baseline (last available rolling average before the first dose of study drug) and Week 4

  • Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 2

    Baseline and Week 2

  • Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1

    Baseline (last available rolling average before the first dose of study drug) and Week 1

  • +39 more secondary outcomes

Study Arms (3)

Placebo / Upadacitinib

PLACEBO COMPARATOR

Participants will receive placebo orally once a day (QD) for 16 weeks in the double-blind treatment period. At Week 16 participants will be re-randomized to receive either upadacitinib 15 mg or upadacitinib 30 mg QD up to Week 260.

Drug: Placebo for UpadacitinibDrug: Upadacitinib

Upadacitinib 15 mg QD

EXPERIMENTAL

Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks.

Drug: Upadacitinib

Upadacitinib 30 mg QD

EXPERIMENTAL

Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks.

Drug: Upadacitinib

Interventions

Tablets taken orally once a day

Placebo / Upadacitinib

Tablets taken orally once a day

Also known as: ABT-494, RINVOQ™
Placebo / UpadacitinibUpadacitinib 15 mg QDUpadacitinib 30 mg QD

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Body weight of ≥ 40 kg at Baseline Visit for participants between ≥ 12 and \< 18 years of age
  • Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years before Baseline Visit and subject meets Hanifin and Rajka criteria.
  • Active moderate to severe AD defined by:
  • Eczema Area and Severity Index (EASI) score ≥ 16 at the Screening and Baseline Visits;
  • Validated Investigator's Global Assessment (vIGA) score ≥ 3 at the Screening and Baseline Visits;
  • ≥ 10% Body surface area (BSA) of AD involvement at the Screening and Baseline Visits;
  • Baseline weekly average of daily Worst Pruritus NRS ≥ 4.
  • Candidate for systemic therapy or have recently required systemic therapy for AD
  • Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days before the Baseline Visit.
  • Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months before Baseline Visit

You may not qualify if:

  • Prior exposure to any Janus kinase (JAK) inhibitor
  • Unable or unwilling to discontinue current atopic dermatitis treatments prior to the study
  • Requirement of prohibited medications during the study
  • Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
  • Female subject who is pregnant, breastfeeding, or considering pregnancy during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (180)

Alliance Dermatology and MOHs /ID# 200375

Phoenix, Arizona, 85032, United States

Location

Clear Dermatology & Aesthetics Center /ID# 201256

Scottsdale, Arizona, 85255-4134, United States

Location

Bakersfield Derma & Skin Cance /ID# 200433

Bakersfield, California, 93309, United States

Location

First OC Dermatology /ID# 201910

Fountain Valley, California, 92708-3701, United States

Location

California Allergy and Asthma Medical Group /ID# 200727

Los Angeles, California, 90025-7014, United States

Location

Allergy & Asthma Associates of Southern California /ID# 200733

Mission Viejo, California, 92691-6410, United States

Location

Dermatology Clinical Trials /ID# 205876

Newport Beach, California, 92660-7853, United States

Location

UC Davis /ID# 203622

Sacramento, California, 95817, United States

Location

Synergy Dermatology /ID# 200842

San Francisco, California, 94132-1909, United States

Location

San Luis Derm and Laser Clinic /ID# 200372

San Luis Obispo, California, 93405, United States

Location

Stanford University /ID# 200440

Stanford, California, 94305, United States

Location

Care Access Research - Walnut Creek /ID# 200940

Walnut Creek, California, 94598-2488, United States

Location

Dermatology Physicians of Connecticut /ID# 200928

Shelton, Connecticut, 06484-6211, United States

Location

Foxhall Research Center /ID# 213682

Washington D.C., District of Columbia, 20016-4300, United States

Location

Duplicate_George Washington Univ Med /ID# 200364

Washington D.C., District of Columbia, 20037, United States

Location

Clearlyderm Dermatology /ID# 208371

Boca Raton, Florida, 33428, United States

Location

Skin Care Research, LLC /ID# 200811

Boca Raton, Florida, 33486-2269, United States

Location

Olympian Clinical Research /ID# 202914

Clearwater, Florida, 33756, United States

Location

Multi-Speciality Research Associates /ID# 213254

Lake City, Florida, 32055-8835, United States

Location

GSI Clinical Research, LLC /ID# 200849

Margate, Florida, 33063, United States

Location

Florida International Rsrch cr /ID# 218507

Miami, Florida, 33173, United States

Location

Tory P Sullivan, MD PA /ID# 200671

North Miami Beach, Florida, 33162-4708, United States

Location

Leavitt Medical Associates of Florida /ID# 200880

Ormond Beach, Florida, 32174, United States

Location

Precision Clinical Research /ID# 209002

Sunrise, Florida, 33351-7311, United States

Location

Integrated Clinical Research LLC /ID# 200900

West Palm Beach, Florida, 33406-6063, United States

Location

Christie Clinic, LLC /ID# 200427

Champaign, Illinois, 61820, United States

Location

Northwestern University Feinberg School of Medicine /ID# 201644

Chicago, Illinois, 60611-2927, United States

Location

Dawes Fretzin, LLC /ID# 200366

Indianapolis, Indiana, 46256, United States

Location

The South Bend Clinic Center /ID# 200371

South Bend, Indiana, 46617, United States

Location

Clinical Trials Management, LLC - Covington /ID# 212658

Covington, Louisiana, 70433, United States

Location

Clinical Trials Management, LLC - Metairie /ID# 212659

Metairie, Louisiana, 70006-4165, United States

Location

Northeast Dermatology /ID# 201338

Beverly, Massachusetts, 01915, United States

Location

Massachusetts General Hospital /ID# 200474

Boston, Massachusetts, 02114, United States

Location

Integrated Dermatology of Massachusetts, LLC /ID# 209468

Quincy, Massachusetts, 02169, United States

Location

Clin Res Inst of Michigan, LLC /ID# 208019

Chesterfield, Michigan, 48047, United States

Location

Henry Ford Medical Center /ID# 204191

Detroit, Michigan, 48202-3046, United States

Location

Cleaver Dermatology /ID# 202825

Kirksville, Missouri, 63501-5362, United States

Location

Advanced Dermatology of the Midlands /ID# 201689

Omaha, Nebraska, 68144-1105, United States

Location

Clinical Research Consortium /ID# 200734

Las Vegas, Nevada, 89119-5190, United States

Location

AllCutis Research Inc /ID# 200981

Portsmouth, New Hampshire, 03801, United States

Location

Forest Hills Dermatology Group /ID# 209244

Kew Gardens, New York, 11415, United States

Location

Icahn School of Medicine at Mount Sinai /ID# 200370

New York, New York, 10029-6504, United States

Location

Montefiore Medical Center /ID# 200456

The Bronx, New York, 10467, United States

Location

J. Schwartz, MD, PLLC /ID# 202121

Troy, New York, 12180-2323, United States

Location

Velocity clinical research /ID# 202653

Cleveland, Ohio, 44122, United States

Location

Lynn Health Science Institute (LHSI) /ID# 212676

Oklahoma City, Oklahoma, 73112, United States

Location

Newton Clinical Research /ID# 204169

Oklahoma City, Oklahoma, 73120-5049, United States

Location

Oregon Medical Res Center PC /ID# 200428

Portland, Oregon, 97223, United States

Location

Oregon Health and Science University /ID# 200992

Portland, Oregon, 97239, United States

Location

Dermdox Dermatology Centers, PC /ID# 213782

Hazleton, Pennsylvania, 18201, United States

Location

Clinical Partners, LLC /ID# 200460

Johnston, Rhode Island, 02919, United States

Location

Coastal Clinical Research Center of the Carolinas /ID# 200402

Charleston, South Carolina, 29414, United States

Location

Arlington Research Center, Inc /ID# 200391

Arlington, Texas, 76011, United States

Location

Orion Clinical Research /ID# 204703

Austin, Texas, 78759-4100, United States

Location

Modern Research Associates, PL /ID# 200705

Dallas, Texas, 75231, United States

Location

Menter Dermatology Res Inst /ID# 200390

Dallas, Texas, 75246, United States

Location

Center for Clinical Studies - Webster TX /ID# 203185

Webster, Texas, 77598, United States

Location

Dermatology Specialists of Spokane /ID# 202068

Spokane, Washington, 99202, United States

Location

Framingham Centro Medico /ID# 202688

La Plata, Buenos Aires, 1902, Argentina

Location

Instituto de Neumonología y Dermatología /ID# 203444

Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1425, Argentina

Location

Psoriahue Med Interdisciplinar /ID# 202451

Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1425, Argentina

Location

Woden Dermatology /ID# 205799

Phillip, Australian Capital Territory, 2606, Australia

Location

Holdsworth House Medical Practice /ID# 211236

Darlinghurst, New South Wales, 2010, Australia

Location

North Eastern Health Specialists /ID# 205802

Hectorville, South Australia, 5073, Australia

Location

Skin Health Institute Inc /ID# 204791

Carlton, Victoria, 3053, Australia

Location

Fremantle Dermatology /ID# 205305

Fremantle, Western Australia, 6160, Australia

Location

University Clinical Centre of the Republic of Srpska /ID# 202666

Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina

Location

University Clinical Centre of the Republic of Srpska /ID# 202667

Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina

Location

Clinical Center University of Sarajevo /ID# 202668

Sarajevo, 71000, Bosnia and Herzegovina

Location

Clinical Center University of Sarajevo /ID# 202669

Sarajevo, 71000, Bosnia and Herzegovina

Location

UMHAT Alexandrovska EAD /ID# 201519

Sofiya, Sofia, 1431, Bulgaria

Location

UMHAT Dr Georgi Stranski EAD /ID# 201521

Pleven, 5800, Bulgaria

Location

UMHAT Professor Stoyan Kirkovich /ID# 201522

Stara Zagora, 6000, Bulgaria

Location

Kirk Barber Research, CA /ID# 200324

Calgary, Alberta, T2G 1B1, Canada

Location

Dermatology Research Institute Inc. /ID# 200318

Calgary, Alberta, T2J 7E1, Canada

Location

Dr. Chih-ho Hong Medical Inc. /ID# 200311

Surrey, British Columbia, V3R 6A7, Canada

Location

Enverus Medical Research /ID# 200307

Surrey, British Columbia, V3V 0C6, Canada

Location

Wiseman Dermatology Research /ID# 200323

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Dr. Irina Turchin PC Inc. /ID# 200322

Fredericton, New Brunswick, E3B 1G9, Canada

Location

Karma Clinical Trials /ID# 200316

St. John's, Newfoundland and Labrador, A1A 4Y3, Canada

Location

Hamilton Health Sciences - McMaster University Medical Centre /ID# 200313

Hamilton, Ontario, L8S 4K1, Canada

Location

Dr. Wei Jing Loo Medicine Prof /ID# 206051

London, Ontario, N6H 5L5, Canada

Location

Lynderm Research Inc. /ID# 200315

Markham, Ontario, L3P 1X2, Canada

Location

Dermatology Ottawa Research Centre /ID# 200319

Ottawa, Ontario, K2C 3N2, Canada

Location

K. Papp Clinical Research /ID# 200317

Waterloo, Ontario, N2J 1C4, Canada

Location

Innovaderm Research Inc. /ID# 200320

Montreal, Quebec, H2X 2V1, Canada

Location

Dr. David Gratton Dermat Inc. /ID# 200309

Montreal, Quebec, H3H 1V4, Canada

Location

Dre Angelique Gagne-Henley M.D. inc. /ID# 200326

Saint-Jérôme, Quebec, J7Z 7E2, Canada

Location

Peking University People's Hospital /ID# 202549

Beijing, Beijing Municipality, 100044, China

Location

Peking University Third Hospital /ID# 202612

Beijing, Beijing Municipality, 100191, China

Location

Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 208597

Guangzhou, Guangdong, 510120, China

Location

The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 202548

Guangzhou, Guangdong, 510630, China

Location

The First Hospital of China Medical University /ID# 202615

Shenyang, Liaoning, 110001, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 202554

Shanghai, Shanghai Municipality, 200065, China

Location

The second Affiliated hospital of Zhejiang University school of Medicine /ID# 202608

Hangzhou, Zhejiang, 310009, China

Location

Beijing Friendship Hospital /ID# 202601

Beijing, 100032, China

Location

Huashan Hospital of Fudan University /ID# 205760

Shanghai, 200040, China

Location

Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 208598

Wuhan, 420022, China

Location

Clinisalud del sur /ID# 218100

Medellín, Antioquia, 055422, Colombia

Location

Fundacion Hospital San Vicente de Paul - Rionegro /ID# 202043

Rionegro, Antioquia, 054040, Colombia

Location

Ctr Int de Reum del Caribe SAS /ID# 201620

Barranquilla, Atlántico, 80002, Colombia

Location

Fundacion Centro de Excelencia en Enfermedades Cronicas no Transmisibles - FUNCE /ID# 201905

Montería, Departamento de Córdoba, 230002, Colombia

Location

Klinicki bolnicki centar Zagreb /ID# 201879

Zagreb, City of Zagreb, 10000, Croatia

Location

Klinika za dječje bolesti Zagreb /ID# 203151

Zagreb, City of Zagreb, 10000, Croatia

Location

Duplicate_Klinicki bolnicki centar Osijek /ID# 201523

Osijek, County of Osijek-Baranja, 31000, Croatia

Location

Klinicki bolnicki centar Rijeka /ID# 217423

Rijeka, Primorje-Gorski Kotar County, 51000, Croatia

Location

Klinicki bolnicki centar Split /ID# 201527

Split, Split-Dalmatia County, 21000, Croatia

Location

Bispebjerg and Frederiksberg Hospital /ID# 200979

Copenhagen NV, Capital Region, 2400, Denmark

Location

Herlev and Gentofte Hospital /ID# 200736

Hellerup, Capital Region, 2900, Denmark

Location

Aarhus University Hospital /ID# 200737

Aarhus N, Central Jutland, 8200, Denmark

Location

North Estonia Medical Centre /ID# 200951

Mustamäe, Harju, 13419, Estonia

Location

Confido Private Medical Clinic /ID# 200846

Tallinn, Harju, 11313, Estonia

Location

Tartu University Hospital /ID# 200847

Tartu, Tartu, 50406, Estonia

Location

Mehiläinen Neo /ID# 201116

Turku, Southwest Finland, 20520, Finland

Location

Kuopio University Hospital /ID# 202449

Kuopio, 70210, Finland

Location

Terveystalo Tampere /ID# 201117

Tampere, 33100, Finland

Location

HCL - Hôpital Lyon Sud /ID# 201529

Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France

Location

CHU de Nantes, Hotel Dieu -HME /ID# 206377

Nantes, Pays de la Loire Region, 44000, France

Location

Centre Hospitalier du Mans /ID# 205991

Le Mans, Sarthe, 72037, France

Location

Hopital Saint Vincent de Paul /ID# 218253

Lille, 59020, France

Location

Le Bateau BLanc /ID# 206833

Martigues, 13500, France

Location

AP-HP - Hopital Necker /ID# 218364

Paris, 75015, France

Location

Hôpital Charles-Nicolle /ID# 201525

Rouen, 76000, France

Location

CHU Toulouse - Hopital Larrey /ID# 201528

Toulouse, 31400, France

Location

Duplicate_Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202087

Munich, Bavaria, 80802, Germany

Location

Universitaetsklinikum Frankfurt /ID# 202089

Frankfurt am Main, Hesse, 60590, Germany

Location

Universitaetsklinikum Muenster /ID# 202085

Münster, North Rhine-Westphalia, 48149, Germany

Location

CMS3 Company for Medical Study /ID# 205193

Selters, Rhineland-Palatinate, 56242, Germany

Location

Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202255

Kiel, Schleswig-Holstein, 24105, Germany

Location

Universitaetsklinikum Bonn /ID# 202086

Bonn, 53127, Germany

Location

TFS Trial Form Support GmbH /ID# 202083

Hamburg, 20537, Germany

Location

Medizinische Hochschule Hannover /ID# 202091

Hanover, 30625, Germany

Location

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205192

Mainz, 55131, Germany

Location

Fondazione PTV Policlinico Tor Vergata /ID# 201136

Rome, Roma, 00133, Italy

Location

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200692

Ancona, 60126, Italy

Location

A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 200746

Bologna, 40138, Italy

Location

A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200741

Catania, 95123, Italy

Location

Azienda Ospedaliera Universitaria Federico II /ID# 200750

Napoli, 80131, Italy

Location

Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 200695

Pisa, 56126, Italy

Location

Aichi Medical University Hospital /ID# 202833

Nagakute-shi, Aichi-ken, 480-1195, Japan

Location

Fukuoka University Hospital /ID# 201309

Fukuoka, Fukuoka, 814-0180, Japan

Location

Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers /ID# 202891

Fukuoka, Fukuoka, 815-8588, Japan

Location

Gifu University Hospital /ID# 201760

Gifu, Gifu, 501-1194, Japan

Location

Ogaki Municipal Hospital /ID# 203463

Ogaki-shi, Gifu, 503-8502, Japan

Location

Takagi Dermatology Clinic /ID# 201238

Obihiro-shi, Hokkaido, 080-0013, Japan

Location

Medical Cooperation Kojinkai Sapporo Skin Clinic /ID# 201239

Sapporo, Hokkaido, 060-0063, Japan

Location

University Hospital Kyoto Prefectural University of Medicine /ID# 201876

Kyoto, Kyoto, 602-8566, Japan

Location

Kume Clinic /ID# 201912

Sakai-shi, Osaka, 5938324, Japan

Location

NTT Medical Center Tokyo /ID# 201759

Shinagawa-ku, Tokyo, 141-8625, Japan

Location

University of Yamanashi Hospital /ID# 204174

Chuo-shi, Yamanashi, 409-3821, Japan

Location

Hospital Raja Permaisuri Bainun /ID# 204375

Ipoh, Perak, 30450, Malaysia

Location

Queen Elizabeth Hospital /ID# 204379

Division Pantai Barat Utara, Sabah, 88200, Malaysia

Location

Hospital Selayang /ID# 204378

Batu Caves, Selangor, 68100, Malaysia

Location

Clinical Trials NZ /ID# 205335

Hamilton, 3204, New Zealand

Location

Cruz-Santana, Carolina, PR /ID# 201096

Carolina, 00985, Puerto Rico

Location

Ponce Medical School Foundation /ID# 201821

Ponce, 00716-0377, Puerto Rico

Location

Clinical Research Puerto Rico /ID# 203309

San Juan, 00909, Puerto Rico

Location

Spitalul Clinic Colentina /ID# 205860

Bucharest, 020121, Romania

Location

Cabinet Medical de Dermatovenerologie Dr. Remus Orasan /ID# 205862

Cluj-Napoca, 400105, Romania

Location

Chelyabinsk Regional Clinical Dermatovenerologic Dispensary /ID# 201996

Chelyabinsk, Chelyabinsk Oblast, 454048, Russia

Location

Clinical Dermatovenerology Dispensary /ID# 203439

Krasnodar, Krasnodarskiy Kray, 350020, Russia

Location

Saratov State Medical University n.a. V.I. Razumovskiy /ID# 201595

Saratov, Saratov Oblast, 410012, Russia

Location

Ural Research Institute of dermatovenerology and immunopathology /ID# 201593

Yekaterinburg, Sverdlovsk Oblast, 620076, Russia

Location

National Medical Research Center for Children's Health /ID# 203440

Moscow, 119296, Russia

Location

Universitätsspital Basel /ID# 201599

Basel, Canton of Basel-City, 4031, Switzerland

Location

Hôpitaux Universitaires Genève /ID# 201600

Geneva, Canton of Geneva, 1205, Switzerland

Location

CHUV, Centre hospitalier universitaire vaudois /ID# 200910

Lausanne, Canton of Vaud, 1011, Switzerland

Location

CHUV, Centre hospitalier universitaire vaudois /ID# 206505

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Inselspital, Universitätsspital Bern /ID# 201598

Bern, 3010, Switzerland

Location

Erciyes University Medical Fac /ID# 204098

Melikgazi, Kayseri, 38030, Turkey (Türkiye)

Location

Hacettepe University Faculty of Medicine /ID# 204099

Ankara, 06100, Turkey (Türkiye)

Location

Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 204100

Istanbul, 34098, Turkey (Türkiye)

Location

Gazi Universitesi Tip Fakultes /ID# 204176

Yenimahalle, 06560, Turkey (Türkiye)

Location

Military Hospital of Military-Medical Clinical Center of Southern Region /ID# 201962

Zaporizhzhya, Zaporizhzhia Oblast, 69063, Ukraine

Location

ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 210504

Rivne, 33028, Ukraine

Location

West Middlesex University Hospital /ID# 202273

Isleworth, London, City of, TW7 6AF, United Kingdom

Location

Barts Health NHS Trust /ID# 201043

London, London, City of, E1 2ES, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust /ID# 201192

London, London, City of, SE1 9RT, United Kingdom

Location

Chelsea and Westminster Hospital NHS Foundation Trust9 /ID# 201971

London, SW10 9NH, United Kingdom

Location

Northern Care Alliance NHS Group /ID# 201194

Salford, M6 8HD, United Kingdom

Location

Related Publications (13)

  • Irvine AD, Prajapati VH, Guttman-Yassky E, Simpson EL, Papp KA, Blauvelt A, Chu CY, Hong HC, Gold LFS, de Bruin-Weller M, Bieber T, Kabashima K, Rosmarin D, Sancho C, Calimlim BM, Grada A, Yang Y, Wu X, Levy G, Raymundo EM, Teixeira HD, Silverberg JI. Efficacy and Safety of Upadacitinib in Patients With Moderate-to-Severe Atopic Dermatitis: Phase 3 Randomized Clinical Trial Results Through 140 Weeks. Am J Clin Dermatol. 2025 Nov;26(6):1003-1016. doi: 10.1007/s40257-025-00975-3. Epub 2025 Sep 3.

  • Burmester GR, Deodhar A, Irvine AD, Panaccione R, Winthrop KL, Vleugels RA, Levy G, Suravaram S, Palac H, Wegrzyn L, Ford S, Meerwein S, Guttman-Yassky E. Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease. Adv Ther. 2025 Oct;42(10):5215-5237. doi: 10.1007/s12325-025-03328-y. Epub 2025 Aug 28.

  • Simpson EL, Silverberg JI, Prajapati VH, Eyerich K, Katoh N, Boguniewicz M, Guttman-Yassky E, Song EJ, Lee WJ, Teixeira HD, Wu T, Sancho Sanchez C, Vigna N, Calimlim BM, de Bruin-Weller M. Rapid Itch Improvement and Skin Clearance with Upadacitinib Versus Placebo (Measure Up 1 and Measure Up 2) and Versus Dupilumab (Heads Up): Results from Three Phase 3 Clinical Trials in Patients with Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2025 Aug;15(8):2061-2076. doi: 10.1007/s13555-025-01443-w. Epub 2025 Jun 2.

  • Paller AS, Mendes-Bastos P, Siegfried E, Eichenfield LF, Soong W, Prajapati VH, Lio P, Simpson EL, Raymundo EM, Suravaram S, Hu X, Yang Y, Huang X, Calimlim BM, Platt AM, Su JC, Zheng M, Yamamoto-Hanada K, Teixeira HD, Irvine AD. Upadacitinib in Adolescents With Moderate to Severe Atopic Dermatitis: Analysis of 3 Phase 3 Randomized Clinical Trials Through 76 Weeks. JAMA Dermatol. 2024 Dec 1;160(12):1304-1313. doi: 10.1001/jamadermatol.2024.3696.

  • Blauvelt A, Eyerich K, Irvine AD, de Bruin-Weller M, Kwatra SG, Gooderham M, Kim B, Calimlim BM, Lee WJ, Raymundo EM, Liu Y, Ofori S, Platt AM, Silverberg JI. More Time Spent with Clear Skin and No Itch with Upadacitinib versus Dupilumab for Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Sep;14(9):2621-2630. doi: 10.1007/s13555-024-01242-9. Epub 2024 Aug 7.

  • Simpson EL, Prajapati VH, Leshem YA, Chovatiya R, de Bruin-Weller MS, Stander S, Pink AE, Calimlim BM, Lee WJ, Teixeira H, Ladizinski B, Hu X, Yang Y, Liu Y, Liu M, Grada A, Platt AM, Silverberg JI. Upadacitinib Rapidly Improves Patient-Reported Outcomes in Atopic Dermatitis: 16-Week Results from Phase 3 Clinical Trials (Measure Up 1 and 2). Dermatol Ther (Heidelb). 2024 May;14(5):1127-1144. doi: 10.1007/s13555-024-01157-5. Epub 2024 May 2.

  • Silverberg JI, Gooderham MJ, Paller AS, Deleuran M, Bunick CG, Gold LFS, Hijnen D, Calimlim BM, Lee WJ, Teixeira HD, Hu X, Zhang S, Yang Y, Grada A, Platt AM, Thaci D. Early and Sustained Improvements in Symptoms and Quality of Life with Upadacitinib in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: 52-Week Results from Two Phase III Randomized Clinical Trials (Measure Up 1 and Measure Up 2). Am J Clin Dermatol. 2024 May;25(3):485-496. doi: 10.1007/s40257-024-00853-4. Epub 2024 Mar 25.

  • Thyssen JP, Thaci D, Bieber T, Gooderham M, de Bruin-Weller M, Soong W, Kabashima K, Barbarot S, Luna PC, Xu J, Hu X, Liu Y, Raymundo EM, Calimlim BM, Nduaka C, Gamelli A, Simpson EL. Upadacitinib for moderate-to-severe atopic dermatitis: Stratified analysis from three randomized phase 3 trials by key baseline characteristics. J Eur Acad Dermatol Venereol. 2023 Sep;37(9):1871-1880. doi: 10.1111/jdv.19232. Epub 2023 Jun 21.

  • Paller AS, Ladizinski B, Mendes-Bastos P, Siegfried E, Soong W, Prajapati VH, Lio P, Thyssen JP, Simpson EL, Platt AM, Raymundo EM, Liu J, Calimlim BM, Huang X, Gu Y, Hu X, Yang Y, Su JC, Zheng M, Yamamoto-Hanada K, Teixeira HD, Irvine AD. Efficacy and Safety of Upadacitinib Treatment in Adolescents With Moderate-to-Severe Atopic Dermatitis: Analysis of the Measure Up 1, Measure Up 2, and AD Up Randomized Clinical Trials. JAMA Dermatol. 2023 May 1;159(5):526-535. doi: 10.1001/jamadermatol.2023.0391.

  • Burmester GR, Cohen SB, Winthrop KL, Nash P, Irvine AD, Deodhar A, Mysler E, Tanaka Y, Liu J, Lacerda AP, Palac H, Shaw T, Mease PJ, Guttman-Yassky E. Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. 2023 Feb;9(1):e002735. doi: 10.1136/rmdopen-2022-002735.

  • Mendes-Bastos P, Ladizinski B, Guttman-Yassky E, Jiang P, Liu J, Prajapati VH, Simpson EL, Vigna N, Teixeira HD, Barbarot S. Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis: A post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials. J Am Acad Dermatol. 2022 Oct;87(4):784-791. doi: 10.1016/j.jaad.2022.06.012. Epub 2022 Jun 15.

  • Simpson EL, Papp KA, Blauvelt A, Chu CY, Hong HC, Katoh N, Calimlim BM, Thyssen JP, Chiou AS, Bissonnette R, Stein Gold LF, Wegzyn C, Hu X, Liu M, Liu J, Tenorio AR, Chu AD, Guttman-Yassky E. Efficacy and Safety of Upadacitinib in Patients With Moderate to Severe Atopic Dermatitis: Analysis of Follow-up Data From the Measure Up 1 and Measure Up 2 Randomized Clinical Trials. JAMA Dermatol. 2022 Apr 1;158(4):404-413. doi: 10.1001/jamadermatol.2022.0029.

  • Guttman-Yassky E, Teixeira HD, Simpson EL, Papp KA, Pangan AL, Blauvelt A, Thaci D, Chu CY, Hong HC, Katoh N, Paller AS, Calimlim B, Gu Y, Hu X, Liu M, Yang Y, Liu J, Tenorio AR, Chu AD, Irvine AD. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. Lancet. 2021 Jun 5;397(10290):2151-2168. doi: 10.1016/S0140-6736(21)00588-2. Epub 2021 May 21.

Related Links

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie

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 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

June 14, 2018

First Posted

June 26, 2018

Study Start

August 13, 2018

Primary Completion

January 6, 2021

Study Completion

October 10, 2025

Last Updated

October 24, 2025

Results First Posted

February 3, 2022

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
More information

Locations