NCT03607422

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 Jul 2018

Longer than P75 for phase_3

Geographic Reach
22 countries

192 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

July 25, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

July 27, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2021

Completed
1 year until next milestone

Results Posted

Study results publicly available

March 28, 2022

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2025

Completed
Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

2.6 years

First QC Date

July 25, 2018

Results QC Date

March 1, 2022

Last Update Submit

November 18, 2025

Conditions

Keywords

Atopic DermatitisUpadacitinibABT-494Measure Up 2

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, no oozing or crusting; * 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 ≥ 12 and \< 18 years of age
  • Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline and subject meets Hanifin and Rajka criteria
  • Active moderate to severe AD defined by Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, body surface area (BSA) affected by AD ≥ 10%, and weekly average of daily Worst Pruritus numerical rating scale (NRS) score ≥ 4.
  • Candidate for systemic therapy or have recently required systemic therapy for AD
  • Documented history (within 6 months prior to Baseline) of inadequate response to topical corticosteroid (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD or for whom topical treatments are otherwise medically inadvisable due to side effects or safety risks

You may not qualify if:

  • Prior exposure to any Janus kinase (JAK) inhibitor
  • Unable or unwilling to discontinue current AD 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 (196)

Total Skin and Beauty Derm Ctr /ID# 205129

Birmingham, Alabama, 35205, United States

Location

Medical Dermatology Specialist /ID# 205516

Phoenix, Arizona, 85006-2722, United States

Location

Arizona Research Center, Inc. /ID# 205795

Phoenix, Arizona, 85053-4061, United States

Location

The Dermatology Clinic of Arkansas /ID# 218749

Bryant, Arkansas, 72022-7514, United States

Location

Arkansas Research Trials /ID# 218469

North Little Rock, Arkansas, 72117, United States

Location

Encino Research Center /ID# 207472

Encino, California, 91436, United States

Location

University of California Irvine /ID# 205136

Irvine, California, 92697-1385, United States

Location

Ark Clinical Research /ID# 218193

Long Beach, California, 90806-2325, United States

Location

Keck School of Medicine of USC /ID# 206971

Los Angeles, California, 90033, United States

Location

Wallace Medical Group /ID# 205701

Los Angeles, California, 90056, United States

Location

Child Hosp of Orange County,CA /ID# 205735

Orange, California, 92868, United States

Location

Palmtree Clinical Research Inc. /Id# 206184

Palm Springs, California, 92262, United States

Location

Rady Children's Hospital San Diego /ID# 208244

San Diego, California, 92123, United States

Location

Southern California Derma. Inc /ID# 205734

Santa Ana, California, 92701, United States

Location

Innovative Clinical Research - Lafayette /ID# 208400

Lafayette, Colorado, 80026, United States

Location

New England Research Associates, LLC /ID# 206896

Bridgeport, Connecticut, 06606-1827, United States

Location

Ideal Clinical Research Inc. /ID# 209880

Aventura, Florida, 33180, United States

Location

Skin Care Research, LLC /ID# 207099

Boca Raton, Florida, 33486-2269, United States

Location

Midflorida Clinical Research, Inc. /ID# 213700

Brandon, Florida, 33511-5335, United States

Location

Clinical Research of West Florida, Inc /ID# 206146

Clearwater, Florida, 33765, United States

Location

Revival Research /ID# 208383

Doral, Florida, 33122-1902, United States

Location

Universal Axon Clinical Research /ID# 213703

Doral, Florida, 33166, United States

Location

Lakes Research, LLC /ID# 209156

Miami, Florida, 33014, United States

Location

Miami Dade Medical Research Institute /ID# 209413

Miami, Florida, 33176, United States

Location

Savin Medical Group, LLC /ID# 206902

Miami Lakes, Florida, 33014-2490, United States

Location

Floridian Clinical Research /ID# 207433

Miami Lakes, Florida, 33016-1842, United States

Location

Advanced Research for Health Improvement /ID# 217987

Naples, Florida, 34102-5430, United States

Location

Advanced Research for Health Improvement /ID# 218003

Naples, Florida, 34102-5430, United States

Location

Complete Health Research /ID# 213459

Ormond Beach, Florida, 32174-6302, United States

Location

Precision Clinical Research /ID# 207364

Sunrise, Florida, 33351-7311, United States

Location

Clinical Research Trials of Florida, Inc. /ID# 206840

Tampa, Florida, 33607, United States

Location

ForCare Clinical Research /ID# 205120

Tampa, Florida, 33613-1244, United States

Location

Georgia Pollens Clinical Research Centers, Inc /ID# 218567

Albany, Georgia, 31707-1282, United States

Location

Marietta Dermatology Clinical Research /ID# 210317

Marietta, Georgia, 30060-1047, United States

Location

Agile Clinical Research Trials /ID# 218080

Sandy Springs, Georgia, 30342, United States

Location

Treasure Valley Medical Research /ID# 210298

Boise, Idaho, 83706, United States

Location

Great Lakes Clinical Trials /ID# 205830

Chicago, Illinois, 60640, United States

Location

Ashira Dermatology /ID# 205512

Gurnee, Illinois, 60031-3393, United States

Location

Clinical Investigation Specialists, Inc. /ID# 206898

Gurnee, Illinois, 60031, United States

Location

Northshore University Health System Dermatology Clinical Trials Unit /ID# 205135

Skokie, Illinois, 60077, United States

Location

Raga Clinical Studies, LLC. /ID# 206749

Crown Point, Indiana, 46307, United States

Location

Hutchinson Clinic /ID# 205970

Hutchinson, Kansas, 67502-1131, United States

Location

Continental Clinical Solutions /ID# 210327

Towson, Maryland, 21204, United States

Location

Beacon Clinical Research, LLC /ID# 206894

Quincy, Massachusetts, 02169, United States

Location

David Fivenson, MD, PLC /ID# 206903

Ann Arbor, Michigan, 48103, United States

Location

University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 206895

Ann Arbor, Michigan, 48109, United States

Location

Allergy, Asthma & Immunology Associates, PC /ID# 218169

Lincoln, Nebraska, 68505-2343, United States

Location

Skin Specialists, PC /ID# 205515

Omaha, Nebraska, 68144, United States

Location

Duplicate_Summit Medical Group /ID# 213863

Clifton, New Jersey, 07012-1647, United States

Location

Skin Laser and Surgery Specialists of NY and NJ /ID# 206754

Hackensack, New Jersey, 07601-1997, United States

Location

Care Access Research /ID# 218476

Hoboken, New Jersey, 07030-2757, United States

Location

University of New Mexico School of Medicine /ID# 206756

Albuquerque, New Mexico, 87131-0001, United States

Location

Fordham Dermatology /ID# 218508

The Bronx, New York, 10458-5046, United States

Location

PMG Research of Wilmington LLC /ID# 205968

Wilmington, North Carolina, 28401, United States

Location

University Hospitals Case Medical Center /ID# 206639

Cleveland, Ohio, 44106, United States

Location

Awasty Research Network, LLC /ID# 206748

Marion, Ohio, 43302-6225, United States

Location

Southside Dermatology /ID# 214451

Tulsa, Oklahoma, 74132, United States

Location

Vital Prospects Clinical Research Institute, PC /ID# 205824

Tulsa, Oklahoma, 74136-7049, United States

Location

Cyn3rgy Research /ID# 218064

Gresham, Oregon, 97030-8316, United States

Location

Velocity Clinical Research Hallandale Beach /ID# 207544

Medford, Oregon, 97504, United States

Location

Clinical Research Solutions, LLC /ID# 218416

Jackson, Tennessee, 38305-2163, United States

Location

Stones River Dermatology /ID# 205178

Murfreesboro, Tennessee, 37129-3194, United States

Location

Metroplex Dermatology /ID# 213307

Arlington, Texas, 76014-3105, United States

Location

Bellaire Dermatology /ID# 205470

Bellaire, Texas, 77401, United States

Location

Center for Clinical Studies /ID# 213186

Cypress, Texas, 77433, United States

Location

Dermatology Treatment and Research Center, PA /ID# 205473

Dallas, Texas, 75230, United States

Location

Epiphany Dermatology - Fort Worth /ID# 210073

Fort Worth, Texas, 76244-6548, United States

Location

Styde Research, LLC /ID# 213469

Lewisville, Texas, 75067, United States

Location

Austin Institute for Clinical Research /ID# 206640

Pflugerville, Texas, 78660, United States

Location

Derm Clin Res Ctr San Antonio /ID# 205469

San Antonio, Texas, 78229, United States

Location

EPIC Medical Research /ID# 206382

Murray, Utah, 84123-5632, United States

Location

Aspen Clinical Research /ID# 208399

Orem, Utah, 84058, United States

Location

Timber Lane Allergy & Asthma Research, LLC /ID# 206897

South Burlington, Vermont, 05403-7204, United States

Location

The Education & Research Foundation, Inc. /ID# 206900

Lynchburg, Virginia, 24501-1403, United States

Location

Bellingham Asthma Allergy and Immunology Clinic /ID# 210357

Bellingham, Washington, 98225-1945, United States

Location

Clinical Investigation Specialist, Inc - Kenosha /ID# 215933

Kenosha, Wisconsin, 53144-1782, United States

Location

The Skin Hospital /ID# 217846

Westmead, New South Wales, 2145, Australia

Location

The Skin Centre /ID# 205922

Benowa, Queensland, 4217, Australia

Location

Box Hill Hospital /ID# 206023

Box Hill, Victoria, 3128, Australia

Location

Monash Children's Hospital /ID# 217917

Clayton, Victoria, 3168, Australia

Location

Sinclair Dermatology /ID# 217791

East Melbourne, Victoria, 3002, Australia

Location

The Royal Melbourne Hospital /ID# 205919

Parkville, Victoria, 3050, Australia

Location

Murdoch Children's Research Institute /ID# 205667

Parkville, Victoria, 3052, Australia

Location

Universitaetsklinikum St. Poelten /ID# 206909

Sankt Pölten, Lower Austria, 3100, Austria

Location

Ordensklinikum Linz GmbH Elisabethinen /ID# 206573

Linz, Upper Austria, 4010, Austria

Location

Klinik Donaustadt /ID# 206572

Vienna, Vienna, 1220, Austria

Location

Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 208281

Salzburg, 5020, Austria

Location

UCL Saint-Luc /ID# 205537

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

Location

UZ Gent /ID# 205181

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 204938

Liège, 4000, Belgium

Location

Medical center Sveti Panteleimon /ID# 210414

Sofia, 1000, Bulgaria

Location

Acibadem City Clinic Tokuda University Hospital EAD /ID# 205292

Sofia, 1407, Bulgaria

Location

Military Medical Academy Multiprofile Hospital /ID# 205291

Sofia, 1606, Bulgaria

Location

Medical complex Doverie /ID# 211289

Sofia, 1632, Bulgaria

Location

Stratica Medical /ID# 205415

Edmonton, Alberta, T5K 1X3, Canada

Location

Alberta DermaSurgery Centre /ID# 205422

Edmonton, Alberta, T6G 1C3, Canada

Location

UBC Department of Dermatology and Skin Science The Skin Care Centre /ID# 207837

Vancouver, British Columbia, V5Z 4E8, Canada

Location

Pacific Derm /ID# 206797

Vancouver, British Columbia, V6H 4E1, Canada

Location

Skin Care Studio /ID# 205420

St. John's, Newfoundland and Labrador, A1E 1V4, Canada

Location

SimcoDerm Medical and Surgical Dermatology Center /ID# 206333

Barrie, Ontario, L4M 7G1, Canada

Location

Kingsway Clinical Research /ID# 206005

Etobicoke, Ontario, M8X 1Y9, Canada

Location

Dr. Lyne Giroux Medicine Professional Corporation /ID# 206771

Greater Sudbury, Ontario, P3C 1X8, Canada

Location

Dr. Dusan Sajic Medicine Professional Corporation /ID# 206890

Guelph, Ontario, N1L 0B7, Canada

Location

The Guenther Dermatology Research Centre /ID# 206772

London, Ontario, N6A 3H7, Canada

Location

DermEdge Research Inc. /ID# 206036

Mississauga, Ontario, L5H 1G9, Canada

Location

Dr. S.K. Siddha Medicine Professional Corporation /ID# 207138

Newmarket, Ontario, L3Y 5G8, Canada

Location

Allergy Research Canada Inc. /ID# 213547

Niagara Falls, Ontario, L2H 1H5, Canada

Location

Niakosari Medicine Professional Corporation /ID# 206004

Toronto, Ontario, M2M 4J5, Canada

Location

Skinsense Medical Research /ID# 206873

Saskatoon, Saskatchewan, S7K 0H6, Canada

Location

DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 205429

Zagreb, City of Zagreb, 10000, Croatia

Location

Djecja bolnica Srebrnjak /ID# 205926

Zagreb, City of Zagreb, 10000, Croatia

Location

Poliklinika Vlatka Cavka d.o.o. /ID# 211126

Zagreb, City of Zagreb, 10000, Croatia

Location

Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 203448

Ivanić-Grad, Zagreb County, 10310, Croatia

Location

Fakultni nemocnice Plzen /ID# 205096

Pilsen, 305 99, Czechia

Location

Sanatorium profesora Arenbergera /ID# 205098

Prague, 110 00, Czechia

Location

Vseobecna fakultni nemocnice v Praze /ID# 205201

Prague, 128 08, Czechia

Location

Fakultni Nemocnice v Motole /ID# 218192

Prague, 150 06, Czechia

Location

Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o. z. /ID# 205097

Ústí nad Labem, 400 11, Czechia

Location

Aarhus University Hospital /ID# 205524

Aarhus N, Central Jutland, 8200, Denmark

Location

Sjællands Universitetshospital /ID# 205960

Roskilde, Region Sjælland, 4000, Denmark

Location

Hopital Saint-Andre /ID# 206554

Bordeaux, 33075, France

Location

CHRU de Brest - Hopital Morvan /ID# 206555

Brest, 29200, France

Location

C.H. de Bretagne Sud /ID# 206910

Lorient, 56322, France

Location

AP-HP - Hopital Saint-Louis /ID# 206552

Paris, 75010, France

Location

Hopital Prive d'Antony /ID# 206553

Antony, Île-de-France Region, 92160, France

Location

Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 206658

Kiel, Schleswig-Holstein, 24105, Germany

Location

Klinikum Darmstadt /ID# 207483

Darmstadt, 64283, Germany

Location

Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 205767

Dresden, 01307, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 207982

Hamburg, 20246, Germany

Location

Dermatologische Gemeinschaftspraxis Mahlow /ID# 205765

Mahlow, 15831, Germany

Location

Haut- und Laserzentrum Hunsrück /ID# 205768

Simmern, 55469, Germany

Location

Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 205766

Witten, 58453, Germany

Location

CentroDerm GmbH /ID# 206861

Wuppertal, 42287, Germany

Location

251 Airforce General Hospital /ID# 205841

Athens, Attica, 11525, Greece

Location

401 GSNA - 401 Army General Hospital /ID# 205352

Athens, Attica, 11525, Greece

Location

General Hospital Andreas Syggros /ID# 204527

Athens, Attica, 16121, Greece

Location

Papageorgiou General Hospital Thessaloniki /ID# 204526

Stavroupoli (Thessalonikis), Thessaloniki, 55536, Greece

Location

Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 218072

Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary

Location

Bugat Pal Korhaz /ID# 211247

Gyöngyös, Heves County, 3200, Hungary

Location

Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 205611

Kaposvár, Somogy County, 7400, Hungary

Location

Drug Research Center /ID# 217855

Balatonfüred, Veszprém megye, 8230, Hungary

Location

Clinexpert Kft /ID# 211246

Budapest, 1033, Hungary

Location

Synexus Magyarorszag Kft. /ID# 206008

Budapest, 1036, Hungary

Location

Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 205085

Pécs, 7624, Hungary

Location

St James Hospital /ID# 204264

Dublin, Dublin, D08 NHY1, Ireland

Location

South Infirmary Victoria University Hospital /ID# 204265

Cork, T12 X23H, Ireland

Location

University Hospital Galway /ID# 209965

Galway, H91 YR71, Ireland

Location

University Hospital Waterford /ID# 204266

Waterford, X91 ER8E, Ireland

Location

IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 205986

Rome, Lazio, 00144, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 205987

Rome, Lazio, 00168, Italy

Location

ASST Spedali civili di Brescia /ID# 205927

Brescia, 25123, Italy

Location

Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 205168

Cagliari, 09124, Italy

Location

Presidio Ospedaliero San Salvatore /ID# 205167

L’Aquila, 67100, Italy

Location

Azienda Ospedaliero-Universitaria di Modena /ID# 205169

Modena, 41124, Italy

Location

Bravis Ziekenhuis /ID# 206676

Bergen op Zoom, North Brabant, 4624 VT, Netherlands

Location

Centrum Oosterwal /ID# 209640

Alkmaar, 1817 MS, Netherlands

Location

Reinier de Graaf /ID# 205811

Delft, 2625 AD, Netherlands

Location

Universitair Medisch Centrum Groningen /ID# 205162

Groningen, 9713 GZ, Netherlands

Location

Greenlane Clinical Centre /ID# 205664

Epsom, Auckland, 1051, New Zealand

Location

CCA Braga - Hospital de Braga /ID# 205854

Braga, 4710-243, Portugal

Location

Centro Hospitalar de Leiria, EPE /ID# 209906

Leiria, 2410-197, Portugal

Location

Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 205839

Lisbon, 1649-035, Portugal

Location

Hospital CUF Descobertas /ID# 205431

Lisbon, 1998-018, Portugal

Location

CHP, EPE- Hospital Geral de Sa /ID# 205187

Porto, 4050, Portugal

Location

Centro Hospitalar Universitario de Sao Joao, EPE /ID# 205679

Porto, 4200-319, Portugal

Location

National Skin Centre /ID# 205222

Singapore, Central Singapore, 308205, Singapore

Location

National University Hospital /ID# 205224

Singapore, 119074, Singapore

Location

Singapore General Hospital /ID# 205225

Singapore, 169608, Singapore

Location

KK Women's & Children Hospital /ID# 206693

Singapore, 229899, Singapore

Location

Changi General Hospital /ID# 205223

Singapore, 529889, Singapore

Location

Korea University Ansan Hospital /ID# 206342

Ansan, Gyeonggido, 15355, South Korea

Location

SoonChunHyang University Buchon Hospital /ID# 206391

Habun, Gyeonggido, 14584, South Korea

Location

Ajou University Hospital /ID# 206341

Suwon, Gyeonggido, 16499, South Korea

Location

The Catholic University of Korea Incheon St.Mary's Hospital /ID# 206529

Incheon, 21431, South Korea

Location

Seoul National University Hospital /ID# 206396

Seoul, 03080, South Korea

Location

Chung-Ang University Hostipal /ID# 206397

Seoul, 06973, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital /ID# 206343

Seoul, 07441, South Korea

Location

Hospital Sant Joan de Deu /ID# 218047

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital Vital Alvarez Buylla /ID# 205770

Mieres, Principality of Asturias, 33611, Spain

Location

Hospital Parc de Salut del Mar /ID# 204709

Barcelona, 08003, Spain

Location

Hospital Clinic de Barcelona /ID# 210564

Barcelona, 08036, Spain

Location

Hospital Universitario Reina Sofia /ID# 204712

Córdoba, 14004, Spain

Location

Hospital Campus de la Salud /ID# 205544

Granada, 18016, Spain

Location

Hospital General Universitario Gregorio Maranon /ID# 204380

Madrid, 28007, Spain

Location

Hospital Infantil Universitario Nino Jesus /ID# 210437

Madrid, 28009, Spain

Location

Hospital Universitario Infanta Leonor /ID# 204710

Madrid, 28031, Spain

Location

Hospital General Universitario de Valencia /ID# 210565

Valencia, 46014, Spain

Location

Taipei Medical University Shuang Ho Hospital /ID# 204804

New Taipei City, 23561, Taiwan

Location

Chung Shan Medical University Hospital /ID# 205092

Taichung, 40201, Taiwan

Location

National Taiwan University Hospital /ID# 204803

Taipei, 100, Taiwan

Location

Linkou Chang Gung Memorial Ho /ID# 204783

Taoyuan, 333, Taiwan

Location

University Hospital Southampton NHS Foundation Trust /ID# 205711

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Northwick Park Hospital /ID# 205250

Middlesex, Harrow, HA1 3UJ, United Kingdom

Location

Barts Health NHS Trust /ID# 206491

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

Location

The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 204993

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

University Hospital Plymouth NHS Trust /ID# 204649

Plymouth, PL6 8DH, United Kingdom

Location

Related Publications (14)

  • 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.

  • Silverberg JI, Gooderham M, Katoh N, Aoki V, Pink AE, Binamer Y, Glick B, Staubach P, Calimlim B, Li C, Grada A, Moreira A, Lee WJ, Wollenberg A. Achieving Optimal Treatment Targets and Minimal Disease Activity with Upadacitinib for Moderate-to-Severe Atopic Dermatitis: Integrated Analysis of Phase 3 Studies (Measure Up 1 and 2). Dermatol Ther (Heidelb). 2025 Sep;15(9):2583-2594. doi: 10.1007/s13555-025-01485-0. Epub 2025 Jul 14.

  • 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

July 25, 2018

First Posted

July 31, 2018

Study Start

July 27, 2018

Primary Completion

March 11, 2021

Study Completion

November 11, 2025

Last Updated

December 3, 2025

Results First Posted

March 28, 2022

Record last verified: 2025-11

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
For details on when studies are available for sharing, please refer to the link below.
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 Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
More information

Locations