Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema) (Measure Up 1)

October 22, 2025 updated by: AbbVie

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study includes a 35-day screening period, a 16-week double-blind period, a blinded extension period up to Week 260, and a 30-day follow-up visit.

Participants who meet eligibility criteria in the main study will be randomized in a 1:1:1 ratio to receive a daily oral dose of upadacitinib 30 mg or upadacitinib 15 mg or matching placebo. Upon completion of enrollment of 810 participants in the main study, a supplemental study will continue to enroll adolescents (adolescent sub-study) until a total of 180 adolescent participants are enrolled in the overall study (main study + adolescent sub-study).

Randomization for the main study will be stratified by baseline disease severity (validated Investigator Global Assessment scale for Atopic Dermatitis [vIGA-AD] score of moderate [3] versus severe [4]), by geographic region (United States [US]/Puerto Rico/Canada, Japan, China, and Other), and by age (adolescent [ages 12 to 17] versus adult [ages 18 to 75]). The separate randomization for the adolescent sub-study will be stratified by baseline disease severity (moderate [vIGA-AD 3] vs. severe [vIGA-AD 4]) and by geographic region (US/Puerto Rico/Canada and Other).

At Week 16 of the main study and the adolescent sub-study, participants in the placebo group will be re-randomized in a 1:1 ratio to receive daily oral doses of upadacitinib 30 mg or upadacitinib 15 mg in the blinded extension period. In the main study the re-randomization at Week 16 will be stratified by Week 16 50% improvement in Eczema Area and Severity Index [EASI 50] responder [yes/no], geographic region [US/Puerto Rico/Canada, China [Mainland], Japan, and other], and age group [adolescent/adult]. For the adolescent sub-study, the re-randomization will be stratified by EASI 50 responder (Yes/No) and by geographic region (US/Puerto Rico/Canada and Other).

Participants originally randomized to upadacitinib will continue upadacitinib in the extension period at the same dose.

Starting at the Week 4 visit, rescue treatment for AD may be provided at the discretion of the investigator if medically necessary.

The Primary Analysis for the main study will be conducted after all ongoing participants have completed Week 16. In addition, a Primary Analysis for the adolescent population (including the adolescent participants from the main study and the adolescent sub-study) will be conducted after all ongoing adolescent participants have completed Week 16.

Study Type

Interventional

Enrollment (Actual)

912

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, 1902
        • Framingham Centro Medico /ID# 202688
    • Ciuadad Autonoma de Buenos Aires
      • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, Argentina, 1425
        • Instituto de Neumonología y Dermatología /ID# 203444
      • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, Argentina, 1425
        • Psoriahue Med Interdisciplinar /ID# 202451
  • Australia
    • Australian Capital Territory
      • Phillip, Australian Capital Territory, Australia, 2606
        • Woden Dermatology /ID# 205799
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Holdsworth House Medical Practice /ID# 211236
    • South Australia
      • Hectorville, South Australia, Australia, 5073
        • North Eastern Health Specialists /ID# 205802
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • Skin Health Institute Inc /ID# 204791
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Fremantle Dermatology /ID# 205305
  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Clinical Center University of Sarajevo /ID# 202668
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Clinical Center University of Sarajevo /ID# 202669
    • Republika Srpska
      • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
        • University Clinical Centre of the Republic of Srpska /ID# 202666
      • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
        • University Clinical Centre of the Republic of Srpska /ID# 202667
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • UMHAT Dr Georgi Stranski EAD /ID# 201521
      • Stara Zagora, Bulgaria, 6000
        • UMHAT Professor Stoyan Kirkovich /ID# 201522
    • Sofia
      • Sofiya, Sofia, Bulgaria, 1431
        • UMHAT Alexandrovska EAD /ID# 201519
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2G 1B1
        • Kirk Barber Research, CA /ID# 200324
      • Calgary, Alberta, Canada, T2J 7E1
        • Dermatology Research Institute Inc. /ID# 200318
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • Dr. Chih-ho Hong Medical Inc. /ID# 200311
      • Surrey, British Columbia, Canada, V3V 0C6
        • Enverus Medical Research /ID# 200307
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3Z4
        • Wiseman Dermatology Research /ID# 200323
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 1G9
        • Dr. Irina Turchin PC Inc. /ID# 200322
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
        • Karma Clinical Trials /ID# 200316
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4K1
        • Hamilton Health Sciences - McMaster University Medical Centre /ID# 200313
      • London, Ontario, Canada, N6H 5L5
        • Dr. Wei Jing Loo Medicine Prof /ID# 206051
      • Markham, Ontario, Canada, L3P 1X2
        • Lynderm Research Inc. /ID# 200315
      • Ottawa, Ontario, Canada, K2C 3N2
        • Dermatology Ottawa Research Centre /ID# 200319
      • Waterloo, Ontario, Canada, N2J 1C4
        • K. Papp Clinical Research /ID# 200317
    • Quebec
      • Montreal, Quebec, Canada, H3H 1V4
        • Dr. David Gratton Dermat Inc. /ID# 200309
      • Montreal, Quebec, Canada, H2X 2V1
        • Innovaderm Research Inc. /ID# 200320
      • Saint-Jérôme, Quebec, Canada, J7Z 7E2
        • Dre Angelique Gagne-Henley M.D. inc. /ID# 200326
  • China
      • Beijing, China, 100032
        • Beijing Friendship Hospital /ID# 202601
      • Shanghai, China, 200040
        • Huashan Hospital of Fudan University /ID# 205760
      • Wuhan, China, 420022
        • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 208598
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100044
        • Peking University People's Hospital /ID# 202549
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital /ID# 202612
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 208597
      • Guangzhou, Guangdong, China, 510630
        • The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 202548
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • The First Hospital of China Medical University /ID# 202615
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200065
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 202554
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The second Affiliated hospital of Zhejiang University school of Medicine /ID# 202608
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 055422
        • Clinisalud del sur /ID# 218100
      • Rionegro, Antioquia, Colombia, 054040
        • Fundacion Hospital San Vicente de Paul - Rionegro /ID# 202043
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 80002
        • Ctr Int de Reum del Caribe SAS /ID# 201620
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, Colombia, 230002
        • Fundacion Centro de Excelencia en Enfermedades Cronicas no Transmisibles - FUNCE /ID# 201905
  • Croatia
    • City of Zagreb
      • Zagreb, City of Zagreb, Croatia, 10000
        • Klinicki bolnicki centar Zagreb /ID# 201879
      • Zagreb, City of Zagreb, Croatia, 10000
        • Klinika za dječje bolesti Zagreb /ID# 203151
    • County of Osijek-Baranja
      • Osijek, County of Osijek-Baranja, Croatia, 31000
        • Duplicate_Klinicki bolnicki centar Osijek /ID# 201523
    • Primorje-Gorski Kotar County
      • Rijeka, Primorje-Gorski Kotar County, Croatia, 51000
        • Klinicki bolnicki centar Rijeka /ID# 217423
    • Split-Dalmatia County
      • Split, Split-Dalmatia County, Croatia, 21000
        • Klinicki bolnicki centar Split /ID# 201527
  • Denmark
    • Capital Region
      • Copenhagen NV, Capital Region, Denmark, 2400
        • Bispebjerg and Frederiksberg Hospital /ID# 200979
      • Hellerup, Capital Region, Denmark, 2900
        • Herlev and Gentofte Hospital /ID# 200736
    • Central Jutland
      • Aarhus N, Central Jutland, Denmark, 8200
        • Aarhus University Hospital /ID# 200737
  • Estonia
    • Harju
      • Mustamäe, Harju, Estonia, 13419
        • North Estonia Medical Centre /ID# 200951
      • Tallinn, Harju, Estonia, 11313
        • Confido Private Medical Clinic /ID# 200846
    • Tartu
      • Tartu, Tartu, Estonia, 50406
        • Tartu University Hospital /ID# 200847
  • Finland
      • Kuopio, Finland, 70210
        • Kuopio University Hospital /ID# 202449
      • Tampere, Finland, 33100
        • Terveystalo Tampere /ID# 201117
    • Southwest Finland
      • Turku, Southwest Finland, Finland, 20520
        • Mehiläinen Neo /ID# 201116
  • France
      • Lille, France, 59020
        • Hopital Saint Vincent de Paul /ID# 218253
      • Martigues, France, 13500
        • Le Bateau BLanc /ID# 206833
      • Paris, France, 75015
        • AP-HP - Hopital Necker /ID# 218364
      • Rouen, France, 76000
        • Hôpital Charles-Nicolle /ID# 201525
      • Toulouse, France, 31400
        • CHU Toulouse - Hopital Larrey /ID# 201528
    • Auvergne-Rhône-Alpes
      • Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69495
        • HCL - Hôpital Lyon Sud /ID# 201529
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, France, 44000
        • CHU de Nantes, Hotel Dieu -HME /ID# 206377
    • Sarthe
      • Le Mans, Sarthe, France, 72037
        • Centre Hospitalier du Mans /ID# 205991
  • Germany
      • Bonn, Germany, 53127
        • Universitaetsklinikum Bonn /ID# 202086
      • Hamburg, Germany, 20537
        • TFS Trial Form Support GmbH /ID# 202083
      • Hanover, Germany, 30625
        • Medizinische Hochschule Hannover /ID# 202091
      • Mainz, Germany, 55131
        • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205192
    • Bavaria
      • Munich, Bavaria, Germany, 80802
        • Duplicate_Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202087
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • Universitaetsklinikum Frankfurt /ID# 202089
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Universitaetsklinikum Muenster /ID# 202085
    • Rhineland-Palatinate
      • Selters, Rhineland-Palatinate, Germany, 56242
        • CMS3 Company for Medical Study /ID# 205193
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202255
  • Italy
      • Ancona, Italy, 60126
        • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200692
      • Bologna, Italy, 40138
        • A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 200746
      • Catania, Italy, 95123
        • A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200741
      • Napoli, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico II /ID# 200750
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 200695
    • Roma
      • Rome, Roma, Italy, 00133
        • Fondazione PTV Policlinico Tor Vergata /ID# 201136
  • Japan
    • Aichi-ken
      • Nagakute-shi, Aichi-ken, Japan, 480-1195
        • Aichi Medical University Hospital /ID# 202833
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital /ID# 201309
      • Fukuoka, Fukuoka, Japan, 815-8588
        • Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers /ID# 202891
    • Gifu
      • Gifu, Gifu, Japan, 501-1194
        • Gifu University Hospital /ID# 201760
      • Ogaki-shi, Gifu, Japan, 503-8502
        • Ogaki Municipal Hospital /ID# 203463
    • Hokkaido
      • Obihiro-shi, Hokkaido, Japan, 080-0013
        • Takagi Dermatology Clinic /ID# 201238
      • Sapporo, Hokkaido, Japan, 060-0063
        • Medical Cooperation Kojinkai Sapporo Skin Clinic /ID# 201239
    • Kyoto
      • Kyoto, Kyoto, Japan, 602-8566
        • University Hospital Kyoto Prefectural University of Medicine /ID# 201876
    • Osaka
      • Sakai-shi, Osaka, Japan, 5938324
        • Kume Clinic /ID# 201912
    • Tokyo
      • Shinagawa-ku, Tokyo, Japan, 141-8625
        • NTT Medical Center Tokyo /ID# 201759
    • Yamanashi
      • Chuo-shi, Yamanashi, Japan, 409-3821
        • University of Yamanashi Hospital /ID# 204174
  • Malaysia
    • Perak
      • Ipoh, Perak, Malaysia, 30450
        • Hospital Raja Permaisuri Bainun /ID# 204375
    • Sabah
      • Division Pantai Barat Utara, Sabah, Malaysia, 88200
        • Queen Elizabeth Hospital /ID# 204379
    • Selangor
      • Batu Caves, Selangor, Malaysia, 68100
        • Hospital Selayang /ID# 204378
  • New Zealand
      • Hamilton, New Zealand, 3204
        • Clinical Trials NZ /ID# 205335
  • Puerto Rico
      • Carolina, Puerto Rico, 00985
        • Cruz-Santana, Carolina, PR /ID# 201096
      • Ponce, Puerto Rico, 00716-0377
        • Ponce Medical School Foundation /ID# 201821
      • San Juan, Puerto Rico, 00909
        • Clinical Research Puerto Rico /ID# 203309
  • Romania
      • Bucharest, Romania, 020121
        • Spitalul Clinic Colentina /ID# 205860
      • Cluj-Napoca, Romania, 400105
        • Cabinet Medical de Dermatovenerologie Dr. Remus Orasan /ID# 205862
  • Russia
      • Moscow, Russia, 119296
        • National Medical Research Center for Children's Health /ID# 203440
    • Chelyabinsk Oblast
      • Chelyabinsk, Chelyabinsk Oblast, Russia, 454048
        • Chelyabinsk Regional Clinical Dermatovenerologic Dispensary /ID# 201996
    • Krasnodarskiy Kray
      • Krasnodar, Krasnodarskiy Kray, Russia, 350020
        • Clinical Dermatovenerology Dispensary /ID# 203439
    • Saratov Oblast
      • Saratov, Saratov Oblast, Russia, 410012
        • Saratov State Medical University n.a. V.I. Razumovskiy /ID# 201595
    • Sverdlovsk Oblast
      • Yekaterinburg, Sverdlovsk Oblast, Russia, 620076
        • Ural Research Institute of dermatovenerology and immunopathology /ID# 201593
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital, Universitätsspital Bern /ID# 201598
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Switzerland, 4031
        • Universitätsspital Basel /ID# 201599
    • Canton of Geneva
      • Geneva, Canton of Geneva, Switzerland, 1205
        • Hôpitaux Universitaires Genève /ID# 201600
    • Canton of Vaud
      • Lausanne, Canton of Vaud, Switzerland, 1011
        • CHUV, Centre hospitalier universitaire vaudois /ID# 200910
      • Lausanne, Canton of Vaud, Switzerland, 1011
        • CHUV, Centre hospitalier universitaire vaudois /ID# 206505
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06100
        • Hacettepe University Faculty of Medicine /ID# 204099
      • Istanbul, Turkey (Türkiye), 34098
        • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 204100
      • Yenimahalle, Turkey (Türkiye), 06560
        • Gazi Universitesi Tip Fakultes /ID# 204176
    • Kayseri
      • Melikgazi, Kayseri, Turkey (Türkiye), 38030
        • Erciyes University Medical Fac /ID# 204098
  • Ukraine
      • Rivne, Ukraine, 33028
        • ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 210504
    • Zaporizhzhia Oblast
      • Zaporizhzhya, Zaporizhzhia Oblast, Ukraine, 69063
        • Military Hospital of Military-Medical Clinical Center of Southern Region /ID# 201962
  • United Kingdom
      • London, United Kingdom, SW10 9NH
        • Chelsea and Westminster Hospital NHS Foundation Trust9 /ID# 201971
      • Salford, United Kingdom, M6 8HD
        • Northern Care Alliance NHS Group /ID# 201194
    • London, City of
      • Isleworth, London, City of, United Kingdom, TW7 6AF
        • West Middlesex University Hospital /ID# 202273
      • London, London, City of, United Kingdom, E1 2ES
        • Barts Health NHS Trust /ID# 201043
      • London, London, City of, United Kingdom, SE1 9RT
        • Guy's and St Thomas' NHS Foundation Trust /ID# 201192
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Alliance Dermatology and MOHs /ID# 200375
      • Scottsdale, Arizona, United States, 85255-4134
        • Clear Dermatology & Aesthetics Center /ID# 201256
    • California
      • Bakersfield, California, United States, 93309
        • Bakersfield Derma & Skin Cance /ID# 200433
      • Fountain Valley, California, United States, 92708-3701
        • First OC Dermatology /ID# 201910
      • Los Angeles, California, United States, 90025-7014
        • California Allergy and Asthma Medical Group /ID# 200727
      • Mission Viejo, California, United States, 92691-6410
        • Allergy & Asthma Associates of Southern California /ID# 200733
      • Newport Beach, California, United States, 92660-7853
        • Dermatology Clinical Trials /ID# 205876
      • Sacramento, California, United States, 95817
        • UC Davis /ID# 203622
      • San Francisco, California, United States, 94132-1909
        • Synergy Dermatology /ID# 200842
      • San Luis Obispo, California, United States, 93405
        • San Luis Derm and Laser Clinic /ID# 200372
      • Stanford, California, United States, 94305
        • Stanford University /ID# 200440
      • Walnut Creek, California, United States, 94598-2488
        • Care Access Research - Walnut Creek /ID# 200940
    • Connecticut
      • Shelton, Connecticut, United States, 06484-6211
        • Dermatology Physicians of Connecticut /ID# 200928
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016-4300
        • Foxhall Research Center /ID# 213682
      • Washington D.C., District of Columbia, United States, 20037
        • Duplicate_George Washington Univ Med /ID# 200364
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Clearlyderm Dermatology /ID# 208371
      • Boca Raton, Florida, United States, 33486-2269
        • Skin Care Research, LLC /ID# 200811
      • Clearwater, Florida, United States, 33756
        • Olympian Clinical Research /ID# 202914
      • Lake City, Florida, United States, 32055-8835
        • Multi-Speciality Research Associates /ID# 213254
      • Margate, Florida, United States, 33063
        • GSI Clinical Research, LLC /ID# 200849
      • Miami, Florida, United States, 33173
        • Florida International Rsrch cr /ID# 218507
      • North Miami Beach, Florida, United States, 33162-4708
        • Tory P Sullivan, MD PA /ID# 200671
      • Ormond Beach, Florida, United States, 32174
        • Leavitt Medical Associates of Florida /ID# 200880
      • Sunrise, Florida, United States, 33351-7311
        • Precision Clinical Research /ID# 209002
      • West Palm Beach, Florida, United States, 33406-6063
        • Integrated Clinical Research LLC /ID# 200900
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Christie Clinic, LLC /ID# 200427
      • Chicago, Illinois, United States, 60611-2927
        • Northwestern University Feinberg School of Medicine /ID# 201644
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Dawes Fretzin, LLC /ID# 200366
      • South Bend, Indiana, United States, 46617
        • The South Bend Clinic Center /ID# 200371
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Clinical Trials Management, LLC - Covington /ID# 212658
      • Metairie, Louisiana, United States, 70006-4165
        • Clinical Trials Management, LLC - Metairie /ID# 212659
    • Massachusetts
      • Beverly, Massachusetts, United States, 01915
        • Northeast Dermatology /ID# 201338
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital /ID# 200474
      • Quincy, Massachusetts, United States, 02169
        • Integrated Dermatology of Massachusetts, LLC /ID# 209468
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clin Res Inst of Michigan, LLC /ID# 208019
      • Detroit, Michigan, United States, 48202-3046
        • Henry Ford Medical Center /ID# 204191
    • Missouri
      • Kirksville, Missouri, United States, 63501-5362
        • Cleaver Dermatology /ID# 202825
    • Nebraska
      • Omaha, Nebraska, United States, 68144-1105
        • Advanced Dermatology of the Midlands /ID# 201689
    • Nevada
      • Las Vegas, Nevada, United States, 89119-5190
        • Clinical Research Consortium /ID# 200734
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • AllCutis Research Inc /ID# 200981
    • New York
      • Kew Gardens, New York, United States, 11415
        • Forest Hills Dermatology Group /ID# 209244
      • New York, New York, United States, 10029-6504
        • Icahn School of Medicine at Mount Sinai /ID# 200370
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center /ID# 200456
      • Troy, New York, United States, 12180-2323
        • J. Schwartz, MD, PLLC /ID# 202121
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Velocity clinical research /ID# 202653
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute (LHSI) /ID# 212676
      • Oklahoma City, Oklahoma, United States, 73120-5049
        • Newton Clinical Research /ID# 204169
    • Oregon
      • Portland, Oregon, United States, 97223
        • Oregon Medical Res Center PC /ID# 200428
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University /ID# 200992
    • Pennsylvania
      • Hazleton, Pennsylvania, United States, 18201
        • Dermdox Dermatology Centers, PC /ID# 213782
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Clinical Partners, LLC /ID# 200460
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Coastal Clinical Research Center of the Carolinas /ID# 200402
    • Texas
      • Arlington, Texas, United States, 76011
        • Arlington Research Center, Inc /ID# 200391
      • Austin, Texas, United States, 78759-4100
        • Orion Clinical Research /ID# 204703
      • Dallas, Texas, United States, 75231
        • Modern Research Associates, PL /ID# 200705
      • Dallas, Texas, United States, 75246
        • Menter Dermatology Res Inst /ID# 200390
      • Webster, Texas, United States, 77598
        • Center for Clinical Studies - Webster TX /ID# 203185
    • Washington
      • Spokane, Washington, United States, 99202
        • Dermatology Specialists of Spokane /ID# 202068

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo / Upadacitinib
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 Upadacitinib
Tablets taken orally once a day
Drug: Upadacitinib
Tablets taken orally once a day
Other Names:
  • ABT-494
  • RINVOQ™
Experimental: Upadacitinib 15 mg QD
Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks.
Drug: Upadacitinib
Tablets taken orally once a day
Other Names:
  • ABT-494
  • RINVOQ™
Experimental: Upadacitinib 30 mg QD
Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks.
Drug: Upadacitinib
Tablets taken orally once a day
Other Names:
  • ABT-494
  • RINVOQ™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline and 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
Time Frame: Baseline and 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16
Time Frame: Baseline (last available rolling average before the first dose of study drug) and Week 16
Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.
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
Time Frame: Baseline and 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 a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4
Time Frame: Baseline (last available rolling average before the first dose of study drug) and Week 4
Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.
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
Time Frame: Baseline and Week 2

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.

An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.
Baseline and Week 2
Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1
Time Frame: Baseline (last available rolling average before the first dose of study drug) and Week 1
Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.
Baseline (last available rolling average before the first dose of study drug) and Week 1
Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 2
Time Frame: Baseline and Day 2

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).

The percentage of participants who had a 4-point or greater improvement from Baseline in Worst Pruritus NRS score at Day 2 was pre-specified as a ranked secondary endpoint for participants in the upadacitinib 30 mg group versus placebo group only.
Baseline and Day 2
Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 3
Time Frame: Baseline and Day 3

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).

The percentage of participants who had a 4-point or greater improvement in Worst Pruritus NRS score from Baseline at Day 3 was pre-specified as a ranked secondary endpoint for participants in the upadacitinib 15 mg group versus placebo group only.
Baseline and Day 3
Main Study: Percentage of Participants Experiencing a Flare During the Double-blind Treatment Period
Time Frame: From first dose of study drug to Week 16
A flare, characterized as a clinically meaningful worsening in EASI, is defined as an increase in EASI score of ≥ 6.6 points from Baseline during the double-blind treatment period and prior to use of any rescue medication. Flare was assessed in participants with an EASI score of 65.4 or less at Baseline.
From first dose of study drug to Week 16
Main Study: Percentage of Participants Achieving a Reduction of ≥ 12 Points From Baseline in Atopic Dermatitis Impact Scale (ADerm-IS) Sleep Domain Score at Week 16
Time Frame: Baseline (last available rolling average before the first dose of study drug) and Week 16

The ADerm-IS is a 10-item patient reported outcome (PRO) questionnaire designed to assess a variety of impacts that participants experience from their AD.

The ADerm-IS sleep domain consists of 3 questions designed to assess the impact of AD on sleep on a daily basis over a 24-hour recall period. The items include difficulty falling asleep, impact on sleep, and waking at night. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The ADerm-IS sleep domain score is the sum of the 3 item scores and ranges from 0 (no impact) to 30 (worst impact). The ADerm-IS sleep domain was analyzed based on weekly rolling averages of daily scores.

The minimal clinically important difference for ADerm-IS sleep domain score is 12.
Baseline (last available rolling average before the first dose of study drug) and Week 16
Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Atopic Dermatitis Symptom Scale (ADerm-SS) Skin Pain Score at Week 16
Time Frame: Baseline (last available rolling average before the first dose of study drug) and Week 16
The ADerm-SS is an 11-item PRO questionnaire designed to assess signs and symptoms that patients may experience due to AD using a 24-hour recall period. For the skin pain item participants were asked on a daily basis to indicate how bad their worst skin pain due to AD was in the past 24 hours on an NRS from 0 (no pain) to 10 (worst imaginable pain). The ADerm-SS skin pain score was analyzed using weekly rolling averages of daily scores. The minimal clinically important difference for ADerm-SS skin pain score is 4.
Baseline (last available rolling average before the first dose of study drug) and Week 16
Main Study: Percentage of Participants Achieving a Reduction of ≥ 28 Points From Baseline in ADerm-SS 7-Item Total Symptom Score (TSS-7) at Week 16
Time Frame: Baseline and Week 16
The ADerm-SS is an 11-item questionnaire designed to assess signs and symptoms that participants may experience due to AD using a 24-hour recall period. The 7-item total symptom score includes 7 symptoms (items 1-7 of the ADerm-SS), each assessed on a NRS from 0 (no symptom) to 10 (worst imaginable). The 7 symptoms included in the score are itch while asleep, itch while awake, skin pain (each assessed daily), skin cracking, skin cracking pain, dry skin, and skin flaking (assessed weekly). The TSS-7 score ranges from 0 to 70, with higher scores indicating worsening symptoms. The minimal clinically important difference for ADerm-SS TSS-7 is 28.
Baseline and Week 16
Main Study: Percentage of Participants Achieving a Reduction of ≥ 11 Points From Baseline in ADerm-IS Emotional State Domain Score at Week 16
Time Frame: Baseline and Week 16

The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD.

ADerm-IS emotional state sums three items [Items 8-10] measuring self-consciousness, embarrassment, and sadness with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The emotional state domain score ranges from 0 to 30, where higher scores represent worst impact.

The minimal clinically important difference for ADerm-IS emotional state domain score is 11.
Baseline and Week 16
Main Study: Percentage of Participants Achieving a Reduction of ≥ 14 Points From Baseline in in ADerm-IS Daily Activities Domain Score at Week 16
Time Frame: Baseline and Week 16

The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD.

ADerm-IS daily activities sums four items measuring limitations of household, physical, and social activities, and difficulty concentrating with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The daily activities domain score ranges from 0 to 40, where higher scores represent worst impact.

The minimal clinically important difference for the ADerm-IS daily activities domain score is 14.
Baseline and Week 16
Main Study: Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16
Time Frame: Baseline and 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: Percent Change From Baseline in Worst Pruritus NRS at Week 16
Time Frame: Baseline (last available rolling average before the first dose of study drug) and Week 16
Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.
Baseline (last available rolling average before the first dose of study drug) and Week 16
Main Study: Percent Change From Baseline in EASI Score at Week 16
Time Frame: Baseline and 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; a negative change from Baseline indicates improvement.
Baseline and Week 16
Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Week 16
Time Frame: Baseline and Week 16
The POEM is a 7-item, validated questionnaire used to assess disease symptoms in both children and adults. Participants respond to 7 questions, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency of occurrence during the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores are added to provide a total score ranging from 0 (clear) to 28 (very severe atopic eczema). A change in POEM score of 3.4 points is considered the minimal clinically important difference.
Baseline and Week 16
Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
Time Frame: Baseline and Week 16

The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).

Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL.

the DLQI was administered to participants who were ≥ 16 (16 to 75) years old at the time of the Screening visit.
Baseline and Week 16
Main Study: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16
Time Frame: Baseline and Week 16
SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A negative change from Baseline indicates improvement.
Baseline and Week 16
Main Study: Percentage of Participants Achieving a Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score and Hospital Anxiety and Depression Scale-Depression (HADS-D) Score of < 8 at Week 16
Time Frame: Baseline and Week 16
The HADS is a 14-item questionnaire, with seven items related to anxiety (HADS-A) and seven items related to depression (HADS-D). Each item is scored from 0 to 3; scores for each subscale range from 0 to 21, with higher scores indicating more distress. For each domain, scores 7 or lower are considered normal, 8 to 10 are borderline, and 11 or higher indicate clinical anxiety or depression.
Baseline and Week 16
Main Study: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16
Time Frame: Week 16

The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).

Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all.

the DLQI was administered to participants who were ≥ 16 (16 to 75) years old at the time of the Screening visit.
Week 16
Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 16
Time Frame: Baseline and 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.

An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.
Baseline and Week 16
Adolescents: Percentage of Participants Achieving a vIGA-AD of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16
Time Frame: Baseline and 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 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, possible oozing or crusting;
  • 4 - Severe: Marked erythema, induration/papulation and/or lichenification; possible oozing or crusting.
Baseline and Week 16
Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 16
Time Frame: Baseline (last available rolling average before the first dose of study drug) and Week 16
Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.
Baseline (last available rolling average before the first dose of study drug) and Week 16
Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 16
Time Frame: Baseline and 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.

An EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score.
Baseline and Week 16
Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4
Time Frame: Baseline (last available rolling average before the first dose of study drug) and Week 4
Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.
Baseline (last available rolling average before the first dose of study drug) and Week 4
Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 2
Time Frame: Baseline and Week 2

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.

An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.
Baseline and Week 2
Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1
Time Frame: Baseline (last available rolling average before the first dose of study drug) and Week 1
Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.
Baseline (last available rolling average before the first dose of study drug) and Week 1
Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 2
Time Frame: Baseline and Day 2
Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Baseline and Day 2
Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 3
Time Frame: Baseline and Day 3
Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Baseline and Day 3
Adolescents: Percentage of Participants Experiencing a Flare During the Double-blind Treatment Period
Time Frame: From first dose of study drug to Week 16
A flare, characterized as a clinically meaningful worsening in EASI, is defined as an increase in EASI score of ≥ 6.6 points from Baseline during the double-blind treatment period and prior to use of any rescue medication. Flares were assessed in participants with an EASI score of 65.4 or less at Baseline.
From first dose of study drug to Week 16
Adolescents: Percentage of Participants Achieving a Reduction of ≥ 12 Points From Baseline in ADerm-IS Sleep Domain Score at Week 16
Time Frame: Baseline (last available rolling average before the first dose of study drug) and Week 16

The ADerm-IS is a 10-item patient reported outcome questionnaire designed to assess a variety of impacts that participants experience from their AD.

The ADerm-IS sleep domain consists of 3 questions designed to assess the impact of AD on sleep on a daily basis over a 24-hour recall period. The items include difficulty falling asleep, impact on sleep, and waking at night. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The ADerm-IS sleep domain score is the sum of the 3 item scores and ranges from 0 (no impact) to 30 (worst impact). The ADerm-IS sleep domain was analyzed based on weekly rolling averages of daily scores.

The minimal clinically important difference for ADerm-IS sleep domain score is 12.
Baseline (last available rolling average before the first dose of study drug) and Week 16
Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in ADerm-SS Skin Pain Score at Week 16
Time Frame: Baseline (last available rolling average before the first dose of study drug) and Week 16

The ADerm-SS is an 11-item PRO questionnaire designed to assess signs and symptoms that patients may experience due to AD using a 24-hour recall period. For the skin pain item participants were asked to indicate on a daily basis how bad their worst skin pain due to AD was in the past 24 hours on an NRS from 0 (no pain) to 10 (worst imaginable pain). The minimal clinically important difference for ADerm-SS skin pain score is 4.

The ADerm-SS skin pain score was analyzed based on weekly rolling averages of daily scores.
Baseline (last available rolling average before the first dose of study drug) and Week 16
Adolescents: Percentage of Participants Achieving a Reduction of ≥ 28 Points From Baseline in ADerm-SS TSS-7 at Week 16
Time Frame: Baseline and Week 16
The ADerm-SS is an 11-item questionnaire designed to assess signs and symptoms that participants may experience due to AD using a 24-hour recall period. The 7-item total symptom score includes 7 symptoms (items 1-7 of the ADerm-SS), each assessed on a NRS from 0 (no symptom) to 10 (worst imaginable). The 7 symptoms included in the score are itch while asleep, itch while awake, skin pain (each assessed daily), skin cracking, skin cracking pain, dry skin, and skin flaking (assessed weekly). The TSS-7 score ranges from 0 to 70, with higher scores indicating worsening symptoms. The minimal clinically important difference for ADerm-SS TSS-7 is 28.
Baseline and Week 16
Adolescents: Percentage of Participants Achieving a Reduction of ≥ 11 Points From Baseline in ADerm-IS Emotional State Domain Score at Week 16
Time Frame: Baseline and Week 16

The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD.

ADerm-IS emotional state sums three items [Items 8-10] measuring self-consciousness, embarrassment, and sadness with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The emotional state domain score ranges from 0 to 30, where higher scores represent worst impact.

The minimal clinically important difference for ADerm-IS emotional state domain score is 11.
Baseline and Week 16
Adolescents: Percentage of Participants Achieving a Reduction of ≥ 14 Points From Baseline in ADerm-IS Daily Activities Domain Score at Week 16
Time Frame: Baseline and Week 16

The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD.

ADerm-IS daily activities sums four items measuring limitations of household, physical, and social activities, and difficulty concentrating with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The daily activities domain score ranges from 0 to 40, where higher scores represent worst impact.

The minimal clinically important difference for the ADerm-IS daily activities domain score is 14.
Baseline and Week 16
Adolescents: Percentage of Participants Achieving an EASI 100 Response at Week 16
Time Frame: Baseline and 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.

An EASI 100 response is defined as a 100% reduction (improvement) from Baseline in EASI score.
Baseline and Week 16
Adolescents: Percent Change From Baseline in Worst Pruritus NRS at Week 16
Time Frame: Baseline (last available rolling average before the first dose of study drug) and Week 16
Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.
Baseline (last available rolling average before the first dose of study drug) and Week 16
Adolescents: Percent Change From Baseline in EASI Score at Week 16
Time Frame: Baseline and 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; a negative change from Baseline indicates improvement.
Baseline and Week 16
Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in POEM Total Score at Week 16
Time Frame: Baseline and Week 16
The POEM is a 7-item, validated questionnaire used to assess disease symptoms in both children and adults. Participants respond to 7 questions, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency of occurrence during the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores are added to provide a total score ranging from 0 (clear) to 28 (very severe atopic eczema). A change in POEM score of 3.4 points is considered the minimal clinically important difference.
Baseline and Week 16
Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in DLQI Score at Week 16
Time Frame: Baseline and Week 16

The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).

Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL.

the DLQI was administered to participants who were ≥ 16 (16 to 75) years old at the time of the Screening visit.
Baseline and Week 16
Adolescents: Percent Change From Baseline in SCORAD Score at Week 16
Time Frame: Baseline and Week 16
SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A negative change from Baseline indicates improvement.
Baseline and Week 16
Adolescents: Percentage of Participants Achieving HADS-A Score and HADS-D Score of < 8 at Week 16
Time Frame: Baseline and Week 16
The HADS is a 14-item questionnaire, with seven items related to anxiety (HADS-A) and seven items related to depression (HADS-D). Each item is scored from 0 to 3; scores for each subscale range from 0 to 21, with higher scores indicating more distress. For each domain, scores 7 or lower are considered normal, 8 to 10 are borderline, and 11 or higher indicate clinical anxiety or depression.
Baseline and Week 16
Adolescents: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16
Time Frame: Baseline and Week 16

The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).

Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all.

the DLQI was administered to participants who were ≥ 16 (16 to 75) years old at the time of the Screening visit.
Baseline and Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2018

Primary Completion (Actual)

January 6, 2021

Study Completion (Actual)

October 10, 2025

Study Registration Dates

First Submitted

June 14, 2018

First Submitted That Met QC Criteria

June 22, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Estimated)

October 24, 2025

Last Update Submitted That Met QC Criteria

October 22, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M16-045
  • 2022-502938-30-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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