A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2)

March 1, 2024 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

Active, not recruiting

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 a minimum 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 overall (main study + adolescent sub-study).

Randomization in 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, 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, 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

No longer 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

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • The Skin Hospital /ID# 217846
    • Queensland
      • Benowa, Queensland, Australia, 4217
        • The Skin Centre /ID# 205922
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital /ID# 206023
      • Clayton, Victoria, Australia, 3168
        • Monash Children's Hospital /ID# 217917
      • East Melbourne, Victoria, Australia, 3002
        • Sinclair Dermatology /ID# 217791
      • Parkville, Victoria, Australia, 3050
        • The Royal Melbourne Hospital /ID# 205919
      • Parkville, Victoria, Australia, 3052
        • Murdoch Children's Research Institute /ID# 205667
  • Austria
      • Salzburg, Austria, 5020
        • Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 208281
    • Niederoesterreich
      • Sankt Poelten, Niederoesterreich, Austria, 3100
        • Universitaetsklinikum St. Poelten /ID# 206909
    • Oberoesterreich
      • Linz, Oberoesterreich, Austria, 4010
        • Ordensklinikum Linz GmbH Elisabethinen /ID# 206573
    • Wien
      • Vienna, Wien, Austria, 1220
        • Klinik Donaustadt /ID# 206572
  • Belgium
      • Liege, Belgium, 4000
        • Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 204938
    • Bruxelles-Capitale
      • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
        • UCL Saint-Luc /ID# 205537
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent /ID# 205181
  • Bulgaria
      • Sofia, Bulgaria, 1000
        • Medical center Sveti Panteleimon /ID# 210414
      • Sofia, Bulgaria, 1407
        • Acibadem City Clinic Tokuda University Hospital EAD /ID# 205292
      • Sofia, Bulgaria, 1606
        • Military Medical Academy Multiprofile Hospital /ID# 205291
      • Sofia, Bulgaria, 1632
        • Medical complex Doverie /ID# 211289
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5K 1X3
        • Stratica Medical /ID# 205415
      • Edmonton, Alberta, Canada, T6G 1C3
        • Alberta DermaSurgery Centre /ID# 205422
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E8
        • UBC Department of Dermatology and Skin Science The Skin Care Centre /ID# 207837
      • Vancouver, British Columbia, Canada, V6H 4E1
        • Pacific Derm /ID# 206797
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1E 1V4
        • Skin Care Studio /ID# 205420
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • SimcoDerm Medical and Surgical Dermatology Center /ID# 206333
      • Etobicoke, Ontario, Canada, M8X 1Y9
        • Kingsway Clinical Research /ID# 206005
      • Guelph, Ontario, Canada, N1L 0B7
        • Dr. Dusan Sajic Medicine Professional Corporation /ID# 206890
      • London, Ontario, Canada, N6A 3H7
        • The Guenther Dermatology Research Centre /ID# 206772
      • Mississauga, Ontario, Canada, L5H 1G9
        • DermEdge Research Inc. /ID# 206036
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Dr. S.K. Siddha Medicine Professional Corporation /ID# 207138
      • Niagara Falls, Ontario, Canada, L2H 1H5
        • Allergy Research Canada Inc. /ID# 213547
      • Sudbury, Ontario, Canada, P3C 1X8
        • Dr. Lyne Giroux Medicine Professional Corporation /ID# 206771
      • Toronto, Ontario, Canada, M2M 4J5
        • Niakosari Medicine Professional Corporation /ID# 206004
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
        • Skinsense Medical Research /ID# 206873
  • Croatia
    • Grad Zagreb
      • Zagreb, Grad Zagreb, Croatia, 10000
        • DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 205429
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Djecja bolnica Srebrnjak /ID# 205926
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Poliklinika Vlatka Cavka d.o.o. /ID# 211126
    • Zagrebacka Zupanija
      • Ivanic-Grad, Zagrebacka Zupanija, Croatia, 10310
        • Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 203448
  • Czechia
      • Plzen, Czechia, 305 99
        • Fakultni nemocnice Plzen /ID# 205096
      • Praha, Czechia, 110 00
        • Sanatorium profesora Arenbergera /ID# 205098
      • Praha, Czechia, 128 08
        • Vseobecna fakultni nemocnice v Praze /ID# 205201
      • Praha, Czechia, 150 06
        • Fakultni Nemocnice v Motole /ID# 218192
      • Usti nad Labem, Czechia, 400 11
        • Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o. z. /ID# 205097
  • Denmark
    • Midtjylland
      • Aarhus N, Midtjylland, Denmark, 8200
        • Aarhus University Hospital /ID# 205524
    • Sjælland
      • Roskilde, Sjælland, Denmark, 4000
        • Sjællands Universitetshospital /ID# 205960
  • France
      • Bordeaux, France, 33075
        • Hopital Saint-Andre /ID# 206554
      • Brest, France, 29200
        • CHRU de Brest - Hopital Morvan /ID# 206555
      • Lorient, France, 56322
        • C.H. de Bretagne Sud /ID# 206910
      • Paris, France, 75010
        • AP-HP - Hopital Saint-Louis /ID# 206552
    • Ile-de-France
      • Antony, Ile-de-France, France, 92160
        • Hopital Prive d'Antony /ID# 206553
  • Germany
      • Darmstadt, Germany, 64283
        • Klinikum Darmstadt /ID# 207483
      • Dresden, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 205767
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 207982
      • Mahlow, Germany, 15831
        • Dermatologische Gemeinschaftspraxis Mahlow /ID# 205765
      • Simmern, Germany, 55469
        • Haut- und Laserzentrum Hunsrück /ID# 205768
      • Witten, Germany, 58453
        • Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 205766
      • Wuppertal, Germany, 42287
        • CentroDerm GmbH /ID# 206861
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 206658
  • Greece
    • Attiki
      • Athens, Attiki, Greece, 11525
        • 251 Airforce General Hospital /ID# 205841
      • Athens, Attiki, Greece, 11525
        • 401 GSNA - 401 Army General Hospital /ID# 205352
      • Athens, Attiki, Greece, 16121
        • General Hospital Andreas Syggros /ID# 204527
    • Thessaloniki
      • Stavroupoli (Thessalonikis), Thessaloniki, Greece, 55536
        • Papageorgiou General Hospital Thessaloniki /ID# 204526
  • Hungary
      • Budapest, Hungary, 1033
        • Clinexpert Kft /ID# 211246
      • Budapest, Hungary, 1036
        • Synexus Magyarorszag Kft. /ID# 206008
      • Pecs, Hungary, 7624
        • Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 205085
    • Borsod-Abauj-Zemplen
      • Miskolc, Borsod-Abauj-Zemplen, Hungary, 3526
        • Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 218072
    • Heves
      • Gyöngyös, Heves, Hungary, 3200
        • Bugat Pal Korhaz /ID# 211247
    • Somogy
      • Kaposvár, Somogy, Hungary, 7400
        • Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 205611
    • Veszprem
      • Balatonfured, Veszprem, Hungary, 8230
        • Drug Research Center /ID# 217855
  • Ireland
      • Cork, Ireland, T12 X23H
        • South Infirmary Victoria University Hospital /ID# 204265
      • Galway, Ireland, H91 YR71
        • University Hospital Galway /ID# 209965
      • Waterford, Ireland, X91 ER8E
        • University Hospital Waterford /ID# 204266
    • Dublin
      • Dublin 8, Dublin, Ireland, D08 NHY1
        • St James Hospital /ID# 204264
  • Italy
      • Brescia, Italy, 25123
        • ASST Spedali civili di Brescia /ID# 205927
      • Cagliari, Italy, 09124
        • Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 205168
      • L'Aquila, Italy, 67100
        • Presidio Ospedaliero San Salvatore /ID# 205167
      • Modena, Italy, 41124
        • Azienda Ospedaliero-Universitaria di Modena /ID# 205169
    • Lazio
      • Rome, Lazio, Italy, 00144
        • IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 205986
      • Rome, Lazio, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 205987
  • Korea, Republic of
      • Incheon, Korea, Republic of, 21431
        • The Catholic University of Korea Incheon St.Mary's Hospital /ID# 206529
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital /ID# 206396
      • Seoul, Korea, Republic of, 06973
        • Chung-Ang University Hostipal /ID# 206397
      • Seoul, Korea, Republic of, 07441
        • Hallym University Kangnam Sacred Heart Hospital /ID# 206343
    • Gyeonggido
      • Ansan, Gyeonggido, Korea, Republic of, 15355
        • Korea University Ansan Hospital /ID# 206342
      • Buncheon, Gyeonggido, Korea, Republic of, 14584
        • SoonChunHyang University Buchon Hospital /ID# 206391
      • Suwon, Gyeonggido, Korea, Republic of, 16499
        • Ajou University Hospital /ID# 206341
  • Netherlands
      • Alkmaar, Netherlands, 1817 MS
        • Centrum Oosterwal /ID# 209640
      • Delft, Netherlands, 2625 AD
        • Reinier de Graaf /ID# 205811
      • Groningen, Netherlands, 9713 GZ
        • Universitair Medisch Centrum Groningen /ID# 205162
    • Noord-Brabant
      • Bergen op Zoom, Noord-Brabant, Netherlands, 4624 VT
        • Bravis Ziekenhuis /ID# 206676
  • New Zealand
    • Auckland
      • Epsom, Auckland, New Zealand, 1051
        • Greenlane Clinical Centre /ID# 205664
  • Portugal
      • Braga, Portugal, 4710-243
        • CCA Braga - Hospital de Braga /ID# 205854
      • Leiria, Portugal, 2410-197
        • Centro Hospitalar de Leiria, EPE /ID# 209906
      • Lisboa, Portugal, 1649-035
        • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 205839
      • Lisboa, Portugal, 1998-018
        • Hospital CUF Descobertas /ID# 205431
      • Porto, Portugal, 4050
        • CHP, EPE- Hospital Geral de Sa /ID# 205187
      • Porto, Portugal, 4200-319
        • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 205679
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital /ID# 205224
      • Singapore, Singapore, 169608
        • Singapore General Hospital /ID# 205225
      • Singapore, Singapore, 229899
        • KK Women's & Children Hospital /ID# 206693
      • Singapore, Singapore, 529889
        • Changi General Hospital /ID# 205223
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 308205
        • National Skin Centre /ID# 205222
  • Spain
      • Barcelona, Spain, 08003
        • Hospital Parc de Salut del Mar /ID# 204709
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona /ID# 210564
      • Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofia /ID# 204712
      • Granada, Spain, 18016
        • Hospital Campus de la Salud /ID# 205544
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon /ID# 204380
      • Madrid, Spain, 28009
        • Hospital Infantil Universitario Nino Jesus /ID# 210437
      • Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor /ID# 204710
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia /ID# 210565
    • Asturias
      • Mieres, Asturias, Spain, 33611
        • Hospital Vital Alvarez Buylla /ID# 205770
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Spain, 08950
        • Hospital Sant Joan de Deu /ID# 218047
  • Taiwan
      • New Taipei City, Taiwan, 23561
        • Taipei Medical University Shuang Ho Hospital /ID# 204804
      • Taichung, Taiwan, 40201
        • Chung Shan Medical University Hospital /ID# 205092
      • Taipei City, Taiwan, 100
        • National Taiwan University Hospital /ID# 204803
      • Taoyuan City, Taiwan, 333
        • Linkou Chang Gung Memorial Ho /ID# 204783
  • United Kingdom
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 204993
      • Plymouth, United Kingdom, PL6 8DH
        • University Hospital Plymouth NHS Trust /ID# 204649
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust /ID# 205711
    • Harrow
      • Middlesex, Harrow, United Kingdom, HA1 3UJ
        • Northwick Park Hospital /ID# 205250
    • London, City Of
      • London, London, City Of, United Kingdom, E1 2ES
        • Barts Health NHS Trust /ID# 206491
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Total Skin and Beauty Derm Ctr /ID# 205129
    • Arizona
      • Phoenix, Arizona, United States, 85006-2722
        • Medical Dermatology Specialist /ID# 205516
      • Phoenix, Arizona, United States, 85053-4061
        • Arizona Research Center, Inc. /ID# 205795
    • Arkansas
      • Bryant, Arkansas, United States, 72022-7514
        • The Dermatology Clinic of Arkansas /ID# 218749
      • North Little Rock, Arkansas, United States, 72117
        • Arkansas Research Trials /ID# 218469
    • California
      • Encino, California, United States, 91436
        • Encino Research Center /ID# 207472
      • Irvine, California, United States, 92697-1385
        • University of California Irvine /ID# 205136
      • Long Beach, California, United States, 90806-2325
        • Ark Clinical Research /ID# 218193
      • Los Angeles, California, United States, 90033
        • Keck School of Medicine of USC /ID# 206971
      • Los Angeles, California, United States, 90056
        • Wallace Medical Group /ID# 205701
      • Orange, California, United States, 92868
        • Child Hosp of Orange County,CA /ID# 205735
      • Palm Springs, California, United States, 92262
        • Palmtree Clinical Research Inc. /Id# 206184
      • San Diego, California, United States, 92123
        • Rady Children's Hospital San Diego /ID# 208244
      • Santa Ana, California, United States, 92701
        • Southern California Derma. Inc /ID# 205734
    • Colorado
      • Lafayette, Colorado, United States, 80026
        • Innovative Clinical Research - Lafayette /ID# 208400
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606-1827
        • New England Research Associates, LLC /ID# 206896
    • Florida
      • Aventura, Florida, United States, 33180
        • Ideal Clinical Research Inc. /ID# 209880
      • Boca Raton, Florida, United States, 33486-2269
        • Skin Care Research, LLC /ID# 207099
      • Brandon, Florida, United States, 33511-5335
        • Midflorida Clinical Research, Inc. /ID# 213700
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc /ID# 206146
      • Doral, Florida, United States, 33122-1902
        • Revival Research /ID# 208383
      • Doral, Florida, United States, 33166
        • Universal Axon Clinical Research /ID# 213703
      • Miami, Florida, United States, 33014
        • Lakes Research, LLC /ID# 209156
      • Miami, Florida, United States, 33176
        • Miami Dade Medical Research Institute /ID# 209413
      • Miami Lakes, Florida, United States, 33014-2490
        • Savin Medical Group, LLC /ID# 206902
      • Miami Lakes, Florida, United States, 33016-1842
        • Floridian Clinical Research /ID# 207433
      • Naples, Florida, United States, 34102-5430
        • Advanced Research for Health Improvement /ID# 217987
      • Naples, Florida, United States, 34102-5430
        • Advanced Research for Health Improvement /ID# 218003
      • Ormond Beach, Florida, United States, 32174-6302
        • Complete Health Research /ID# 213459
      • Sunrise, Florida, United States, 33351-7311
        • Precision Clinical Research /ID# 207364
      • Tampa, Florida, United States, 33607
        • Clinical Research Trials of Florida, Inc. /ID# 206840
      • Tampa, Florida, United States, 33613-1244
        • ForCare Clinical Research /ID# 205120
    • Georgia
      • Albany, Georgia, United States, 31707-1282
        • Georgia Pollens Clinical Research Centers, Inc /ID# 218567
      • Marietta, Georgia, United States, 30060-1047
        • Marietta Dermatology Clinical Research /ID# 210317
      • Sandy Springs, Georgia, United States, 30342
        • Agile Clinical Research Trials /ID# 218080
    • Idaho
      • Boise, Idaho, United States, 83706
        • Treasure Valley Medical Research /ID# 210298
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials /ID# 205830
      • Gurnee, Illinois, United States, 60031-3393
        • Ashira Dermatology /ID# 205512
      • Gurnee, Illinois, United States, 60031
        • Clinical Investigation Specialists, Inc. /ID# 206898
      • Skokie, Illinois, United States, 60077
        • Northshore University Health System Dermatology Clinical Trials Unit /ID# 205135
    • Indiana
      • Crown Point, Indiana, United States, 46307
        • Raga Clinical Studies, LLC. /ID# 206749
    • Kansas
      • Hutchinson, Kansas, United States, 67502-1131
        • Hutchinson Clinic /ID# 205970
    • Maryland
      • Towson, Maryland, United States, 21204
        • Continental Clinical Solutions /ID# 210327
    • Massachusetts
      • Quincy, Massachusetts, United States, 02169
        • Beacon Clinical Research, LLC /ID# 206894
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • David Fivenson, MD, PLC /ID# 206903
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 206895
    • Nebraska
      • Lincoln, Nebraska, United States, 68505-2343
        • Allergy, Asthma & Immunology Associates, PC /ID# 218169
      • Omaha, Nebraska, United States, 68144
        • Skin Specialists, PC /ID# 205515
    • New Jersey
      • Clifton, New Jersey, United States, 07012-1647
        • Duplicate_Summit Medical Group /ID# 213863
      • Hackensack, New Jersey, United States, 07601-1997
        • Skin Laser and Surgery Specialists of NY and NJ /ID# 206754
      • Hoboken, New Jersey, United States, 07030-2757
        • Care Access Research /ID# 218476
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • University of New Mexico School of Medicine /ID# 206756
    • New York
      • Bronx, New York, United States, 10458-5046
        • Fordham Dermatology /ID# 218508
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington LLC /ID# 205968
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center /ID# 206639
      • Marion, Ohio, United States, 43302-6225
        • Awasty Research Network, LLC /ID# 206748
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74132
        • Southside Dermatology /ID# 214451
      • Tulsa, Oklahoma, United States, 74136-7049
        • Vital Prospects Clinical Research Institute, PC /ID# 205824
    • Oregon
      • Gresham, Oregon, United States, 97030-8316
        • Cyn3rgy Research /ID# 218064
      • Medford, Oregon, United States, 97504
        • Velocity Clinical Research Hallandale Beach /ID# 207544
    • Tennessee
      • Jackson, Tennessee, United States, 38305-2163
        • Clinical Research Solutions, LLC /ID# 218416
      • Murfreesboro, Tennessee, United States, 37129-3194
        • Stones River Dermatology /ID# 205178
    • Texas
      • Arlington, Texas, United States, 76014-3105
        • Metroplex Dermatology /ID# 213307
      • Bellaire, Texas, United States, 77401
        • Bellaire Dermatology /ID# 205470
      • Cypress, Texas, United States, 77433
        • Center for Clinical Studies /ID# 213186
      • Dallas, Texas, United States, 75230
        • Dermatology Treatment and Research Center, PA /ID# 205473
      • Fort Worth, Texas, United States, 76244-6548
        • Epiphany Dermatology - Fort Worth /ID# 210073
      • Lewisville, Texas, United States, 75067
        • Styde Research, LLC /ID# 213469
      • Pflugerville, Texas, United States, 78660
        • Austin Institute for Clinical Research /ID# 206640
      • San Antonio, Texas, United States, 78229
        • Derm Clin Res Ctr San Antonio /ID# 205469
    • Utah
      • Murray, Utah, United States, 84123-5632
        • EPIC Medical Research /ID# 206382
      • Orem, Utah, United States, 84058
        • Aspen Clinical Research /ID# 208399
    • Vermont
      • South Burlington, Vermont, United States, 05403-7204
        • Timber Lane Allergy & Asthma Research, LLC /ID# 206897
    • Virginia
      • Lynchburg, Virginia, United States, 24501-1403
        • The Education & Research Foundation, Inc. /ID# 206900
    • Washington
      • Bellingham, Washington, United States, 98225-1945
        • Bellingham Asthma Allergy and Immunology Clinic /ID# 210357
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53144-1782
        • Clinical Investigation Specialist, Inc - Kenosha /ID# 215933

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 ≥ 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

Exclusion Criteria:

  • 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

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, 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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 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 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 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 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
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 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 ≥ 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 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
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). 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
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). 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
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). 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
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 ≥ 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
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). Worst 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: 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 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: 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.
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 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, 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, 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 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: 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). Worst 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: Percentage of Participants Achieving HADS-A Score and HADS-D Score of < 8 at Week 16
Time Frame: 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.
Week 16
Adolescents: 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

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)

July 27, 2018

Primary Completion (Actual)

March 11, 2021

Study Completion (Estimated)

December 3, 2025

Study Registration Dates

First Submitted

July 25, 2018

First Submitted That Met QC Criteria

July 25, 2018

First Posted (Actual)

July 31, 2018

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M18-891
  • 2022-502936-38-00 (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

For details on when studies are available for sharing, please refer to the link below.

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 Use Agreement (DUA). 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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