A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis (AD Up)

April 11, 2024 updated by: AbbVie

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids 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 combined with topical corticosteroids (TCS) for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Study Overview

Status

Enrolling by invitation

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, a blinded Long-term Extension (LTE) Period after Week 260 to Week 524, and a 30-day follow-up visit. Participants who meet eligibility criteria in the Main Study will be randomly assigned in a 1:1:1 ratio to receive upadacitinib 15 mg, upadacitinib 30 mg, or placebo once daily, in combination with topical corticosteroids.

Upon completion of enrollment of 810 participants in the Main Study, a supplemental study will continue to enroll adolescent participants (Adolescent Sub-study) until a total of 180 adolescent participants are enrolled in the overall study (Main Study + Adolescent Sub-study).

Approximately 1000 participants from M16-045 or M18-891 and approximately 500 participants from M16-047 will have the opportunity to enroll into the blinded Long-Term Extension (LTE) period (Week 260 - Week 524) after reaching Week 260 in their respective studies.

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 (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] versus severe [vIGA-AD 4]) and by geographic region (US/Puerto Rico/Canada and Other).

At Week 16 of both 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, and participants originally randomized to upadacitinib will continue upadacitinib in the extension period at the same dose. For the Main Study, the re-randomization will be stratified by Eczema Area and Severity Index (EASI) 50 responder status (Yes/No), by geographic region (US/Puerto Rico/Canada, Japan, China, and Other) and by age (adolescent [ages 12 to 17] versus adult [ages 18 to 75]). 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).

Starting at Week 4, 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 (Estimated)

1500

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
      • Kogarah, New South Wales, Australia, 2217
        • St George Dermatology & Skin Cancer Centre /ID# 204788
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital /ID# 204639
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital /ID# 205682
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Veracity Clinical Research /ID# 204793
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Fremantle Dermatology /ID# 205306
  • Austria
    • Oberoesterreich
      • Linz, Oberoesterreich, Austria, 4010
        • Ordensklinikum Linz GmbH Elisabethinen /ID# 209567
      • Linz, Oberoesterreich, Austria, 4021
        • Kepler Universitaetsklinikum GmbH /ID# 201075
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Medizinische Universitaet Innsbruck /ID# 210897
    • Wien
      • Vienna, Wien, Austria, 1090
        • Medizinische Universitaet Wien /ID# 201080
  • Belgium
      • Loverval, Belgium, 6280
        • IMTR - Grand Hopital de Charleroi /ID# 202029
    • Bruxelles-Capitale
      • Jette, Bruxelles-Capitale, Belgium, 1090
        • UZ Brussel /ID# 203557
      • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
        • UCL Saint-Luc /ID# 202028
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent /ID# 202030
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2G 1B1
        • Kirk Barber Research, CA /ID# 200329
      • Calgary, Alberta, Canada, T2J 7E1
        • Dermatology Research Institute Inc. /ID# 200341
      • Edmonton, Alberta, Canada, T6G 1C3
        • Alberta DermaSurgery Centre /ID# 205674
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
        • Karma Clinical Trials /ID# 200339
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1Z2
        • Eastern Canada Cutaneous Resea /ID# 200335
    • Ontario
      • Markham, Ontario, Canada, L3P 1X2
        • Lynderm Research Inc. /ID# 200338
      • Mississauga, Ontario, Canada, L5H 1G9
        • DermEdge Research Inc. /ID# 200337
      • Oakville, Ontario, Canada, L6J 7W5
        • The Centre for Clinical Trials /ID# 205404
      • Ottawa, Ontario, Canada, K1H 7X3
        • Angela Montgomery Medicine Professional Corporation /ID# 212653
      • Peterborough, Ontario, Canada, K9J 5K2
        • SKIN Centre for Dermatology /ID# 200331
      • Richmond Hill, Ontario, Canada, L4B 1A5
        • The Center For Dermatology /ID# 205409
      • Toronto, Ontario, Canada, M3H 5Y8
        • Toronto Research Centre /ID# 205411
      • Toronto, Ontario, Canada, M4W 2N4
        • Research Toronto /ID# 205410
      • Windsor, Ontario, Canada, N8W 1E6
        • XLR8 Medical Research /ID# 205405
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • CHU Sainte-Justine /ID# 206013
      • Québec, Quebec, Canada, G1V 4X7
        • Centre de recheche dermatologique du Quebec Metropolitain /ID# 205403
      • Saint-Jerome, Quebec, Canada, J7Z 7E2
        • Dre Angelique Gagne-Henley M.D. inc. /ID# 200330
  • China
      • Beijing, China, 100032
        • Beijing Friendship Hospital /ID# 207434
      • Changsha, China, 410008
        • Xiangya Hospital Central South University /ID# 207510
      • Shanghai, China, 200040
        • Huashan Hospital of Fudan University /ID# 207437
    • Beijing
      • Beijing, Beijing, China, 100853
        • Chinese PLA General Hospital /ID# 206786
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 206728
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 206669
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • The First Hospital of China Medical University /ID# 209840
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 207132
      • Hangzhou, Zhejiang, China, 310009
        • The second Affiliated hospital of Zhejiang University school of Medicine /ID# 207442
  • Czechia
      • Plzen, Czechia, 305 99
        • Fakultni nemocnice Plzen /ID# 202044
      • Prague, Czechia, 128 08
        • Duplicate_Vseobecna Fakultni Nemocnice /ID# 205248
      • Praha, Czechia, 110 00
        • Sanatorium profesora Arenbergera /ID# 202082
      • Praha, Czechia, 128 08
        • Vseobecna fakultni nemocnice v Praze /ID# 202045
  • France
      • Bordeaux, France, 33075
        • Hopital Saint-Andre /ID# 206129
      • Reims, France, 51100
        • Polyclinique Courlancy /ID# 201537
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06200
        • Chu de Nice-Hopital L'Archet Ii /Id# 205780
    • Bouches-du-Rhone
      • Marseille CEDEX 05, Bouches-du-Rhone, France, 13385
        • AP-HM - Hopital de la Timone /ID# 206128
    • Centre-Val De Loire
      • Tours, Centre-Val De Loire, France, 37044
        • CHRU Tours - Hopital Gatien de Clocheville /ID# 218209
  • Germany
      • Bonn, Germany, 53127
        • Universitaetsklinikum Bonn /ID# 202092
      • Hamburg, Germany, 20537
        • TFS Trial Form Support GmbH /ID# 202096
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover /ID# 202098
      • Mainz, Germany, 55131
        • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205194
      • Munich, Germany, 81675
        • Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202093
    • Baden-Wuerttemberg
      • Heidelberg, Baden-Wuerttemberg, Germany, 69120
        • Universitaetsklinik Heidelberg /ID# 202097
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60590
        • Universitaetsklinikum Frankfurt /ID# 202095
    • Nordrhein-Westfalen
      • Muenster, Nordrhein-Westfalen, Germany, 48149
        • Universitaetsklinikum Muenster /ID# 202094
    • Rheinland-Pfalz
      • Selters, Rheinland-Pfalz, Germany, 56242
        • CMS3 Company for Medical Study /ID# 205195
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202256
  • Greece
      • Thessaloniki, Greece, 54643
        • Thessaloniki Hospital of Skin and Venereal Diseases /ID# 201124
    • Attiki
      • Athens, Attiki, Greece, 11525
        • 401 GSNA - 401 Army General Hospital /ID# 211963
      • Athens, Attiki, Greece, 11527
        • Children's Hosp P. A. Kyriakou /ID# 217573
      • Athens, Attiki, Greece, 12462
        • University General Hospital Attikon /ID# 201126
      • Athens, Attiki, Greece, 16121
        • General Hospital Andreas Syggros /ID# 201123
    • Thessaloniki
      • Stavroupoli (Thessalonikis), Thessaloniki, Greece, 55536
        • Papageorgiou General Hospital Thessaloniki /ID# 202392
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Prince of Wales Hospital /ID# 205152
      • Hong Kong, Hong Kong, 999077
        • Queen Mary Hospital /ID# 205146
  • Hungary
      • Debrecen, Hungary, 4031
        • Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 217866
      • Szolnok, Hungary, 5000
        • Allergo-Derm Bakos Kft. /ID# 205361
    • Bekes
      • Oroshaza, Bekes, Hungary, 5900
        • Oroshazi Korhaz /ID# 203525
    • Csongrad
      • Szeged, Csongrad, Hungary, 6725
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 204144
    • Hajdu-Bihar
      • Debrecen, Hajdu-Bihar, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont /ID# 201765
  • Ireland
      • Cork, Ireland, T12 X23H
        • South Infirmary Victoria University Hospital /ID# 201079
      • Waterford, Ireland, X91 ER8E
        • University Hospital Waterford /ID# 201253
    • Dublin
      • Dublin 8, Dublin, Ireland, D08 NHY1
        • St James Hospital /ID# 201118
  • Israel
      • Afula, Israel, 1834111
        • HaEmek Medical Center /ID# 201958
      • Petakh Tikva, Israel, 4941492
        • Rabin Medical Center /ID# 201959
    • HaDarom
      • Be'er Sheva, HaDarom, Israel, 8443901
        • Soroka University Medical Center /ID# 206652
    • Tel-Aviv
      • Ramat Gan, Tel-Aviv, Israel, 5265601
        • The Chaim Sheba Medical Center /ID# 201611
      • Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center /ID# 201608
  • Italy
      • Ancona, Italy, 60126
        • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200690
      • Catania, Italy, 95123
        • A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200742
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 200744
      • Napoli, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico II /ID# 200751
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 203014
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas /ID# 200739
  • Japan
    • Aichi
      • Nagoya-shi, Aichi, Japan, 457-8510
        • Chukyo Hospital /ID# 202311
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 819-0373
        • Medical Corporation Matsuo Clinic /ID# 202312
    • Hiroshima
      • Hiroshima-shi, Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital /ID# 201914
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 060-0063
        • Medical Corporation Kojinkai Sapporo Skin Clinic /ID#258665
    • Hyogo
      • Amagasaki-shi, Hyogo, Japan, 661-0953
        • Hiramoto skin clinic /ID# 204048
    • Kanagawa
      • Sagamihara-shi, Kanagawa, Japan, 252-0392
        • National Hospital Organization Sagamihara National Hospital /ID# 201658
      • Yokohama-shi, Kanagawa, Japan, 220-6208
        • Queens Square Medical Center dermatology allergology /ID# 203850
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 606-8507
        • Kyoto University Hospital /ID# 201654
      • Kyoto-shi, Kyoto, Japan, 602-8566
        • University Hospital Kyoto Prefectural University of Medicine /ID#258604
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 9808574
        • Tohoku University Hospital /ID# 206322
    • Osaka
      • Habikino-shi, Osaka, Japan, 583-8588
        • Osaka Habikino Medical Center /ID# 204243
    • Tochigi
      • Shimotsuke-shi, Tochigi, Japan, 329-0498
        • Jichi Medical University Hospital /ID# 201913
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Juntendo University Hospital /ID# 202888
      • Hachioji-shi, Tokyo, Japan, 192-0032
        • Tokai University Hachioji Hospital /ID# 201711
      • Koto-ku, Tokyo, Japan, 136-0074
        • Maruyama Dermatology Clinic /ID# 202350
      • Shinjuku-ku, Tokyo, Japan, 1690075
        • Yamate Dermatological Clinic /ID# 202130
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum /ID# 202193
      • Groningen, Netherlands, 9713 GZ
        • Universitair Medisch Centrum Groningen /ID# 202195
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum Utrecht /ID# 202194
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
        • Erasmus Medisch Centrum /ID# 202196
  • New Zealand
      • Hamilton, New Zealand, 3204
        • Clinical Trials NZ /ID# 205336
  • Norway
      • Oslo, Norway, 0450
        • Rikshospitalet OUS HF /ID# 201271
    • Hordaland
      • Bergen, Hordaland, Norway, 5021
        • Haukeland University Hospital /ID# 201152
    • Troms
      • Harstad, Troms, Norway, 9406
        • Universitetssykehuset N-Norge, Harstad /ID# 201269
      • Tromso, Troms, Norway, 9019
        • Universitetssykehuset N-Norge, Tromso /ID# 201270
  • Puerto Rico
      • Caguas, Puerto Rico, 00727
        • Dr. Samuel Sanchez PSC /ID# 202002
      • San Juan, Puerto Rico, 00909
        • Clinical Research Puerto Rico /ID# 203644
      • San Juan, Puerto Rico, 00917-3104
        • GCM Medical Group PSC - Hato Rey /ID# 202003
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
        • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 204372
      • Martin, Slovakia, 036 01
        • Univerzitna nemocnica Martin /ID# 203851
      • Nove Zamky, Slovakia, 940 34
        • Fakultna nemocnica s poliklinikou Nove Zamky /ID# 204240
      • Presov, Slovakia, 081 01
        • Fakultna nemocnica s poliklinikou J.A. Reimana Presov /ID# 204373
  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario Alicante /ID# 200873
      • Barcelona, Spain, 08041
        • Hospital Santa Creu i Sant Pau /ID# 201325
      • Madrid, Spain, 28006
        • Hospital Universitario de la Princesa /ID# 201517
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre /ID# 201135
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz /ID# 205438
    • Cadiz
      • Puerto Real, Cadiz, Spain, 11510
        • Hospital Universitario de Puerto Real /ID# 200875
  • Sweden
      • Stockholm, Sweden, 118 83
        • Sodersjukhuset /ID# 201242
      • Stockholm, Sweden, 171 76
        • Karolinska University Hospital /ID# 201243
    • Skane Lan
      • Lund, Skane Lan, Sweden, SE 221 41
        • Skane University Hospital Lund /ID# 201244
    • Vastra Gotalands Lan
      • Gothenburg, Vastra Gotalands Lan, Sweden, 413 46
        • Sahlgrenska University Hospital /ID# 201274
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • Leeds Teaching Hospitals NHS Trust /ID# 201106
    • London, City Of
      • London, London, City Of, United Kingdom, E1 2ES
        • Barts Health NHS Trust /ID# 201044
      • London, London, City Of, United Kingdom, SE1 9RT
        • Guy's and St Thomas' NHS Foundation Trust /ID# 201193
      • London, London, City Of, United Kingdom, SE1 9RT
        • Guy's and St Thomas' NHS Foundation Trust /ID# 204642
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Oxford University Hospitals NHS Foundation Trust /ID# 202052
    • Scotland
      • Dundee, Scotland, United Kingdom, DD2 1UB
        • NHS Tayside /ID# 202081
      • Glasgow, Scotland, United Kingdom, G12 0XH
        • NHS Greater Glasgow and Clyde /ID# 201374
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Total Skin and Beauty Derm Ctr /ID# 200548
      • Birmingham, Alabama, United States, 35209-6802
        • Clinical Research Center AL /ID# 201865
      • Birmingham, Alabama, United States, 35218
        • ACCEL Research Sites /ID# 213364
      • Mobile, Alabama, United States, 36605-3004
        • Advanced Dermatology and Skin Care Centre /ID# 213550
    • Arizona
      • Phoenix, Arizona, United States, 85053-4061
        • Arizona Research Center, Inc. /ID# 200546
      • Phoenix, Arizona, United States, 85032
        • Alliance Dermatology and MOHs Center, PC /ID#200540
      • Scottsdale, Arizona, United States, 85255-4134
        • Clear Dermatology & Aesthetics Center /ID# 201257
      • Tucson, Arizona, United States, 85719
        • University of Arizona /ID# 201059
    • California
      • Bakersfield, California, United States, 93309
        • Bakersfield Derma & Skin Cance /ID# 200892
      • Beverly Hills, California, United States, 90211
        • Mosaic Dermatology /ID# 200553
      • Irvine, California, United States, 92697-1385
        • University of California Irvine /ID# 200902
      • San Diego, California, United States, 92123
        • Therapeutics Clinical Research /ID# 200593
      • Stanford, California, United States, 94305
        • Stanford University /ID# 200597
    • Colorado
      • Aurora, Colorado, United States, 80045-2517
        • Duplicate_University of Colorado Anchutz Medical Campus /ID# 202822
      • Centennial, Colorado, United States, 80111-1724
        • Colorado Center for Dermatology, PLLC /ID# 203626
      • Wheat Ridge, Colorado, United States, 80033-2896
        • Duplicate_Western States Clinical Research, Inc. /ID# 201702
    • Connecticut
      • Shelton, Connecticut, United States, 06484-6211
        • Dermatology Physicians of Connecticut /ID# 201004
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Clearlyderm Dermatology /ID# 207709
      • Boca Raton, Florida, United States, 33486-2269
        • Skin Care Research, LLC /ID# 200812
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc /ID# 203643
      • Coral Gables, Florida, United States, 33134
        • Florida Academic Centers Research and Education /ID# 200544
      • North Miami Beach, Florida, United States, 33162-4708
        • Tory P Sullivan, MD PA /ID# 201174
      • Orange Park, Florida, United States, 32073
        • Park Avenue Dermatology, PA /ID# 201012
      • Sunrise, Florida, United States, 33351-7311
        • Precision Clinical Research /ID# 208734
    • Idaho
      • Boise, Idaho, United States, 83713
        • Advanced Clinical Research at Treasure Valley Dermatology & Skin Cancer Center /ID# 203628
    • Illinois
      • Chicago, Illinois, United States, 60611-2927
        • Northwestern University Feinberg School of Medicine /ID# 201646
      • Skokie, Illinois, United States, 60077
        • Northshore University Health System Dermatology Clinical Trials Unit /ID# 200556
      • Wheaton, Illinois, United States, 60189-3801
        • DuPage Medical Group /ID# 202065
    • Indiana
      • Evansville, Indiana, United States, 47713-1227
        • Deaconess Clinic Downtown /ID# 201001
      • Indianapolis, Indiana, United States, 46202
        • Indiana University /ID# 200515
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Epiphany Dermatology of Kansas LLC /ID# 203026
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • ORA, Inc. /ID# 202824
      • Boston, Massachusetts, United States, 02111-1552
        • Tufts Medical Center /ID# 200570
      • Boston, Massachusetts, United States, 02215-5400
        • Beth Israel Deaconess Medical Center /ID# 200545
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clin Res Inst of Michigan, LLC /ID# 208020
      • Clarkston, Michigan, United States, 48346
        • Michigan Center for Research Company /ID# 200560
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • MediSearch Clinical Trials /ID# 201006
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Skin Specialists, PC /ID# 200573
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center /ID# 200918
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Psoriasis Treatment Center of Central New Jersey /ID# 200714
    • New York
      • New York, New York, United States, 10022-3204
        • Juva Skin and Laser Center /ID# 200997
      • Troy, New York, United States, 12180-2323
        • J. Schwartz, MD, PLLC /ID# 202122
    • Ohio
      • Bexley, Ohio, United States, 43209-2422
        • Bexley Dermatology Research /ID# 200899
      • Columbus, Ohio, United States, 43210-1257
        • The Ohio State University /ID# 200542
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136-7049
        • Vital Prospects Clinical Research Institute, PC /ID# 200901
    • Oregon
      • Portland, Oregon, United States, 97210
        • Oregon Dermatology and Research Center /ID# 200601
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh MC /ID# 206057
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital /ID# 200566
      • Warwick, Rhode Island, United States, 02886-2876
        • AAPRI Clinical Research /ID# 221134
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072-2301
        • Rivergate Dermatology & Skin Care Center /ID# 201698
      • Murfreesboro, Tennessee, United States, 37129-3194
        • Stones River Dermatology /ID# 204962
    • Texas
      • Arlington, Texas, United States, 76011
        • Arlington Research Center, Inc /ID# 200559
      • Houston, Texas, United States, 77004
        • Center for Clinical Studies /ID# 200582
      • San Antonio, Texas, United States, 78229
        • Progressive Clinical Research /ID# 201582
      • Webster, Texas, United States, 77598
        • Center for Clinical Studies - Webster TX /ID# 203186
    • Utah
      • Salt Lake City, Utah, United States, 84117-4209
        • Advanced Clinical Research - Woseth Dermatology /ID# 213745
    • Virginia
      • Norfolk, Virginia, United States, 23507-1627
        • Eastern Virginia Med School /ID# 200994
    • Washington
      • Seattle, Washington, United States, 98101
        • Dermatology Associates of Seattle /ID# 200717
    • Wisconsin
      • Madison, Wisconsin, United States, 53715-1218
        • University of Wisconsin - Madison /ID# 204933

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

10 years to 73 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 Visit and subject meets Hanifin and Rajka criteria.
  • Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, ≥ 10% of body surface area (BSA) with AD involvement, and weekly average of daily Worst Pruritus numerical rating scale (NRS) ≥ 4.
  • 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 or topical calcineurin inhibitor OR documented systemic treatment for AD within 6 months prior to Baseline Visit

Exclusion Criteria:

  • Prior exposure to any Janus kinase (JAK) inhibitor
  • Unable or unwilling to discontinue current atopic dermatitis (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 + Topical Corticosteroids
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. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.
Drug: Upadacitinib
Tablets taken orally once a day
Other Names:
  • ABT-494
  • RINVOQ™
Drug: Placebo
Tablets taken orally once a day
Drug: Topical corticosteroids (TCS)

Topical corticosteroids will be applied in a stepdown regimen, starting with medium potency once daily to areas with active lesions until lesions are clear or almost clear, or for 3 consecutive weeks, whichever is shorter; then low potency topical corticosteroids once daily. If lesions return or persist, this step-down approach will be repeated until lesion resolution or evidence of local or systemic topical corticosteroids toxicity.

Recommended TCS include triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment as medium potency topical corticosteroids and hydrocortisone 1% cream as low potency topical corticosteroid.
Experimental: Upadacitinib 15 mg QD + Topical Corticosteroids
Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.
Drug: Upadacitinib
Tablets taken orally once a day
Other Names:
  • ABT-494
  • RINVOQ™
Drug: Topical corticosteroids (TCS)

Topical corticosteroids will be applied in a stepdown regimen, starting with medium potency once daily to areas with active lesions until lesions are clear or almost clear, or for 3 consecutive weeks, whichever is shorter; then low potency topical corticosteroids once daily. If lesions return or persist, this step-down approach will be repeated until lesion resolution or evidence of local or systemic topical corticosteroids toxicity.

Recommended TCS include triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment as medium potency topical corticosteroids and hydrocortisone 1% cream as low potency topical corticosteroid.
Experimental: Upadacitinib 30 mg QD + Topical Corticosteroids
Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52.
Drug: Upadacitinib
Tablets taken orally once a day
Other Names:
  • ABT-494
  • RINVOQ™
Drug: Topical corticosteroids (TCS)

Topical corticosteroids will be applied in a stepdown regimen, starting with medium potency once daily to areas with active lesions until lesions are clear or almost clear, or for 3 consecutive weeks, whichever is shorter; then low potency topical corticosteroids once daily. If lesions return or persist, this step-down approach will be repeated until lesion resolution or evidence of local or systemic topical corticosteroids toxicity.

Recommended TCS include triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment as medium potency topical corticosteroids and hydrocortisone 1% cream as low potency topical corticosteroid.
Experimental: Long-Term Extension
Participants who reach Week 260 in Studies M16-045, M18-891, and M16-047 will have the opportunity to roll over into the blinded LTE period of M16-047 to continue receiving the same daily dose of upadacitinib for up to Week 524.
Drug: Upadacitinib
Tablets taken orally once a day
Other Names:
  • ABT-494
  • RINVOQ™
Drug: Topical corticosteroids (TCS)

Topical corticosteroids will be applied in a stepdown regimen, starting with medium potency once daily to areas with active lesions until lesions are clear or almost clear, or for 3 consecutive weeks, whichever is shorter; then low potency topical corticosteroids once daily. If lesions return or persist, this step-down approach will be repeated until lesion resolution or evidence of local or systemic topical corticosteroids toxicity.

Recommended TCS include triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment as medium potency topical corticosteroids and hydrocortisone 1% cream as low potency topical corticosteroid.

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 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: 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
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: 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
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 4
Time Frame: Baseline and Week 4

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 4
Main Study: Percentage of Participants Achieving an EASI 90 Response at Week 4
Time Frame: Baseline and Week 4

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 4
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 from 0 [none], to 3 [severe]) for redness, thickness, scratching, and lichenification.

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.

The percentage of participants with an EASI 100 response at Week 16 was pre-specified as a ranked secondary endpoint for participants in the Upadacitinib 30 mg + Topical Corticosteroids group versus Placebo + Topical Corticosteroids group only.
Baseline and Week 16
Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 4
Time Frame: Baseline and Week 4

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 4
Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 4
Time Frame: Baseline and Week 4

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 4
Adolescents: Percentage of Participants Achieving an EASI 100 Response at Week 16
Time Frame: Baseline and Week 16

EASI is used to measure the extent 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. and the severity score is calculated as the sum of the intensity scores (scored from 0 [none], to 3 [severe]) for redness, thickness, scratching, and lichenification.

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.

The percentage of participants with an EASI 100 response at Week 16 was pre-specified as a secondary endpoint for participants in the Upadacitinib 30 mg + TCS group versus Placebo + TCS group only.
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 9, 2018

Primary Completion (Actual)

February 16, 2021

Study Completion (Estimated)

November 16, 2030

Study Registration Dates

First Submitted

June 14, 2018

First Submitted That Met QC Criteria

June 14, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M16-047
  • 2017-005126-37 (EudraCT Number)

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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