A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis (Level Up)

January 24, 2025 updated by: AbbVie

A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects With Moderate to Severe Atopic Dermatitis (Level-Up)

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed.

Upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis (AD). The study is comprised of a 35-day Screening Period, a 16-week treatment Period 1 and a 16-week treatment Period 2. Participants are randomly assigned to 1 of 2 groups called treatment arms to receive upadacitinib Dose A or dupilumab in Period 1. There is a 30-day or 12-week follow-up visit for those on upadacitinib or dupilumab respectively, who will not enter Period 2. In Period 2, participants will receive upadacitinib Dose A or Dose B for 16 weeks, followed by a 30-day follow-up visit. Approximately 880 adolescent and adult participants ages 12 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 330 sites worldwide.

There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

920

Phase

  • Phase 3

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
        • Premier Specialist /ID# 250572
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Veracity Clinical Research /ID# 249943
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • Skin Health Institute Inc /ID# 249938
      • East Melbourne, Victoria, Australia, 3002
        • Sinclair Dermatology - Melbourne /ID# 249937
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Fremantle Dermatology /ID# 249941
  • Belgium
      • Liege, Belgium, 4000
        • CHU de Liege /ID# 251400
    • Bruxelles-Capitale
      • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
        • Cliniques Universitaires UCL Saint-Luc /ID# 251403
    • Hainaut
      • Charleroi, Hainaut, Belgium, 6000
        • Grand Hopital de Charleroi /ID# 251401
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Universitair Ziekenhuis Leuven /ID# 251399
  • Bulgaria
      • Plovdiv, Bulgaria, 4001
        • DCC Pulmed AD /ID# 251271
      • Sofia, Bulgaria, 1606
        • Medical center EuroHealth /ID# 251270
      • Sofia, Bulgaria, 1606
        • Military Medical Academy Multiprofile Hospital /ID# 251187
      • Sofia, Bulgaria, 1407
        • Ambulatory for Specialized Medical Care for skin and venereal diseases /ID# 251272
      • Sofiya, Bulgaria, 1606
        • Medical Center Euroderma /ID# 251267
      • Sofiya, Bulgaria, 1463
        • Diagnostic consultative center Focus-5 /ID# 251269
      • Stara Zagora, Bulgaria, 6000
        • MC Zara-Med EOOD /ID# 251135
    • Smolyan
      • Pleven, Smolyan, Bulgaria, 5800
        • UMHAT Dr Georgi Stranski EAD /ID# 251268
    • Sofia
      • Sofiya, Sofia, Bulgaria, 1431
        • Diagnostic Consultative Center Aleksandrovska /ID# 251137
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3A 2N1
        • Beacon Dermatology Inc /ID# 250336
      • Calgary, Alberta, Canada, T2J 7E1
        • Dermatology Research Institute - Blackfoot Trail /ID# 251642
      • Edmonton, Alberta, Canada, T6G 1C3
        • Alberta DermaSurgery Centre /ID# 250217
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • Dr. Chih-ho Hong Medical Inc. /ID# 251643
      • Surrey, British Columbia, Canada, V3V 0C6
        • Enverus Medical Research /ID# 251645
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3Z4
        • Wiseman Dermatology Research /ID# 250219
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 1G9
        • Brunswick Dermatology Center /ID# 250220
    • Ontario
      • Hamilton, Ontario, Canada, L8L 3C3
        • LEADER Research /ID# 251647
      • London, Ontario, Canada, N6H 5L5
        • DermEffects /ID# 250223
      • Markham, Ontario, Canada, L3P 1X2
        • Lynde Institute for Dermatology /ID# 251854
      • Mississauga, Ontario, Canada, L4Y 4C5
        • DermEdge Research Inc. /ID# 250216
      • Peterborough, Ontario, Canada, K9J 5K2
        • SKiN Centre for Dermatology /ID# 251853
      • Toronto, Ontario, Canada, M4W 2N4
        • Research Toronto /ID# 250222
      • Toronto, Ontario, Canada, M3H 5Y8
        • Toronto Dermatology Centre /ID# 252098
      • Waterloo, Ontario, Canada, N2J 1C4
        • Private Practice - Dr. Kim Papp Clinical Research /ID# 251644
    • Quebec
      • Québec, Quebec, Canada, G1V 4X7
        • Centre de Recherche dermatologique du Quebec Metropolitain /ID# 250427
  • China
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • The First Affiliated Hospital Of Fujian Medical University /ID# 249674
    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • Guangzhou First People's Hospital /ID# 249695
      • Guangzhou, Guangdong, China, 510260
        • The Second Affiliated Hospital of Guangzhou Medical University /ID# 249694
      • Guangzhou, Guangdong, China, 510091
        • Dermatology Hospital of Southern Medical University /ID# 250121
      • Shenzhen, Guangdong, China, 518048
        • The University of Hong Kong- Shenzhen Hospital /ID# 249436
    • Guizhou
      • Changsha, Guizhou, China, 410011
        • The Second Xiangya Hospital of Central South University /ID# 249657
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 251485
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • The First Hospital of China Medical University /ID# 249638
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Huashan Hospital, Fudan University /ID# 250025
      • Shanghai, Shanghai, China, 200443
        • Shanghai Skin Disease Hospital /ID# 249392
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Tianjin Medical University General Hospital /ID# 250246
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Hangzhou First People's Hospital /ID# 249437
      • Hangzhou, Zhejiang, China, 310009
        • The second affiliated hospital of Zhejiang University school of medicine /ID# 249655
      • Hangzhou, Zhejiang, China, 310014
        • Zhejiang Provincial People's Hospital /ID# 249653
  • Croatia
      • Grad Zagreb, Croatia, 10000
        • Poliklinika Solmed /ID# 252138
    • Grad Zagreb
      • Zagreb, Grad Zagreb, Croatia, 10000
        • DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 249591
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Djecja bolnica Srebrnjak /ID# 249594
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Klinicki bolnicki centar Zagreb /ID# 249596
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Klinika za dječje bolesti Zagreb /ID# 249590
    • Primorsko-goranska Zupanija
      • Rijeka, Primorsko-goranska Zupanija, Croatia, 51000
        • Klinicki bolnicki centar Rijeka /ID# 249593
    • Splitsko-dalmatinska Zupanija
      • Split, Splitsko-dalmatinska Zupanija, Croatia, 21000
        • Klinicki Bolnicki Centar (KBC) Split /ID# 249879
  • Denmark
    • Hovedstaden
      • Copenhagen NV, Hovedstaden, Denmark, 2400
        • Bispebjerg and Frederiksberg Hospital /ID# 248902
      • Hellerup, Hovedstaden, Denmark, 2900
        • Herlev and Gentofte Hospital /ID# 248900
    • Midtjylland
      • Aarhus, Midtjylland, Denmark, 8200
        • Aarhus Universitetshospital - Skejby /ID# 248899
    • Sjælland
      • Roskilde, Sjælland, Denmark, 4000
        • Roskilde Sygehus /ID# 248901
  • France
      • Paris, France, 75010
        • Hôpital Saint-Louis /ID# 251052
      • Rouen, France, 76000
        • Hôpital Charles-Nicolle /ID# 251055
      • Toulouse, France, 31400
        • CHU Toulouse - Hopital Larrey /ID# 251344
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13008
        • Hopital Saint Joseph /ID# 251053
    • Pays-de-la-Loire
      • Nantes, Pays-de-la-Loire, France, 44000
        • CHU de Nantes, Hotel Dieu -HME /ID# 251347
    • Rhone
      • Pierre Benite CEDEX, Rhone, France, 69495
        • HCL - Hopital Lyon Sud /ID# 251343
  • Germany
      • Bochum, Germany, 44793
        • Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 251566
      • Dresden, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 251844
      • Friedrichshafen, Germany, 88045
        • Derma Study Center Friedrichshafen GmbH /ID# 251460
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf /ID# 249547
      • Hamburg, Germany, 20354
        • Dermatologikum Hamburg /ID# 251390
      • Munich, Germany, 81675
        • Klinikum rechts der Isar /ID# 249548
    • Baden-Wuerttemberg
      • Freiburg, Baden-Wuerttemberg, Germany, 79106
        • Universitaetsklinikum Freiburg /ID# 249555
      • Heidelberg, Baden-Wuerttemberg, Germany, 69120
        • Universitaetsklinik Heidelberg /ID# 251458
      • Tubingen, Baden-Wuerttemberg, Germany, 72076
        • Universitaetsklinikum Tuebingen /ID# 249552
    • Brandenburg
      • Blankenfelde-Mahlow, Brandenburg, Germany, 15831
        • Dermatologische Gemeinschaftspraxis Mahlow /ID# 250306
    • Hessen
      • Darmstadt, Hessen, Germany, 64283
        • Klinikum Darmstadt /ID# 251391
      • Frankfurt am Main, Hessen, Germany, 60590
        • Universitaetsklinikum Frankfurt /ID# 249544
    • Niedersachsen
      • Bramsche, Niedersachsen, Germany, 49565
        • Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 251392
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Germany, 53127
        • Universitaetsklinikum Bonn /ID# 250307
      • Muenster, Nordrhein-Westfalen, Germany, 48149
        • Universitaetsklinikum Muenster /ID# 249404
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • Universitaetsmedizin Mainz /ID# 249549
    • Saarland
      • Bad Bentheim, Saarland, Germany, 48455
        • Fachklinik Bad Bentheim /ID# 249545
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Universitaetsklinikum Leipzig /ID# 249562
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 249560
  • Greece
    • Attiki
      • Athens, Attiki, Greece, 11527
        • 401 GSNA - 401 Army General Hospital /ID# 251843
      • Athens, Attiki, Greece, 16121
        • General Hospital Andreas Syggros /ID# 251842
    • Evrytania
      • Thessaloniki, Evrytania, Greece, 56429
        • Papageorgiou General Hospital /ID# 251840
  • Hungary
      • Budapest, Hungary, 1033
        • Clinexpert Kft /ID# 249822
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem /ID# 251368
      • Budapest, Hungary, 1135
        • UNO Medical Trials /ID# 249820
      • Debrecen, Hungary, 4031
        • DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 249819
      • Szeged, Hungary, 6720
        • Szegedi Tudományegyetem /ID# 249818
      • Szolnok, Hungary, 5000
        • Allergo-Derm Bakos Kft. /ID# 249821
    • Bacs-Kiskun
      • Kecskemet, Bacs-Kiskun, Hungary, 6000
        • Bacs-Kiskun Varmegyei Oktatokorhaz /ID# 249850
    • Hajdu-Bihar
      • Debrecen, Hajdu-Bihar, Hungary, 4032
        • Debreceni Egyetem-Klinikai Kozpont /ID# 249849
    • Heves
      • Gyongyos, Heves, Hungary, 3200
        • Gyongyosi Bugat Pal Korhaz /ID# 251367
    • Nograd
      • Pecs, Nograd, Hungary, 7624
        • Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 250419
    • Somogy
      • Kaposvár, Somogy, Hungary, 7400
        • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 249848
  • Israel
      • Haifa, Israel, 4941492
        • Rabin Medical Center /ID# 251578
    • Yerushalayim
      • Jerusalem, Yerushalayim, Israel, 91120
        • Hadassah Medical Center-Hebrew University /ID# 251576
  • Italy
      • Brescia, Italy, 25123
        • ASST degli Spedali Civili di Brescia /ID# 250129
      • Florence, Italy, 50122
        • Ospedale Piero Palagi /ID# 250206
      • Milano, Italy, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 250123
      • Modena, Italy, 41124
        • Azienda Ospedaliero-Universitaria di Modena /ID# 250128
      • Perugia, Italy, 06156
        • Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 251572
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana /ID# 250124
    • L Aquila
      • Chieti, L Aquila, Italy, 66100
        • CAST - Center for Advanced Studies and Technology /ID# 251495
      • L'Aquila, L Aquila, Italy, 67100
        • Presidio Ospedaliero San Salvatore /ID# 250127
    • Milano
      • Rozzano, Milano, Italy, 20089
        • IRCCS Istituto Clinico Humanitas /ID# 251493
    • Roma
      • Rome, Roma, Italy, 00133
        • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 250125
      • Rome, Roma, Italy, 00144
        • IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 250558
      • Rome, Roma, Italy, 00168
        • Policlinico Agostino Gemelli /ID# 251494
  • Japan
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 060-0063
        • Medical Corporation Kojinkai Sapporo Skin Clinic /ID# 252549
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan, 211-0063
        • Medical corporation Kojunkai Kosugi Dermatology Clinic /ID# 252554
      • Sagamihara-shi, Kanagawa, Japan, 252-0392
        • National Hospital Organization Sagamihara National Hospital /ID# 254518
      • Yokohama-shi, Kanagawa, Japan, 220-6208
        • Queen's Square Medical Center, Dermatology and Allergology /ID# 252551
    • Osaka
      • Habikino-shi, Osaka, Japan, 583-8588
        • Osaka Habikino Medical Center /ID# 252550
      • Sakai-shi, Osaka, Japan, 5938324
        • Dermatology and Ophthalmology Kume Clinic /ID# 254570
    • Tokyo
      • Setagaya-ku, Tokyo, Japan, 158-0097
        • Naoko Dermatology Clinic /ID# 254571
  • Korea, Republic of
    • Busan Gwang Yeogsi
      • Busan, Busan Gwang Yeogsi, Korea, Republic of, 49241
        • Pusan National University Hospital /ID# 249852
    • Daegu Gwang Yeogsi
      • 중구, Daegu Gwang Yeogsi, Korea, Republic of, 41944
        • Kyungpook National University Hospital /ID# 249855
    • Gyeonggido
      • Ansan-si, Gyeonggido, Korea, Republic of, 15355
        • Korea University Ansan Hospital /ID# 249814
      • Bucheon-si, Gyeonggido, Korea, Republic of, 14584
        • Soon Chun Hyang University Hospital Bucheon /ID# 249812
      • Dongjak-gu, Gyeonggido, Korea, Republic of, 06973
        • Chungang University Hospital /ID# 251490
      • Suwon-si, Gyeonggido, Korea, Republic of, 16499
        • Ajou University Hospital /ID# 251491
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05030
        • Konkuk University Medical Center /ID# 249811
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
        • Seoul National University Hospital /ID# 251492
  • Mexico
      • Mexico City, Mexico, 06100
        • Cryptex Investigacion Clinica S.A de C.V /ID# 249994
      • Tlalnepantla de Baz, Mexico, 54055
        • Clinical Research Institute SC /ID# 249647
      • Veracruz, Mexico, 91910
        • Arké Estudios Clinicos Veracruz /ID# 250147
    • Baja California
      • Monterrey, Baja California, Mexico, 64640
        • Centro de Dermatologia de Monterrey /ID# 249126
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64718
        • Eukarya PharmaSite, SC /ID# 249702
  • Netherlands
    • Noord-Brabant
      • Bergen op Zoom, Noord-Brabant, Netherlands, 4624 VT
        • Bravis Ziekenhuis /ID# 251395
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
        • Amsterdam UMC, locatie AMC /ID# 251397
  • Poland
      • Cracow, Poland, 30-033
        • Centrum Medyczne ALL-MED Badania Kliniczne /ID# 249630
    • Kujawsko-pomorskie
      • Torun, Kujawsko-pomorskie, Poland, 87-100
        • MICS Centrum Medyczne Torun /ID# 251433
    • Lodzkie
      • Lodz, Lodzkie, Poland, 90-265
        • Dermed Centrum Medyczne Sp. z o.o /ID# 251429
    • Malopolskie
      • Cracow, Malopolskie, Poland, 30-438
        • Lidia Rajzer - Specjalistyczny Gabinet Dermatologiczno-Kosmetyczny /ID# 252082
      • Krakow, Malopolskie, Poland, 31-011
        • Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 251437
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 02-962
        • Royalderm Agnieszka Nawrocka /ID# 251432
      • Warszawa, Mazowieckie, Poland, 02-953
        • Klinika Ambroziak Sp. z o.o. /ID# 249406
      • Warszawa, Mazowieckie, Poland, 03-712
        • Bodyclinic Sp. z o.o. sp.k. /ID# 249599
    • Podkarpackie
      • Iwonicz-Zdrój, Podkarpackie, Poland, 38-440
        • Zespol Naukowo-Leczniczy Iwolang Dermatologiczne Centrum Uzdrowiskowe Sp. z o.o /ID# 249598
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-077
        • INTER CLINIC Piotr Adrian Klimiuk /ID# 251430
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-546
        • Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 251431
    • Warminsko-mazurskie
      • Elblag, Warminsko-mazurskie, Poland, 82-300
        • Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 251438
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 60-529
        • Solumed Centrum Medyczne /ID# 249641
  • Portugal
      • Braga, Portugal, 4710-243
        • 2CA-Braga, Hospital de Braga /ID# 250480
      • Leiria, Portugal, 2410-197
        • Unidade Local de Saude da Regiao de Leiria, EPE /ID# 249194
      • Lisbon, Portugal, 1169-050
        • Centro Hospitalar de Lisboa Central /ID# 249195
      • Matosinhos, Portugal, 4464-513
        • Unidade Local de Saúde de Matosinhos, EPE /ID# 249197
      • Porto, Portugal, 4200-319
        • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 249192
    • Braga
      • Guimarães, Braga, Portugal, 4839-008
        • Centro Hospitalar Do Alto Ave - Hospital Senhora Da Oliveira /ID# 249196
    • Regiao Autonoma Da Madeira
      • Lisboa, Regiao Autonoma Da Madeira, Portugal, 1998-018
        • Hospital CUF Descobertas /ID# 249193
      • Porto, Regiao Autonoma Da Madeira, Portugal, 4099-001
        • Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 249191
    • Setubal
      • Almada, Setubal, Portugal, 2805-267
        • Hospital Garcia de Orta /ID# 251455
  • Puerto Rico
      • Caguas, Puerto Rico, 00727
        • Dr. Samuel Sanchez PSC /ID# 250389
      • Carolina, Puerto Rico, 00985
        • Alma M. Cruz Santana, MD-Private practice /ID# 250393
      • San Juan, Puerto Rico, 00917-3104
        • GCM Medical Group PSC /ID# 250391
      • San Juan, Puerto Rico, 00909-1711
        • Clinical Research Puerto Rico /ID# 250394
  • Romania
    • Bucuresti
      • Bucharest, Bucuresti, Romania, 010701
        • Bio Terra Med SRL /ID# 249624
    • Cluj
      • Cluj Napoca, Cluj, Romania, 400006
        • Private Practice - Dr. Orasan Remus /ID# 249625
  • Slovakia
      • Bratislava, Slovakia, 811 09
        • Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 249746
      • Bratislava, Slovakia, 841 04
        • BeneDerma s.r.o. /ID# 251791
    • Bratislavsky Kraj
      • Bratislava, Bratislavsky Kraj, Slovakia, 851 01
        • Derma therapy spol /ID# 249783
  • South Africa
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0001
        • University of Pretoria /ID# 250208
      • Pretoria, Gauteng, South Africa, 0181
        • About Allergy /ID# 249697
    • Kwazulu-Natal
      • Durban, Kwazulu-Natal, South Africa, 3630
        • Highway Medical Centre /ID# 250103
    • Western Cape
      • CAPE TOWN Milnerton, Western Cape, South Africa, 7441
        • Spoke Research Inc /ID# 250091
      • Cape Town, Western Cape, South Africa, 7700
        • Allergy & Immunology (AIU) /ID# 249619
  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante Doctor Balmis /ID# 251517
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves /ID# 249785
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz /ID# 251518
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena /ID# 249603
      • Valencia, Spain, 46026
        • Hospital Universitario y Politecnico La Fe /ID# 251524
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol /ID# 251523
      • Esplugues de Llobregat, Barcelona, Spain, 08950
        • Hospital Sant Joan de Deu /ID# 249602
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital Universitario Basurto /ID# 249784
  • Sweden
      • Eskilstuna, Sweden, 633 49
        • Malarsjukhuset /ID# 251908
    • Skane Lan
      • Malmo, Skane Lan, Sweden, 214 28
        • Skane University hospital /ID# 250332
    • Stockholms Lan
      • Solna, Stockholms Lan, Sweden, 171 64
        • Karolinska University Hospital Solna /ID# 250328
    • Vasterbottens Lan
      • Umea, Vasterbottens Lan, Sweden, 581 85
        • Norrlands University hospital /ID# 250329
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital, Universitaetsspital Bern /ID# 250577
    • Sankt Gallen
      • St. Gallen, Sankt Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen /ID# 250606
  • Taiwan
      • Hsinchu City, Taiwan, 30059
        • National Taiwan University Hospital - Hsinchu branch /ID# 249265
      • New Taipei City, Taiwan, 23561
        • Taipei Medical University Shuang Ho Hospital /ID# 249256
      • Taipei, Taiwan, 116
        • Taipei Municipal Wan Fang Hospital /ID# 251500
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hosp /ID# 249263
      • Taipei City, Taiwan, 104
        • Mackay Memorial Hospital /ID# 249259
      • Taoyuan City, Taiwan, 333
        • Linkou Chang Gung Memorial Hospital /ID# 249257
    • Kaohsiung
      • Kaohsiung City, Kaohsiung, Taiwan, 833
        • Kaohsiung Chang Gung Memorial Hospital /ID# 249260
    • Keelung
      • Taichung, Keelung, Taiwan, 40705
        • Taichung Veterans General Hospital /ID# 249261
    • Taipei
      • Taipei City, Taipei, Taiwan, 100
        • National Taiwan University Hospital /ID# 249258
  • Turkey
      • Ankara, Turkey, 06800
        • Ankara City Hospital /ID# 249870
      • Antalya, Turkey, 07059
        • Akdeniz Universitesi Tip Fakul /ID# 249866
      • Bursa, Turkey, 16059
        • Uludag University Medical Faculty /ID# 249864
      • Kayseri, Turkey, 38039
        • Erciyes University Medical Faculty /ID# 249863
      • Samsun, Turkey, 55139
        • Ondokuz Mayis Universitesi /ID# 249865
    • Adana
      • Gaziantep, Adana, Turkey, 27310
        • Gaziantep Universitesi /ID# 249868
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Medical Dermatology Specialists /ID# 250212
      • Phoenix, Arizona, United States, 85032
        • Alliance Dermatology and Mohs Center /ID# 249671
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Clinical Trials Institute - Northwest Arkansas /ID# 249838
      • North Little Rock, Arkansas, United States, 72217
        • Arkansas Research Trials /ID# 250722
    • California
      • Encino, California, United States, 91436
        • Joseph Raoof Md,Inc /Id# 250211
      • Fountain Valley, California, United States, 92708
        • First OC Dermatology /ID# 250686
      • Lancaster, California, United States, 93534
        • Antelope Valley Clinical Trials /ID# 249946
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates /ID# 249829
      • Sacramento, California, United States, 95817
        • University of California Davis Health /ID# 250044
      • Thousand Oaks, California, United States, 91320-2130
        • Clinical Trials Research Institute /ID# 250213
    • Colorado
      • Wheat Ridge, Colorado, United States, 80033-2896
        • Western States Clinical Res /ID# 250274
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • UConn Health /ID# 253807
      • New Haven, Connecticut, United States, 06519
        • Yale Center for Clinical Investigation /ID# 254791
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Clearlyderm Dermatology /ID# 250457
      • Boca Raton, Florida, United States, 33486-2269
        • Skin Care Research Boca Raton /ID# 250458
      • Clearwater, Florida, United States, 33756
        • Olympian Clinical Research /ID# 250453
      • Hollywood, Florida, United States, 33021-6748
        • Skin Care Research - Hollywood /ID# 250459
      • Jacksonville, Florida, United States, 32256
        • Solutions Through Adv Rch /ID# 250455
      • Margate, Florida, United States, 33063
        • GSI Clinical Research, LLC /ID# 250768
      • Miami, Florida, United States, 33173
        • Florida International Rsrch cr /ID# 249667
      • Miami, Florida, United States, 33155
        • D&H National Research Centers /ID# 250734
      • Miami Lakes, Florida, United States, 33016
        • Wellness Clinical Research - Miami Lakes /ID# 250236
      • North Miami Beach, Florida, United States, 33162-4708
        • Tory P Sullivan, MD PA /ID# 251136
      • Sunrise, Florida, United States, 33351-7311
        • Precision Clinical Research /ID# 250990
      • Tampa, Florida, United States, 33607
        • Advanced Clinical Research Institute /ID# 250460
      • West Palm Beach, Florida, United States, 33401
        • Metabolic Research Inst /ID# 250046
    • Idaho
      • Boise, Idaho, United States, 83706
        • Treasure Valley Medical Research /ID# 250727
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Dawes Fretzin, LLC /ID# 250276
      • West Lafayette, Indiana, United States, 47906-1569
        • Randall Dermatology of West Lafayette /ID# 250234
    • Massachusetts
      • Boston, Massachusetts, United States, 02215-5400
        • Beth Israel Deaconess Medical Center /ID# 251212
      • Quincy, Massachusetts, United States, 02169
        • Beacon Clinical Research, LLC /ID# 251412
    • Michigan
      • Clarkston, Michigan, United States, 48346
        • Clarkston Dermatology /ID# 250225
      • Detroit, Michigan, United States, 48202-3046
        • Henry Ford Medical Center - New Center One /ID# 250228
    • Missouri
      • Kirksville, Missouri, United States, 63501-5362
        • Cleaver Dermatology /ID# 250725
      • Saint Joseph, Missouri, United States, 64506
        • MediSearch Clinical Trials /ID# 250272
    • Nebraska
      • Lincoln, Nebraska, United States, 68505-2343
        • Duplicate_Allergy, Asthma & Immunology Associates, PC /ID# 250616
      • Lincoln, Nebraska, United States, 68516
        • Physician Research Collaboration, LLC /ID# 251099
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center - Moses Campus /ID# 251214
    • Ohio
      • Bexley, Ohio, United States, 43209-2422
        • Derm of Greater Columbus /ID# 250049
      • Cleveland, Ohio, United States, 44106
        • Univ Hosp Cleveland /ID# 250699
      • Fairborn, Ohio, United States, 45324-2640
        • Wright State Physicians - Fairborn /ID# 254167
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136-7049
        • Vital Prospects Clinical Research Institute, PC /ID# 249840
    • Oregon
      • Portland, Oregon, United States, 97210
        • Oregon Dermatology and Research Center /ID# 250726
      • Portland, Oregon, United States, 97239
        • Oregon Medical Research Center /ID# 250712
      • Portland, Oregon, United States, 97223
        • Oregon Medical Research Center /ID# 249666
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh MC /ID# 251208
    • South Carolina
      • Charleston, South Carolina, United States, 29425-8903
        • Duplicate_Medical University of South Carolina /ID# 251218
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Health Concepts /ID# 250988
    • Tennessee
      • Murfreesboro, Tennessee, United States, 37130-2450
        • International Clinical Research - Tennessee LLC /ID# 250724
    • Texas
      • Arlington, Texas, United States, 76011
        • Arlington Research Center, Inc /ID# 250468
      • Austin, Texas, United States, 78759-4100
        • Orion Clinical Research /ID# 250473
      • Bellaire, Texas, United States, 77401
        • Bellaire Dermatology Associates /ID# 250739
      • Dallas, Texas, United States, 75231
        • Modern Research Associates, PLLC /ID# 250688
      • Houston, Texas, United States, 77065
        • Center for Clinical Studies - Houston - Northwest Freeway /ID# 250039
      • San Antonio, Texas, United States, 78218-3128
        • Texas Dermatology and Laser Specialists /ID# 250367
    • Utah
      • Murray, Utah, United States, 84107
        • University of Utah /ID# 250042
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia - Dermatology /ID# 254166
      • Norfolk, Virginia, United States, 23502
        • Virginia Clinical Research, Inc. /ID# 249908

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 64 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to baseline and participant meets Hanifin and Rajka criteria.
  • Eczema area and severity index (EASI) score ≥ 16;validated Investigator´s Global Assessment for AD (vIGA-AD) score ≥ 3 and ≥ 10% Body Surface Area Involvement of Atopic Dermatitis (BSA of AD) involvement at the Baseline Visit.
  • Baseline weekly average of daily Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4.
  • Documented history of inadequate response to previous systemic treatment defined as documented history of previous inadequate response to at least one prior systemic treatment for AD OR for whom other systemic treatments are otherwise medically inadvisable.

Exclusion Criteria:

  • History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
  • History of an organ transplant which requires continued immunosuppression.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dupilumab (Period 1)

Adult participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection at the Baseline visit followed by 300 mg dupilumab SC every other week (EOW) until Week 16.

Adolescents (12 to 17 years of age and weighing at least 40 kg) received treatment according to their body weight. Participants weighing 40 to < 60 kg received a loading dose of 400 mg dupilumab SC at the Baseline visit followed by 200 mg SC EOW until Week 16. Those weighing 60 kg or more received a loading dose of 600 mg dupilumab SC at the Baseline visit followed by 300 mg dupilumab SC EOW until Week 16.
Drug: Dupilumab
Dupilumab is administered as a subcutaneous (SC) injection.
Other Names:
  • Dupixent®
Experimental: Upadacitinib (Period 1)
Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a < 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a < 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a < EASI 75 response.
Drug: Upadacitinib
Extended-release tablet
Other Names:
  • RINVOQ
  • ABT-494
Experimental: Dupilumab -> Upadacitinib (Period 2)
At Week 16, participants receiving dupilumab as per its label in Period 1 were reassigned based on their Eczema Area and Severity Index (EASI) response. Those with < EASI 75 were offered the option to receive oral doses of upadacitinib 15 mg QD in Period 2 up to Week 32. Those with ≥ EASI 75 completed the end of study procedures. Starting at Week 20, participants with < EASI 75 or a < 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average) had their dose increased to 30 mg QD up to Week 32.
Drug: Upadacitinib
Extended-release tablet
Other Names:
  • RINVOQ
  • ABT-494
Experimental: Upadacitinib -> Upadacitinib 30 mg (Period 2)
At Week 16, participants receiving upadacitinib in Period 1 were reassigned based on their Eczema Area and Severity Index (EASI) response. Those with < EASI 75 were allocated or continued to receive upadacitinib 30 mg QD in Period 2. Those with ≥ EASI 75 completed the end of study procedures.
Drug: Upadacitinib
Extended-release tablet
Other Names:
  • RINVOQ
  • ABT-494

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16
Time Frame: Baseline and Week 16

The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).

The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Baseline and Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 16
Time Frame: Baseline and Week 16
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).
Baseline and Week 16
Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 Among Participants With Baseline WP-NRS > 1
Time Frame: Baseline and Week 16
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Baseline and Week 16
Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 at Week 16 Among Those With Baseline WP-NRS ≥ 4
Time Frame: Baseline and Week 16
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Baseline and Week 16
Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 4 Among Participants With Baseline WP-NRS > 1
Time Frame: Baseline and Week 4
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Baseline and Week 4
Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 2 Among Participants With Baseline WP-NRS > 1
Time Frame: Baseline and Week 2
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Baseline and Week 2
Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 4
Time Frame: Baseline and Week 4
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).
Baseline and Week 4
Percentage of Participants Achieving a ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 2
Time Frame: Baseline and Week 2
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).
Baseline and Week 2
Percentage of Participants Achieving a 100% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 100) at Week 16
Time Frame: Baseline and Week 16
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).
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.

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)

November 28, 2022

Primary Completion (Actual)

March 19, 2024

Study Completion (Actual)

August 8, 2024

Study Registration Dates

First Submitted

October 31, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 1, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 24, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M23-696
  • 2022-002482-15 (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, analyses plans, 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 visit https://vivli.org/ourmember/abbvie/

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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

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.

Yes

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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