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)

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. During period 1, participants are randomly assigned in 1 of 2 groups, called treatment arms to receive upadacitinib Dose A or dupilumab. In Period 2, participants will receive upadacitinib Dose A or Dose B. 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.

Participants will receive upadacitinib oral tablets once daily or dupilumab as per its label for 32 weeks and followed for 30 days.

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: Active, not recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Upadacitinib; Drug: Dupilumab

• Study Type: Interventional
• Enrollment (Estimated): 880
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

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
  • Pleven, Bulgaria, 5800
    • UMHAT Dr Georgi Stranski EAD /ID# 251268
  • 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
    • ASMC-IPSMC-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
  • 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
  • Changsha, China, 410011
    • The Second Xiangya Hospital of Central South University /ID# 249657
  • 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
  • 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 djecje 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
    • AP-HP - Hopital 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
  • Bad Bentheim, Germany, 48455
    • Fachklinik Bad Bentheim /ID# 249545
  • Bochum, Germany, 44793
    • Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 251566
  • Bonn, Germany, 53127
    • Universitaetsklinikum Bonn /ID# 250307
  • 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 - Grafenstrasse /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
    • Muenster, Nordrhein-Westfalen, Germany, 48149
      • Universitaetsklinikum Muenster /ID# 249404
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Universitaetsmedizin Mainz /ID# 249549
  • Sachsen
    • Leipzig, Sachsen, Germany, 04103
      • Universitaetsklinikum Leipzig /ID# 249562
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 249560
• Greece
  • Thessaloniki, Greece, 56429
    • Papageorgiou General Hospital /ID# 251840
  • Attiki
    • Athens, Attiki, Greece, 11527
      • 401 GSNA - 401 Army General Hospital /ID# 251843
    • Athens, Attiki, Greece, 16121
      • General Hospital Andreas Syggros /ID# 251842
• 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
  • Kecskemet, Hungary, 6000
    • Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem AOK Oktató Kórháza /ID# 249850
  • Pecs, Hungary, 7624
    • Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 250419
  • Szeged, Hungary, 6720
    • Szegedi Tudományegyetem /ID# 249818
  • Szolnok, Hungary, 5000
    • Allergo-Derm Bakos Kft. /ID# 249821
  • Hajdu-Bihar
    • Debrecen, Hajdu-Bihar, Hungary, 4032
      • Debreceni Egyetem-Klinikai Kozpont /ID# 249849
  • Heves
    • Gyongyos, Heves, Hungary, 3200
      • Gyongyosi Bugat Pal Korhaz /ID# 251367
  • 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 Spedali civili di Brescia /ID# 250129
  • Chieti, Italy, 66100
    • CAST - Center for Advanced Studies and Technology /ID# 251495
  • Florence, Italy, 50122
    • Ospedale Piero Palagi /ID# 250206
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 250123
  • Modena, Italy, 41124
    • Azienda Ospedaliero-Universitaria di Modena /ID# 250128
  • Pisa, Italy, 56126
    • Azienda Ospedaliero Universitaria Pisana /ID# 250124
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli /ID# 251494
  • L Aquila
    • L'Aquila, L Aquila, Italy, 67100
      • Presidio Ospedaliero San Salvatore /ID# 250127
  • Milano
    • Rozzano, Milano, Italy, 20089
      • 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
  • Umbria
    • Perugia, Umbria, Italy, 06129
      • Azienda Ospedaliera di Perugia /ID# 251572
• 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, Korea, Republic of, 49241
    • Pusan National University Hospital /ID# 249852
  • Daegu, Korea, Republic of, 41944
    • Kyungpook National University Hospital /ID# 249855
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital /ID# 251492
  • Gyeonggido
    • Ansan, 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
• Mexico
  • Mexico City, Mexico, 06100
    • Cryptex Investigacion Clinica S.A de C.V /ID# 249994
  • Monterrey, Mexico, 64640
    • Centro de Dermatologia de Monterrey /ID# 249126
  • Tlalnepantla de Baz, Mexico, 54055
    • Clinical Research Institute SC /ID# 249647
  • Veracruz, Mexico, 91910
    • Arké Estudios Clinicos Veracruz /ID# 250147
  • 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
      • Academisch Medisch Centrum /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
  • Almada, Portugal, 2805-267
    • Hospital Garcia de Orta, EPE /ID# 251455
  • 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
  • Lisboa, Portugal, 1998-018
    • Hospital CUF Descobertas /ID# 249193
  • 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, 4099-001
    • Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 249191
  • Porto, Portugal, 4200-319
    • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 249192
  • Braga
    • Guimaraes, Braga, Portugal, 4835-044
      • Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 249196
• 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, 00909
    • Clinical Research Puerto Rico /ID# 250394
  • San Juan, Puerto Rico, 00917-3104
    • GCM Medical Group PSC /ID# 250391
• 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
  • Stockholm, Sweden, 171 76
    • Karolinska University Hospital /ID# 250328
  • Skane Lan
    • Malmo, Skane Lan, Sweden, 214 28
      • Skane University hospital /ID# 250332
  • 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
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital /ID# 249261
  • Taipei, Taiwan, 116
    • Taipei Municipal Wan Fang Hospital /ID# 251500
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hosp /ID# 249263
  • Taipei City, Taiwan, 100
    • National Taiwan University Hospital /ID# 249258
  • Taoyuan City, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital /ID# 249257
  • Kaohsiung
    • Kaohsiung City, Kaohsiung, Taiwan, 833
      • Kaohsiung Chang Gung Memorial Hospital /ID# 249260
  • Taipei
    • Taipei City, Taipei, Taiwan, 10449
      • MacKay Memorial Hospital /ID# 249259
• 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
  • Gaziantep, Turkey, 27310
    • Gaziantep Universitesi /ID# 249868
  • Kayseri, Turkey, 38039
    • Erciyes University Medical Faculty /ID# 249863
  • Samsun, Turkey, 55139
    • Ondokuz Mayis Universitesi Tip /ID# 249865
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Alliance Dermatology and MOHs Center, PC /ID# 249671
    • Phoenix, Arizona, United States, 85006
      • Medical Dermatology Specialists /ID# 250212
  • 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, 92708-3701
      • First OC Dermatology Research /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, 95816-3300
      • UC 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, 33155-3244
      • D&H National Research Centers /ID# 250734
    • Miami, Florida, United States, 33173
      • Florida International Rsrch cr /ID# 249667
    • 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
      • MUSC - Rutledge Tower /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 /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

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Upadacitinib; Participants will receive upadacitinib dose A daily in period 1. Eligible participants will receive upadacitinib dose B daily in period 2.	Drug: Upadacitinib; Oral Tablets; Other Names: RINVOQ
Experimental: Dupilumab followed by Upadacitinib; Participants will receive dupilumab as per its label in period 1. Eligible participants will receive upadacitinib dose A in period 2.	Drug: Upadacitinib; Oral Tablets; Other Names: RINVOQ; Drug: Dupilumab; Subcutaneous Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving both 90% Eczema Area and Severity Index (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WPNRS 0/1)	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72. The WP-NRS is an assessment tool that participants used to report the intensity of their pruritus during a daily recall period. On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst imaginable itch'.	At week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving at least 90% of Eczema Area and Severity Index (EASI 90)	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of Atopic Dermatitis (AD). The EASI is a composite index with scores ranging from 0 to 72.	Up to week 16
Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) among Participants with Baseline WP-NRS > 1	The WP-NRS is an assessment tool that participants used to report the intensity of their pruritus during a daily recall period. On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst imaginable itch'.	Up to week 16
Percentage of Participants Achieving an improvement in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 among those with Baseline WP-NRS ≥ 4	The WP-NRS is an assessment tool that participants used to report the intensity of their pruritus during a daily recall period. On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst imaginable itch'.	At week 16
Percentage of Participants Achieving 75% of Eczema Area and Severity Index (EASI 75)	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of Atopic Dermatitis (AD). The EASI is a composite index with scores ranging from 0 to 72.	At week 2
Percentage of Participants Achieving 100% of Eczema Area and Severity Index (EASI 100)	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of Atopic Dermatitis (AD). The EASI is a composite index with scores ranging from 0 to 72.	At week 16

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related info

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2022
• Primary Completion (Actual): March 19, 2024
• Study Completion (Estimated): July 9, 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 (Estimated): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Upadacitinib; Atopic Dermatitis; AD; Dupilumab; RINVOQ; Level-Up
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Protein Kinase Inhibitors; Janus Kinase Inhibitors; Upadacitinib
• 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