Actively Recruiting
A Study to Assess Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis
Led by AbbVie · Updated on 2026-04-07
675
Participants Needed
148
Research Sites
306 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Topical therapies applied 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 pediatric participants with moderate to severe AD who are candidates for systemic therapy. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for treating AD patients aged 12 or older. Participants will receive upadacitinib (given as daily dose) or dupilumab (given at label indicated dose every 2 or 4 weeks). Participants will be stratified depending on disease severity, age and response to previous treatment. There is 1 in 5 chance for participants to receive dupilumab during the randomized cohort. Approximately 675 participants aged 2 to less than 12 years of age will be enrolled in this study at approximately 150 sites worldwide. The study population (As defined by participants age or prior treatment) to be enrolled in the study is dependent on local regulatory requirement and/or agreement. Participants will receive upadacitinib oral tablets once daily (or oral solution twice a day) for 160 weeks, or dupilumab as per its label for 52 weeks, and followed for 30 days after the last dose of upadacitinib and at least 12 weeks after the last dose of dupilumab. 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 clinical assessments, blood tests, checking for side effects and completing questionnaires.
CONDITIONS
Official Title
A Study to Assess Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child weighs at least 10 kg and has weight and height above the 5th percentile for age according to local growth charts at baseline
- Diagnosed with atopic dermatitis according to Hanifin and Rajka criteria, with symptoms starting at least 6 months before baseline
- Moderate to severe disease with EASI score of 16 or higher, vIGA-AD score of 3 or higher (or 4 in countries where dupilumab is approved only for severe AD), at least 10% body surface area affected, and an average worst itch score of 4 or higher
- Meets at least one of the following: inadequate response or intolerance to topical corticosteroids or calcineurin inhibitors, history of inadequate response to systemic therapies other than dupilumab or corticosteroids, history of inadequate response to two or more courses of oral corticosteroids within 6 months, prior exposure to dupilumab without safety or efficacy issues, or previous inadequate response or intolerance to dupilumab combined with inadequate response or intolerance to topical treatments
You will not qualify if you...
- Current or past other active skin diseases or infections requiring systemic treatment within 4 weeks before baseline
- Use of topical AD treatments (except emollients) within 7 days before baseline or prohibited systemic AD treatments within specified timeframes prior to baseline including corticosteroids, methotrexate, cyclosporine, azathioprine, PDE-4 inhibitors, interferon-gamma, mycophenolate mofetil within 4 weeks
- Use of dupilumab within 8 weeks before baseline
- Use of other targeted biologic treatments within 5 half-lives or 12 weeks prior to baseline
- Phototherapy, laser therapy, tanning, or extended sun exposure within 4 weeks before baseline
- History of retinal detachment, cataract surgery, significant eye trauma, or congenital eye abnormalities
- For randomized cohort: active or suspected parasitic infection unless ruled out by clinical or lab assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 148 locations
1
Applied Research Center Of Arkansas /ID# 268547
Little Rock, Arkansas, United States, 72205
Actively Recruiting
2
Stanford University School of Medicine - Palo Alto /ID# 269622
Palo Alto, California, United States, 94304
Actively Recruiting
3
Integrative Skin Science and Research /ID# 265108
Sacramento, California, United States, 95815
Actively Recruiting
4
Clearlyderm Dermatology - West Boca /ID# 266323
Boca Raton, Florida, United States, 33428
Completed
5
Pediatric Skin Research /ID# 266308
Coral Gables, Florida, United States, 33146
Actively Recruiting
6
Neoclinical Research - Hialeah /ID# 269694
Hialeah, Florida, United States, 33016
Completed
7
Cleaver Medical Group Dermatology /ID# 265099
Dawsonville, Georgia, United States, 30534
Completed
8
Aeroallergy Research Laboratory /ID# 267247
Savannah, Georgia, United States, 31406
Actively Recruiting
9
Treasure Valley Medical Research /ID# 266838
Boise, Idaho, United States, 83706
Actively Recruiting
10
Northwestern University Feinberg School of Medicine /ID# 265117
Chicago, Illinois, United States, 60611-2927
Actively Recruiting
11
Sneeze Wheeze & Itch Associates /ID# 267238
Normal, Illinois, United States, 61761
Actively Recruiting
12
Dawes Fretzin, LLC /ID# 265097
Indianapolis, Indiana, United States, 46256
Actively Recruiting
13
Equity Medical, LLC /ID# 268270
Bowling Green, Kentucky, United States, 42104
Actively Recruiting
14
Maryland Allergy & Asthma Center /ID# 268032
Lanham, Maryland, United States, 20706
Actively Recruiting
15
DermAssociates - Rockville /ID# 266457
Rockville, Maryland, United States, 20850
Actively Recruiting
16
Washington University School of Medicine - St. Louis /ID# 268545
St Louis, Missouri, United States, 63130
Actively Recruiting
17
Skin Specialists /ID# 266331
Omaha, Nebraska, United States, 68144
Actively Recruiting
18
DOCS Clinical Research - Canal Winchester /ID# 268271
Canal Winchester, Ohio, United States, 43110-2069
Actively Recruiting
19
Wright State Physicians Health Center /ID# 268841
Fairborn, Ohio, United States, 45324
Actively Recruiting
20
Oregon Health and Science University /ID# 266483
Portland, Oregon, United States, 97239
Actively Recruiting
21
Medical University of South Carolina /ID# 265113
Charleston, South Carolina, United States, 29425
Actively Recruiting
22
International Clinical Research - Tennessee /ID# 268548
Murfreesboro, Tennessee, United States, 37130
Completed
23
Arlington Research Center, Inc /ID# 266330
Arlington, Texas, United States, 76011
Actively Recruiting
24
3A Research - East location /ID# 267622
El Paso, Texas, United States, 79925
Actively Recruiting
25
Prime Clinical Research - Mansfield - East Broad Street /ID# 268042
Mansfield, Texas, United States, 76063
Actively Recruiting
26
Texas Dermatology and Laser Specialists /ID# 267249
San Antonio, Texas, United States, 78218
Actively Recruiting
27
Progressive Clinical Research - San Antonio /ID# 267262
San Antonio, Texas, United States, 78229
Actively Recruiting
28
Jordan Valley Dermatology & Research Center /ID# 267092
South Jordan, Utah, United States, 84095
Actively Recruiting
29
West Virginia University Hospitals /ID# 265114
Morgantown, West Virginia, United States, 26506
Actively Recruiting
30
Wisconsin Medical Center /ID# 267236
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
31
Sanatorio 9 de Julio /ID# 267678
San Miguel de Tucumán, Tucumán Province, Argentina, 4000
Actively Recruiting
32
Conexa Investigacion Clinica /ID# 268728
Buenos Aires, Argentina, 1012
Actively Recruiting
33
Instituto de Neumonología y Dermatología /ID# 266146
Buenos Aires, Argentina, 1425
Actively Recruiting
34
Psoriahue - Buenos Aires /ID# 267737
Buenos Aires, Argentina, 1425
Actively Recruiting
35
The Children's Hospital at Westmead /ID# 265430
Westmead, New South Wales, Australia, 2145
Actively Recruiting
36
Monash Health - Monash Medical Centre /ID# 267149
Clayton, Victoria, Australia, 3168
Actively Recruiting
37
Institute for Skin, Health and Immunity /ID# 266158
Mitcham, Victoria, Australia, 3132
Actively Recruiting
38
Medizinische Universitaet Graz /ID# 262741
Graz, Styria, Austria, 8010
Actively Recruiting
39
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 265427
Salzburg, Austria, 5020
Actively Recruiting
40
Medizinische Universitaet Wien /ID# 265417
Vienna, Austria, 1090
Actively Recruiting
41
Irmandade da Santa Casa de Misericórdia de Porto Alegre /ID# 267455
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
Actively Recruiting
42
Hospital e Maternidade Celso Pierro - PUC-Campinas /ID# 266965
Campinas, São Paulo, Brazil, 13034-685
Actively Recruiting
43
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 266964
Ribeirão Preto, São Paulo, Brazil, 14049-900
Actively Recruiting
44
Clinica de Alergia Martti Antila /ID# 266197
Sorocaba, São Paulo, Brazil, 18040-425
Actively Recruiting
45
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 266667
São Paulo, Brazil, 05403-000
Actively Recruiting
46
UMHAT Alexandrovska EAD /ID# 265256
Sofiya, Sofia, Bulgaria, 1431
Completed
47
Medical Center Cordis /ID# 265250
Pleven, Bulgaria, 5800
Completed
48
Dermatology Research Institute - Blackfoot Trail /ID# 266744
Calgary, Alberta, Canada, T2J 7E1
Actively Recruiting
49
Rejuvenation Dermatology - Edmonton Downtown /ID# 267871
Edmonton, Alberta, Canada, T5J 3S9
Actively Recruiting
50
British Columbia Children and Women's Hospital and Health Centre /ID# 265395
Vancouver, British Columbia, Canada, V6H 3N1
Actively Recruiting
51
Maritime Dermatology /ID# 267359
Halifax, Nova Scotia, Canada, B3K 5R3
Completed
52
Leader Research /ID# 266745
Hamilton, Ontario, Canada, L8L 3C3
Actively Recruiting
53
Triple A Lab Inc /ID# 266615
Hamilton, Ontario, Canada, L8S 1G5
Actively Recruiting
54
Lynderm Research Inc /ID# 267006
Markham, Ontario, Canada, L3P 1X2
Actively Recruiting
55
Allergy Research Canada /ID# 270230
Niagara Falls, Ontario, Canada, L2H 1H5
Actively Recruiting
56
DermAtelier on Avenue /ID# 267850
Toronto, Ontario, Canada, M5M 3Z8
Actively Recruiting
57
Centre Hospitalier Universitaire (CHU) Sainte-Justine /ID# 266831
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
58
Clinica Dermacross /ID# 266309
Vitacura, Region Metropolitana Santiago, Chile, 7640881
Actively Recruiting
59
Fundacion Innovacion Cardiovascular /ID# 266742
Independencia, Santiago Metropolitan, Chile, 8380465
Actively Recruiting
60
Beijing Children's Hospital /ID# 266350
Beijing, Beijing Municipality, China, 100045
Actively Recruiting
61
Children's Hospital Affiliated to Chongqing Medical University /ID# 266876
Yuzhong District, Chongqing Municipality, China, 400015
Actively Recruiting
62
Xiamen Children's Hospital /ID# 266384
Xiamen, Fujian, China, 361006
Actively Recruiting
63
Shenzhen Children's Hospital /ID# 266401
Shenzhen, Guangdong, China, 518026
Actively Recruiting
64
Henan Children's Hospital Zhengzhou Children's Hospital /ID# 266832
Zhengzhou, Henan, China, 450018
Actively Recruiting
65
Hunan Children's Hospital /ID# 266365
Changsha, Hunan, China, 410007
Actively Recruiting
66
Dalian Women and Children's Medical Group /ID# 266675
Dalian, Liaoning, China, 116012
Actively Recruiting
67
Chengdu Women and Children Center Hospital /ID# 266402
Chengdu, Sichuan, China, 610091
Actively Recruiting
68
Kunming Childrens Hospital /ID# 266555
Kunming, Yunnan, China, 650103
Actively Recruiting
69
The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU /ID# 266708
Wenzhou, Zhejiang, China, 325027
Actively Recruiting
70
Klinika za dječje bolesti Zagreb /ID# 264936
Zagreb, City of Zagreb, Croatia, 10000
Actively Recruiting
71
Poliklinika DermaPlus /ID# 265724
Zagreb, City of Zagreb, Croatia, 10000
Actively Recruiting
72
Poliklinika Solmed /ID# 265070
Zagreb, City of Zagreb, Croatia, 10000
Actively Recruiting
73
Specialty Hospital Medico /ID# 266116
Rijeka, Primorje-Gorski Kotar County, Croatia, 51000
Actively Recruiting
74
Klinicki Bolnicki Centar KBC Split /ID# 265359
Split, Split-Dalmatia County, Croatia, 21000
Completed
75
CHU Toulouse - Hopital Larrey /ID# 255048
Toulouse, Haute-Garonne, France, 31400
Actively Recruiting
76
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 265455
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54511
Actively Recruiting
77
CHU Bordeaux - Hopital Pellegrin /ID# 266818
Bordeaux, New Aquitaine, France, 33076
Actively Recruiting
78
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu /ID# 265449
Nantes, Pays de la Loire Region, France, 44000
Actively Recruiting
79
Centre Hospitalier Universitaire de Clermont Ferrand - Hopital Estaing /ID# 267327
Clermont-Ferrand, Puy-de-Dome, France, 63100
Actively Recruiting
80
CHU Amiens-Picardie Site Sud /ID# 255083
Amiens, Somme, France, 80054
Actively Recruiting
81
AP-HP - Hopital Necker /ID# 255050
Paris, France, 75015
Actively Recruiting
82
Centre Hospitalier d Argenteuil Victor Dupouy /ID# 265448
Argenteuil, Île-de-France Region, France, 95107
Actively Recruiting
83
Universitaetsklinikum Erlangen /ID# 255168
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
84
Fachklinik Bad Bentheim /ID# 255165
Bad Bentheim, Lower Saxony, Germany, 48455
Actively Recruiting
85
Universitaetsklinikum Muenster /ID# 255166
Münster, North Rhine-Westphalia, Germany, 48149
Actively Recruiting
86
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 255167
Dresden, Saxony, Germany, 01307
Actively Recruiting
87
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 267411
Berlin, Germany, 10117
Actively Recruiting
88
DermaMed Research - Oroshaza /ID# 266995
Orosháza, Bekes County, Hungary, 5900
Actively Recruiting
89
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 265653
Szeged, Csongrád megye, Hungary, 6725
Completed
90
Debreceni Egyetem-Klinikai Kozpont /ID# 265331
Debrecen, Hajdú-Bihar, Hungary, 4032
Actively Recruiting
91
Schneider Childrens Medical Center of Israel /ID# 265617
Petah Tikva, Central District, Israel, 4920235
Actively Recruiting
92
HaEmek Medical Center /ID# 266416
Afula, Haifa District, Israel, 1834111
Actively Recruiting
93
Hadassah Medical Center-Hebrew University /ID# 255041
Jerusalem, Jerusalem, Israel, 91120
Actively Recruiting
94
Soroka Medical Center /ID# 265251
Beersheba, Southern District, Israel, 8410101
Actively Recruiting
95
The Chaim Sheba Medical Center /ID# 265254
Ramat Gan, Tel Aviv, Israel, 5265601
Actively Recruiting
96
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 267070
Rome, Roma, Italy, 00161
Completed
97
Ospedale Pediatrico Bambino Gesù /ID# 266118
Rome, Roma, Italy, 00165
Actively Recruiting
98
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 255118
Bologna, Italy, 40138
Actively Recruiting
99
Eukarya PharmaSite /ID# 265274
Monterrey, Nuevo León, Mexico, 64718
Actively Recruiting
100
Arke Smo Sa de Cv /Id# 266650
Veracruz, Mexico, 91910
Actively Recruiting
101
Amsterdam UMC, locatie AMC /ID# 265406
Amsterdam, North Holland, Netherlands, 1105 AZ
Actively Recruiting
102
Erasmus Medisch Centrum /ID# 265408
Rotterdam, South Holland, Netherlands, 3015 CE
Actively Recruiting
103
Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus /ID# 265457
Poznan, Greater Poland Voivodeship, Poland, 60-693
Actively Recruiting
104
MICS Centrum Medyczne Torun /ID# 265454
Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
Actively Recruiting
105
Centrum Nowoczesnych Terapii Dobry Lekarz sp.z.o.o. /ID# 266030
Krakow, Lesser Poland Voivodeship, Poland, 31-011
Actively Recruiting
106
Klinika Osipowicz & Turkowski sp.z.o.o /ID# 267490
Warsaw, Masovian Voivodeship, Poland, 00-716
Actively Recruiting
107
Clinical Research Group Sp. z o.o. /ID# 266924
Warsaw, Masovian Voivodeship, Poland, 01-142
Actively Recruiting
108
Klinika Ambroziak Dermatologia /ID# 265458
Warsaw, Masovian Voivodeship, Poland, 02-953
Actively Recruiting
109
Royalderm Agnieszka Nawrocka /ID# 266606
Warsaw, Masovian Voivodeship, Poland, 02-962
Actively Recruiting
110
NZOZ Specjalistyczny Osrodek Dermatologiczny Dermal /ID# 266613
Bialystok, Podlaskie Voivodeship, Poland, 15-453
Actively Recruiting
111
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 265451
Gdansk, Pomeranian Voivodeship, Poland, 80-546
Actively Recruiting
112
Centrum Medyczne Angelius Provita /ID# 265456
Katowice, Silesian Voivodeship, Poland, 40-615
Actively Recruiting
113
Unidade Local de Saude de Coimbra, EPE /ID# 266115
Coimbra, Portugal, 3000-075
Actively Recruiting
114
Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 266112
Porto, Portugal, 4099-003
Actively Recruiting
115
Unidade Local de Saude Sao Joao, EPE /ID# 266111
Porto, Portugal, 4200-319
Actively Recruiting
116
Clinical Research Investigator Group, LLC /ID# 268366
Bayamón, Puerto Rico, 00960
Actively Recruiting
117
Private Practice - Dr. Alma Cruz /ID# 264234
Carolina, Puerto Rico, 00985
Completed
118
National University Hospital /ID# 265685
Singapore, Singapore, 119074
Actively Recruiting
119
KK Women's and Children's Hospital /ID# 266519
Singapore, Singapore, 229899
Actively Recruiting
120
Narodny Ustav Detskych Chorob /ID# 265253
Bratislava, Bratislava Region, Slovakia, 831 01
Actively Recruiting
121
ALERSA, s.r.o. /ID# 266245
Košice, Košice Region, Slovakia, 040 01
Actively Recruiting
122
Univerzitna nemocnica L. Pasteura Kosice /ID# 265239
Košice, Košice Region, Slovakia, 040 01
Actively Recruiting
123
Fakultna nemocnica Trnava /ID# 265245
Trnava, Slovakia, 917 02
Completed
124
Univerzitna nemocnica Martin /ID# 265947
Martin, Žilina Region, Slovakia, 036 01
Actively Recruiting
125
Korea University Ansan Hospital /ID# 264169
Ansan-si, Gyeonggido, South Korea, 15355
Actively Recruiting
126
Soon Chun Hyang University Hospital Bucheon /ID# 264171
Bucheon-si, Gyeonggido, South Korea, 14584
Actively Recruiting
127
Chungang University Hospital /ID# 266383
Dongjak-gu, Seoul Teugbyeolsi, South Korea, 06973
Actively Recruiting
128
Seoul National University Hospital /ID# 264176
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Actively Recruiting
129
Konkuk University Medical Center /ID# 264178
Seoul, Seoul Teugbyeolsi, South Korea, 05030
Actively Recruiting
130
Hallym University Kangnam Sacred Heart Hospital /ID# 267318
Seoul, Seoul Teugbyeolsi, South Korea, 07441
Actively Recruiting
131
Hospital Sant Joan de Deu /ID# 255287
Esplugues de Llobregat, Barcelona, Spain, 08950
Actively Recruiting
132
Hospital General Universitario Gregorio Maranon /ID# 255288
Madrid, Spain, 28007
Actively Recruiting
133
Hospital Universitario La Paz /ID# 255286
Madrid, Spain, 28046
Actively Recruiting
134
Consorci Hospital General Universitario de Valencia /ID# 255289
Valencia, Spain, 46014
Actively Recruiting
135
Hospital Universitario Miguel Servet /ID# 255290
Zaragoza, Spain, 50009
Actively Recruiting
136
Kaohsiung Chang Gung Memorial Hospital /ID# 267791
Kaohsiung City, Kaohsiung, Taiwan, 833
Actively Recruiting
137
New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical /ID# 266349
New Taipei City, Taiwan, 236
Actively Recruiting
138
National Taiwan University Hospital /ID# 265510
Taipei, Taiwan, 100
Actively Recruiting
139
Taipei Veterans General Hospital- Taipei City /ID# 265507
Taipei, Taiwan, 112
Actively Recruiting
140
Linkou Chang Gung Memorial Hospital - Taoyuan /ID# 263664
Taoyuan City, Taiwan, 333
Actively Recruiting
141
Derriford Hospital and the Royal Eye Infirmary /ID# 266980
Plymouth, Devon, United Kingdom, PL6 8DH
Actively Recruiting
142
St Thomas' Hospital - Guy's and St Thomas' NHS Foundation Trust /ID# 265237
London, Greater London, United Kingdom, SE1 7EH
Actively Recruiting
143
Chelsea and Westminster Hospital /ID# 266389
London, Greater London, United Kingdom, SW10 9NH
Actively Recruiting
144
St George University Hospitals NHS Foundation Trust /ID# 266984
London, Greater London, United Kingdom, SW17 0QT
Actively Recruiting
145
University Hospital Southampton /ID# 266655
Southampton, Hampshire, United Kingdom, SO16 6YD
Actively Recruiting
146
Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde /ID# 265219
Glasgow, Lanarkshire, United Kingdom, G51 4TF
Actively Recruiting
147
Manchester University NHS Foundation Trust /ID# 267693
Manchester, United Kingdom, M9 2AA
Actively Recruiting
148
Royal Victoria Infirmary /ID# 265238
Newcastle upon Tyne, United Kingdom, NE1 4LP
Completed
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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