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
Start Date
8/19/2024
Completion Date
7/1/2030
Summary
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.
Eligibility Criteria
Age Range: 2 years to 11 years
Interventions
Upadacitinib
Dupilumab
Conditions
Locations
Applied Research Center Of Arkansas /ID# 268547
Little Rock, Arkansas 72205
United States
Stanford University School of Medicine - Palo Alto /ID# 269622
Palo Alto, California 94304
United States
Integrative Skin Science and Research /ID# 265108
Sacramento, California 95815
United States
Clearlyderm Dermatology - West Boca /ID# 266323
Boca Raton, Florida 33428
United States
Pediatric Skin Research /ID# 266308
Coral Gables, Florida 33146
United States
Neoclinical Research - Hialeah /ID# 269694
Hialeah, Florida 33016
United States
Cleaver Medical Group Dermatology /ID# 265099
Dawsonville, Georgia 30534
United States
Aeroallergy Research Laboratory /ID# 267247
Savannah, Georgia 31406
United States
Treasure Valley Medical Research /ID# 266838
Boise, Idaho 83706
United States
Northwestern University Feinberg School of Medicine /ID# 265117
Chicago, Illinois 60611-2927
United States
Sneeze Wheeze & Itch Associates /ID# 267238
Normal, Illinois 61761
United States
Dawes Fretzin, LLC /ID# 265097
Indianapolis, Indiana 46256
United States
Equity Medical, LLC /ID# 268270
Bowling Green, Kentucky 42104
United States
Maryland Allergy & Asthma Center /ID# 268032
Lanham, Maryland 20706
United States
DermAssociates - Rockville /ID# 266457
Rockville, Maryland 20850
United States
Washington University School of Medicine - St. Louis /ID# 268545
St Louis, Missouri 63130
United States
Skin Specialists /ID# 266331
Omaha, Nebraska 68144
United States
DOCS Clinical Research - Canal Winchester /ID# 268271
Canal Winchester, Ohio 43110-2069
United States
Wright State Physicians Health Center /ID# 268841
Fairborn, Ohio 45324
United States
Oregon Health and Science University /ID# 266483
Portland, Oregon 97239
United States
Medical University of South Carolina /ID# 265113
Charleston, South Carolina 29425
United States
International Clinical Research - Tennessee /ID# 268548
Murfreesboro, Tennessee 37130
United States
Arlington Research Center, Inc /ID# 266330
Arlington, Texas 76011
United States
3A Research - East location /ID# 267622
El Paso, Texas 79925
United States
Prime Clinical Research - Mansfield - East Broad Street /ID# 268042
Mansfield, Texas 76063
United States
Texas Dermatology and Laser Specialists /ID# 267249
San Antonio, Texas 78218
United States
Progressive Clinical Research - San Antonio /ID# 267262
San Antonio, Texas 78229
United States
Jordan Valley Dermatology & Research Center /ID# 267092
South Jordan, Utah 84095
United States
West Virginia University Hospitals /ID# 265114
Morgantown, West Virginia 26506
United States
Wisconsin Medical Center /ID# 267236
Milwaukee, Wisconsin 53226
United States
Sanatorio 9 de Julio /ID# 267678
San Miguel de Tucumán, Tucumán Province 4000
Argentina
Conexa Investigacion Clinica /ID# 268728
Buenos Aires, 1012
Argentina
Instituto de Neumonología y Dermatología /ID# 266146
Buenos Aires, 1425
Argentina
Psoriahue - Buenos Aires /ID# 267737
Buenos Aires, 1425
Argentina
The Children's Hospital at Westmead /ID# 265430
Westmead, New South Wales 2145
Australia
Monash Health - Monash Medical Centre /ID# 267149
Clayton, Victoria 3168
Australia
Institute for Skin, Health and Immunity /ID# 266158
Mitcham, Victoria 3132
Australia
Medizinische Universitaet Graz /ID# 262741
Graz, Styria 8010
Austria
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 265427
Salzburg, 5020
Austria
Medizinische Universitaet Wien /ID# 265417
Vienna, 1090
Austria
Irmandade da Santa Casa de Misericórdia de Porto Alegre /ID# 267455
Porto Alegre, Rio Grande do Sul 90020-090
Brazil
Hospital e Maternidade Celso Pierro - PUC-Campinas /ID# 266965
Campinas, São Paulo 13034-685
Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 266964
Ribeirão Preto, São Paulo 14049-900
Brazil
Clinica de Alergia Martti Antila /ID# 266197
Sorocaba, São Paulo 18040-425
Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 266667
São Paulo, 05403-000
Brazil
UMHAT Alexandrovska EAD /ID# 265256
Sofiya, Sofia 1431
Bulgaria
Medical Center Cordis /ID# 265250
Pleven, 5800
Bulgaria
Dermatology Research Institute - Blackfoot Trail /ID# 266744
Calgary, Alberta T2J 7E1
Canada
Rejuvenation Dermatology - Edmonton Downtown /ID# 267871
Edmonton, Alberta T5J 3S9
Canada
British Columbia Children and Women's Hospital and Health Centre /ID# 265395
Vancouver, British Columbia V6H 3N1
Canada
Maritime Dermatology /ID# 267359
Halifax, Nova Scotia B3K 5R3
Canada
Leader Research /ID# 266745
Hamilton, Ontario L8L 3C3
Canada
Triple A Lab Inc /ID# 266615
Hamilton, Ontario L8S 1G5
Canada
Lynderm Research Inc /ID# 267006
Markham, Ontario L3P 1X2
Canada
Allergy Research Canada /ID# 270230
Niagara Falls, Ontario L2H 1H5
Canada
DermAtelier on Avenue /ID# 267850
Toronto, Ontario M5M 3Z8
Canada
Centre Hospitalier Universitaire (CHU) Sainte-Justine /ID# 266831
Montreal, Quebec H3T 1C5
Canada
Clinica Dermacross /ID# 266309
Vitacura, Region Metropolitana Santiago 7640881
Chile
Fundacion Innovacion Cardiovascular /ID# 266742
Independencia, Santiago Metropolitan 8380465
Chile
Beijing Children's Hospital /ID# 266350
Beijing, Beijing Municipality 100045
China
Children's Hospital Affiliated to Chongqing Medical University /ID# 266876
Yuzhong District, Chongqing Municipality 400015
China
Xiamen Children's Hospital /ID# 266384
Xiamen, Fujian 361006
China
Shenzhen Children's Hospital /ID# 266401
Shenzhen, Guangdong 518026
China
Henan Children's Hospital Zhengzhou Children's Hospital /ID# 266832
Zhengzhou, Henan 450018
China
Hunan Children's Hospital /ID# 266365
Changsha, Hunan 410007
China
Dalian Women and Children's Medical Group /ID# 266675
Dalian, Liaoning 116012
China
Chengdu Women and Children Center Hospital /ID# 266402
Chengdu, Sichuan 610091
China
Kunming Childrens Hospital /ID# 266555
Kunming, Yunnan 650103
China
The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU /ID# 266708
Wenzhou, Zhejiang 325027
China
Klinika za dječje bolesti Zagreb /ID# 264936
Zagreb, City of Zagreb 10000
Croatia
Poliklinika DermaPlus /ID# 265724
Zagreb, City of Zagreb 10000
Croatia
Poliklinika Solmed /ID# 265070
Zagreb, City of Zagreb 10000
Croatia
Specialty Hospital Medico /ID# 266116
Rijeka, Primorje-Gorski Kotar County 51000
Croatia
Klinicki Bolnicki Centar KBC Split /ID# 265359
Split, Split-Dalmatia County 21000
Croatia
CHU Toulouse - Hopital Larrey /ID# 255048
Toulouse, Haute-Garonne 31400
France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 265455
Vandœuvre-lès-Nancy, Meurthe-et-Moselle 54511
France
CHU Bordeaux - Hopital Pellegrin /ID# 266818
Bordeaux, New Aquitaine 33076
France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu /ID# 265449
Nantes, Pays de la Loire Region 44000
France
Centre Hospitalier Universitaire de Clermont Ferrand - Hopital Estaing /ID# 267327
Clermont-Ferrand, Puy-de-Dome 63100
France
CHU Amiens-Picardie Site Sud /ID# 255083
Amiens, Somme 80054
France
AP-HP - Hopital Necker /ID# 255050
Paris, 75015
France
Centre Hospitalier d Argenteuil Victor Dupouy /ID# 265448
Argenteuil, Île-de-France Region 95107
France
Universitaetsklinikum Erlangen /ID# 255168
Erlangen, Bavaria 91054
Germany
Fachklinik Bad Bentheim /ID# 255165
Bad Bentheim, Lower Saxony 48455
Germany
Universitaetsklinikum Muenster /ID# 255166
Münster, North Rhine-Westphalia 48149
Germany
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 255167
Dresden, Saxony 01307
Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 267411
Berlin, 10117
Germany
DermaMed Research - Oroshaza /ID# 266995
Orosháza, Bekes County 5900
Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 265653
Szeged, Csongrád megye 6725
Hungary
Debreceni Egyetem-Klinikai Kozpont /ID# 265331
Debrecen, Hajdú-Bihar 4032
Hungary
Schneider Childrens Medical Center of Israel /ID# 265617
Petah Tikva, Central District 4920235
Israel
HaEmek Medical Center /ID# 266416
Afula, Haifa District 1834111
Israel
Hadassah Medical Center-Hebrew University /ID# 255041
Jerusalem, Jerusalem 91120
Israel
Soroka Medical Center /ID# 265251
Beersheba, Southern District 8410101
Israel
The Chaim Sheba Medical Center /ID# 265254
Ramat Gan, Tel Aviv 5265601
Israel
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 267070
Rome, Roma 00161
Italy
Ospedale Pediatrico Bambino Gesù /ID# 266118
Rome, Roma 00165
Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 255118
Bologna, 40138
Italy
Eukarya PharmaSite /ID# 265274
Monterrey, Nuevo León 64718
Mexico
Arke Smo Sa de Cv /Id# 266650
Veracruz, 91910
Mexico
Amsterdam UMC, locatie AMC /ID# 265406
Amsterdam, North Holland 1105 AZ
Netherlands
Erasmus Medisch Centrum /ID# 265408
Rotterdam, South Holland 3015 CE
Netherlands
Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus /ID# 265457
Poznan, Greater Poland Voivodeship 60-693
Poland
MICS Centrum Medyczne Torun /ID# 265454
Torun, Kuyavian-Pomeranian Voivodeship 87-100
Poland
Centrum Nowoczesnych Terapii Dobry Lekarz sp.z.o.o. /ID# 266030
Krakow, Lesser Poland Voivodeship 31-011
Poland
Klinika Osipowicz & Turkowski sp.z.o.o /ID# 267490
Warsaw, Masovian Voivodeship 00-716
Poland
Clinical Research Group Sp. z o.o. /ID# 266924
Warsaw, Masovian Voivodeship 01-142
Poland
Klinika Ambroziak Dermatologia /ID# 265458
Warsaw, Masovian Voivodeship 02-953
Poland
Royalderm Agnieszka Nawrocka /ID# 266606
Warsaw, Masovian Voivodeship 02-962
Poland
NZOZ Specjalistyczny Osrodek Dermatologiczny Dermal /ID# 266613
Bialystok, Podlaskie Voivodeship 15-453
Poland
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 265451
Gdansk, Pomeranian Voivodeship 80-546
Poland
Centrum Medyczne Angelius Provita /ID# 265456
Katowice, Silesian Voivodeship 40-615
Poland
Unidade Local de Saude de Coimbra, EPE /ID# 266115
Coimbra, 3000-075
Portugal
Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 266112
Porto, 4099-003
Portugal
Unidade Local de Saude Sao Joao, EPE /ID# 266111
Porto, 4200-319
Portugal
Clinical Research Investigator Group, LLC /ID# 268366
Bayamón, 00960
Puerto Rico
Private Practice - Dr. Alma Cruz /ID# 264234
Carolina, 00985
Puerto Rico
National University Hospital /ID# 265685
Singapore, 119074
Singapore
KK Women's and Children's Hospital /ID# 266519
Singapore, 229899
Singapore
Narodny Ustav Detskych Chorob /ID# 265253
Bratislava, Bratislava Region 831 01
Slovakia
ALERSA, s.r.o. /ID# 266245
Košice, Košice Region 040 01
Slovakia
Univerzitna nemocnica L. Pasteura Kosice /ID# 265239
Košice, Košice Region 040 01
Slovakia
Fakultna nemocnica Trnava /ID# 265245
Trnava, 917 02
Slovakia
Univerzitna nemocnica Martin /ID# 265947
Martin, Žilina Region 036 01
Slovakia
Korea University Ansan Hospital /ID# 264169
Ansan-si, Gyeonggido 15355
South Korea
Soon Chun Hyang University Hospital Bucheon /ID# 264171
Bucheon-si, Gyeonggido 14584
South Korea
Chungang University Hospital /ID# 266383
Dongjak-gu, Seoul Teugbyeolsi 06973
South Korea
Seoul National University Hospital /ID# 264176
Seoul, Seoul Teugbyeolsi 03080
South Korea
Konkuk University Medical Center /ID# 264178
Seoul, Seoul Teugbyeolsi 05030
South Korea
Hallym University Kangnam Sacred Heart Hospital /ID# 267318
Seoul, Seoul Teugbyeolsi 07441
South Korea
Hospital Sant Joan de Deu /ID# 255287
Esplugues de Llobregat, Barcelona 08950
Spain
Hospital General Universitario Gregorio Maranon /ID# 255288
Madrid, 28007
Spain
Hospital Universitario La Paz /ID# 255286
Madrid, 28046
Spain
Consorci Hospital General Universitario de Valencia /ID# 255289
Valencia, 46014
Spain
Hospital Universitario Miguel Servet /ID# 255290
Zaragoza, 50009
Spain
Kaohsiung Chang Gung Memorial Hospital /ID# 267791
Kaohsiung City, Kaohsiung 833
Taiwan
New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical /ID# 266349
New Taipei City, 236
Taiwan
National Taiwan University Hospital /ID# 265510
Taipei, 100
Taiwan
Taipei Veterans General Hospital- Taipei City /ID# 265507
Taipei, 112
Taiwan
Linkou Chang Gung Memorial Hospital - Taoyuan /ID# 263664
Taoyuan City, 333
Taiwan
Derriford Hospital and the Royal Eye Infirmary /ID# 266980
Plymouth, Devon PL6 8DH
United Kingdom
St Thomas' Hospital - Guy's and St Thomas' NHS Foundation Trust /ID# 265237
London, Greater London SE1 7EH
United Kingdom
Chelsea and Westminster Hospital /ID# 266389
London, Greater London SW10 9NH
United Kingdom
St George University Hospitals NHS Foundation Trust /ID# 266984
London, Greater London SW17 0QT
United Kingdom
University Hospital Southampton /ID# 266655
Southampton, Hampshire SO16 6YD
United Kingdom
Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde /ID# 265219
Glasgow, Lanarkshire G51 4TF
United Kingdom
Manchester University NHS Foundation Trust /ID# 267693
Manchester, M9 2AA
United Kingdom
Royal Victoria Infirmary /ID# 265238
Newcastle upon Tyne, NE1 4LP
United Kingdom