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 Up)

April 3, 2026 updated by: AbbVie

A Phase 3, Open-label, Efficacy-Assessor-Blinded Study, Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis

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.

Study Overview

Status

Recruiting

Conditions

Atopic Dermatitis

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

675

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 Contact

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

Study Locations

Argentina
- - Buenos Aires, Argentina, 1425
    - Recruiting
    - Instituto de Neumonología y Dermatología /ID# 266146
  - Buenos Aires, Argentina, 1425
    - Recruiting
    - Psoriahue - Buenos Aires /ID# 267737
  - Buenos Aires, Argentina, 1012
    - Recruiting
    - Conexa Investigacion Clinica /ID# 268728
- Tucumán Province
  - San Miguel de Tucumán, Tucumán Province, Argentina, 4000
    - Recruiting
    - Sanatorio 9 de Julio /ID# 267678
Australia
- New South Wales
  - Westmead, New South Wales, Australia, 2145
    - Recruiting
    - The Children's Hospital at Westmead /ID# 265430
- Victoria
  - Clayton, Victoria, Australia, 3168
    - Recruiting
    - Monash Health - Monash Medical Centre /ID# 267149
  - Mitcham, Victoria, Australia, 3132
    - Recruiting
    - Institute for Skin, Health and Immunity /ID# 266158
Austria
- - Salzburg, Austria, 5020
    - Recruiting
    - Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 265427
  - Vienna, Austria, 1090
    - Recruiting
    - Medizinische Universitaet Wien /ID# 265417
- Styria
  - Graz, Styria, Austria, 8010
    - Recruiting
    - Medizinische Universitaet Graz /ID# 262741
Brazil
- - São Paulo, Brazil, 05403-000
    - Recruiting
    - Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 266667
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
    - Recruiting
    - Irmandade da Santa Casa de Misericórdia de Porto Alegre /ID# 267455
- São Paulo
  - Campinas, São Paulo, Brazil, 13034-685
    - Recruiting
    - Hospital e Maternidade Celso Pierro - PUC-Campinas /ID# 266965
  - Ribeirão Preto, São Paulo, Brazil, 14049-900
    - Recruiting
    - Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 266964
  - Sorocaba, São Paulo, Brazil, 18040-425
    - Recruiting
    - Clinica de Alergia Martti Antila /ID# 266197
Bulgaria
- - Pleven, Bulgaria, 5800
    - Completed
    - Medical Center Cordis /ID# 265250
- Sofia
  - Sofiya, Sofia, Bulgaria, 1431
    - Completed
    - UMHAT Alexandrovska EAD /ID# 265256
Canada
- Alberta
  - Calgary, Alberta, Canada, T2J 7E1
    - Recruiting
    - Dermatology Research Institute - Blackfoot Trail /ID# 266744
  - Edmonton, Alberta, Canada, T5J 3S9
    - Recruiting
    - Rejuvenation Dermatology - Edmonton Downtown /ID# 267871
- British Columbia
  - Vancouver, British Columbia, Canada, V6H 3N1
    - Recruiting
    - British Columbia Children and Women's Hospital and Health Centre /ID# 265395
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3K 5R3
    - Completed
    - Maritime Dermatology /ID# 267359
- Ontario
  - Hamilton, Ontario, Canada, L8S 1G5
    - Recruiting
    - Triple A Lab Inc /ID# 266615
  - Hamilton, Ontario, Canada, L8L 3C3
    - Recruiting
    - Leader Research /ID# 266745
  - Markham, Ontario, Canada, L3P 1X2
    - Recruiting
    - Lynderm Research Inc /ID# 267006
  - Niagara Falls, Ontario, Canada, L2H 1H5
    - Recruiting
    - Allergy Research Canada /ID# 270230
  - Toronto, Ontario, Canada, M5M 3Z8
    - Recruiting
    - DermAtelier on Avenue /ID# 267850
- Quebec
  - Montreal, Quebec, Canada, H3T 1C5
    - Recruiting
    - Centre Hospitalier Universitaire (CHU) Sainte-Justine /ID# 266831
Chile
- Region Metropolitana Santiago
  - Vitacura, Region Metropolitana Santiago, Chile, 7640881
    - Recruiting
    - Clinica Dermacross /ID# 266309
- Santiago Metropolitan
  - Independencia, Santiago Metropolitan, Chile, 8380465
    - Recruiting
    - Fundacion Innovacion Cardiovascular /ID# 266742
China
- Beijing Municipality
  - Beijing, Beijing Municipality, China, 100045
    - Recruiting
    - Beijing Children's Hospital /ID# 266350
- Chongqing Municipality
  - Yuzhong District, Chongqing Municipality, China, 400015
    - Recruiting
    - Children's Hospital Affiliated to Chongqing Medical University /ID# 266876
- Fujian
  - Xiamen, Fujian, China, 361006
    - Recruiting
    - Xiamen Children's Hospital /ID# 266384
- Guangdong
  - Shenzhen, Guangdong, China, 518026
    - Recruiting
    - Shenzhen Children's Hospital /ID# 266401
- Henan
  - Zhengzhou, Henan, China, 450018
    - Recruiting
    - Henan Children's Hospital Zhengzhou Children's Hospital /ID# 266832
- Hunan
  - Changsha, Hunan, China, 410007
    - Recruiting
    - Hunan Children's Hospital /ID# 266365
- Liaoning
  - Dalian, Liaoning, China, 116012
    - Recruiting
    - Dalian Women and Children's Medical Group /ID# 266675
- Sichuan
  - Chengdu, Sichuan, China, 610091
    - Recruiting
    - Chengdu Women and Children Center Hospital /ID# 266402
- Yunnan
  - Kunming, Yunnan, China, 650103
    - Recruiting
    - Kunming Childrens Hospital /ID# 266555
- Zhejiang
  - Wenzhou, Zhejiang, China, 325027
    - Recruiting
    - The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU /ID# 266708
Croatia
- City of Zagreb
  - Zagreb, City of Zagreb, Croatia, 10000
    - Recruiting
    - Klinika za dječje bolesti Zagreb /ID# 264936
  - Zagreb, City of Zagreb, Croatia, 10000
    - Recruiting
    - Poliklinika DermaPlus /ID# 265724
  - Zagreb, City of Zagreb, Croatia, 10000
    - Recruiting
    - Poliklinika Solmed /ID# 265070
- Primorje-Gorski Kotar County
  - Rijeka, Primorje-Gorski Kotar County, Croatia, 51000
    - Recruiting
    - Specialty Hospital Medico /ID# 266116
- Split-Dalmatia County
  - Split, Split-Dalmatia County, Croatia, 21000
    - Completed
    - Klinicki Bolnicki Centar KBC Split /ID# 265359
France
- - Paris, France, 75015
    - Recruiting
    - AP-HP - Hopital Necker /ID# 255050
- Haute-Garonne
  - Toulouse, Haute-Garonne, France, 31400
    - Recruiting
    - CHU Toulouse - Hopital Larrey /ID# 255048
- Meurthe-et-Moselle
  - Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54511
    - Recruiting
    - Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 265455
- Nouvelle-Aquitaine
  - Bordeaux, Nouvelle-Aquitaine, France, 33076
    - Recruiting
    - CHU Bordeaux - Hopital Pellegrin /ID# 266818
- Pays de la Loire Region
  - Nantes, Pays de la Loire Region, France, 44000
    - Recruiting
    - Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu /ID# 265449
- Puy-de-Dome
  - Clermont-Ferrand, Puy-de-Dome, France, 63100
    - Recruiting
    - Centre Hospitalier Universitaire de Clermont Ferrand - Hopital Estaing /ID# 267327
- Somme
  - Amiens, Somme, France, 80054
    - Recruiting
    - CHU Amiens-Picardie Site Sud /ID# 255083
- Île-de-France Region
  - Argenteuil, Île-de-France Region, France, 95107
    - Recruiting
    - Centre Hospitalier d Argenteuil Victor Dupouy /ID# 265448
Germany
- - Berlin, Germany, 10117
    - Recruiting
    - Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 267411
- Bavaria
  - Erlangen, Bavaria, Germany, 91054
    - Recruiting
    - Universitaetsklinikum Erlangen /ID# 255168
- Lower Saxony
  - Bad Bentheim, Lower Saxony, Germany, 48455
    - Recruiting
    - Fachklinik Bad Bentheim /ID# 255165
- North Rhine-Westphalia
  - Münster, North Rhine-Westphalia, Germany, 48149
    - Recruiting
    - Universitaetsklinikum Muenster /ID# 255166
- Saxony
  - Dresden, Saxony, Germany, 01307
    - Recruiting
    - Universitaetsklinikum Carl Gustav Carus Dresden /ID# 255167
Hungary
- Bekes County
  - Orosháza, Bekes County, Hungary, 5900
    - Recruiting
    - DermaMed Research - Oroshaza /ID# 266995
- Csongrád megye
  - Szeged, Csongrád megye, Hungary, 6725
    - Completed
    - Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 265653
- Hajdú-Bihar
  - Debrecen, Hajdú-Bihar, Hungary, 4032
    - Recruiting
    - Debreceni Egyetem-Klinikai Kozpont /ID# 265331
Israel
- Central District
  - Petah Tikva, Central District, Israel, 4920235
    - Recruiting
    - Schneider Childrens Medical Center of Israel /ID# 265617
- Haifa District
  - Afula, Haifa District, Israel, 1834111
    - Recruiting
    - HaEmek Medical Center /ID# 266416
- Jerusalem
  - Jerusalem, Jerusalem, Israel, 91120
    - Recruiting
    - Hadassah Medical Center-Hebrew University /ID# 255041
- Southern District
  - Beersheba, Southern District, Israel, 8410101
    - Recruiting
    - Soroka Medical Center /ID# 265251
- Tel Aviv
  - Ramat Gan, Tel Aviv, Israel, 5265601
    - Recruiting
    - The Chaim Sheba Medical Center /ID# 265254
Italy
- - Bologna, Italy, 40138
    - Recruiting
    - IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 255118
- Roma
  - Rome, Roma, Italy, 00165
    - Recruiting
    - Ospedale Pediatrico Bambino Gesù /ID# 266118
  - Rome, Roma, Italy, 00161
    - Completed
    - Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 267070
Mexico
- - Veracruz, Mexico, 91910
    - Recruiting
    - Arke Smo Sa de Cv /Id# 266650
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64718
    - Recruiting
    - Eukarya PharmaSite /ID# 265274
Netherlands
- North Holland
  - Amsterdam, North Holland, Netherlands, 1105 AZ
    - Recruiting
    - Amsterdam UMC, locatie AMC /ID# 265406
- South Holland
  - Rotterdam, South Holland, Netherlands, 3015 CE
    - Recruiting
    - Erasmus Medisch Centrum /ID# 265408
Poland
- Greater Poland Voivodeship
  - Poznan, Greater Poland Voivodeship, Poland, 60-693
    - Recruiting
    - Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus /ID# 265457
- Kuyavian-Pomeranian Voivodeship
  - Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
    - Recruiting
    - MICS Centrum Medyczne Torun /ID# 265454
- Lesser Poland Voivodeship
  - Krakow, Lesser Poland Voivodeship, Poland, 31-011
    - Recruiting
    - Centrum Nowoczesnych Terapii Dobry Lekarz sp.z.o.o. /ID# 266030
- Masovian Voivodeship
  - Warsaw, Masovian Voivodeship, Poland, 00-716
    - Recruiting
    - Klinika Osipowicz & Turkowski sp.z.o.o /ID# 267490
  - Warsaw, Masovian Voivodeship, Poland, 01-142
    - Recruiting
    - Clinical Research Group Sp. z o.o. /ID# 266924
  - Warsaw, Masovian Voivodeship, Poland, 02-953
    - Recruiting
    - Klinika Ambroziak Dermatologia /ID# 265458
  - Warsaw, Masovian Voivodeship, Poland, 02-962
    - Recruiting
    - Royalderm Agnieszka Nawrocka /ID# 266606
- Podlaskie Voivodeship
  - Bialystok, Podlaskie Voivodeship, Poland, 15-453
    - Recruiting
    - NZOZ Specjalistyczny Osrodek Dermatologiczny Dermal /ID# 266613
- Pomeranian Voivodeship
  - Gdansk, Pomeranian Voivodeship, Poland, 80-546
    - Recruiting
    - Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 265451
- Silesian Voivodeship
  - Katowice, Silesian Voivodeship, Poland, 40-615
    - Recruiting
    - Centrum Medyczne Angelius Provita /ID# 265456
Portugal
- - Coimbra, Portugal, 3000-075
    - Recruiting
    - Unidade Local de Saude de Coimbra, EPE /ID# 266115
  - Porto, Portugal, 4099-003
    - Recruiting
    - Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 266112
  - Porto, Portugal, 4200-319
    - Recruiting
    - Unidade Local de Saude Sao Joao, EPE /ID# 266111
Puerto Rico
- - Bayamón, Puerto Rico, 00960
    - Recruiting
    - Clinical Research Investigator Group, LLC /ID# 268366
  - Carolina, Puerto Rico, 00985
    - Completed
    - Private Practice - Dr. Alma Cruz /ID# 264234
Singapore
- - Singapore, Singapore, 119074
    - Recruiting
    - National University Hospital /ID# 265685
  - Singapore, Singapore, 229899
    - Recruiting
    - KK Women's and Children's Hospital /ID# 266519
Slovakia
- - Trnava, Slovakia, 917 02
    - Completed
    - Fakultna nemocnica Trnava /ID# 265245
- Bratislava Region
  - Bratislava, Bratislava Region, Slovakia, 831 01
    - Recruiting
    - Narodny Ustav Detskych Chorob /ID# 265253
- Košice Region
  - Košice, Košice Region, Slovakia, 040 01
    - Recruiting
    - ALERSA, s.r.o. /ID# 266245
  - Košice, Košice Region, Slovakia, 040 01
    - Recruiting
    - Univerzitna nemocnica L. Pasteura Kosice /ID# 265239
- Žilina Region
  - Martin, Žilina Region, Slovakia, 036 01
    - Recruiting
    - Univerzitna nemocnica Martin /ID# 265947
South Korea
- Gyeonggido
  - Ansan-si, Gyeonggido, South Korea, 15355
    - Recruiting
    - Korea University Ansan Hospital /ID# 264169
  - Bucheon-si, Gyeonggido, South Korea, 14584
    - Recruiting
    - Soon Chun Hyang University Hospital Bucheon /ID# 264171
- Seoul Teugbyeolsi
  - Dongjak-gu, Seoul Teugbyeolsi, South Korea, 06973
    - Recruiting
    - Chungang University Hospital /ID# 266383
  - Seoul, Seoul Teugbyeolsi, South Korea, 03080
    - Recruiting
    - Seoul National University Hospital /ID# 264176
  - Seoul, Seoul Teugbyeolsi, South Korea, 05030
    - Recruiting
    - Konkuk University Medical Center /ID# 264178
  - Seoul, Seoul Teugbyeolsi, South Korea, 07441
    - Recruiting
    - Hallym University Kangnam Sacred Heart Hospital /ID# 267318
Spain
- - Madrid, Spain, 28007
    - Recruiting
    - Hospital General Universitario Gregorio Maranon /ID# 255288
  - Madrid, Spain, 28046
    - Recruiting
    - Hospital Universitario La Paz /ID# 255286
  - Valencia, Spain, 46014
    - Recruiting
    - Consorci Hospital General Universitario de Valencia /ID# 255289
  - Zaragoza, Spain, 50009
    - Recruiting
    - Hospital Universitario Miguel Servet /ID# 255290
- Barcelona
  - Esplugues de Llobregat, Barcelona, Spain, 08950
    - Recruiting
    - Hospital Sant Joan de Deu /ID# 255287
Taiwan
- - New Taipei City, Taiwan, 236
    - Recruiting
    - New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical /ID# 266349
  - Taipei, Taiwan, 100
    - Recruiting
    - National Taiwan University Hospital /ID# 265510
  - Taipei, Taiwan, 112
    - Recruiting
    - Taipei Veterans General Hospital- Taipei City /ID# 265507
  - Taoyuan, Taiwan, 333
    - Recruiting
    - Linkou Chang Gung Memorial Hospital - Taoyuan /ID# 263664
- Kaohsiung
  - Kaohsiung City, Kaohsiung, Taiwan, 833
    - Recruiting
    - Kaohsiung Chang Gung Memorial Hospital /ID# 267791
United Kingdom
- - Manchester, United Kingdom, M9 2AA
    - Recruiting
    - Manchester University NHS Foundation Trust /ID# 267693
  - Newcastle upon Tyne, United Kingdom, NE1 4LP
    - Completed
    - Royal Victoria Infirmary /ID# 265238
- Devon
  - Plymouth, Devon, United Kingdom, PL6 8DH
    - Recruiting
    - Derriford Hospital and the Royal Eye Infirmary /ID# 266980
- Greater London
  - London, Greater London, United Kingdom, SW10 9NH
    - Recruiting
    - Chelsea and Westminster Hospital /ID# 266389
  - London, Greater London, United Kingdom, SW17 0QT
    - Recruiting
    - St George University Hospitals NHS Foundation Trust /ID# 266984
  - London, Greater London, United Kingdom, SE1 7EH
    - Recruiting
    - St Thomas' Hospital - Guy's and St Thomas' NHS Foundation Trust /ID# 265237
- Hampshire
  - Southampton, Hampshire, United Kingdom, SO16 6YD
    - Recruiting
    - University Hospital Southampton /ID# 266655
- Lanarkshire
  - Glasgow, Lanarkshire, United Kingdom, G51 4TF
    - Recruiting
    - Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde /ID# 265219
United States
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Recruiting
    - Applied Research Center Of Arkansas /ID# 268547
- California
  - Palo Alto, California, United States, 94304
    - Recruiting
    - Stanford University School of Medicine - Palo Alto /ID# 269622
    - Contact:
      
      Site Coordinator
      
      Phone Number: 650-725-9600
      
      Email: chong@stanfordchildrens.org
  - Sacramento, California, United States, 95815
    - Recruiting
    - Integrative Skin Science and Research /ID# 265108
- Florida
  - Boca Raton, Florida, United States, 33428
    - Completed
    - Clearlyderm Dermatology - West Boca /ID# 266323
  - Coral Gables, Florida, United States, 33146
    - Recruiting
    - Pediatric Skin Research /ID# 266308
    - Contact:
      
      Site Coordinator
      
      Phone Number: (786) 707-4888
  - Hialeah, Florida, United States, 33016
    - Completed
    - Neoclinical Research - Hialeah /ID# 269694
- Georgia
  - Dawsonville, Georgia, United States, 30534
    - Completed
    - Cleaver Medical Group Dermatology /ID# 265099
  - Savannah, Georgia, United States, 31406
    - Recruiting
    - Aeroallergy Research Laboratory /ID# 267247
- Idaho
  - Boise, Idaho, United States, 83706
    - Recruiting
    - Treasure Valley Medical Research /ID# 266838
- Illinois
  - Chicago, Illinois, United States, 60611-2927
    - Recruiting
    - Northwestern University Feinberg School of Medicine /ID# 265117
  - Normal, Illinois, United States, 61761
    - Recruiting
    - Sneeze Wheeze & Itch Associates /ID# 267238
- Indiana
  - Indianapolis, Indiana, United States, 46256
    - Recruiting
    - Dawes Fretzin, LLC /ID# 265097
- Kentucky
  - Bowling Green, Kentucky, United States, 42104
    - Recruiting
    - Equity Medical, LLC /ID# 268270
    - Contact:
      
      Site Coordinator
      
      Phone Number: 270-213-7777
- Maryland
  - Lanham, Maryland, United States, 20706
    - Recruiting
    - Maryland Allergy & Asthma Center /ID# 268032
  - Rockville, Maryland, United States, 20850
    - Recruiting
    - DermAssociates - Rockville /ID# 266457
- Missouri
  - St Louis, Missouri, United States, 63130
    - Recruiting
    - Washington University School of Medicine - St. Louis /ID# 268545
- Nebraska
  - Omaha, Nebraska, United States, 68144
    - Recruiting
    - Skin Specialists /ID# 266331
    - Contact:
      
      Site Coordinator
      
      Phone Number: 402-697-6599
- Ohio
  - Canal Winchester, Ohio, United States, 43110-2069
    - Recruiting
    - DOCS Clinical Research - Canal Winchester /ID# 268271
  - Fairborn, Ohio, United States, 45324
    - Recruiting
    - Wright State Physicians Health Center /ID# 268841
- Oregon
  - Portland, Oregon, United States, 97239
    - Recruiting
    - Oregon Health and Science University /ID# 266483
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Recruiting
    - Medical University of South Carolina /ID# 265113
- Tennessee
  - Murfreesboro, Tennessee, United States, 37130
    - Completed
    - International Clinical Research - Tennessee /ID# 268548
- Texas
  - Arlington, Texas, United States, 76011
    - Recruiting
    - Arlington Research Center, Inc /ID# 266330
  - El Paso, Texas, United States, 79925
    - Recruiting
    - 3A Research - East location /ID# 267622
  - Mansfield, Texas, United States, 76063
    - Recruiting
    - Prime Clinical Research - Mansfield - East Broad Street /ID# 268042
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - Progressive Clinical Research - San Antonio /ID# 267262
    - Contact:
      
      Site Coordinator
      
      Phone Number: 210-614-5557
  - San Antonio, Texas, United States, 78218
    - Recruiting
    - Texas Dermatology and Laser Specialists /ID# 267249
    - Contact:
      
      Site Coordinator
      
      Phone Number: 210-852-2779
- Utah
  - South Jordan, Utah, United States, 84095
    - Recruiting
    - Jordan Valley Dermatology & Research Center /ID# 267092
- West Virginia
  - Morgantown, West Virginia, United States, 26506
    - Recruiting
    - West Virginia University Hospitals /ID# 265114
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - Recruiting
    - Wisconsin Medical Center /ID# 267236
    - Contact:
      
      Site Coordinator
      
      Phone Number: (414) 955-5773

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

Child

Accepts Healthy Volunteers

Description

Inclusion Criteria:

A minimum weight of 10 kg and weight and height > 5th percentile for their age according to local standard growth charts at the Baseline Visit.
Atopic Dermatitis (AD), according to Hanifin and Rajka criteria, with onset of symptoms at least 6 months prior to Baseline.
Eczema Area and Severity Index (EASI) score >= 16; vIGA-AD score >= 3 (Note: In countries where dupilumab is only approved for severe AD, subjects to be included in the Randomized Cohort should have severe AD [vIGA-AD = 4]); >= 10% Body Surface Area of AD involvement at the Baseline Visit; and Baseline weekly average of daily Worst Itch Scale (WIS) or Worst Scratch/Itch numerical rating scale (WSI-NRS) >= 4.
Participant must satisfy at least one of the following criteria (Note: More than 1 criterion may apply to an individual participant. All applicable criteria for each individual participant should be reported):
To be included in the Randomized Cohort (Note: Participants must have severe AD [vIGA-AD = 4] in countries where dupilumab is approved only for severe AD.):
1. [For all countries except US] Documented history of inadequate response or intolerance to TCS and/or TCI OR for whom use of one or more of these topical treatments is medically inadvisable (e.g., high disease burden, Scoring Atopic Dermatitis (SCORAD) > 50, EASI score > 21, or vIGA-AD > 3).
2. For dupilumab-naïve participants: History of inadequate response to a systemic therapy for AD other than dupilumab or oral corticosteroids or for whom the available systemic treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks).
3. History of inadequate response to 2 or more courses of oral corticosteroid therapy given for >= 14 days within 6 months prior to Screening or history of oral corticosteroid rebound, defined as recurrence of AD symptoms within 4 months after its discontinuation.
4. For dupilumab-exposed participants: Prior exposure to dupilumab without documented history of inadequate response or intolerance (i.e., discontinuation of dupilumab for a non-medical reason, such as, but not limited to, non-coverage or loss of coverage for the drug by health insurance, or other logistic challenges [not safety- or efficacy-related] precluding the participants continued access to dupilumab).
To be included in the Dupi-IR/Dupi-Medically Inadvisable Cohort:
- Previous inadequate response or intolerance to dupilumab OR
- Dupilumab is medically inadvisable (e.g., allergy to a component of dupilumab, etc.) AND a documented history of inadequate response or intolerance to TCS and/or TCI.

Exclusion Criteria:

Current or past history of other active skin diseases (e.g., psoriasis or Netherton syndrome or lupus erythematosus) or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline Visit or which would interfere with the appropriate assessment of AD lesions.
Have used topical treatments for AD (except for topical emollient treatments) including but not limited to TCS, TCI, or topical phosphodiesterase type 4 (PDE-4) inhibitors, within 7 days of the Baseline Visit or any the following prohibited concomitant AD treatments within the specified timeframes below prior to the Baseline Visit:
- Systemic therapy for AD, including but not limited to corticosteroids, methotrexate, cyclosporine, azathioprine, PDE-4 inhibitors, interferon-γ, and mycophenolate mofetil within 4 weeks;
- Dupilumab within 8 weeks;
- Targeted biologic treatments (other than dupilumab) within 5 half-lives (if known) or within 12 weeks, whichever is longer;
- Phototherapy treatment, laser therapy, tanning booth, or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks.
Known history of retinal detachment, previous cataract surgery, previous significant ocular trauma, or a known congenital ocular abnormality.
For Randomized Cohort: diagnosed active parasitic infection; suspected or high risk of parasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization.

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: Single

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Randomized Cohort Participants in the Randomized Cohort will be randomized to receive either medium dose upadacitinib daily adult equivalent dose, low dose upadacitinib daily adult equivalent dose or dupilumab every 2 weeks or 4 weeks (at the label-indicated dose and frequency).	Drug: Dupilumab Subcutaneous Injection Drug: Upadacitinib Oral Tablet or Oral Solution Other Names: ABT-494 RINVOQ® RINVOQ LQ
Experimental: Dupi-IR Cohort Participants in this cohort will receive upadacitinib medium dose.	Drug: Upadacitinib Oral Tablet or Oral Solution Other Names: ABT-494 RINVOQ® RINVOQ LQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving a 75% Reduction from Baseline in Eczema Area and Severity Index 75 (EASI 75) Score (other than US) Time Frame: At Week 16	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.	At Week 16
Percentage of participants achieving validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) 0 or 1 with a reduction from Baseline of ≥ 2 points (US and China only, descriptive) Time Frame: Week 16	The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale: 0 - Clear: No inflammatory signs of AD; 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification; 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting; 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present; 4 - Severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present.	Week 16
Number of Participants with Adverse Events (AEs) Time Frame: Up to Approximately Week 172	An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.	Up to Approximately Week 172

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants achieving an improved (reduced) Patient Oriented Eczema Measure (POEM) of ≥ 4 points from from participants with POEM ≥ 4 at Baseline Time Frame: At Week 16	The POEM is a 7-item, validated questionnaire used to assess disease symptoms in both children and adults. Participants respond to 7 questions, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency of occurrence during the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores are added to provide a total score ranging from 0 (clear) to 28 (very severe atopic eczema). A change in POEM score of 3.4 points is considered the minimal clinically important difference.	At Week 16
Percentage of participants ≥ 4 years of age with a Baseline Children's Dermatology Life Quality Index (CDLQI) score of >1 achieving a CDLQI score of 0 or 1 Time Frame: At Week 8	The CDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatological disease symptoms and treatment on quality of life. The CDLQI has been validated for use in Participants 4 to 16 years of age. It consists of 10 questions assessing impact of skin diseases on different aspects of quality of life over the prior week. The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale: 0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of quality of life.	At Week 8
Percent change in Scoring Atopic Dermatitis (SCORAD) from Baseline Time Frame: At Week 16	SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A negative change from Baseline indicates improvement.	At Week 16
Use of topical or systemic rescue therapy from Baseline to Week 16 Time Frame: Baseline to Week 16		Baseline to Week 16
Number of days on rescue topical corticosteroid or topical calcineurin inhibitor from Baseline to Week 16 Time Frame: Baseline to Week 16		Baseline to Week 16
Percentage of participants achieving a EASI 75 response for low dose upadacitinib daily adult equivalent dose Time Frame: At Week 16	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], An EASI 75 response is defined as a 75% reduction (improvement) from Baseline in EASI score.	At Week 16
Percentage of Participants Achieving a 75% Reduction from Baseline in EASI 75 Score (US) Time Frame: At Week 16	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.	At Week 16
Percentage of participants achieving vIGA-AD of 0 or 1 (on a 5-point scale) with a reduction from Baseline of ≥ 2 Points Time Frame: At Week 16	The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale: 0 - Clear: No inflammatory signs of AD; 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification; 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting; 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present; 4 - Severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present.	At Week 16
Percentage of participants achieving a 50% reduction from Baseline in EASI 50 score Time Frame: At Week 16	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.	At Week 16
Percentage of participants achieving vIGA-AD of 0 or 1 (on a 5-point scale) with a reduction from Baseline of ≥ 2 Points Time Frame: At Week 52	The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale: 0 - Clear: No inflammatory signs of AD; 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification; 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting; 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present; 4 - Severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present.	At Week 52
Percentage of participants achieving vIGA-AD of 0 or 1 (on a 5-point scale) with a reduction from Baseline of ≥ 2 Points Time Frame: At Week 160	The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale: 0 - Clear: No inflammatory signs of AD; 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification; 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting; 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present; 4 - Severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present.	At Week 160
Percentage of participants ≥ 4 years of age with a Baseline CDLQI score of >1 achieving a CDLQI score of 0 or 1 Time Frame: At Week 16	The CDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatological disease symptoms and treatment on quality of life. The CDLQI has been validated for use in Participants 4 to 16 years of age. It consists of 10 questions assessing impact of skin diseases on different aspects of quality of life over the prior week. The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale: 0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of quality of life.	At 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

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2024

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2030

Study Registration Dates

First Submitted

June 12, 2024

First Submitted That Met QC Criteria

June 12, 2024

First Posted (Actual)

June 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

M17-380
2023-504713-76-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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