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NCT06461897PHASE3Recruiting

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

AbbVie

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

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.

Interventions

DRUG

Upadacitinib

DRUG

Dupilumab

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Conditions

Atopic Dermatitis

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