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NCT06461897

PHASE3

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

Sponsor: AbbVie

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

2 Years - 11 Years

Study Type

INTERVENTIONAL

Enrollment

699

Start Date

2024-08-19

Completion Date

2029-11

Last Updated

2026-10-16

Healthy Volunteers

Conditions

Atopic Dermatitis

Interventions

DRUG

Upadacitinib

Oral Tablet or Oral Solution

DRUG

Dupilumab

Subcutaneous Injection

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.

Locations (150)

Applied Research Center and Wellness Clinic /ID# 268547

Little Rock, Arkansas, United States

Stanford University School of Medicine /ID# 269622

Palo Alto, California, United States

Integrative Skin Science and Research /ID# 265108

Sacramento, California, United States

Clearlyderm Dermatology - West Boca /ID# 266323

Boca Raton, Florida, United States

Neoclinical Research - Hialeah /ID# 269694

Hialeah, Florida, United States

Pediatric Skin Research - Miami /ID# 266308

Miami, Florida, United States

Emory University School Of Medicine - Atlanta /ID# 268832

Atlanta, Georgia, United States

Cleaver Medical Group Dermatology /ID# 265099

Dawsonville, Georgia, United States

Aeroallergy Research Laboratory /ID# 267247

Savannah, Georgia, United States

Treasure Valley Medical Research /ID# 266838

Boise, Idaho, United States

Northwestern Medicine - Northwestern Memorial Hospital /ID# 265117

Chicago, Illinois, United States

Sneeze Wheeze & Itch Associates /ID# 267238

Normal, Illinois, United States

Dawes Fretzin /ID# 265097

Indianapolis, Indiana, United States

Equity Medical, LLC /ID# 268270

Bowling Green, Kentucky, United States

Maryland Allergy & Asthma Center /ID# 268032

Lanham, Maryland, United States

DermAssociates - Rockville /ID# 266457

Rockville, Maryland, United States

Washington University School of Medicine - St. Louis /ID# 268545

St Louis, Missouri, United States

Skin Specialists /ID# 266331

Omaha, Nebraska, United States

DOCS Clinical Research - Canal Winchester /ID# 268271

Canal Winchester, Ohio, United States

Wright State Physicians Health Center /ID# 268841

Fairborn, Ohio, United States

Oregon Health and Science University /ID# 266483

Portland, Oregon, United States

Medical University of South Carolina /ID# 265113

Charleston, South Carolina, United States

International Clinical Research - Tennessee /ID# 268548

Murfreesboro, Tennessee, United States

Arlington Research Center, Inc /ID# 266330

Arlington, Texas, United States

3A Research - East location /ID# 267622

El Paso, Texas, United States

Prime Clinical Research - Mansfield - East Broad Street /ID# 268042

Mansfield, Texas, United States

Texas Dermatology and Laser Specialists /ID# 267249

San Antonio, Texas, United States

Progressive Clinical Research - San Antonio /ID# 267262

San Antonio, Texas, United States

Jordan Valley Dermatology & Research Center /ID# 267092

South Jordan, Utah, United States

West Virginia University Hospitals /ID# 265114

Morgantown, West Virginia, United States

Medical College Of Wisconsin - Milwaukee Campus /ID# 267236

Milwaukee, Wisconsin, United States

Sanatorio 9 de Julio /ID# 267678

San Miguel de Tucumán, Tucumán Province, Argentina

Conexa Investigacion Clinica /ID# 268728

Buenos Aires, Argentina

Instituto de Neumonologia y Dermatologia /ID# 266146

Buenos Aires, Argentina

Psoriahue - Buenos Aires /ID# 267737

Buenos Aires, Argentina

The Children's Hospital at Westmead /ID# 265430

Westmead, New South Wales, Australia

Monash Health - Monash Medical Centre - Clayton /ID# 267149

Clayton, Victoria, Australia

Institute for Skin, Health and Immunity /ID# 266158

Mitcham, Victoria, Australia

Medizinische Universitaet Graz /ID# 262741

Graz, Styria, Austria

Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 265427

Salzburg, Austria

Medizinische Universitaet Wien /ID# 265417

Vienna, Austria

Irmandade da Santa Casa de Misericordia de Porto Alegre /ID# 267455

Porto Alegre, Rio Grande do Sul, Brazil

Hospital e Maternidade Celso Pierro - PUC-Campinas /ID# 266965

Campinas, São Paulo, Brazil

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 266964

Ribeirão Preto, São Paulo, Brazil

Clinica de Alergia Martti Antila /ID# 266197

Sorocaba, São Paulo, Brazil

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 266667

São Paulo, Brazil

UMHAT Alexandrovska /ID# 265256

Sofiya, Sofia, Bulgaria

Medical Center Cordis /ID# 265250

Pleven, Bulgaria

Dermatology Research Institute - Blackfoot Trail /ID# 266744

Calgary, Alberta, Canada

Rejuvenation Dermatology - Edmonton Downtown /ID# 267871

Edmonton, Alberta, Canada

British Columbia Children and Women's Hospital and Health Centre /ID# 265395

Vancouver, British Columbia, Canada

Maritime Dermatology /ID# 267359

Halifax, Nova Scotia, Canada

Leader Research /ID# 266745

Hamilton, Ontario, Canada

Hamilton Allergy /ID# 266615

Hamilton, Ontario, Canada

Lynderm Research Inc /ID# 267006

Markham, Ontario, Canada

Allergy Research Canada /ID# 270230

Niagara Falls, Ontario, Canada

DermAtelier on Avenue - Toronto /ID# 267850

Toronto, Ontario, Canada

Centre Hospitalier Universitaire (CHU) Sainte-Justine /ID# 266831

Montreal, Quebec, Canada

Clinica Dermacross /ID# 266309

Vitacura, Region Metropolitana Santiago, Chile

Fundacion Innovacion Cardiovascular /ID# 266742

Independencia, Santiago Metropolitan, Chile

Centro De Especialidades Dermatologicas /ID# 267483

Viña del Mar, Valparaiso, Chile

Beijing Children's Hospital /ID# 266350

Beijing, Beijing Municipality, China

Children's Hospital Affiliated to Chongqing Medical University /ID# 266876

Yuzhong District, Chongqing Municipality, China

Xiamen Children's Hospital /ID# 266384

Xiamen, Fujian, China

Shenzhen Children's Hospital /ID# 266401

Shenzhen, Guangdong, China

Henan Children's Hospital Zhengzhou Children's Hospital /ID# 266832

Zhengzhou, Henan, China

Hunan Children's Hospital /ID# 266365

Changsha, Hunan, China

Dalian Women and Children's Medical Group /ID# 266675

Dalian, Liaoning, China

Chengdu Women and Children Center Hospital /ID# 266402

Chengdu, Sichuan, China

Kunming Childrens Hospital /ID# 266555

Kunming, Yunnan, China

The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU /ID# 266708

Wenzhou, Zhejiang, China

Klinika za dječje bolesti Zagreb /ID# 264936

Zagreb, City of Zagreb, Croatia

Poliklinika DermaPlus /ID# 265724

Zagreb, City of Zagreb, Croatia

Poliklinika Solmed /ID# 265070

Zagreb, City of Zagreb, Croatia

Specialty Hospital Medico /ID# 266116

Rijeka, Primorje-Gorski Kotar County, Croatia

Klinicki Bolnicki Centar Split /ID# 265359

Split, Split-Dalmatia County, Croatia

CHU Toulouse - Hopital Larrey /ID# 255048

Toulouse, Haute-Garonne, France

Centre Hospitalier Regional Universitaire de Nancy - Hopitaux de Brabois /ID# 265455

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France

Chu Bordeaux - Hopital Pellegrin /ID# 266818

Bordeaux, New Aquitaine, France

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hotel-Dieu /ID# 265449

Nantes, Pays de la Loire Region, France

Centre Hospitalier Universitaire de Clermont Ferrand - Hopital Estaing /ID# 267327

Clermont-Ferrand, Puy-de-Dome, France

CHU Amiens-Picardie Site Sud /ID# 255083

Amiens, Somme, France

AP-HP - Hopital Necker /ID# 255050

Paris, France

Centre Hospitalier d Argenteuil Victor Dupouy /ID# 265448

Argenteuil, Île-de-France Region, France

Universitaetsklinikum Erlangen /ID# 255168

Erlangen, Bavaria, Germany

Fachklinik Bad Bentheim /ID# 255165

Bad Bentheim, Lower Saxony, Germany

Universitaetsklinikum Muenster - Von-Esmarch-Strasse /ID# 255166

Münster, North Rhine-Westphalia, Germany

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 255167

Dresden, Saxony, Germany

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 267411

Berlin, Germany

DermaMed Research - Oroshaza /ID# 266995

Orosháza, Bekes County, Hungary

Szegedi Tudomanyegyetem /ID# 265653

Szeged, Csongrád megye, Hungary

Debreceni Egyetem /ID# 265331

Debrecen, Hungary

Schneider Childrens Medical Center of Israel /ID# 265617

Petah Tikva, Central District, Israel

Haemek Medical Center /ID# 266416

Afula, Haifa District, Israel

Hadassah Medical Center-Hebrew University /ID# 255041

Jerusalem, Jerusalem, Israel

Soroka Medical Center /ID# 265251

Beersheba, Southern District, Israel

The Chaim Sheba Medical Center /ID# 265254

Ramat Gan, Tel Aviv, Israel

Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 267070

Rome, Roma, Italy

Ospedale Pediatrico Bambino Gesu /ID# 266118

Rome, Roma, Italy

IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 255118

Bologna, Italy

And 50 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (150)