AzTrials
AzTrials

Atopic DermatitisPhase 3Start UpNCT06461897

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

A Phase 3 study testing Upadacitinib and Dupilumab in people with Atopic Dermatitis, run by AbbVie at 150 sites in 26 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 11 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Upadacitinib and Dupilumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
699 participants
Where
150 sitesin 26 countries
Study dates
19 Aug 2024to Nov 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.):
  • [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).
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  • 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).
  • 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.
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

150 sites in 26 countries.

150 sites in 26 countries

United States31 sites

  • Arlington Research Center, Inc /ID# 266330

    Arlington, Texas, 76011

  • Emory University School Of Medicine - Atlanta /ID# 268832

    Atlanta, Georgia, 30322

  • Clearlyderm Dermatology - West Boca /ID# 266323

    Boca Raton, Florida, 33428

  • Treasure Valley Medical Research /ID# 266838

    Boise, Idaho, 83706

  • Equity Medical, LLC /ID# 268270

    Bowling Green, Kentucky, 42104

  • DOCS Clinical Research - Canal Winchester /ID# 268271

    Canal Winchester, Ohio, 43110-2069

  • Medical University of South Carolina /ID# 265113

    Charleston, South Carolina, 29425

  • Northwestern Medicine - Northwestern Memorial Hospital /ID# 265117

    Chicago, Illinois, 60611

  • Cleaver Medical Group Dermatology /ID# 265099

    Dawsonville, Georgia, 30534

  • 3A Research - East location /ID# 267622

    El Paso, Texas, 79925

  • Wright State Physicians Health Center /ID# 268841

    Fairborn, Ohio, 45324

  • Neoclinical Research - Hialeah /ID# 269694

    Hialeah, Florida, 33016

  • Dawes Fretzin /ID# 265097

    Indianapolis, Indiana, 46256

  • Maryland Allergy & Asthma Center /ID# 268032

    Lanham, Maryland, 20706

  • Applied Research Center and Wellness Clinic /ID# 268547

    Little Rock, Arkansas, 72205

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

    Mansfield, Texas, 76063

  • Pediatric Skin Research - Miami /ID# 266308

    Miami, Florida, 33156

  • Medical College Of Wisconsin - Milwaukee Campus /ID# 267236

    Milwaukee, Wisconsin, 53226

  • West Virginia University Hospitals /ID# 265114

    Morgantown, West Virginia, 26506

  • International Clinical Research - Tennessee /ID# 268548

    Murfreesboro, Tennessee, 37130

  • Sneeze Wheeze & Itch Associates /ID# 267238

    Normal, Illinois, 61761

  • Skin Specialists /ID# 266331

    Omaha, Nebraska, 68144

  • Stanford University School of Medicine /ID# 269622

    Palo Alto, California, 94304

  • Oregon Health and Science University /ID# 266483

    Portland, Oregon, 97239

  • DermAssociates - Rockville /ID# 266457

    Rockville, Maryland, 20850

  • Integrative Skin Science and Research /ID# 265108

    Sacramento, California, 95815

  • Texas Dermatology and Laser Specialists /ID# 267249

    San Antonio, Texas, 78218

  • Progressive Clinical Research - San Antonio /ID# 267262

    San Antonio, Texas, 78229

  • Aeroallergy Research Laboratory /ID# 267247

    Savannah, Georgia, 31406

  • Jordan Valley Dermatology & Research Center /ID# 267092

    South Jordan, Utah, 84095

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

    St Louis, Missouri, 63130

Other trials in United States

Canada10 sites

  • Dermatology Research Institute - Blackfoot Trail /ID# 266744

    Calgary, Alberta, T2J 7E1

  • Rejuvenation Dermatology - Edmonton Downtown /ID# 267871

    Edmonton, Alberta, T5J 3S9

  • Maritime Dermatology /ID# 267359

    Halifax, Nova Scotia, B3K 5R3

  • Leader Research /ID# 266745

    Hamilton, Ontario, L8L 3C3

  • Hamilton Allergy /ID# 266615

    Hamilton, Ontario, L8S 1G5

  • Lynderm Research Inc /ID# 267006

    Markham, Ontario, L3P 1X2

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

    Montreal, Quebec, H3T 1C5

  • Allergy Research Canada /ID# 270230

    Niagara Falls, Ontario, L2H 1H5

  • DermAtelier on Avenue - Toronto /ID# 267850

    Toronto, Ontario, M5M 3Z8

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

    Vancouver, British Columbia, V6H 3N1

Other trials in Canada

China10 sites

  • Beijing Children's Hospital /ID# 266350

    Beijing, Beijing Municipality, 100045

  • Hunan Children's Hospital /ID# 266365

    Changsha, Hunan, 410007

  • Chengdu Women and Children Center Hospital /ID# 266402

    Chengdu, Sichuan, 610091

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

    Dalian, Liaoning, 116012

  • Kunming Childrens Hospital /ID# 266555

    Kunming, Yunnan, 650103

  • Shenzhen Children's Hospital /ID# 266401

    Shenzhen, Guangdong, 518026

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

    Wenzhou, Zhejiang, 325027

  • Xiamen Children's Hospital /ID# 266384

    Xiamen, Fujian, 361006

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

    Yuzhong District, Chongqing Municipality, 400015

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

    Zhengzhou, Henan, 450018

Other trials in China

Poland10 sites

  • NZOZ Specjalistyczny Osrodek Dermatologiczny Dermal /ID# 266613

    Bialystok, Podlaskie Voivodeship, 15-453

  • Centrum Medyczne Angelius Provita /ID# 265456

    Katowice, Silesian Voivodeship, 40-615

  • Centrum Nowoczesnych Terapii Dobry Lekarz sp.z.o.o. /ID# 266030

    Krakow, Lesser Poland Voivodeship, 31-011

  • Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus /ID# 265457

    Poznan, Greater Poland Voivodeship, 60-693

  • Medicover Integrated Clinical Services - Torun (SMO/Network/Consortium) /ID# 265454

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Klinika Osipowicz & Turkowski sp.z.o.o /ID# 267490

    Warsaw, Masovian Voivodeship, 00-716

  • Clinical Research Group Sp. z o.o. /ID# 266924

    Warsaw, Masovian Voivodeship, 01-142

  • Klinika Ambroziak Dermatologia /ID# 265458

    Warsaw, Masovian Voivodeship, 02-953

  • Royalderm Agnieszka Nawrocka /ID# 266606

    Warsaw, Masovian Voivodeship, 02-962

  • Penta Hospitals Badania Kliniczne /ID# 265451

    Wroclaw, Lower Silesian Voivodeship, 54-429

Other trials in Poland

France8 sites

  • CHU Amiens-Picardie Site Sud /ID# 255083

    Amiens, Somme, 80054

  • Centre Hospitalier d Argenteuil Victor Dupouy /ID# 265448

    Argenteuil, Île-de-France Region, 95107

  • Chu Bordeaux - Hopital Pellegrin /ID# 266818

    Bordeaux, New Aquitaine, 33076

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

    Clermont-Ferrand, Puy-de-Dome, 63100

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

    Nantes, Pays de la Loire Region, 44000

  • AP-HP - Hopital Necker /ID# 255050

    Paris, 75015

  • CHU Toulouse - Hopital Larrey /ID# 255048

    Toulouse, Haute-Garonne, 31400

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

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511

Other trials in France

United Kingdom8 sites

  • Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde /ID# 265219

    Glasgow, Lanarkshire, G51 4TF

  • St Thomas' Hospital - Guy's and St Thomas' NHS Foundation Trust /ID# 265237

    London, Greater London, SE1 7EH

  • Chelsea and Westminster Hospital /ID# 266389

    London, Greater London, SW10 9NH

  • St George University Hospitals NHS Foundation Trust /ID# 266984

    London, Greater London, SW17 0QT

  • Royal Manchester Children'S Hospital /ID# 267693

    Manchester, M13 9WL

  • Royal Victoria Infirmary /ID# 265238

    Newcastle upon Tyne, NE1 4LP

  • University Hospitals Plymouth NHS Trust /ID# 266980

    Plymouth, Devon, PL6 8DH

  • University Hospital Southampton /ID# 266655

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

South Korea6 sites

  • Korea University Ansan Hospital /ID# 264169

    Ansan-si, Gyeonggido, 15355

  • Soon Chun Hyang University Hospital Bucheon /ID# 264171

    Bucheon-si, Gyeonggido, 14584

  • Seoul National University Hospital /ID# 264176

    Seoul, Seoul Teugbyeolsi, 03080

  • Konkuk University Medical Center /ID# 264178

    Seoul, Seoul Teugbyeolsi, 05030

  • Chungang University Hospital /ID# 266383

    Seoul, Seoul Teugbyeolsi, 06973

  • Hallym University Kangnam Sacred Heart Hospital /ID# 267318

    Seoul, Seoul Teugbyeolsi, 07441

Other trials in South Korea

Brazil5 sites

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

    Campinas, São Paulo, 13034-685

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

    Porto Alegre, Rio Grande do Sul, 90020-090

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

    Ribeirão Preto, São Paulo, 14049-900

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

    São Paulo, 05403-000

  • Clinica de Alergia Martti Antila /ID# 266197

    Sorocaba, São Paulo, 18040-425

Other trials in Brazil

Croatia5 sites

  • Specialty Hospital Medico /ID# 266116

    Rijeka, Primorje-Gorski Kotar County, 51000

  • Klinicki Bolnicki Centar Split /ID# 265359

    Split, Split-Dalmatia County, 21000

  • Klinika za dječje bolesti Zagreb /ID# 264936

    Zagreb, City of Zagreb, 10000

  • Poliklinika DermaPlus /ID# 265724

    Zagreb, City of Zagreb, 10000

  • Poliklinika Solmed /ID# 265070

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Germany5 sites

  • Fachklinik Bad Bentheim /ID# 255165

    Bad Bentheim, Lower Saxony, 48455

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 267411

    Berlin, 10117

  • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 255167

    Dresden, Saxony, 01307

  • Universitaetsklinikum Erlangen /ID# 255168

    Erlangen, Bavaria, 91054

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

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

Israel5 sites

  • Haemek Medical Center /ID# 266416

    Afula, Haifa District, 1834111

  • Soroka Medical Center /ID# 265251

    Beersheba, Southern District, 8410101

  • Hadassah Medical Center-Hebrew University /ID# 255041

    Jerusalem, Jerusalem, 91120

  • Schneider Childrens Medical Center of Israel /ID# 265617

    Petah Tikva, Central District, 4920235

  • The Chaim Sheba Medical Center /ID# 265254

    Ramat Gan, Tel Aviv, 5265601

Other trials in Israel

Slovakia5 sites

  • Narodny Ustav Detskych Chorob /ID# 265253

    Bratislava, Bratislava Region, 831 01

  • ALERSA, s.r.o. /ID# 266245

    Košice, Košice Region, 040 01

  • Univerzitna nemocnica L. Pasteura Kosice /ID# 265239

    Košice, Košice Region, 041 90

  • Univerzitna nemocnica Martin /ID# 265947

    Martin, Žilina Region, 036 01

  • Fakultna nemocnica Trnava /ID# 265245

    Trnava, Trnava Region, 917 02

Other trials in Slovakia

Spain5 sites

  • Hospital Sant Joan de Deu /ID# 255287

    Esplugues de Llobregat, Barcelona, 08950

  • Hospital General Universitario Gregorio Maranon /ID# 255288

    Madrid, 28007

  • Hospital Universitario La Paz /ID# 255286

    Madrid, 28046

  • Consorci Hospital General Universitario de Valencia /ID# 255289

    Valencia, 46014

  • Hospital Universitario Miguel Servet /ID# 255290

    Zaragoza, 50009

Other trials in Spain

Taiwan5 sites

  • Kaohsiung Chang Gung Memorial Hospital /ID# 267791

    Kaohsiung City, 833

  • New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical /ID# 266349

    New Taipei City, 236

  • National Taiwan University Hospital /ID# 265510

    Taipei, 100

  • Taipei Veterans General Hospital /ID# 265507

    Taipei, 112

  • Linkou Chang Gung Memorial Hospital /ID# 263664

    Taoyuan City, 333

Other trials in Taiwan

Argentina4 sites

  • Conexa Investigacion Clinica /ID# 268728

    Buenos Aires, 1012

  • Instituto de Neumonologia y Dermatologia /ID# 266146

    Buenos Aires, 1425

  • Psoriahue - Buenos Aires /ID# 267737

    Buenos Aires, 1425

  • Sanatorio 9 de Julio /ID# 267678

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Australia3 sites

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

    Clayton, Victoria, 3168

  • Institute for Skin, Health and Immunity /ID# 266158

    Mitcham, Victoria, 3132

  • The Children's Hospital at Westmead /ID# 265430

    Westmead, New South Wales, 2145

Other trials in Australia

Austria3 sites

  • Medizinische Universitaet Graz /ID# 262741

    Graz, Styria, 8010

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

    Salzburg, 5020

  • Medizinische Universitaet Wien /ID# 265417

    Vienna, 1090

Other trials in Austria

Chile3 sites

  • Fundacion Innovacion Cardiovascular /ID# 266742

    Independencia, Santiago Metropolitan, 8380465

  • Centro De Especialidades Dermatologicas /ID# 267483

    Viña del Mar, Valparaiso, 2531169

  • Clinica Dermacross /ID# 266309

    Vitacura, Region Metropolitana Santiago, 7640881

Other trials in Chile

Hungary3 sites

  • Debreceni Egyetem /ID# 265331

    Debrecen, 4032

  • DermaMed Research - Oroshaza /ID# 266995

    Orosháza, Bekes County, 5900

  • Szegedi Tudomanyegyetem /ID# 265653

    Szeged, Csongrád megye, 6720

Other trials in Hungary

Italy3 sites

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

    Bologna, 40138

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 267070

    Rome, Roma, 00161

  • Ospedale Pediatrico Bambino Gesu /ID# 266118

    Rome, Roma, 00165

Other trials in Italy

Portugal3 sites

  • Unidade Local de Saude de Coimbra /ID# 266115

    Coimbra, 3000-075

  • Unidade Local de Saude de Santo Antonio /ID# 266112

    Porto, 4099-003

  • Unidade Local de Saude Sao Joao /ID# 266111

    Porto, 4200-319

Other trials in Portugal

Bulgaria2 sites

  • Medical Center Cordis /ID# 265250

    Pleven, 5800

  • UMHAT Alexandrovska /ID# 265256

    Sofiya, Sofia, 1431

Other trials in Bulgaria

Mexico2 sites

  • Eukarya PharmaSite /ID# 265274

    Monterrey, Nuevo León, 64718

  • Arke Estudios Clinicos S.A. de C.V. - Veracruz (SMO/Network/Consortium) /ID# 266650

    Veracruz, 91910

Other trials in Mexico

Netherlands2 sites

  • Amsterdam University Medical Center /ID# 265406

    Amsterdam, North Holland, 1105 AZ

  • Erasmus Medisch Centrum /ID# 265408

    Rotterdam, South Holland, 3015 CE

Other trials in Netherlands

Puerto Rico2 sites

  • Clinical Research Investigator Group /ID# 268366

    Bayamón, 00960

  • Private Practice - Dr. Alma Cruz /ID# 264234

    Carolina, 00985

Other trials in Puerto Rico

Singapore2 sites

  • National University Hospital /ID# 265685

    Singapore, Central Singapore, 119074

  • KK Women's and Children's Hospital /ID# 266519

    Singapore, 229899

Other trials in Singapore

About this study

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

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.

Read more

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.

Being tested
Upadacitinib, Dupilumab
Keywords
Atopic Dermatitis, Upadacitinib, RINVOQ
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UpadacitinibDrug

    Also called ABT-494, RINVOQ®, RINVOQ LQ

    Oral Tablet or Oral Solution

  • DupilumabDrug

    Subcutaneous Injection

Study groups in NCT06461897
Study groupRoleWhat they receive
Dupi-IR CohortExperimentalParticipants in this cohort will receive upadacitinib medium dose.
Receives: Drug: Upadacitinib
Randomized CohortExperimentalParticipants 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).
Receives: Drug: Upadacitinib; Drug: Dupilumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving a 75% Reduction from Baseline in Eczema Area and Severity Index 75 (EASI 75) Score (other than US)

    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.

    Measured: At Week 16

  2. 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)

    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.

    Measured: Week 16

  3. Number of Participants with Adverse Events (AEs)

    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.

    Measured: Up to Approximately Week 172

Secondary outcomes (12)

  1. Percentage of Participants Achieving a 75% Reduction from Baseline in EASI 75 Score (US)

    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.

    Measured: At Week 16

  2. Percentage of participants achieving vIGA-AD of 0 or 1 (on a 5-point scale) with a reduction from Baseline of ≥ 2 Points

    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.

    Measured: At Week 16

  3. Percentage of participants achieving a 50% reduction from Baseline in EASI 50 score

    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.

    Measured: At Week 16

  4. Percentage of participants achieving vIGA-AD of 0 or 1 (on a 5-point scale) with a reduction from Baseline of ≥ 2 Points

    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.

    Measured: At Week 52

  5. Percentage of participants achieving vIGA-AD of 0 or 1 (on a 5-point scale) with a reduction from Baseline of ≥ 2 Points

    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.

    Measured: At Week 160

  6. Percentage of participants achieving an improved (reduced) Patient Oriented Eczema Measure (POEM) of ≥ 4 points from from participants with POEM ≥ 4 at Baseline

    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.

    Measured: At Week 16

  7. 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

    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.

    Measured: At Week 8

  8. Percentage of participants ≥ 4 years of age with a Baseline CDLQI score of >1 achieving a CDLQI score of 0 or 1

    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.

    Measured: At Week 16

  9. Percent change in Scoring Atopic Dermatitis (SCORAD) from Baseline

    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.

    Measured: At Week 16

  10. Use of topical or systemic rescue therapy from Baseline to Week 16

    Measured: Baseline to Week 16

  11. Number of days on rescue topical corticosteroid or topical calcineurin inhibitor from Baseline to Week 16

    Measured: Baseline to Week 16

  12. Percentage of participants achieving a EASI 75 response for low dose upadacitinib daily adult equivalent dose

    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.

    Measured: At Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2024
  2. Study start19 Aug 2024
  3. Primary completionNov 2029 (estimated)
  4. Study completionNov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
699 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06461897
Sponsor's protocol ID
M17-380
Other IDs
2023-504713-76-00, 2023
Acronym
Start Up
Status last verified
Oct 2026
First submitted
12 Jun 2024
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Upadacitinib and Dupilumab in people with Atopic Dermatitis, run by AbbVie at 150 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 150 sites in United States, Canada, China, Poland, France and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06461897.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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