A Study to Assess Real-World Use, Safety, and Effectiveness of Oral Upadacitinib in Adult and Adolescent (>=12 Years Old) Participants With Atopic Dermatitis

NCT ID: NCT05081557

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

873 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-17

Study Completion Date

2026-10-31

Brief Summary

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Atopic dermatitis (AD; also known as atopic eczema) is an inflammatory skin disease. The safety and effectiveness of upadacitinib for AD has been well-documented in previous studies, however, important information is missing on the use patterns and outcomes with upadacitinib in a real-world setting. Therefore, the purpose of this observational study is to help inform real-world usage patterns regarding the safety and effectiveness and duration of response of upadacitinib in adolescent and adult AD participants \>=12 years old in the real-world setting.

Upadacitinib is an approved drug being developed for the treatment of AD. Around 975 adolescent and adult participants who are prescribed upadacitinib for the treatment of AD in routine clinical practice will be enrolled worldwide.

Participants will receive oral upadacitinib as prescribed by their physician. Data from these participants will be collected for approximately 2 years.

There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.

Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants Receiving Upadacitinib

Participants receiving upadacitinib for atopic dermatitis.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Physician confirmed diagnosis of atopic dermatitis (AD) or atopic eczema at baseline.
* Symptom onset \>=1-year prior to baseline.
* Initiation of upadacitinib treatment for AD is indicated and prescribed per local label.
* The decision to prescribe UPA is made prior to and independently of study participation.
* Medical and medication history available for previous 6 months.
* Participants who can understand the questionnaires, with parental support as required for adolescents.
* Participants who are able to understand and communicate with the investigator and comply with the requirements of the study.
* Participants who are willing and able to participate in the collection of patient-reported data via cloud-based mobile application using a smart device (i.e., tablet).
* Participants who are willing and able to complete the patient-reported questionnaires.

Exclusion Criteria

\- Participants who are currently participating in interventional research (not including non-interventional study, post-marketing observational study, or registry participation).
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Hospital Universitario Austral /ID# 241607

Pilar, Buenos Aires, Argentina

Site Status

Buenos Aires Skin /ID# 241606

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina

Site Status

CEDIC Centro de Investigaciones Clinicas /ID# 241605

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina

Site Status

Instituto de Neumonologia y Dermatologia /ID# 241604

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina

Site Status

Centro Respiratorio Infantil /ID# 241609

Rosario, Santa Fe Province, Argentina

Site Status

Hospital Italiano /ID# 241608

CABA, , Argentina

Site Status

Kingsway Dermatology & Aesthetics /ID# 242276

Miranda, New South Wales, Australia

Site Status

Veracity Clinical Research /ID# 242275

Woolloongabba, Queensland, Australia

Site Status

Flinders Medical Centre /ID# 242162

Bedford Park, South Australia, Australia

Site Status

Sinclair Dermatology - Melbourne /ID# 242163

East Melbourne, Victoria, Australia

Site Status

Burswood Dermatology /ID# 243767

Victoria Park, Western Australia, Australia

Site Status

Sydney Skin /ID# 242277

Newtown, , Australia

Site Status

Ordensklinikum Linz GmbH Elisabethinen /ID# 246565

Linz, Upper Austria, Austria

Site Status

Klinikum Wels-Grieskirchen GmbH /ID# 247369

Wels, Upper Austria, Austria

Site Status

Medizin am Hauptbahnhof /ID# 246567

Vienna, Vienna, Austria

Site Status

EZW HAUT Entzuendungszentrum Wien /ID# 246566

Vienna, Vienna, Austria

Site Status

Dr. Achim Schneeberger /ID# 247370

Nenzing, Vorarlberg, Austria

Site Status

Rejuvenation Dermatology - Edmonton Downtown /ID# 240377

Edmonton, Alberta, Canada

Site Status

Winnipeg Clinic /ID# 239603

Winnipeg, Manitoba, Canada

Site Status

Dr. Irina Turchin PC Inc. /ID# 240358

Fredericton, New Brunswick, Canada

Site Status

Karma Clinical Trials /ID# 239602

St. John's, Newfoundland and Labrador, Canada

Site Status

NewLab Clinical Research Inc. /ID# 239600

St. John's, Newfoundland and Labrador, Canada

Site Status

Dr Melinda Gooderham Medicine Profession /ID# 239745

Cobourg, Ontario, Canada

Site Status

Dr. Lyne Giroux Medicine Professional Corporation /ID# 240084

Greater Sudbury, Ontario, Canada

Site Status

Lima's Excellence in Allergy and Dermatology Research Inc /ID# 239854

Hamilton, Ontario, Canada

Site Status

Lynde Institute for Dermatology /ID# 240025

Markham, Ontario, Canada

Site Status

Gordon Sussman Medicine Professional Corporation /ID# 243383

North York, Ontario, Canada

Site Status

JRB Research /ID# 241862

Ottawa, Ontario, Canada

Site Status

Dr. Michael Cecchini Medicine Professional Corporation /ID# 239605

Richmond Hill, Ontario, Canada

Site Status

North York Research Inc /ID# 253191

Toronto, Ontario, Canada

Site Status

Canadian Dermatology Centre /ID# 240585

Toronto, Ontario, Canada

Site Status

Centricity Research - Toronto Dermatology /ID# 241019

Toronto, Ontario, Canada

Site Status

Dr Maksym Breslavets Medicine Professional Corporation /ID# 239741

Whitby, Ontario, Canada

Site Status

Clinique D /ID# 239601

Laval, Quebec, Canada

Site Status

Roula Rassi MD Inc /ID# 252562

Laval, Quebec, Canada

Site Status

Dre Angelique Gagne-Henley M.D. inc. /ID# 239604

Saint-Jérôme, Quebec, Canada

Site Status

Clinique de Dermatologie du Haut-Richelieu /ID# 239742

St-Jean Sur Le Richelieu, Quebec, Canada

Site Status

Nemocnice Na Bulovce /ID# 246482

Prague, Central Bohemia, Czechia

Site Status

Nemocnice Ceske Budejovice a.s. /ID# 246479

České Budějovice, Praha 17, Czechia

Site Status

Fakultni nemocnice Olomouc /ID# 251177

Olomouc, , Czechia

Site Status

Fakultni nemocnice Kralovske Vinohrady /ID# 250792

Prague, , Czechia

Site Status

Duplicate_Fakultni Nemocnice v Motole /ID# 246480

Prague, , Czechia

Site Status

Olympion General Clinic /ID# 261694

Pátrai, Achaia, Greece

Site Status

Hygeia Hospital /ID# 254188

Amaroussio, Attica, Greece

Site Status

401 GSNA - 401 Army General Hospital /ID# 253222

Athens, Attica, Greece

Site Status

401 GSNA - 401 Army General Hospital /ID# 253228

Athens, Attica, Greece

Site Status

University General Hospital Attikon /ID# 253221

Athens, Attica, Greece

Site Status

General Hospital Andreas Syggros /ID# 253220

Athens, Attica, Greece

Site Status

Tzaneio general hospital of Piraeus /ID# 253223

Piraeus, Attica, Greece

Site Status

Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 253225

Thessaloniki, Evrytania, Greece

Site Status

Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 253230

Thessaloniki, Evrytania, Greece

Site Status

Papageorgiou General Hospital /ID# 253226

Thessaloniki, Evrytania, Greece

Site Status

Naval Hospital of Athens /ID# 253229

Athens, , Greece

Site Status

University General Hospital of Larissa /ID# 254216

Larissa, , Greece

Site Status

Semmelweis Egyetem /ID# 239948

Budapest, Budapest, Hungary

Site Status

Debreceni Egyetem-Klinikai Kozpont /ID# 239949

Debrecen, Hajdú-Bihar, Hungary

Site Status

Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 239950

Pecs, Nógrád megye, Hungary

Site Status

Szegedi Tudományegyetem /ID# 239947

Szeged, Szeged, Hungary

Site Status

Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 239951

Szombathely, Vas County, Hungary

Site Status

Duplicate_Kaplan Medical Center /ID# 244903

Rehovot, Central District, Israel

Site Status

Leumit /ID# 260022

Rehovot, Central District, Israel

Site Status

HaEmek Medical Center /ID# 247834

Afula, H_efa, Israel

Site Status

Rambam Health Care Campus /ID# 244904

Haifa, H_efa, Israel

Site Status

Maccabi /ID# 252598

Haifa, H_efa, Israel

Site Status

Shaare Zedek Medical Center /ID# 247833

Jerusalem, Jerusalem, Israel

Site Status

ZIV Medical Center /ID# 244908

Safed, Northern District, Israel

Site Status

The Edith Wolfson Medical Center /ID# 244902

Ashkelon, Southern District, Israel

Site Status

Sheba Medical Center /ID# 244905

Ramat Gan, Tel Aviv, Israel

Site Status

Tel Aviv Sourasky Medical Center /ID# 244907

Tel Aviv, Tel Aviv, Israel

Site Status

A.O.U. Consorziale Policlinico di Bari /ID# 254612

Bari, Bari, Italy

Site Status

AOU Policlinico G. Rodolico - San Marco /ID# 255707

Catania, Catania, Italy

Site Status

Ospedale San Martino /ID# 255081

Genoa, Genova, Italy

Site Status

AOU Gaetano Martino /ID# 255080

Messina, Messina, Italy

Site Status

IRCCS Ospedale San Raffaele /ID# 255285

Milan, Milano, Italy

Site Status

AOU Citta della Salute e della Scienza di Torino /ID# 254615

Turin, Piedmont, Italy

Site Status

Fondazione Policlinico Universitario Campus Bio-Medico /ID# 255283

Roma, Roma, Italy

Site Status

AOU San Giovanni e Ruggi Salerno - Presidio Ospedaliero S.M.I. dell'Olmo /ID# 254689

Cava de' Tirreni, Salerno, Italy

Site Status

Azienda ULSS 8 Berica /ID# 255011

Vicenza, Vicenza, Italy

Site Status

Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 254613

Novara, , Italy

Site Status

Centro de Investigacion Biologica y Terapia Avanzada SC (CIMBYTA) /ID# 243820

Guadalajara, Jalisco, Mexico

Site Status

Centro Dermatologico Del Country S de Rl de Cv /Id# 243818

Guadalajara, Jalisco, Mexico

Site Status

Grupo Clinico Catei Sociedad Civil /Id# 243809

Guadalajara, Jalisco, Mexico

Site Status

Consultorio Medico Privado Desiree Larenas Linnemann /Id# 244150

Mexico City, Mexico City, Mexico

Site Status

Welsh Derm Centro de Especialidades Medicas /Id# 268403

Monterrey, Nuevo León, Mexico

Site Status

Consultorio Medico Privado Alejandra Macias Weinmann /Id# 244159

Monterrey, Nuevo León, Mexico

Site Status

Clinica Dermassad /Id# 264048

San Pedro Garza García, Nuevo León, Mexico

Site Status

Consultorio Medico Privado Cipactli Ariel Navarro Hernandez /Id# 244165

Oaxaca City, Oaxaca, Mexico

Site Status

Consultorio Medico Privado Yuri Igor Lopez Carrera /Id# 244164

San Andrés Cholula, Puebla, Mexico

Site Status

Neki Servicios Medicos Profesionales S D Rl de Cv /Id# 243817

Toluca, State of Mexico, Mexico

Site Status

Consultorio Privado Leslie Lourdes Rodriguez /Id# 243819

Mérida, Yucatán, Mexico

Site Status

Centro Especializado en Diabetes, Obesidad y Prevencion de Enfermedades Cardiova /ID# 243856

Mexico City, , Mexico

Site Status

Maciej Pastuszczak Indywidualna Praktyka Lekarska /ID# 253105

Krakow, Lesser Poland Voivodeship, Poland

Site Status

Luxderm Specjalistyczny Gabinet Dermatologiczny, /ID# 253106

Lublin, Lublin Voivodeship, Poland

Site Status

Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 252447

Warsaw, Masovian Voivodeship, Poland

Site Status

Prywatna Praktyka Lekarska Witold Owczarek /ID# 252448

Warsaw, Masovian Voivodeship, Poland

Site Status

KSW nr1 w Rzeszowie /ID# 251251

Rzeszów, Podkarpackie Voivodeship, Poland

Site Status

Dermoklinika Medical Center /ID# 251249

Lodz, Łódź Voivodeship, Poland

Site Status

Chelyabinsk Regional Clinical Dermatovenerologic Dispensary /ID# 248262

Chelyabinsk, Chelyabinsk Oblast, Russia

Site Status

Clinical Dermatovenerology Dispensary /ID# 245225

Krasnodar, Krasnodarskiy Kray, Russia

Site Status

Republican hospital named after V.A. Baranov /ID# 245230

Petrozavodsk, Kursk Oblast, Russia

Site Status

National Research Center Institute of Immunology of the FMBA of Russia /ID# 245221

Moscow, Moscow, Russia

Site Status

Research and Clinical Center for Hematology, Oncology and Immunology, Ryazan Sta /ID# 245220

Ryazan, Ryazan Oblast, Russia

Site Status

LLC Scientific Medical Center for General Therapy and Pharmacology /ID# 245229

Stavropol, Stavropol Kray, Russia

Site Status

LLC Medical Center ABC of Health /ID# 244816

Kazan', Tatarstan, Respublika, Russia

Site Status

Hospital Universitario Germans Trias i Pujol /ID# 248512

Badalona, Barcelona, Spain

Site Status

Hospital Parc de Salut del Mar /ID# 258675

Barcelona, Barcelona, Spain

Site Status

Hospital Santa Creu i Sant Pau /ID# 248511

Barcelona, Barcelona, Spain

Site Status

Hospital Universitari de Bellvitge /ID# 248513

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Hospital Universitari Mútua Terrassa /ID# 254292

Terrassa, Barcelona, Spain

Site Status

Hospital Universitario Virgen de las Nieves /ID# 248528

Granada, Granada, Spain

Site Status

Hospital Universitario Clinico San Cecilio /ID# 248530

Granada, Granada, Spain

Site Status

Hospital Juan Ramon Jimenez /ID# 251960

Huelva, Huelva, Spain

Site Status

Hospital Universitario de Jaen /ID# 251959

Jaén, Jaen, Spain

Site Status

Hospital San Pedro /ID# 248538

Logroño, La Rioja, Spain

Site Status

Hospital Universitario Dr. Negrin /ID# 248533

Las Palmas de Gran Canaria, Las Palmas, Spain

Site Status

Hospital Universitario Lucus Augusti /ID# 248507

Lugo, Lugo, Spain

Site Status

Hospital Universitario Virgen de la Victoria /ID# 248531

Málaga, Malaga, Spain

Site Status

Hospital Santa María del Rosell /ID# 251956

Cartagena, Murcia, Spain

Site Status

Hospital Universitario de Salamanca /ID# 253356

Salamanca, Salamanca, Spain

Site Status

Hospital Universitario Canarias /ID# 251957

San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain

Site Status

Hospital Universitario Nuestra Señora de Candelaria /ID# 251961

Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain

Site Status

Hospital Universitario Virgen del Rocio /ID# 248527

Seville, Sevilla, Spain

Site Status

Hospital Clinico Universitario de Valladolid /ID# 253355

Valladolid, Valladolid, Spain

Site Status

Hospital Universitario Basurto /ID# 248508

Bilbao, Vizcaya, Spain

Site Status

Kantonsspital Aarau AG /ID# 245517

Aarau, Canton of Aargau, Switzerland

Site Status

Dermatology & Skin Care Clinic /ID# 238348

Buochs, Canton of Nidwalden, Switzerland

Site Status

Kantonsspital St. Gallen /ID# 239244

Sankt Gallen, Canton of St. Gallen, Switzerland

Site Status

University Hospital Zurich /ID# 240076

Zurich, Canton of Zurich, Switzerland

Site Status

EOC Ospedale Regionale di Bellinzona e Valli /ID# 239246

Bellinzona, Canton Ticino, Switzerland

Site Status

Haut- und Laserzentrum Weinfelden /ID# 239248

Weinfelden, Telangana, Switzerland

Site Status

Basile Darbellay SA /ID# 239245

Orsières, Valais, Switzerland

Site Status

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 244758

Kaohsiung City, Keelung, Taiwan

Site Status

Chung Shan Medical University Hospital /ID# 244757

Taichung, Keelung, Taiwan

Site Status

National Taiwan University Hospital /ID# 244754

Taipei City, Taipei, Taiwan

Site Status

Chang Gung Memorial Foundation-Taipei Branch /ID# 244760

Taipei, , Taiwan

Site Status

Taipei Veterans General Hosp /ID# 244759

Taipei, , Taiwan

Site Status

Linkou Chang Gung Memorial Hospital /ID# 244756

Taoyuan, , Taiwan

Site Status

New Medical Center Hospital /ID# 245106

Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates

Site Status

Safa Clinic /ID# 248492

Dubai, Dubai, United Arab Emirates

Site Status

Tawam Hospital /ID# 249696

Abu Dhabi, , United Arab Emirates

Site Status

Countries

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Argentina Australia Austria Canada Czechia Greece Hungary Israel Italy Mexico Poland Russia Spain Switzerland Taiwan United Arab Emirates

Related Links

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https://www.rxabbvie.com/

This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Other Identifiers

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P20-441

Identifier Type: -

Identifier Source: org_study_id

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