AzTrials
AzTrials

Atopic DermatitisADVISE MCOSNCT05081557

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

An observational study of Atopic Dermatitis, run by AbbVie at 140 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Atopic Dermatitis
How many people
873 participants
Where
140 sitesin 16 countries
Study dates
17 Nov 2021to 2 Sep 2026
Phase
Observational
Are there results?
None posted in the registry

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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Adolescents (12-17 years of age at baseline) and adults (>=18 years of age at baseline), with a physician-confirmed diagnosis of atopic dermatitis (AD), who are prescribed upadacitinib according to the local label and local practice.

Who may be able to join

  • 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.
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  • 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.

Who cannot join

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

Trial locations and contacts

140 sites in 16 countries.

140 sites in 16 countries

Canada20 sites
  • Dr Melinda Gooderham Medicine Profession /ID# 239745

    Cobourg, Ontario, K9A 0Z4

  • Rejuvenation Dermatology - Edmonton Downtown /ID# 240377

    Edmonton, Alberta, T5J 3S9

  • Dr. Irina Turchin PC Inc. /ID# 240358

    Fredericton, New Brunswick, E3B 1G9

  • Dr. Lyne Giroux Medicine Professional Corporation /ID# 240084

    Greater Sudbury, Ontario, P3C 1X3

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

    Hamilton, Ontario, L8L 3C3

  • Clinique D /ID# 239601

    Laval, Quebec, H7N 6L2

  • Roula Rassi MD Inc /ID# 252562

    Laval, Quebec, H7P 4K7

  • Lynderm Research Inc /ID# 240025

    Markham, Ontario, L3P 1X2

  • Gordon Sussman Medicine Professional Corporation /ID# 243383

    North York, Ontario, M3B 3S6

  • JRB Research /ID# 241862

    Ottawa, Ontario, K1H 7X3

  • Dr. Michael Cecchini Medicine Professional Corporation /ID# 239605

    Richmond Hill, Ontario, L4B 1L1

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

    Saint-Jérôme, Quebec, J7Z 7E2

  • Clinique de Dermatologie du Haut-Richelieu /ID# 239742

    St-Jean Sur Le Richelieu, Quebec, J3A 1B5

  • Karma Clinical Trials /ID# 239602

    St. John's, Newfoundland and Labrador, A1A 4Y3

  • NewLab Clinical Research Inc. /ID# 239600

    St. John's, Newfoundland and Labrador, A1C 2H5

  • North York Research Inc /ID# 253191

    Toronto, Ontario, M2N 3A6

  • Canadian Dermatology Centre /ID# 240585

    Toronto, Ontario, M3B 0A7

  • Centricity Research - Toronto Dermatology /ID# 241019

    Toronto, Ontario, M4C 1L1

  • Dr Maksym Breslavets Medicine Professional Corporation /ID# 239741

    Whitby, Ontario, L1N 8M7

  • Winnipeg Clinic /ID# 239603

    Winnipeg, Manitoba, R3C 0N2

Other trials in Canada

Spain20 sites
  • Hospital Universitario Germans Trias i Pujol /ID# 248512

    Badalona, Barcelona, 08916

  • Hospital Parc de Salut del Mar /ID# 258675

    Barcelona, 08003

  • Hospital Santa Creu i Sant Pau /ID# 248511

    Barcelona, 08041

  • Hospital Universitario Basurto /ID# 248508

    Bilbao, Vizcaya, 48013

  • Hospital Santa María del Rosell /ID# 251956

    Cartagena, Murcia, 30203

  • Hospital Universitario Virgen de las Nieves /ID# 248528

    Granada, 18014

  • Duplicate_Hospital Universitario Clinico San Cecilio /ID# 248530

    Granada, 18016

  • Hospital Juan Ramon Jimenez /ID# 251960

    Huelva, 21005

  • Hospital Universitario de Jaen /ID# 251959

    Jaén, 23007

  • Hospital Universitari de Bellvitge /ID# 248513

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario Dr. Negrin /ID# 248533

    Las Palmas de Gran Canaria, Las Palmas, 35019

  • Hospital San Pedro /ID# 248538

    Logroño, La Rioja, 26006

  • Hospital Universitario Lucus Augusti /ID# 248507

    Lugo, 27003

  • Hospital Universitario Virgen de la Victoria /ID# 248531

    Málaga, 29010

  • Hospital Universitario de Salamanca /ID# 253356

    Salamanca, 37711

  • Hospital Universitario Canarias /ID# 251957

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320

  • Hospital Universitario Nuestra Señora de Candelaria /ID# 251961

    Santa Cruz de Tenerife, 38010

  • Hospital Universitario Virgen del Rocio /ID# 248527

    Seville, 41013

  • Hospital Universitari Mutua Terrassa /ID# 254292

    Terrassa, Barcelona, 08221

  • Hospital Clinico Universitario de Valladolid /ID# 253355

    Valladolid, 47003

Other trials in Spain

Mexico13 sites
  • Centro de Investigacion Biologica y Terapia Avanzada SC (CIMBYTA) /ID# 243820

    Guadalajara, Jalisco, 44130

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

    Guadalajara, Jalisco, 44610

  • Grupo Clinico Catei Sociedad Civil /Id# 243809

    Guadalajara, Jalisco, 44657

  • Consultorio Privado Leslie Lourdes Rodriguez /Id# 243819

    Mérida, Yucatán, 97203

  • Duplicate_Centro Especializado en Diabetes, Obesidad y Prevencion de Enfermedade /ID# 243856

    Mexico City, Mexico City, 11650

  • Consultorio Medico Privado Desiree Larenas Linnemann /Id# 244150

    Mexico City, 14050

  • Welsh Derm Centro de Especialidades Medicas /Id# 268403

    Monterrey, Nuevo León, 64060

  • Consultorio Medico Privado Alejandra Macias Weinmann /Id# 244159

    Monterrey, Nuevo León, 64623

  • Consultorio Medico Privado Cipactli Ariel Navarro Hernandez /Id# 244165

    Oaxaca City, Oaxaca, 68000

  • Consultorio Medico Privado Yuri Igor Lopez Carrera /Id# 244164

    San Andrés Cholula, Puebla, 72820

  • Clinica Dermassad /Id# 264048

    San Pedro Garza García, Nuevo León, 66220

  • L Derm Clinica Dermatologica /Id# 266909

    Tijuana, Estado de Baja California, 22010

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

    Toluca, 50120

Other trials in Mexico

Greece12 sites
  • Hygeia Hospital /ID# 254188

    Amaroussio, Attica, 15123

  • 401 GSNA - 401 Army General Hospital /ID# 253222

    Athens, Attica, 11527

  • 401 GSNA - 401 Army General Hospital /ID# 253228

    Athens, Attica, 11527

  • General Hospital Andreas Syggros /ID# 253220

    Athens, Attica, 16121

  • Naval Hospital of Athens /ID# 253229

    Athens, 11521

  • University General Hospital Attikon /ID# 253221

    Chaïdári, Attica, 12462

  • University General Hospital of Larissa /ID# 254216

    Larissa, 41110

  • Olympion General Clinic /ID# 261694

    Pátrai, Achaia, 26443

  • Tzaneio general hospital of Piraeus /ID# 253223

    Piraeus, Attica, 18536

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

    Thessaloniki, 54643

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

    Thessaloniki, 54643

  • Papageorgiou General Hospital /ID# 253226

    Thessaloniki, 56429

Other trials in Greece

Israel10 sites
  • Haemek Medical Center /ID# 247834

    Afula, Haifa District, 1834111

  • Rambam Health Care Campus /ID# 244904

    Haifa, 3109601

  • Maccabi /ID# 252598

    Haifa, 7176250

  • The Edith Wolfson Medical Center /ID# 244902

    Holon, Southern District, 5822000

  • Shaare Zedek Medical Center /ID# 247833

    Jerusalem, Jerusalem, 91031

  • Sheba Medical Center /ID# 244905

    Ramat Gan, Tel Aviv, 52621

  • Duplicate_Kaplan Medical Center /ID# 244903

    Rehovot, Central District, 7661041

  • Leumit /ID# 260022

    Rehovot, Central District, 9458414

  • ZIV Medical Center /ID# 244908

    Safed, Northern District, 13100

  • Tel Aviv Sourasky Medical Center /ID# 244907

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Italy10 sites
  • Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari /ID# 254612

    Bari, 70124

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

    Catania, 95123

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

    Cava de' Tirreni, Salerno, 84013

  • Ospedale San Martino /ID# 255081

    Genova, 16132

  • Azienda Ospedaliera Universitaria Gaetano Martino /ID# 255080

    Messina, 98125

  • IRCCS Ospedale San Raffaele /ID# 255285

    Milan, Milano, 20132

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

    Novara, 28100

  • Fondazione Policlinico Universitario Campus Bio-Medico /ID# 255283

    Roma, 00128

  • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 254615

    Turin, Piedmont, 10126

  • Azienda ULSS 8 Berica /ID# 255011

    Vicenza, 36100

Other trials in Italy

Russia7 sites
  • Chelyabinsk Regional Clinical Dermatovenerologic Dispensary /ID# 248262

    Chelyabinsk, Chelyabinsk Oblast, 454048

  • LLC Medical Center ABC of Health /ID# 244816

    Kazan', Tatarstan, Respublika, 420111

  • Clinical Dermatovenerology Dispensary /ID# 245225

    Krasnodar, Krasnodarskiy Kray, 350020

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

    Moscow, Moscow, 115522

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

    Petrozavodsk, Murmansk Oblast, 185019

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

    Ryazan, Ryazan Oblast, 390029

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

    Stavropol, Stavropol Kray, 355000

Other trials in Russia

Switzerland7 sites
  • Kantonsspital Aarau AG /ID# 245517

    Aarau, Canton of Aargau, 5001

  • EOC Ospedale Regionale di Bellinzona e Valli /ID# 239246

    Bellinzona, Canton Ticino, 6500

  • Dermatology & Skin Care Clinic /ID# 238348

    Buochs, Canton of Nidwalden, 6374

  • Basile Darbellay SA /ID# 239245

    Orsières, Valais, 1937

  • Kantonsspital St. Gallen /ID# 239244

    Sankt Gallen, Canton of St. Gallen, 9007

  • Haut- und Laserzentrum Weinfelden /ID# 239248

    Weinfelden, Telangana, 8570

  • University Hospital Zurich /ID# 240076

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Argentina6 sites
  • Hospital Italiano /ID# 241608

    CABA, C1199ABB

  • Buenos Aires Skin /ID# 241606

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1055

  • CEDIC Centro de Investigaciones Clinicas /ID# 241605

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1425

  • Instituto de Neumonologia y Dermatologia /ID# 241604

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1425

  • Hospital Universitario Austral /ID# 241607

    Pilar, Buenos Aires, 1629

  • Centro Respiratorio Infantil /ID# 241609

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Australia6 sites
  • Flinders Medical Centre /ID# 242162

    Bedford Park, South Australia, 5042

  • Sinclair Dermatology - Melbourne /ID# 242163

    East Melbourne, Victoria, 3002

  • Kingsway Dermatology & Aesthetics /ID# 242276

    Miranda, New South Wales, 2228

  • Sydney Skin /ID# 242277

    Newtown, 2042

  • Burswood Dermatology /ID# 243767

    Victoria Park, Western Australia, 6100

  • Veracity Clinical Research /ID# 242275

    Woolloongabba, Queensland, 4102

Other trials in Australia

Taiwan6 sites
  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 244758

    Kaohsiung City, 807

  • Chung Shan Medical University Hospital /ID# 244757

    Taichung, 402

  • Chang Gung Memorial Foundation-Taipei Branch /ID# 244760

    Taipei, 05406

  • National Taiwan University Hospital /ID# 244754

    Taipei, 100

  • Taipei Veterans General Hosp /ID# 244759

    Taipei, 11217

  • Linkou Chang Gung Memorial Hospital /ID# 244756

    Taoyuan City, 333

Other trials in Taiwan

Austria5 sites
  • Ordensklinikum Linz Elisabethinen /ID# 246565

    Linz, Upper Austria, 4010

  • Dr. Achim Schneeberger /ID# 247370

    Nenzing, Vorarlberg, 6710

  • Medizin am Hauptbahnhof /ID# 246567

    Vienna, State of Vienna, 1100

  • EZW HAUT Entzuendungszentrum Wien /ID# 246566

    Vienna, State of Vienna, 1130

  • Klinikum Wels-Grieskirchen Gmbh /ID# 247369

    Wels, Upper Austria, 4600

Other trials in Austria

Czechia5 sites
  • Nemocnice Ceske Budejovice a.s. /ID# 246479

    České Budějovice, 370 01

  • Fakultni nemocnice Olomouc /ID# 251177

    Olomouc, 779 00

  • Fakultni nemocnice Bulovka /ID# 246482

    Prague, Central Bohemia, 180 81

  • Fakultni nemocnice Motol a Homolka /ID# 246480

    Prague, Praha 5, 150 06

  • Fakultni nemocnice Kralovske Vinohrady /ID# 250792

    Prague, 100 34

Other trials in Czechia

Hungary5 sites
  • Semmelweis Egyetem /ID# 239948

    Budapest, 1085

  • Debreceni Egyetem-Klinikai Kozpont /ID# 239949

    Debrecen, Hajdú-Bihar, 4032

  • Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 239950

    Pécs, Baranya, 7624

  • Szegedi Tudomanyegyetem /ID# 239947

    Szeged, Csongrád megye, 6720

  • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 239951

    Szombathely, Vas County, 9700

Other trials in Hungary

Poland5 sites
  • Dermoklinika Medical Center /ID# 251249

    Lodz, Łódź Voivodeship, 90-436

  • Luxderm Specjalistyczny Gabinet Dermatologiczny, /ID# 253106

    Lublin, Lublin Voivodeship, 20-573

  • KSW nr1 w Rzeszowie /ID# 251251

    Rzeszów, Podkarpackie Voivodeship, 35-055

  • Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 252447

    Warsaw, Masovian Voivodeship, 02-507

  • Prywatna Praktyka Lekarska Witold Owczarek /ID# 252448

    Warsaw, Masovian Voivodeship, 02-962

Other trials in Poland

United Arab Emirates3 sites
  • New Medical Center Hospital /ID# 245106

    Abu Dhabi

  • Tawam Hospital - Abu Dhabi /ID# 249696

    Abu Dhabi

  • Safa Clinic /ID# 248492

    Dubai

Other trials in United Arab Emirates

About this study

Official title: Real World Utilization of Upadacitinib in Adult and Adolescent Patients Living With Moderate to Severe Atopic Dermatitis (AD-VISE)

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.

Read more

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.

Keywords
Atopic Dermatitis, Atopic Eczema, 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.

Study groups in NCT05081557
Study groupRoleWhat they receive
Participants Receiving UpadacitinibParticipants receiving upadacitinib for atopic dermatitis.

What is being measured

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

  1. Upadacitinib (UPA) Utilization Patterns

    UPA utilization patterns will be achieved by (i) providing descriptive statistics of patient demographics and disease characteristics for patients who starting UPA 15 mg at baseline and patients who starting UPA 30 mg at baseline, respectively; (ii) calculating number and proportion of patients with different UPA and concomitant therapy changes throughout the observation period, and the rationale for any changes.

    Measured: Up to Approximately 24 Months

  2. Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) 0/1

    vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.

    Measured: Month 4

  3. vIGA-AD 0/1 Among Participants Who Achieved vIGA-AD 0/1 at Month 4

    vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.

    Measured: Month 24

Secondary outcomes (55)
  1. Modification of UPA or Concomitant AD Therapy and Associated Timing, Reasons

    This includes UPA dose change, temporary or permanent discontinuation, switching, add or remove TCS.

    Measured: Month 24

  2. Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to Approximately 24 months

  3. Percentage of Participants Achieving EASI 90

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to Approximately 24 Months

  4. Percentage of Participants Achieving EASI 100

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to Approximately 24 Months

  5. Percentage of Participants Achieving EASI <=1

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to Approximately 24 Months

  6. Percentage of Participants Achieving EASI <=5.9

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to Approximately 24 Months

  7. Percentage of Participants Achieving EASI <=7

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to Approximately 24 Months

  8. Percentage of Participants Achieving vIGA-AD 0/1

    vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.

    Measured: Up to Approximately 24 Months (Excluding Month 4 - Primary Outcome)

  9. Percentage of Participants Achieving Worst Pruritus Numerical Rating Scale (WP-NRS) 0/1

    Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.

    Measured: Up to Approximately 24 Months

  10. Percentage of Participants Achieving WP-NRS <=3

    WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.

    Measured: Up to Approximately 24 Months

  11. Percentage of Participants Achieving WP-NRS reduction >=4

    WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.

    Measured: Up to Approximately 24 Months

  12. Percentage of Participants Achieving Patient Oriented Eczema Measurement (POEM) Score <=2

    The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Subjects respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency over 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 (0 to 4) are added to provide a total score range of 0 to 28. The total score reflects disease-related morbidity, and differentiates between "clear/almost clear" (0-2 points), "mild" (3-7 points), "moderate" (8-16 points), "severe" (17-24 points) and "very severe" (25-28 points) AD. A change in POEM score of 3.4 points is considered the MCID.

    Measured: Up to Approximately 24 Months

  13. Percentage of Participants Achieving POEM <=7

    The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Subjects respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency over 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 (0 to 4) are added to provide a total score range of 0 to 28. The total score reflects disease-related morbidity, and differentiates between "clear/almost clear" (0-2 points), "mild" (3-7 points), "moderate" (8-16 points), "severe" (17-24 points) and "very severe" (25-28 points) AD. A change in POEM score of 3.4 points is considered the MCID

    Measured: Up to Approximately 24 Months

  14. Percentage of Participants Achieving POEM Reduction >=4

    The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Subjects respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency over 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 (0 to 4) are added to provide a total score range of 0 to 28. The total score reflects disease-related morbidity, and differentiates between "clear/almost clear" (0-2 points), "mild" (3-7 points), "moderate" (8-16 points), "severe" (17-24 points) and "very severe" (25-28 points) AD. A change in POEM score of 3.4 points is considered the MCID

    Measured: Up to Approximately 24 Months

  15. Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0/1

    DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = 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 HRQoL.

    Measured: Up to Approximately 24 Months

  16. Percentage of Participants Achieving DLQI Score <=5

    DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = 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 HRQoL.

    Measured: Up to Approximately 24 Months

  17. Percentage of Participants Achieving DLQI reduction >=4

    DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = 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 HRQoL.

    Measured: Up to Approximately 24 Months

  18. Percentage of Participants Achieving Atopic Dermatitis Control Tool (ADCT) <7 (control)

    The ADCT is a validated patient self-administered instrument designed to assess AD control status in adult and adolescent patients (12 years and older). Six AD symptoms and impacts are evaluated over the past week including overall severity of symptoms, days with intense episodes of itching, intensity of bother, problem with sleep, impact on daily activities, and impact on mood or emotions. Each item is scored 0-4. The sum of the 6 item scores form the ADCT total score (range 0-24). A higher score indicates lower AD control. A score of ≥7 indicates that the patient is not in control. The threshold for meaningful within-person change is estimated to be 5 points.

    Measured: Up to Approximately 24 Months

  19. Percentage of Participants Achieving ADCT reduction >=5

    The ADCT is a validated patient self-administered instrument designed to assess AD control status in adult and adolescent patients (12 years and older). Six AD symptoms and impacts are evaluated over the past week including overall severity of symptoms, days with intense episodes of itching, intensity of bother, problem with sleep, impact on daily activities, and impact on mood or emotions. Each item is scored 0-4. The sum of the 6 item scores form the ADCT total score (range 0-24). A higher score indicates lower AD control. A score of ≥7 indicates that the patient is not in control. The threshold for meaningful within-person change is estimated to be 5 points.

    Measured: Up to approximately 24 Months

  20. Percentage of Participants who are "Extremely Satisfied" or "Very Satisfied" with their AD Treatment using the Patient Global Impression of Treatment for Atopic Dermatitis (PGIT-AD)

    PGIT-AD is a single item patient self-administered instrument designed to assess patient satisfaction or dissatisfaction with their current treatment for atopic dermatitis based on the following question: "Overall, how satisfied or dissatisfied are you with your current treatment for atopic dermatitis?". Response options range from 1 (extremely dissatisfied) to 7 (extremely satisfied).

    Measured: Up to Approximately 24 Months

  21. Percentage of Participants Remaining on Upadacitinib Once Daily

    Percentage of participants remaining on upadacitinib once daily at all applicable time points.

    Measured: Up to Approximately 24 Months

  22. Percentage of Participants Achieving EASI 75 Among Participants Who Achieved EASI 75 at Month 4

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to Approximately 24 months

  23. Percentage of Participants Achieving EASI 90 Among Participants Who Achieved EASI 90 at Month 4

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to Approximately 24 months

  24. Percentage of Participants Achieving EASI 100 Among Participants Who Achieved EASI 100 at Month 4

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to Approximately 24 months

  25. Percentage of Participants Achieving vIGA-AD 0/1 Among Participants Who Achieved vIGA-AD at Month 4

    vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.

    Measured: Up to Approximately 24 Months (Excluding Month 24 - Primary Outcome)

  26. Percentage of Participants Achieving WP-NRS 0/1 Among Participants Who Achieved WP-NRS 0/1 at Month 4

    WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.

    Measured: Up to Approximately 24 Months

  27. Percentage of Participants Achieving DLQI Score of 0/1 Among Participants Achieving DLQI Score of 0/1 at Month 4

    DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = 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 HRQoL.

    Measured: Up to Approximately 24 Months

  28. Percentage of Participants Achieving ADCT Reduction <7 Among Participants Who Achieved ADCT Reduction <7 at Month 4

    The ADCT is a validated patient self-administered instrument designed to assess AD control status in adult and adolescent patients (12 years and older). Six AD symptoms and impacts are evaluated over the past week including overall severity of symptoms, days with intense episodes of itching, intensity of bother, problem with sleep, impact on daily activities, and impact on mood or emotions. Each item is scored 0-4. The sum of the 6 item scores form the ADCT total score (range 0-24). A higher score indicates lower AD control. A score of ≥7 indicates that the patient is not in control. The threshold for meaningful within-person change is estimated to be 5 points.

    Measured: Up to approximately 24 Months

  29. Absolute Score and Change from Baseline in EASI

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to Approximately 24 months

  30. Absolute Score and Change from Baseline in vIGA-AD

    vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.

    Measured: Up to Approximately 24 months

  31. Absolute Score and Change from Baseline in Body Surface Area (BSA)

    The investigator selects the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus five digits is assumed to be approximately equivalent to 1%. Measurement of the total area of involvement by the investigator is aided by imagining if scattered plaques were moved so that they were next to each other and then estimating the total area involved. Published score bands: 0% (clear), 0.1-15.9% (mild), 16.0-39.9% (moderate), 40-100% (severe).

    Measured: Up to Approximately 24 Months

  32. Absolute Score and Change from Baseline in WP-NRS

    WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.

    Measured: Up to Approximately 24 Months

  33. Absolute Score and Change from Baseline in POEM

    The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Subjects respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency over 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 (0 to 4) are added to provide a total score range of 0 to 28. The total score reflects disease-related morbidity, and differentiates between "clear/almost clear" (0-2 points), "mild" (3-7 points), "moderate" (8-16 points), "severe" (17-24 points) and "very severe" (25-28 points) AD. A change in POEM score of 3.4 points is considered the MCID.

    Measured: Up to Approximately 24 Months

  34. Absolute Score and Change from Baseline in DLQI

    DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = 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 HRQoL.

    Measured: Up to Approximately 24 Months

  35. Absolute Score and Change from Baseline in ADCT

    The ADCT is a validated patient self-administered instrument designed to assess AD control status in adult and adolescent patients (12 years and older). Six AD symptoms and impacts are evaluated over the past week including overall severity of symptoms, days with intense episodes of itching, intensity of bother, problem with sleep, impact on daily activities, and impact on mood or emotions. Each item is scored 0-4. The sum of the 6 item scores form the ADCT total score (range 0-24). A higher score indicates lower AD control. A score of ≥7 indicates that the patient is not in control. The threshold for meaningful within-person change is estimated to be 5 points.

    Measured: Up to Approximately 24 months

  36. Absolute Score and Change from Baseline in PGIT-AD

    PGIT-AD is a single item patient self-administered instrument designed to assess patient satisfaction or dissatisfaction with their current treatment for atopic dermatitis based on the following question: "Overall, how satisfied or dissatisfied are you with your current treatment for atopic dermatitis?". Response options range from 1 (extremely dissatisfied) to 7 (extremely satisfied).

    Measured: Up to Approximately 24 Months

  37. Change from Baseline in Flare Frequency and Duration

    Participants are asked to provide the number of flares in the previous 6 months, and the average duration of flares in the previous 6 months. Participants are asked if currently experiencing an atopic dermatitis flare. Flare is defined as a sudden worsening of AD requiring treatment escalation and/or additional medical advice.

    Measured: Up to Approximately 24 Months

  38. Change from Baseline in the Number of AD-Related Physician Office or Hospital Visits

    Participants are asked the number of AD-related physician office visits in the previous 6 months and the number of AD-related hospital visits in the previous 6 months.

    Measured: Up to Approximately 24 Months

  39. Absolute Score and Change from Baseline in Work Productivity and Activity Impairment Index for Atopic Dermatitis (WPAI-AD)

    The Work Productivity and Activity Impairment Index for Atopic Dermatitis (WPAI-AD) is a validated instrument used to measure loss of productivity at work and impairment in daily activities over the past 7 days. The questionnaire includes four items: absenteeism, presenteeism, overall work impairment, and activity impairment, that range from 0% to 100%, with higher values indicating greater impairment. While absenteeism represents the percentage of work time missed due to AD, presenteeism represents the percentage of impairment while at work due to AD. Overall work impairment represents the total percentage of work time missed due to either absenteeism or presenteeism (since those are mutually exclusive). Activity impairment represents the percentage of impairment during daily activities other than work. The 4 items are all evaluated using an 11-point Likert-type scale from 0 (no effect) to 10 (completely prevented), and the scores are multiplied by ten to arrive at a percentage.

    Measured: Up to Approximately 24 Months

  40. Time to Achieve EASI 75

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to Approximately 24 months

  41. Time to Achieve EASI 90

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to Approximately 24 months

  42. Time to Achieve EASI 100

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to Approximately 24 months

  43. Time to Achieve vIGA-AD 0/1

    vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.

    Measured: Up to Approximately 24 Months

  44. Time to Achieve WP-NRS 0/1

    WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.

    Measured: Up to Approximately 24 Months

  45. Time to Achieve DLQI Score of 0/1

    DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = 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 HRQoL.

    Measured: Up to Approximately 24 Months

  46. Time to Achieve POEM <=2

    The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Subjects respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency over 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 (0 to 4) are added to provide a total score range of 0 to 28. The total score reflects disease-related morbidity, and differentiates between "clear/almost clear" (0-2 points), "mild" (3-7 points), "moderate" (8-16 points), "severe" (17-24 points) and "very severe" (25-28 points) AD. A change in POEM score of 3.4 points is considered the MCID.

    Measured: Up to Approximately 24 Months

  47. Time to Achieve ADCT <7

    The ADCT is a validated patient self-administered instrument designed to assess AD control status in adult and adolescent patients (12 years and older). Six AD symptoms and impacts are evaluated over the past week including overall severity of symptoms, days with intense episodes of itching, intensity of bother, problem with sleep, impact on daily activities, and impact on mood or emotions. Each item is scored 0-4. The sum of the 6 item scores form the ADCT total score (range 0-24). A higher score indicates lower AD control. A score of ≥7 indicates that the patient is not in control. The threshold for meaningful within-person change is estimated to be 5 points.

    Measured: Up to Approximately 24 Months

  48. Time-Weighted EASI Score

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to Approximately 24 Months

  49. Time-Weighted vIGA-AD Score

    vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.

    Measured: Up to Approximately 24 Months

  50. Time-Weighted WP-NRS Score

    WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.

    Measured: Up to Approximately 24 Months

  51. Time-Weighted DLQI Score

    DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = 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 HRQoL.

    Measured: Up to Approximately 24 Months

  52. Percentage of Participants Achieving Treatment Target EASI <8

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to Approximately 24 Months

  53. Percentage of Participants Achieving Treatment Target DLQI <=5

    DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = 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 HRQoL.

    Measured: Up to Approximately 24 Months

  54. Percentage of Participants Achieving Treatment Target WP-NRS <=4

    WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.

    Measured: Up to Approximately 24 Months

  55. Percentage of Participants Achieving Combined Treatment Targets of EASI <8, DLQI <=5, and WP-NRS <=4

    EASI is a validated measure used to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). DLQI is a 10-item, validated questionnaire to assess the impact of AD disease symptoms and treatment on HRQoL. It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = 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 HRQoL. WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours.

    Measured: Up to Approximately 24 Months

Timeline

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

  1. First posted18 Oct 2021
  2. Study start17 Nov 2021
  3. Primary completion2 Sep 2026
  4. Study completion2 Sep 2026

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
873 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05081557
Sponsor's protocol ID
P20-441
Acronym
ADVISE MCOS
Status last verified
Oct 2026
First submitted
7 Oct 2021
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Atopic Dermatitis, run by AbbVie at 140 sites in 16 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 9 inclusion and 1 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: finished, 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 140 sites in Canada, Spain, Mexico, Greece, Israel and 11 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Upadacitinib (UPA) Utilization Patterns (time frame: Up to Approximately 24 Months). 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?
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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