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

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atopic Dermatitis

• Study Type: Observational
• Enrollment (Actual): 873

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, C1199ABB
    • Hospital Italiano /ID# 241608
  • Buenos Aires
    • Pilar, Buenos Aires, Argentina, 1629
      • Hospital Universitario Austral /ID# 241607
  • Ciudad Autonoma de Buenos Aires
    • Ciudad Autonoma de Buenos Aire, Ciudad Autonoma de Buenos Aires, Argentina, 1055
      • Buenos Aires Skin /ID# 241606
    • Ciudad Autonoma de Buenos Aire, Ciudad Autonoma de Buenos Aires, Argentina, 1425
      • CEDIC Centro de Investigaciones Clinicas /ID# 241605
    • Ciudad Autonoma de Buenos Aire, Ciudad Autonoma de Buenos Aires, Argentina, 1425
      • Instituto de Neumonologia y Dermatologia /ID# 241604
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Centro Respiratorio Infantil /ID# 241609
• Australia
  • Newtown, Australia, 2042
    • Sydney Skin /ID# 242277
  • New South Wales
    • Miranda, New South Wales, Australia, 2228
      • Kingsway Dermatology & Aesthetics /ID# 242276
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Veracity Clinical Research /ID# 242275
  • South Australia
    • Bedford, Park, South Australia, Australia, 5042
      • Flinders Medical Centre /ID# 242162
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Sinclair Dermatology - Melbourne /ID# 242163
  • Western Australia
    • Victoria Park, Western Australia, Australia, 6100
      • Burswood Dermatology /ID# 243767
• Austria
  • Oberoesterreich
    • Linz, Oberoesterreich, Austria, 4010
      • Ordensklinikum Linz GmbH Elisabethinen /ID# 246565
    • Wels, Oberoesterreich, Austria, 4600
      • Klinikum Wels-Grieskirchen GmbH /ID# 247369
  • Vorarlberg
    • Nenzing, Vorarlberg, Austria, 6710
      • Dr. Achim Schneeberger /ID# 247370
  • Wien
    • Vienna, Wien, Austria, 1100
      • Medizin am Hauptbahnhof /ID# 246567
    • Vienna, Wien, Austria, 1130
      • EZW HAUT Entzuendungszentrum Wien /ID# 246566
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5J 3S9
      • Rejuvenation Dermatology - Edmonton Downtown /ID# 240377
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3C 0N2
      • Winnipeg Clinic /ID# 239603
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Dr. Irina Turchin PC Inc. /ID# 240358
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
      • Karma Clinical Trials /ID# 239602
    • St. John's, Newfoundland and Labrador, Canada, A1C 2H5
      • NewLab Clinical Research Inc. /ID# 239600
  • Ontario
    • Cobourg, Ontario, Canada, K9A 0Z4
      • Dr Melinda Gooderham Medicine Profession /ID# 239745
    • Hamilton, Ontario, Canada, L8L 3C3
      • Lima's Excellence in Allergy and Dermatology Research Inc /ID# 239854
    • Markham, Ontario, Canada, L3P 1X2
      • Lynde Institute for Dermatology /ID# 240025
    • North York, Ontario, Canada, M3B 3S6
      • Gordon Sussman Medicine Professional Corporation /ID# 243383
    • Ottawa, Ontario, Canada, K1H 7X3
      • JRB Research /ID# 241862
    • Richmond Hill, Ontario, Canada, L4B 1L1
      • Dr. Michael Cecchini Medicine Professional Corporation /ID# 239605
    • Sudbury, Ontario, Canada, P3C 1X3
      • Dr. Lyne Giroux Medicine Professional Corporation /ID# 240084
    • Toronto, Ontario, Canada, M2N 3A6
      • North York Research Inc /ID# 253191
    • Toronto, Ontario, Canada, M3B 0A7
      • Canadian Dermatology Centre /ID# 240585
    • Toronto, Ontario, Canada, M4C 1L1
      • Centricity Research - Toronto Dermatology /ID# 241019
    • Whitby, Ontario, Canada, L1N 8M7
      • Dr Maksym Breslavets Medicine Professional Corporation /ID# 239741
  • Quebec
    • Laval, Quebec, Canada, H7N 6L2
      • Clinique D /ID# 239601
    • Laval, Quebec, Canada, H7P 4K7
      • Roula Rassi MD Inc /ID# 252562
    • Saint-Jerome, Quebec, Canada, J7Z 7E2
      • Dre Angelique Gagne-Henley M.D. inc. /ID# 239604
    • St-Jean sur le Richelieu, Quebec, Canada, J3A 1B5
      • Clinique de Dermatologie du Haut-Richelieu /ID# 239742
• Czechia
  • Olomouc, Czechia, 779 00
    • Fakultni nemocnice Olomouc /ID# 251177
  • Prague, Czechia, 150 00
    • Duplicate_Fakultni Nemocnice v Motole /ID# 246480
  • Praha, Czechia, 100 34
    • Fakultni nemocnice Kralovske Vinohrady /ID# 250792
  • Praha 17
    • Ceske Budejovice, Praha 17, Czechia, 370 01
      • Nemocnice Ceske Budejovice a.s. /ID# 246479
  • Stredocesky kraj
    • Prague, Stredocesky kraj, Czechia, 180 81
      • Nemocnice Na Bulovce /ID# 246482
• Greece
  • Athens, Greece, 11521
    • Naval Hospital of Athens /ID# 253229
  • Larissa, Greece, 41110
    • University General Hospital of Larissa /ID# 254216
  • Achaia
    • Patras, Achaia, Greece, 25443
      • Olympion General Clinic /ID# 261694
  • Attiki
    • Amaroussio, Attiki, Greece, 15123
      • Hygeia Hospital /ID# 254188
    • Athens, Attiki, Greece, 11527
      • 401 GSNA - 401 Army General Hospital /ID# 253222
    • Athens, Attiki, Greece, 11527
      • 401 GSNA - 401 Army General Hospital /ID# 253228
    • Athens, Attiki, Greece, 12462
      • University General Hospital Attikon /ID# 253221
    • Athens, Attiki, Greece, 16121
      • General Hospital Andreas Syggros /ID# 253220
    • Piraeus, Attiki, Greece, 18536
      • Tzaneio general hospital of Piraeus /ID# 253223
  • Evrytania
    • Thessaloniki, Evrytania, Greece, 54643
      • Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 253225
    • Thessaloniki, Evrytania, Greece, 54643
      • Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 253230
    • Thessaloniki, Evrytania, Greece, 56429
      • Papageorgiou General Hospital /ID# 253226
• Hungary
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem /ID# 239948
  • Szeged, Hungary, 6720
    • Szegedi Tudományegyetem /ID# 239947
  • Hajdu-Bihar
    • Debrecen, Hajdu-Bihar, Hungary, 4032
      • Debreceni Egyetem-Klinikai Kozpont /ID# 239949
  • Nograd
    • Pecs, Nograd, Hungary, 7624
      • Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 239950
  • Vas
    • Szombathely, Vas, Hungary, 9700
      • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 239951
• Israel
  • H_efa
    • Afula, H_efa, Israel, 1834111
      • HaEmek Medical Center /ID# 247834
    • Haifa, H_efa, Israel, 3109601
      • Rambam Health Care Campus /ID# 244904
    • Haifa, H_efa, Israel, 7176250
      • Maccabi /ID# 252598
  • HaDarom
    • Ashkelon, HaDarom, Israel, 5822000
      • The Edith Wolfson Medical Center /ID# 244902
  • HaMerkaz
    • Rehovot, HaMerkaz, Israel, 7661041
      • Duplicate_Kaplan Medical Center /ID# 244903
    • Rehovot, HaMerkaz, Israel, 9458414
      • Leumit /ID# 260022
  • HaTsafon
    • Safed, HaTsafon, Israel, 13100
      • ZIV Medical Center /ID# 244908
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 52621
      • Sheba Medical Center /ID# 244905
    • Tel Aviv, Tel-Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 244907
  • Yerushalayim
    • Jerusalem, Yerushalayim, Israel, 91031
      • Shaare Zedek Medical Center /ID# 247833
• Italy
  • Bari, Italy, 70124
    • A.O.U. Consorziale Policlinico di Bari /ID# 254612
  • Catania, Italy, 95123
    • AOU Policlinico G. Rodolico - San Marco /ID# 255707
  • Messina, Italy, 98122
    • AOU Gaetano Martino /ID# 255080
  • Novara, Italy, 28100
    • Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 254613
  • Roma, Italy, 00128
    • Fondazione Policlinico Universitario Campus Bio-Medico /ID# 255283
  • Vicenza, Italy, 36100
    • Azienda ULSS 8 Berica /ID# 255011
  • Genova
    • Genoa, Genova, Italy, 16132
      • Ospedale San Martino /ID# 255081
  • Milano
    • Milan, Milano, Italy, 20132
      • IRCCS Ospedale San Raffaele /ID# 255285
  • Piemonte
    • Torino, Piemonte, Italy, 10126
      • AOU Citta della Salute e della Scienza di Torino /ID# 254615
  • Salerno
    • Cava De' Tirreni, Salerno, Italy, 84013
      • AOU San Giovanni e Ruggi Salerno - Presidio Ospedaliero S.M.I. dell'Olmo /ID# 254689
• Mexico
  • Ciudad de Mexico, Mexico, 14050
    • Consultorio Medico Privado Desiree Larenas Linnemann /Id# 244150
  • Mexico City, Mexico, 11650
    • Centro Especializado en Diabetes, Obesidad y Prevencion de Enfermedades Cardiova /ID# 243856
  • Toluca, Mexico, 50120
    • Neki Servicios Medicos Profesionales S D Rl de Cv /Id# 243817
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44130
      • Centro de Investigacion Biologica y Terapia Avanzada SC (CIMBYTA) /ID# 243820
    • Guadalajara, Jalisco, Mexico, 44610
      • Centro Dermatologico Del Country S de Rl de Cv /Id# 243818
    • Guadalajara, Jalisco, Mexico, 44657
      • Grupo Clinico Catei Sociedad Civil /Id# 243809
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64060
      • Welsh Derm Centro de Especialidades Medicas /Id# 268403
    • Monterrey, Nuevo Leon, Mexico, 64623
      • Consultorio Medico Privado Alejandra Macias Weinmann /Id# 244159
    • San Pedro Garza García, Nuevo Leon, Mexico, 66220
      • Clinica Dermassad /Id# 264048
  • Oaxaca
    • Oaxaca de Juárez, Oaxaca, Mexico, 68000
      • Consultorio Medico Privado Cipactli Ariel Navarro Hernandez /Id# 244165
  • Puebla
    • San Andrés Cholula, Puebla, Mexico, 72820
      • Consultorio Medico Privado Yuri Igor Lopez Carrera /Id# 244164
  • Yucatan
    • Mérida, Yucatan, Mexico, 97203
      • Consultorio Privado Leslie Lourdes Rodriguez /Id# 243819
• Poland
  • Lodzkie
    • Lodz, Lodzkie, Poland, 90-436
      • Dermoklinika Medical Center /ID# 251249
  • Lubelskie
    • Lublin, Lubelskie, Poland, 20-573
      • Luxderm Specjalistyczny Gabinet Dermatologiczny, /ID# 253106
  • Malopolskie
    • Cracow, Malopolskie, Poland, 30-383
      • Maciej Pastuszczak Indywidualna Praktyka Lekarska /ID# 253105
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-507
      • Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 252447
    • Warszawa, Mazowieckie, Poland, 02-962
      • Prywatna Praktyka Lekarska Witold Owczarek /ID# 252448
  • Podkarpackie
    • Rzeszow, Podkarpackie, Poland, 35-055
      • KSW nr1 w Rzeszowie /ID# 251251
• Russian Federation
  • Chelyabinskaya oblast
    • Chelyabinsk, Chelyabinskaya oblast, Russian Federation, 454048
      • Chelyabinsk Regional Clinical Dermatovenerologic Dispensary /ID# 248262
  • Krasnodarskiy kray
    • Krasnodar, Krasnodarskiy kray, Russian Federation, 350020
      • Clinical Dermatovenerology Dispensary /ID# 245225
  • Kurskaya oblast
    • Petrozavodsk, Kurskaya oblast, Russian Federation, 185019
      • Republican hospital named after V.A. Baranov /ID# 245230
  • Moskva
    • Moscow, Moskva, Russian Federation, 115522
      • National Research Center Institute of Immunology of the FMBA of Russia /ID# 245221
  • Ryazanskaya oblast
    • Ryazan, Ryazanskaya oblast, Russian Federation, 390029
      • Research and Clinical Center for Hematology, Oncology and Immunology, Ryazan Sta /ID# 245220
  • Stavropol skiy kray
    • Stavropol, Stavropol skiy kray, Russian Federation, 355000
      • LLC Scientific Medical Center for General Therapy and Pharmacology /ID# 245229
  • Tatarstan, Respublika
    • Kazan, Tatarstan, Respublika, Russian Federation, 420111
      • LLC Medical Center ABC of Health /ID# 244816
• Spain
  • Barcelona, Spain, 08003
    • Hospital Parc de Salut del Mar /ID# 258675
  • Barcelona, Spain, 08041
    • Hospital Santa Creu i Sant Pau /ID# 248511
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de las Nieves /ID# 248528
  • Granada, Spain, 18016
    • Hospital Universitario Clinico San Cecilio /ID# 248530
  • Huelva, Spain, 21005
    • Hospital Juan Ramon Jimenez /ID# 251960
  • Jaen, Spain, 23007
    • Hospital Universitario de Jaen /ID# 251959
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Augusti /ID# 248507
  • Malaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria /ID# 248531
  • Salamanca, Spain, 37711
    • Hospital Universitario de Salamanca /ID# 253356
  • Santa Cruz de Tenerife, Spain, 38010
    • Hospital Universitario Nuestra Señora de Candelaria /ID# 251961
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio /ID# 248527
  • Valladolid, Spain, 47003
    • Hospital Clinico Universitario de Valladolid /ID# 253355
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitario Germans Trias i Pujol /ID# 248512
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitari de Bellvitge /ID# 248513
    • Terrassa, Barcelona, Spain, 08221
      • Hospital Universitari Mútua Terrassa /ID# 254292
  • La Rioja
    • Logroño, La Rioja, Spain, 26006
      • Hospital San Pedro /ID# 248538
  • Las Palmas
    • Las Palmas de Gran Canaria, Las Palmas, Spain, 35019
      • Hospital Universitario Dr. Negrin /ID# 248533
  • Murcia
    • Cartagena, Murcia, Spain, 30203
      • Hospital Santa María del Rosell /ID# 251956
  • Santa Cruz de Tenerife
    • San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain, 38320
      • Hospital Universitario Canarias /ID# 251957
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Hospital Universitario Basurto /ID# 248508
• Switzerland
  • Aargau
    • Aarau, Aargau, Switzerland, 5001
      • Kantonsspital Aarau AG /ID# 245517
  • Nidwalden
    • Buochs, Nidwalden, Switzerland, 6374
      • Dermatology & Skin Care Clinic /ID# 238348
  • Sankt Gallen
    • St. Gallen, Sankt Gallen, Switzerland, 9007
      • Kantonsspital St. Gallen /ID# 239244
  • Telangana
    • Weinfelden, Telangana, Switzerland, 8570
      • Haut- und Laserzentrum Weinfelden /ID# 239248
  • Ticino
    • Bellinzona, Ticino, Switzerland, 6500
      • EOC Ospedale Regionale di Bellinzona e Valli /ID# 239246
  • Valais
    • Orsières, Valais, Switzerland, 1937
      • Basile Darbellay SA /ID# 239245
  • Zuerich
    • Zurich, Zuerich, Switzerland, 8006
      • University Hospital Zurich /ID# 240076
• Taiwan
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hosp /ID# 244759
  • Taipei City, Taiwan, 05406
    • Chang Gung Memorial Foundation-Taipei Branch /ID# 244760
  • Taoyuan City, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital /ID# 244756
  • Keelung
    • Kaohsiung, Keelung, Taiwan, 807
      • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 244758
    • Taichung, Keelung, Taiwan, 40201
      • Chung Shan Medical University Hospital /ID# 244757
  • Taipei
    • Taipei City, Taipei, Taiwan, 100
      • National Taiwan University Hospital /ID# 244754
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • New Medical Center Hospital /ID# 245106
  • Abu Dhabi, United Arab Emirates
    • Tawam Hospital /ID# 249696
  • Dubai, United Arab Emirates
    • Safa Clinic /ID# 248492

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants Receiving Upadacitinib; Participants receiving upadacitinib for atopic dermatitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to Approximately 24 Months
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.	Month 4
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.	Month 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Month 24
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).	Up to Approximately 24 months
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).	Up to Approximately 24 Months
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).	Up to Approximately 24 Months
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).	Up to Approximately 24 Months
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).	Up to Approximately 24 Months
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).	Up to Approximately 24 Months
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.	Up to Approximately 24 Months (Excluding Month 4 - Primary Outcome)
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.	Up to Approximately 24 Months
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.	Up to Approximately 24 Months
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.	Up to Approximately 24 Months
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.	Up to Approximately 24 Months
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	Up to Approximately 24 Months
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	Up to Approximately 24 Months
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.	Up to Approximately 24 Months
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.	Up to Approximately 24 Months
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.	Up to Approximately 24 Months
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.	Up to Approximately 24 Months
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.	Up to approximately 24 Months
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).	Up to Approximately 24 Months
Percentage of Participants Remaining on Upadacitinib Once Daily	Percentage of participants remaining on upadacitinib once daily at all applicable time points.	Up to Approximately 24 Months
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).	Up to Approximately 24 months
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).	Up to Approximately 24 months
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).	Up to Approximately 24 months
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.	Up to Approximately 24 Months (Excluding Month 24 - Primary Outcome)
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.	Up to Approximately 24 Months
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.	Up to Approximately 24 Months
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.	Up to approximately 24 Months
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).	Up to Approximately 24 months
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.	Up to Approximately 24 months
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).	Up to Approximately 24 Months
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.	Up to Approximately 24 Months
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.	Up to Approximately 24 Months
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.	Up to Approximately 24 Months
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.	Up to Approximately 24 months
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).	Up to Approximately 24 Months
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.	Up to Approximately 24 Months
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.	Up to Approximately 24 Months
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.	Up to Approximately 24 Months
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).	Up to Approximately 24 months
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).	Up to Approximately 24 months
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).	Up to Approximately 24 months
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.	Up to Approximately 24 Months
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.	Up to Approximately 24 Months
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.	Up to Approximately 24 Months
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.	Up to Approximately 24 Months
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.	Up to Approximately 24 Months
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).	Up to Approximately 24 Months
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.	Up to Approximately 24 Months
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.	Up to Approximately 24 Months
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.	Up to Approximately 24 Months
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).	Up to Approximately 24 Months
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.	Up to Approximately 24 Months
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.	Up to Approximately 24 Months
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.	Up to Approximately 24 Months

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 18, 2021

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Upadacitinib; Atopic Dermatitis; RINVOQ; Atopic Eczema
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema
• Other Study ID Numbers: P20-441

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No