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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05081557
Other study ID # P20-441
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 17, 2021
Est. completion date October 15, 2026

Study information

Verified date June 2024
Source AbbVie
Contact ABBVIE CALL CENTER
Phone 844-663-3742
Email abbvieclinicaltrials@abbvie.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 975
Est. completion date October 15, 2026
Est. primary completion date October 31, 2025
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Argentina Hospital Italiano /ID# 241608 Caba
Argentina Buenos Aires Skin /ID# 241606 Ciudad Autonoma de Buenos Aire Ciudad Autonoma De Buenos Aires
Argentina CEDIC Centro de Investigaciones Clinicas /ID# 241605 Ciudad Autonoma de Buenos Aire Ciudad Autonoma De Buenos Aires
Argentina Instituto de Neumonologia y Dermatologia /ID# 241604 Ciudad Autonoma de Buenos Aire Ciudad Autonoma De Buenos Aires
Argentina Hospital Universitario Austral /ID# 241607 Pilar Buenos Aires
Argentina Centro Respiratorio Infantil /ID# 241609 Rosario Santa Fe
Australia Flinders Medical Centre /ID# 242162 Bedford, Park South Australia
Australia Sinclair Dermatology - Melbourne /ID# 242163 East Melbourne Victoria
Australia Kingsway Dermatology & Aesthetics /ID# 242276 Miranda New South Wales
Australia Sydney Skin /ID# 242277 Newtown
Australia Burswood Dermatology /ID# 243767 Victoria Park Western Australia
Australia Veracity Clinical Research /ID# 242275 Woolloongabba Queensland
Austria Ordensklinikum Linz GmbH Elisabethinen /ID# 246565 Linz Oberoesterreich
Austria Dr. Achim Schneeberger /ID# 247370 Nenzing Vorarlberg
Austria EZW HAUT Entzuendungszentrum Wien /ID# 246566 Vienna Wien
Austria Medizin am Hauptbahnhof /ID# 246567 Vienna Wien
Austria Klinikum Wels-Grieskirchen GmbH /ID# 247369 Wels Oberoesterreich
Canada Dr Melinda Gooderham Medicine Profession /ID# 239745 Cobourg Ontario
Canada Rejuvenation Dermatology - Edmonton Downtown /ID# 240377 Edmonton Alberta
Canada Dr. Irina Turchin PC Inc. /ID# 240358 Fredericton New Brunswick
Canada Lima's Excellence in Allergy and Dermatology Research Inc /ID# 239854 Hamilton Ontario
Canada Clinique D /ID# 239601 Laval Quebec
Canada Roula Rassi MD Inc /ID# 252562 Laval Quebec
Canada Lynde Institute for Dermatology /ID# 240025 Markham Ontario
Canada Gordon Sussman Medicine Professional Corporation /ID# 243383 North York Ontario
Canada JRB Research /ID# 241862 Ottawa Ontario
Canada Dr. Michael Cecchini Medicine Professional Corporation /ID# 239605 Richmond Hill Ontario
Canada Dre Angelique Gagne-Henley M.D. inc. /ID# 239604 Saint-Jerome Quebec
Canada Clinique de Dermatologie du Haut-Richelieu /ID# 239742 St-Jean Sur Le Richelieu Quebec
Canada Karma Clinical Trials /ID# 239602 St. John's Newfoundland and Labrador
Canada NewLab Clinical Research Inc. /ID# 239600 St. John's Newfoundland and Labrador
Canada Dr. Lyne Giroux Medicine Professional Corporation /ID# 240084 Sudbury Ontario
Canada Canadian Dermatology Centre /ID# 240585 Toronto Ontario
Canada Centricity Research - Toronto Dermatology /ID# 241019 Toronto Ontario
Canada North York Research Inc /ID# 253191 Toronto Ontario
Canada Dr Maksym Breslavets Medicine Professional Corporation /ID# 239741 Whitby Ontario
Canada Winnipeg Clinic /ID# 239603 Winnipeg Manitoba
Czechia Nemocnice Ceske Budejovice a.s. /ID# 246479 Ceske Budejovice
Czechia Fakultni nemocnice Olomouc /ID# 251177 Olomouc
Czechia Duplicate_Fakultni Nemocnice v Motole /ID# 246480 Prague
Czechia Nemocnice Na Bulovce /ID# 246482 Prague Stredocesky Kraj
Czechia Fakultni nemocnice Kralovske Vinohrady /ID# 250792 Praha
Greece Hygeia Hospital /ID# 254188 Amaroussio Attiki
Greece 401 GSNA - 401 Army General Hospital /ID# 253222 Athens Attiki
Greece 401 GSNA - 401 Army General Hospital /ID# 253228 Athens Attiki
Greece General Hospital Andreas Syggros /ID# 253220 Athens Attiki
Greece Naval Hospital of Athens /ID# 253229 Athens
Greece University General Hospital Attikon /ID# 253221 Athens Attiki
Greece University General Hospital of Larissa /ID# 254216 Larissa
Greece Olympion General Clinic /ID# 261694 Patras Achaia
Greece Tzaneio general hospital of Piraeus /ID# 253223 Piraeus Attiki
Greece Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 253225 Thessaloniki
Greece Papageorgiou General Hospital /ID# 253226 Thessaloniki
Hungary Semmelweis Egyetem /ID# 239948 Budapest
Hungary Debreceni Egyetem-Klinikai Kozpont /ID# 239949 Debrecen Hajdu-Bihar
Hungary Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 239950 Pecs
Hungary Szegedi Tudományegyetem /ID# 239947 Szeged
Hungary Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 239951 Szombathely Vas
Israel HaEmek Medical Center /ID# 247834 Afula H_efa
Israel The Edith Wolfson Medical Center /ID# 244902 Ashkelon HaDarom
Israel Maccabi /ID# 252598 Haifa H_efa
Israel Rambam Health Care Campus /ID# 244904 Haifa H_efa
Israel Shaare Zedek Medical Center /ID# 247833 Jerusalem Yerushalayim
Israel Sheba Medical Center /ID# 244905 Ramat Gan Tel-Aviv
Israel Duplicate_Kaplan Medical Center /ID# 244903 Rehovot HaMerkaz
Israel Leumit /ID# 260022 Rehovot HaMerkaz
Israel ZIV Medical Center /ID# 244908 Safed HaTsafon
Israel Tel Aviv Sourasky Medical Center /ID# 244907 Tel Aviv Tel-Aviv
Italy Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 254612 Bari
Italy Presidio Ospedaliero Gaspare Rodolico /ID# 255707 Catania
Italy AOU San Giovanni e Ruggi Salerno - Presidio Ospedaliero S.M.I. dell'Olmo /ID# 254689 Cava De' Tirreni Salerno
Italy Ospedale Policlinico San Martino /ID# 255081 Genoa Genova
Italy AOU Gaetano Martino /ID# 255080 Messina
Italy Ospedale San Raffaele IRCCS /ID# 255285 Milan Milano
Italy Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 254613 Novara
Italy Universita Campus Biomedico /ID# 255283 Rome Roma
Italy AOU Citta della Salute e della Scienza di Torino /ID# 254615 Torino Piemonte
Italy Azienda ULSS 8 Berica/Ospedale San Bortolo di Vicenza /ID# 255011 Vicenza
Mexico Consultorio Medico Privado Desiree Larenas Linnemann /Id# 244150 Ciudad de Mexico
Mexico Centro de Investigacion Biologica y Terapia Avanzada SC (CIMBYTA) /ID# 243820 Guadalajara Jalisco
Mexico Centro Dermatologico Del Country S de Rl de Cv /Id# 243818 Guadalajara Jalisco
Mexico Grupo Clinico Catei Sociedad Civil /Id# 243809 Guadalajara Jalisco
Mexico Consultorio Privado Leslie Lourdes Rodriguez /Id# 243819 Mérida Yucatan
Mexico Centro Especializado en Diabetes, Obesidad y Prevencion de Enfermedades Cardiova /ID# 243856 Mexico City
Mexico Consultorio Medico Privado Alejandra Macias Weinmann /Id# 244159 Monterrey Nuevo Leon
Mexico Consultorio Medico Privado Cipactli Ariel Navarro Hernandez /Id# 244165 Oaxaca de Juárez Oaxaca
Mexico Consultorio Medico Privado Yuri Igor Lopez Carrera /Id# 244164 San Andrés Cholula Puebla
Mexico Clinica Dermassad /Id# 264048 San Pedro Garza García Nuevo Leon
Mexico Neki Servicios Medicos Profesionales S D Rl de Cv /Id# 243817 Toluca
Poland Maciej Pastuszczak Indywidualna Praktyka Lekarska /ID# 253105 Cracow Malopolskie
Poland Dermoklinika Medical Center /ID# 251249 Lodz Lodzkie
Poland Luxderm Specjalistyczny Gabinet Dermatologiczny, /ID# 253106 Lublin Lubelskie
Poland KSW nr1 w Rzeszowie /ID# 251251 Rzeszow Podkarpackie
Poland Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 252447 Warszawa Mazowieckie
Poland Prywatna Praktyka Lekarska Witold Owczarek /ID# 252448 Warszawa Mazowieckie
Russian Federation Chelyabinsk Regional Clinical Dermatovenerologic Dispensary /ID# 248262 Chelyabinsk Chelyabinskaya Oblast
Russian Federation LLC "Medical Center ABC of Health" /ID# 244816 Kazan Tatarstan, Respublika
Russian Federation Clinical Dermatovenerology Dispensary /ID# 245225 Krasnodar Krasnodarskiy Kray
Russian Federation National Research Center " Institute of Immunology" of the FMBA of Russia /ID# 245221 Moscow Moskva
Russian Federation Republican hospital named after V.A. Baranov /ID# 245230 Petrozavodsk
Russian Federation Research and Clinical Center for Hematology, Oncology and Immunology, Ryazan Sta /ID# 245220 Ryazan Ryazanskaya Oblast
Russian Federation LLC Scientific Medical Center for General Therapy and Pharmacology /ID# 245229 Stavropol Stavropol Skiy Kray
Spain Hospital Universitario Germans Trias i Pujol /ID# 248512 Badalona Barcelona
Spain Hospital Parc de Salut del Mar /ID# 258675 Barcelona
Spain Hospital Santa Creu i Sant Pau /ID# 248511 Barcelona
Spain Hospital Universitario Basurto /ID# 248508 Bilbao Vizcaya
Spain Hospital Santa María del Rosell /ID# 251956 Cartagena Murcia
Spain Hospital Universitario Clinico San Cecilio /ID# 248530 Granada
Spain Hospital Universitario Virgen de las Nieves /ID# 248528 Granada
Spain Hospital Juan Ramon Jimenez /ID# 251960 Huelva
Spain Hospital Universitario de Jaen /ID# 251959 Jaen
Spain Hospital Universitari de Bellvitge /ID# 248513 L'Hospitalet de Llobregat Barcelona
Spain Hospital Universitario Dr. Negrin /ID# 248533 Las Palmas de Gran Canaria Las Palmas
Spain Hospital San Pedro /ID# 248538 Logroño La Rioja
Spain Hospital Universitario Lucus Augusti /ID# 248507 Lugo
Spain Hospital Universitario Virgen de la Victoria /ID# 248531 Malaga
Spain Hospital Universitario de Salamanca /ID# 253356 Salamanca
Spain Hospital Universitario Canarias /ID# 251957 San Cristóbal de La Laguna Santa Cruz De Tenerife
Spain Hospital Universitario Nuestra Señora de Candelaria /ID# 251961 Santa Cruz de Tenerife
Spain Hospital Universitario Virgen del Rocio /ID# 248527 Sevilla
Spain Hospital Universitari Mútua Terrassa /ID# 254292 Terrassa Barcelona
Spain Hospital Clinico Universitario de Valladolid /ID# 253355 Valladolid
Switzerland Kantonsspital Aarau AG /ID# 245517 Aarau Aargau
Switzerland EOC Ospedale Regionale di Bellinzona e Valli /ID# 239246 Bellinzona Ticino
Switzerland Dermatology & Skin Care Clinic /ID# 238348 Buochs Nidwalden
Switzerland Basile Darbellay SA /ID# 239245 Orsières Valais
Switzerland Kantonsspital St. Gallen /ID# 239244 St. Gallen Sankt Gallen
Switzerland Haut- und Laserzentrum Weinfelden /ID# 239248 Weinfelden Telangana
Switzerland University Hospital Zurich /ID# 240076 Zurich Zuerich
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 244758 Kaohsiung
Taiwan Chung Shan Medical University Hospital /ID# 244757 Taichung
Taiwan Taipei Veterans General Hosp /ID# 244759 Taipei
Taiwan Chang Gung Memorial Foundation-Taipei Branch /ID# 244760 Taipei City
Taiwan National Taiwan University Hospital /ID# 244754 Taipei City Taipei
Taiwan Linkou Chang Gung Memorial Hospital /ID# 244756 Taoyuan City
United Arab Emirates New Medical Center Hospital /ID# 245106 Abu Dhabi
United Arab Emirates Tawam Hospital /ID# 249696 Abu Dhabi
United Arab Emirates Safa Clinic /ID# 248492 Dubai

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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)
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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)
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
See also
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