Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)

Atopic Dermatitis Clinical Trial

— Measure Up 1  

Official title:

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03569293
• Other study ID #: M16-045
• Secondary ID: 2022-502938-30-0
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 13, 2018
• Est. completion date: October 9, 2025

Study information

• Verified date: March 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Description:

This study includes a 35-day screening period, a 16-week double-blind period, a blinded extension period up to Week 260, and a 30-day follow-up visit. Participants who meet eligibility criteria in the main study will be randomized in a 1:1:1 ratio to receive a daily oral dose of upadacitinib 30 mg or upadacitinib 15 mg or matching placebo. Upon completion of enrollment of 810 participants in the main study, a supplemental study will continue to enroll adolescents (adolescent sub-study) until a total of 180 adolescent participants are enrolled in the overall study (main study + adolescent sub-study). Randomization for the main study will be stratified by baseline disease severity (validated Investigator Global Assessment scale for Atopic Dermatitis [vIGA-AD] score of moderate [3] versus severe [4]), by geographic region (United States [US]/Puerto Rico/Canada, Japan, China, and Other), and by age (adolescent [ages 12 to 17] versus adult [ages 18 to 75]). The separate randomization for the adolescent sub-study will be stratified by baseline disease severity (moderate [vIGA-AD 3] vs. severe [vIGA-AD 4]) and by geographic region (US/Puerto Rico/Canada and Other). At Week 16 of the main study and the adolescent sub-study, participants in the placebo group will be re-randomized in a 1:1 ratio to receive daily oral doses of upadacitinib 30 mg or upadacitinib 15 mg in the blinded extension period. In the main study the re-randomization at Week 16 will be stratified by Week 16 50% improvement in Eczema Area and Severity Index [EASI 50] responder [yes/no], geographic region [US/Puerto Rico/Canada, China [Mainland], Japan, and other], and age group [adolescent/adult]. For the adolescent sub-study, the re-randomization will be stratified by EASI 50 responder (Yes/No) and by geographic region (US/Puerto Rico/Canada and Other). Participants originally randomized to upadacitinib will continue upadacitinib in the extension period at the same dose. Starting at the Week 4 visit, rescue treatment for AD may be provided at the discretion of the investigator if medically necessary. The Primary Analysis for the main study will be conducted after all ongoing participants have completed Week 16. In addition, a Primary Analysis for the adolescent population (including the adolescent participants from the main study and the adolescent sub-study) will be conducted after all ongoing adolescent participants have completed Week 16.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 912
• Est. completion date: October 9, 2025
• Est. primary completion date: January 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

Inclusion Criteria:

• Body weight of = 40 kg at Baseline Visit for participants between = 12 and < 18 years of age
• Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years before Baseline Visit and subject meets Hanifin and Rajka criteria.
• Active moderate to severe AD defined by:
• Eczema Area and Severity Index (EASI) score = 16 at the Screening and Baseline Visits;
• Validated Investigator's Global Assessment (vIGA) score = 3 at the Screening and Baseline Visits;
• = 10% Body surface area (BSA) of AD involvement at the Screening and Baseline Visits;
• Baseline weekly average of daily Worst Pruritus NRS = 4.
• Candidate for systemic therapy or have recently required systemic therapy for AD
• Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days before the Baseline Visit.
• Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months before Baseline Visit

Exclusion Criteria:

• Prior exposure to any Janus kinase (JAK) inhibitor
• Unable or unwilling to discontinue current atopic dermatitis treatments prior to the study
• Requirement of prohibited medications during the study
• Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
• Female subject who is pregnant, breastfeeding, or considering pregnancy during the study

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Placebo for Upadacitinib
Tablets taken orally once a day
• Upadacitinib
Tablets taken orally once a day

Locations

Country	Name	City	State
Argentina	Instituto de Neumonología y Dermatología /ID# 203444	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires
Argentina	Psoriahue Med Interdisciplinar /ID# 202451	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires
Argentina	Framingham Centro Medico /ID# 202688	La Plata	Buenos Aires
Australia	Skin Health Institute Inc /ID# 204791	Carlton	Victoria
Australia	Holdsworth House Medical Practice /ID# 211236	Darlinghurst	New South Wales
Australia	Fremantle Dermatology /ID# 205305	Fremantle	Western Australia
Australia	North Eastern Health Specialists /ID# 205802	Hectorville	South Australia
Australia	Woden Dermatology /ID# 205799	Phillip	Australian Capital Territory
Bosnia and Herzegovina	University Clinical Centre of the Republic of Srpska /ID# 202666	Banja Luka	Republika Srpska
Bosnia and Herzegovina	University Clinical Centre of the Republic of Srpska /ID# 202667	Banja Luka	Republika Srpska
Bosnia and Herzegovina	Clinical Center University of Sarajevo /ID# 202668	Sarajevo
Bosnia and Herzegovina	Clinical Center University of Sarajevo /ID# 202669	Sarajevo
Bulgaria	UMHAT Dr Georgi Stranski EAD /ID# 201521	Pleven
Bulgaria	UMHAT Alexandrovska EAD /ID# 201519	Sofiya	Sofia
Bulgaria	UMHAT Professor Stoyan Kirkovich /ID# 201522	Stara Zagora
Canada	Dermatology Research Institute Inc. /ID# 200318	Calgary	Alberta
Canada	Kirk Barber Research, CA /ID# 200324	Calgary	Alberta
Canada	Dr. Irina Turchin PC Inc. /ID# 200322	Fredericton	New Brunswick
Canada	Hamilton Health Sciences - McMaster University Medical Centre /ID# 200313	Hamilton	Ontario
Canada	Dr. Wei Jing Loo Medicine Prof /ID# 206051	London	Ontario
Canada	Lynderm Research Inc. /ID# 200315	Markham	Ontario
Canada	Dr. David Gratton Dermat Inc. /ID# 200309	Montreal	Quebec
Canada	Innovaderm Research Inc. /ID# 200320	Montréal	Quebec
Canada	Dermatology Ottawa Research Centre /ID# 200319	Ottawa	Ontario
Canada	Dre Angelique Gagne-Henley M.D. inc. /ID# 200326	Saint-Jerome	Quebec
Canada	Karma Clinical Trials /ID# 200316	St. John's	Newfoundland and Labrador
Canada	Dr. Chih-ho Hong Medical Inc. /ID# 200311	Surrey	British Columbia
Canada	Enverus Medical Research /ID# 200307	Surrey	British Columbia
Canada	K. Papp Clinical Research /ID# 200317	Waterloo	Ontario
Canada	Wiseman Dermatology Research /ID# 200323	Winnipeg	Manitoba
China	Beijing Friendship Hospital /ID# 202601	Beijing
China	Peking University People's Hospital /ID# 202549	Beijing	Beijing
China	Peking University Third Hospital /ID# 202612	Beijing	Beijing
China	Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 208597	Guangzhou	Guangdong
China	The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 202548	Guangzhou	Guangdong
China	The second Affiliated hospital of Zhejiang University school of Medicine /ID# 202608	Hangzhou	Zhejiang
China	Huashan Hospital of Fudan University /ID# 205760	Shanghai
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 202554	Shanghai	Shanghai
China	The First Hospital of China Medical University /ID# 202615	Shenyang	Liaoning
China	Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 208598	Wuhan
Colombia	Ctr Int de Reum del Caribe SAS /ID# 201620	Barranquilla	Atlantico
Colombia	Clinisalud del sur /ID# 218100	Medellin	Antioquia
Colombia	Fundacion Centro de Excelencia en Enfermedades Cronicas no Transmisibles - FUNCE /ID# 201905	Monteria	Cordoba
Colombia	Fundacion Hospital San Vicente de Paul - Rionegro /ID# 202043	Rionegro	Antioquia
Croatia	Duplicate_Klinicki bolnicki centar Osijek /ID# 201523	Osijek	Osjecko-baranjska Zupanija
Croatia	Klinicki bolnicki centar Rijeka /ID# 217423	Rijeka	Primorsko-goranska Zupanija
Croatia	Klinicki bolnicki centar Split /ID# 201527	Split	Splitsko-dalmatinska Zupanija
Croatia	Klinicki bolnicki centar Zagreb /ID# 201879	Zagreb	Grad Zagreb
Croatia	Klinika za djecje bolesti Zagreb /ID# 203151	Zagreb	Grad Zagreb
Denmark	Aarhus University Hospital /ID# 200737	Aarhus N	Midtjylland
Denmark	Bispebjerg and Frederiksberg Hospital /ID# 200979	Copenhagen NV	Hovedstaden
Denmark	Herlev and Gentofte Hospital /ID# 200736	Hellerup	Hovedstaden
Estonia	North Estonia Medical Centre /ID# 200951	Mustamäe Linnaosa	Harjumaa
Estonia	Confido Private Medical Clinic /ID# 200846	Tallinn	Harjumaa
Estonia	Tartu University Hospital /ID# 200847	Tartu Linn	Tartumaa
Finland	Kuopio University Hospital /ID# 202449	Kuopio
Finland	Terveystalo Tampere /ID# 201117	Tampere
Finland	Mehiläinen Neo /ID# 201116	Turku	Varsinais-Suomi
France	Centre Hospitalier du Mans /ID# 205991	Le Mans CEDEX 9	Sarthe
France	Hopital Saint Vincent de Paul /ID# 218253	Lille Cedex
France	Le Bateau BLanc /ID# 206833	Martigues
France	CHU de Nantes, Hotel Dieu -HME /ID# 206377	Nantes	Pays-de-la-Loire
France	AP-HP - Hopital Necker /ID# 218364	Paris
France	HCL - Hôpital Lyon Sud /ID# 201529	Pierre Benite CEDEX	Auvergne-Rhone-Alpes
France	Hôpital Charles-Nicolle /ID# 201525	Rouen
France	CHU Toulouse - Hopital Larrey /ID# 201528	Toulouse
Germany	Universitaetsklinikum Bonn /ID# 202086	Bonn
Germany	Universitaetsklinikum Frankfurt /ID# 202089	Frankfurt am Main	Hessen
Germany	TFS Trial Form Support GmbH /ID# 202083	Hamburg
Germany	Medizinische Hochschule Hannover /ID# 202091	Hannover
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202255	Kiel	Schleswig-Holstein
Germany	Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205192	Mainz
Germany	Universitaetsklinikum Muenster /ID# 202085	Muenster	Nordrhein-Westfalen
Germany	Duplicate_Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202087	Munich	Bayern
Germany	CMS3 Company for Medical Study /ID# 205193	Selters	Rheinland-Pfalz
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200692	Ancona
Italy	A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 200746	Bologna
Italy	A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200741	Catania
Italy	Azienda Ospedaliera Universitaria Federico II /ID# 200750	Napoli
Italy	Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 200695	Pisa
Italy	Fondazione PTV Policlinico Tor Vergata /ID# 201136	Rome	Roma
Japan	University of Yamanashi Hospital /ID# 204174	Chuo-shi	Yamanashi
Japan	Fukuoka University Hospital /ID# 201309	Fukuoka-shi	Fukuoka
Japan	Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers /ID# 202891	Fukuoka-shi	Fukuoka
Japan	Gifu University Hospital /ID# 201760	Gifu-shi	Gifu
Japan	University Hospital Kyoto Prefectural University of Medicine /ID# 201876	Kyoto-shi	Kyoto
Japan	Aichi Medical University Hospital /ID# 202833	Nagakute-shi	Aichi
Japan	Takagi Dermatology Clinic /ID# 201238	Obihiro-shi	Hokkaido
Japan	Ogaki Municipal Hospital /ID# 203463	Ogaki-shi	Gifu
Japan	Kume Clinic /ID# 201912	Sakai-shi	Osaka
Japan	Medical Cooperation Kojinkai Sapporo Skin Clinic /ID# 201239	Sapporo-shi	Hokkaido
Japan	NTT Medical Center Tokyo /ID# 201759	Shinagawa-ku	Tokyo
Malaysia	Hospital Selayang /ID# 204378	Batu Caves	Selangor
Malaysia	Queen Elizabeth Hospital /ID# 204379	Division Pantai Barat Utara	Sabah
Malaysia	Hospital Raja Permaisuri Bainun /ID# 204375	Ipoh	Perak
New Zealand	Clinical Trials NZ /ID# 205335	Hamilton
Puerto Rico	Cruz-Santana, Carolina, PR /ID# 201096	Carolina
Puerto Rico	Ponce Medical School Foundation /ID# 201821	Ponce
Puerto Rico	Clinical Research Puerto Rico /ID# 203309	San Juan
Romania	Spitalul Clinic Colentina /ID# 205860	Bucuresti
Romania	Cabinet Medical de Dermatovenerologie Dr. Remus Orasan /ID# 205862	Cluj Napoca
Russian Federation	Chelyabinsk Regional Clinical Dermatovenerologic Dispensary /ID# 201996	Chelyabinsk	Chelyabinskaya Oblast
Russian Federation	Clinical Dermatovenerology Dispensary /ID# 203439	Krasnodar	Krasnodarskiy Kray
Russian Federation	National Medical Research Center for Children's Health /ID# 203440	Moscow
Russian Federation	Saratov State Medical University n.a. V.I. Razumovskiy /ID# 201595	Saratov	Saratovskaya Oblast
Russian Federation	Ural Research Institute of dermatovenerology and immunopathology /ID# 201593	Yekaterinburg	Sverdlovskaya Oblast
Switzerland	Universitätsspital Basel /ID# 201599	Basel	Basel-Stadt
Switzerland	Inselspital, Universitätsspital Bern /ID# 201598	Bern
Switzerland	Hôpitaux Universitaires Genève /ID# 201600	Genève	Geneve
Switzerland	CHUV, Centre hospitalier universitaire vaudois /ID# 200910	Lausanne	Vaud
Switzerland	CHUV, Centre hospitalier universitaire vaudois /ID# 206505	Lausanne	Vaud
Turkey	Hacettepe University Faculty of Medicine /ID# 204099	Ankara
Turkey	Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 204100	Istanbul
Turkey	Erciyes University Medical Fac /ID# 204098	Melikgazi	Kayseri
Turkey	Gazi Universitesi Tip Fakultes /ID# 204176	Yenimahalle
Ukraine	ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 210504	Rivne
Ukraine	Military Hospital of Military-Medical Clinical Center of Southern Region /ID# 201962	Zaporizhzhya	Zaporizka Oblast
United Kingdom	West Middlesex University Hospital /ID# 202273	Isleworth	London, City Of
United Kingdom	Barts Health NHS Trust /ID# 201043	London	London, City Of
United Kingdom	Chelsea and Westminster Hospital NHS Foundation Trust9 /ID# 201971	London
United Kingdom	Guy's and St Thomas' NHS Foundation Trust /ID# 201192	London	London, City Of
United Kingdom	Northern Care Alliance NHS Group /ID# 201194	Salford
United States	Arlington Research Center, Inc /ID# 200391	Arlington	Texas
United States	Orion Clinical Research /ID# 204703	Austin	Texas
United States	Bakersfield Derma & Skin Cance /ID# 200433	Bakersfield	California
United States	Northeast Dermatology /ID# 201338	Beverly	Massachusetts
United States	Clearlyderm Dermatology /ID# 208371	Boca Raton	Florida
United States	Skin Care Research, LLC /ID# 200811	Boca Raton	Florida
United States	Massachusetts General Hospital /ID# 200474	Boston	Massachusetts
United States	Montefiore Medical Center /ID# 200456	Bronx	New York
United States	Christie Clinic, LLC /ID# 200427	Champaign	Illinois
United States	Coastal Clinical Research Center of the Carolinas /ID# 200402	Charleston	South Carolina
United States	Clin Res Inst of Michigan, LLC /ID# 208019	Chesterfield	Michigan
United States	Northwestern University Feinberg School of Medicine /ID# 201644	Chicago	Illinois
United States	Olympian Clinical Research /ID# 202914	Clearwater	Florida
United States	Velocity clinical research /ID# 202653	Cleveland	Ohio
United States	Clinical Trials Management, LLC - Covington /ID# 212658	Covington	Louisiana
United States	Menter Dermatology Res Inst /ID# 200390	Dallas	Texas
United States	Modern Research Associates, PL /ID# 200705	Dallas	Texas
United States	Henry Ford Medical Center /ID# 204191	Detroit	Michigan
United States	First OC Dermatology /ID# 201910	Fountain Valley	California
United States	Dermdox Dermatology Centers, PC /ID# 213782	Hazleton	Pennsylvania
United States	Dawes Fretzin, LLC /ID# 200366	Indianapolis	Indiana
United States	Clinical Partners, LLC /ID# 200460	Johnston	Rhode Island
United States	Forest Hills Dermatology Group /ID# 209244	Kew Gardens	New York
United States	Cleaver Dermatology /ID# 202825	Kirksville	Missouri
United States	Multi-Speciality Research Associates /ID# 213254	Lake City	Florida
United States	Clinical Research Consortium /ID# 200734	Las Vegas	Nevada
United States	California Allergy and Asthma Medical Group /ID# 200727	Los Angeles	California
United States	GSI Clinical Research, LLC /ID# 200849	Margate	Florida
United States	Clinical Trials Management, LLC - Metairie /ID# 212659	Metairie	Louisiana
United States	Florida International Rsrch cr /ID# 218507	Miami	Florida
United States	Allergy & Asthma Associates of Southern California /ID# 200733	Mission Viejo	California
United States	Icahn School of Medicine at Mount Sinai /ID# 200370	New York	New York
United States	Dermatology Clinical Trials /ID# 205876	Newport Beach	California
United States	Tory P Sullivan, MD PA /ID# 200671	North Miami Beach	Florida
United States	Lynn Health Science Institute (LHSI) /ID# 212676	Oklahoma City	Oklahoma
United States	Newton Clinical Research /ID# 204169	Oklahoma City	Oklahoma
United States	Advanced Dermatology of the Midlands /ID# 201689	Omaha	Nebraska
United States	Leavitt Medical Associates of Florida /ID# 200880	Ormond Beach	Florida
United States	Alliance Dermatology and MOHs /ID# 200375	Phoenix	Arizona
United States	Oregon Health and Science University /ID# 200992	Portland	Oregon
United States	Oregon Medical Res Center PC /ID# 200428	Portland	Oregon
United States	AllCutis Research Inc /ID# 200981	Portsmouth	New Hampshire
United States	Integrated Dermatology of Massachusetts, LLC /ID# 209468	Quincy	Massachusetts
United States	UC Davis /ID# 203622	Sacramento	California
United States	Synergy Dermatology /ID# 200842	San Francisco	California
United States	San Luis Derm and Laser Clinic /ID# 200372	San Luis Obispo	California
United States	Clear Dermatology & Aesthetics Center /ID# 201256	Scottsdale	Arizona
United States	Dermatology Physicians of Connecticut /ID# 200928	Shelton	Connecticut
United States	The South Bend Clinic Center /ID# 200371	South Bend	Indiana
United States	Dermatology Specialists of Spokane /ID# 202068	Spokane	Washington
United States	Stanford University /ID# 200440	Stanford	California
United States	Precision Clinical Research /ID# 209002	Sunrise	Florida
United States	J. Schwartz, MD, PLLC /ID# 202121	Troy	New York
United States	Care Access Research - Walnut Creek /ID# 200940	Walnut Creek	California
United States	Duplicate_George Washington Univ Med /ID# 200364	Washington	District of Columbia
United States	Foxhall Research Center /ID# 213682	Washington	District of Columbia
United States	Center for Clinical Studies - Webster TX /ID# 203185	Webster	Texas
United States	Integrated Clinical Research LLC /ID# 200900	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Bosnia and Herzegovina,  Bulgaria,  Canada,  China,  Colombia,  Croatia,  Denmark,  Estonia,  Finland,  France,  Germany,  Italy,  Japan,  Malaysia,  New Zealand,  Puerto Rico,  Romania,  Russian Federation,  Switzerland,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).; The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.	Baseline and Week 16
Primary	Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of = 2 Points at Week 16	The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale: 0 - Clear: No inflammatory signs of AD; 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification; 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting; 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present; 4 - Severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present.	Baseline and Week 16
Secondary	Main Study: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16	Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.	Baseline (last available rolling average before the first dose of study drug) and Week 16
Secondary	Main Study: Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).; The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.	Baseline and Week 16
Secondary	Main Study: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Week 4	Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.	Baseline (last available rolling average before the first dose of study drug) and Week 4
Secondary	Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 2	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).; The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.; An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.	Baseline and Week 2
Secondary	Main Study: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Week 1	Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.	Baseline (last available rolling average before the first dose of study drug) and Week 1
Secondary	Main Study: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Day 2	Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).; The percentage of participants who had a 4-point or greater improvement from Baseline in Worst Pruritus NRS score at Day 2 was pre-specified as a ranked secondary endpoint for participants in the upadacitinib 30 mg group versus placebo group only.	Baseline and Day 2
Secondary	Main Study: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Day 3	Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).; The percentage of participants who had a 4-point or greater improvement in Worst Pruritus NRS score from Baseline at Day 3 was pre-specified as a ranked secondary endpoint for participants in the upadacitinib 15 mg group versus placebo group only.	Baseline and Day 3
Secondary	Main Study: Percentage of Participants Experiencing a Flare During the Double-blind Treatment Period	A flare, characterized as a clinically meaningful worsening in EASI, is defined as an increase in EASI score of = 6.6 points from Baseline during the double-blind treatment period and prior to use of any rescue medication. Flare was assessed in participants with an EASI score of 65.4 or less at Baseline.	From first dose of study drug to Week 16
Secondary	Main Study: Percentage of Participants Achieving a Reduction of = 12 Points From Baseline in Atopic Dermatitis Impact Scale (ADerm-IS) Sleep Domain Score at Week 16	The ADerm-IS is a 10-item patient reported outcome (PRO) questionnaire designed to assess a variety of impacts that participants experience from their AD.; The ADerm-IS sleep domain consists of 3 questions designed to assess the impact of AD on sleep on a daily basis over a 24-hour recall period. The items include difficulty falling asleep, impact on sleep, and waking at night. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The ADerm-IS sleep domain score is the sum of the 3 item scores and ranges from 0 (no impact) to 30 (worst impact). The ADerm-IS sleep domain was analyzed based on weekly rolling averages of daily scores.; The minimal clinically important difference for ADerm-IS sleep domain score is 12.	Baseline (last available rolling average before the first dose of study drug) and Week 16
Secondary	Main Study: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Atopic Dermatitis Symptom Scale (ADerm-SS) Skin Pain Score at Week 16	The ADerm-SS is an 11-item PRO questionnaire designed to assess signs and symptoms that patients may experience due to AD using a 24-hour recall period. For the skin pain item participants were asked on a daily basis to indicate how bad their worst skin pain due to AD was in the past 24 hours on an NRS from 0 (no pain) to 10 (worst imaginable pain). The ADerm-SS skin pain score was analyzed using weekly rolling averages of daily scores. The minimal clinically important difference for ADerm-SS skin pain score is 4.	Baseline (last available rolling average before the first dose of study drug) and Week 16
Secondary	Main Study: Percentage of Participants Achieving a Reduction of = 28 Points From Baseline in ADerm-SS 7-Item Total Symptom Score (TSS-7) at Week 16	The ADerm-SS is an 11-item questionnaire designed to assess signs and symptoms that participants may experience due to AD using a 24-hour recall period. The 7-item total symptom score includes 7 symptoms (items 1-7 of the ADerm-SS), each assessed on a NRS from 0 (no symptom) to 10 (worst imaginable). The 7 symptoms included in the score are itch while asleep, itch while awake, skin pain (each assessed daily), skin cracking, skin cracking pain, dry skin, and skin flaking (assessed weekly). The TSS-7 score ranges from 0 to 70, with higher scores indicating worsening symptoms. The minimal clinically important difference for ADerm-SS TSS-7 is 28.	Baseline and Week 16
Secondary	Main Study: Percentage of Participants Achieving a Reduction of = 11 Points From Baseline in ADerm-IS Emotional State Domain Score at Week 16	The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD.; ADerm-IS emotional state sums three items [Items 8-10] measuring self-consciousness, embarrassment, and sadness with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The emotional state domain score ranges from 0 to 30, where higher scores represent worst impact.; The minimal clinically important difference for ADerm-IS emotional state domain score is 11.	Baseline and Week 16
Secondary	Main Study: Percentage of Participants Achieving a Reduction of = 14 Points From Baseline in in ADerm-IS Daily Activities Domain Score at Week 16	The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD.; ADerm-IS daily activities sums four items measuring limitations of household, physical, and social activities, and difficulty concentrating with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The daily activities domain score ranges from 0 to 40, where higher scores represent worst impact.; The minimal clinically important difference for the ADerm-IS daily activities domain score is 14.	Baseline and Week 16
Secondary	Main Study: Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).; The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.	Baseline and Week 16
Secondary	Main Study: Percent Change From Baseline in Worst Pruritus NRS at Week 16	Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.	Baseline (last available rolling average before the first dose of study drug) and Week 16
Secondary	Main Study: Percent Change From Baseline in EASI Score at Week 16	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1)] moderate [2], or severe [3]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema).; The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.	Baseline and Week 16
Secondary	Main Study: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Week 16	The POEM is a 7-item, validated questionnaire used to assess disease symptoms in both children and adults. Participants respond to 7 questions, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency of occurrence during the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores are added to provide a total score ranging from 0 (clear) to 28 (very severe atopic eczema). A change in POEM score of 3.4 points is considered the minimal clinically important difference.	Baseline and Week 16
Secondary	Main Study: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Dermatology Life Quality Index (DLQI) at Week 16	The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. 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 are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL.; the DLQI was administered to participants who were = 16 (16 to 75) years old at the time of the Screening visit.	Baseline and Week 16
Secondary	Main Study: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16	SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A negative change from Baseline indicates improvement.	Baseline and Week 16
Secondary	Main Study: Percentage of Participants Achieving a Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score and Hospital Anxiety and Depression Scale-Depression (HADS-D) Score of < 8 at Week 16	The HADS is a 14-item questionnaire, with seven items related to anxiety (HADS-A) and seven items related to depression (HADS-D). Each item is scored from 0 to 3; scores for each subscale range from 0 to 21, with higher scores indicating more distress. For each domain, scores 7 or lower are considered normal, 8 to 10 are borderline, and 11 or higher indicate clinical anxiety or depression.	Baseline and Week 16
Secondary	Main Study: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16	The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. 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 are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all.; the DLQI was administered to participants who were = 16 (16 to 75) years old at the time of the Screening visit.	Week 16
Secondary	Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 16	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).; The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.; An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.	Baseline and Week 16
Secondary	Adolescents: Percentage of Participants Achieving a vIGA-AD of 0 or 1 With a Reduction From Baseline of = 2 Points at Week 16	The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale: 0 - Clear: No signs of AD; 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification; 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting; 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, possible oozing or crusting; 4 - Severe: Marked erythema, induration/papulation and/or lichenification; possible oozing or crusting.	Baseline and Week 16
Secondary	Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Week 16	Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.	Baseline (last available rolling average before the first dose of study drug) and Week 16
Secondary	Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 16	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).; The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.; An EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score.	Baseline and Week 16
Secondary	Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Week 4	Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.	Baseline (last available rolling average before the first dose of study drug) and Week 4
Secondary	Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 2	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).; The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.; An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.	Baseline and Week 2
Secondary	Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Week 1	Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.	Baseline (last available rolling average before the first dose of study drug) and Week 1
Secondary	Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Day 2	Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).	Baseline and Day 2
Secondary	Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Day 3	Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).	Baseline and Day 3
Secondary	Adolescents: Percentage of Participants Experiencing a Flare During the Double-blind Treatment Period	A flare, characterized as a clinically meaningful worsening in EASI, is defined as an increase in EASI score of = 6.6 points from Baseline during the double-blind treatment period and prior to use of any rescue medication. Flares were assessed in participants with an EASI score of 65.4 or less at Baseline.	From first dose of study drug to Week 16
Secondary	Adolescents: Percentage of Participants Achieving a Reduction of = 12 Points From Baseline in ADerm-IS Sleep Domain Score at Week 16	The ADerm-IS is a 10-item patient reported outcome questionnaire designed to assess a variety of impacts that participants experience from their AD.; The ADerm-IS sleep domain consists of 3 questions designed to assess the impact of AD on sleep on a daily basis over a 24-hour recall period. The items include difficulty falling asleep, impact on sleep, and waking at night. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The ADerm-IS sleep domain score is the sum of the 3 item scores and ranges from 0 (no impact) to 30 (worst impact). The ADerm-IS sleep domain was analyzed based on weekly rolling averages of daily scores.; The minimal clinically important difference for ADerm-IS sleep domain score is 12.	Baseline (last available rolling average before the first dose of study drug) and Week 16
Secondary	Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in ADerm-SS Skin Pain Score at Week 16	The ADerm-SS is an 11-item PRO questionnaire designed to assess signs and symptoms that patients may experience due to AD using a 24-hour recall period. For the skin pain item participants were asked to indicate on a daily basis how bad their worst skin pain due to AD was in the past 24 hours on an NRS from 0 (no pain) to 10 (worst imaginable pain). The minimal clinically important difference for ADerm-SS skin pain score is 4.; The ADerm-SS skin pain score was analyzed based on weekly rolling averages of daily scores.	Baseline (last available rolling average before the first dose of study drug) and Week 16
Secondary	Adolescents: Percentage of Participants Achieving a Reduction of = 28 Points From Baseline in ADerm-SS TSS-7 at Week 16	The ADerm-SS is an 11-item questionnaire designed to assess signs and symptoms that participants may experience due to AD using a 24-hour recall period. The 7-item total symptom score includes 7 symptoms (items 1-7 of the ADerm-SS), each assessed on a NRS from 0 (no symptom) to 10 (worst imaginable). The 7 symptoms included in the score are itch while asleep, itch while awake, skin pain (each assessed daily), skin cracking, skin cracking pain, dry skin, and skin flaking (assessed weekly). The TSS-7 score ranges from 0 to 70, with higher scores indicating worsening symptoms. The minimal clinically important difference for ADerm-SS TSS-7 is 28.	Baseline and Week 16
Secondary	Adolescents: Percentage of Participants Achieving a Reduction of = 11 Points From Baseline in ADerm-IS Emotional State Domain Score at Week 16	The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD.; ADerm-IS emotional state sums three items [Items 8-10] measuring self-consciousness, embarrassment, and sadness with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The emotional state domain score ranges from 0 to 30, where higher scores represent worst impact.; The minimal clinically important difference for ADerm-IS emotional state domain score is 11.	Baseline and Week 16
Secondary	Adolescents: Percentage of Participants Achieving a Reduction of = 14 Points From Baseline in ADerm-IS Daily Activities Domain Score at Week 16	The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD.; ADerm-IS daily activities sums four items measuring limitations of household, physical, and social activities, and difficulty concentrating with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The daily activities domain score ranges from 0 to 40, where higher scores represent worst impact.; The minimal clinically important difference for the ADerm-IS daily activities domain score is 14.	Baseline and Week 16
Secondary	Adolescents: Percentage of Participants Achieving an EASI 100 Response at Week 16	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).; The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.; An EASI 100 response is defined as a 100% reduction (improvement) from Baseline in EASI score.	Baseline and Week 16
Secondary	Adolescents: Percent Change From Baseline in Worst Pruritus NRS at Week 16	Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.	Baseline (last available rolling average before the first dose of study drug) and Week 16
Secondary	Adolescents: Percent Change From Baseline in EASI Score at Week 16	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1)] moderate [2], or severe [3]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema).; The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.	Baseline and Week 16
Secondary	Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in POEM Total Score at Week 16	The POEM is a 7-item, validated questionnaire used to assess disease symptoms in both children and adults. Participants respond to 7 questions, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency of occurrence during the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores are added to provide a total score ranging from 0 (clear) to 28 (very severe atopic eczema). A change in POEM score of 3.4 points is considered the minimal clinically important difference.	Baseline and Week 16
Secondary	Adolescents: Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in DLQI Score at Week 16	The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. 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 are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL.; the DLQI was administered to participants who were = 16 (16 to 75) years old at the time of the Screening visit.	Baseline and Week 16
Secondary	Adolescents: Percent Change From Baseline in SCORAD Score at Week 16	SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A negative change from Baseline indicates improvement.	Baseline and Week 16
Secondary	Adolescents: Percentage of Participants Achieving HADS-A Score and HADS-D Score of < 8 at Week 16	The HADS is a 14-item questionnaire, with seven items related to anxiety (HADS-A) and seven items related to depression (HADS-D). Each item is scored from 0 to 3; scores for each subscale range from 0 to 21, with higher scores indicating more distress. For each domain, scores 7 or lower are considered normal, 8 to 10 are borderline, and 11 or higher indicate clinical anxiety or depression.	Baseline and Week 16
Secondary	Adolescents: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16	The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. 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 are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all.; the DLQI was administered to participants who were = 16 (16 to 75) years old at the time of the Screening visit.	Baseline and Week 16

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