A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2)

Atopic Dermatitis Clinical Trial

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: NCT03607422
• Other study ID #: M18-891
• Secondary ID: 2022-502936-38-0
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 27, 2018
• Est. completion date: December 3, 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 a minimum 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 overall (main study + adolescent sub-study). Randomization in 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, 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, 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: December 3, 2025
• Est. primary completion date: March 11, 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 = 12 and < 18 years of age
• Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline and subject meets Hanifin and Rajka criteria
• Active moderate to severe AD defined by Eczema Area and Severity Index (EASI) = 16, validated Investigator's Global Assessment (vIGA) = 3, body surface area (BSA) affected by AD = 10%, and weekly average of daily Worst Pruritus numerical rating scale (NRS) score = 4.
• Candidate for systemic therapy or have recently required systemic therapy for AD
• Documented history (within 6 months prior to Baseline) of inadequate response to topical corticosteroid (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD or for whom topical treatments are otherwise medically inadvisable due to side effects or safety risks

Exclusion Criteria:

• Prior exposure to any Janus kinase (JAK) inhibitor
• Unable or unwilling to discontinue current AD 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
Australia	The Skin Centre /ID# 205922	Benowa	Queensland
Australia	Box Hill Hospital /ID# 206023	Box Hill	Victoria
Australia	Monash Children's Hospital /ID# 217917	Clayton	Victoria
Australia	Sinclair Dermatology /ID# 217791	East Melbourne	Victoria
Australia	Murdoch Children's Research Institute /ID# 205667	Parkville	Victoria
Australia	The Royal Melbourne Hospital /ID# 205919	Parkville	Victoria
Australia	The Skin Hospital /ID# 217846	Westmead	New South Wales
Austria	Ordensklinikum Linz GmbH Elisabethinen /ID# 206573	Linz	Oberoesterreich
Austria	Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 208281	Salzburg
Austria	Universitaetsklinikum St. Poelten /ID# 206909	Sankt Poelten	Niederoesterreich
Austria	Klinik Donaustadt /ID# 206572	Vienna	Wien
Belgium	UZ Gent /ID# 205181	Gent	Oost-Vlaanderen
Belgium	Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 204938	Liege
Belgium	UCL Saint-Luc /ID# 205537	Woluwe-Saint-Lambert	Bruxelles-Capitale
Bulgaria	Acibadem City Clinic Tokuda University Hospital EAD /ID# 205292	Sofia
Bulgaria	Medical center Sveti Panteleimon /ID# 210414	Sofia
Bulgaria	Medical complex Doverie /ID# 211289	Sofia
Bulgaria	Military Medical Academy Multiprofile Hospital /ID# 205291	Sofia
Canada	SimcoDerm Medical and Surgical Dermatology Center /ID# 206333	Barrie	Ontario
Canada	Alberta DermaSurgery Centre /ID# 205422	Edmonton	Alberta
Canada	Stratica Medical /ID# 205415	Edmonton	Alberta
Canada	Kingsway Clinical Research /ID# 206005	Etobicoke	Ontario
Canada	Dr. Dusan Sajic Medicine Professional Corporation /ID# 206890	Guelph	Ontario
Canada	The Guenther Dermatology Research Centre /ID# 206772	London	Ontario
Canada	DermEdge Research Inc. /ID# 206036	Mississauga	Ontario
Canada	Dr. S.K. Siddha Medicine Professional Corporation /ID# 207138	Newmarket	Ontario
Canada	Allergy Research Canada Inc. /ID# 213547	Niagara Falls	Ontario
Canada	Skinsense Medical Research /ID# 206873	Saskatoon	Saskatchewan
Canada	Skin Care Studio /ID# 205420	St. John's	Newfoundland and Labrador
Canada	Dr. Lyne Giroux Medicine Professional Corporation /ID# 206771	Sudbury	Ontario
Canada	Niakosari Medicine Professional Corporation /ID# 206004	Toronto	Ontario
Canada	Pacific Derm /ID# 206797	Vancouver	British Columbia
Canada	UBC Department of Dermatology and Skin Science The Skin Care Centre /ID# 207837	Vancouver	British Columbia
Croatia	Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 203448	Ivanic-Grad	Zagrebacka Zupanija
Croatia	DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 205429	Zagreb	Grad Zagreb
Croatia	Djecja bolnica Srebrnjak /ID# 205926	Zagreb	Grad Zagreb
Croatia	Poliklinika Vlatka Cavka d.o.o. /ID# 211126	Zagreb	Grad Zagreb
Czechia	Fakultni nemocnice Plzen /ID# 205096	Plzen
Czechia	Fakultni Nemocnice v Motole /ID# 218192	Praha
Czechia	Sanatorium profesora Arenbergera /ID# 205098	Praha
Czechia	Vseobecna fakultni nemocnice v Praze /ID# 205201	Praha
Czechia	Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o. z. /ID# 205097	Usti nad Labem
Denmark	Aarhus University Hospital /ID# 205524	Aarhus N	Midtjylland
Denmark	Sjællands Universitetshospital /ID# 205960	Roskilde	Sjælland
France	Hopital Prive d'Antony /ID# 206553	Antony	Ile-de-France
France	Hopital Saint-Andre /ID# 206554	Bordeaux
France	CHRU de Brest - Hopital Morvan /ID# 206555	Brest
France	C.H. de Bretagne Sud /ID# 206910	Lorient
France	AP-HP - Hopital Saint-Louis /ID# 206552	Paris
Germany	Klinikum Darmstadt /ID# 207483	Darmstadt
Germany	Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 205767	Dresden
Germany	Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 207982	Hamburg
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 206658	Kiel	Schleswig-Holstein
Germany	Dermatologische Gemeinschaftspraxis Mahlow /ID# 205765	Mahlow
Germany	Haut- und Laserzentrum Hunsrück /ID# 205768	Simmern
Germany	Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 205766	Witten
Germany	CentroDerm GmbH /ID# 206861	Wuppertal
Greece	251 Airforce General Hospital /ID# 205841	Athens	Attiki
Greece	401 GSNA - 401 Army General Hospital /ID# 205352	Athens	Attiki
Greece	General Hospital Andreas Syggros /ID# 204527	Athens	Attiki
Greece	Papageorgiou General Hospital Thessaloniki /ID# 204526	Stavroupoli (Thessalonikis)	Thessaloniki
Hungary	Drug Research Center /ID# 217855	Balatonfured	Veszprem
Hungary	Clinexpert Kft /ID# 211246	Budapest
Hungary	Synexus Magyarorszag Kft. /ID# 206008	Budapest
Hungary	Bugat Pal Korhaz /ID# 211247	Gyöngyös	Heves
Hungary	Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 205611	Kaposvár	Somogy
Hungary	Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 218072	Miskolc	Borsod-Abauj-Zemplen
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 205085	Pecs
Ireland	South Infirmary Victoria University Hospital /ID# 204265	Cork
Ireland	St James Hospital /ID# 204264	Dublin 8	Dublin
Ireland	University Hospital Galway /ID# 209965	Galway
Ireland	University Hospital Waterford /ID# 204266	Waterford
Italy	ASST Spedali civili di Brescia /ID# 205927	Brescia
Italy	Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 205168	Cagliari
Italy	Presidio Ospedaliero San Salvatore /ID# 205167	L'Aquila
Italy	Azienda Ospedaliero-Universitaria di Modena /ID# 205169	Modena
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 205987	Rome	Lazio
Italy	IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 205986	Rome	Lazio
Korea, Republic of	Korea University Ansan Hospital /ID# 206342	Ansan	Gyeonggido
Korea, Republic of	SoonChunHyang University Buchon Hospital /ID# 206391	Buncheon	Gyeonggido
Korea, Republic of	The Catholic University of Korea Incheon St.Mary's Hospital /ID# 206529	Incheon
Korea, Republic of	Chung-Ang University Hostipal /ID# 206397	Seoul
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital /ID# 206343	Seoul
Korea, Republic of	Seoul National University Hospital /ID# 206396	Seoul
Korea, Republic of	Ajou University Hospital /ID# 206341	Suwon	Gyeonggido
Netherlands	Centrum Oosterwal /ID# 209640	Alkmaar
Netherlands	Bravis Ziekenhuis /ID# 206676	Bergen op Zoom	Noord-Brabant
Netherlands	Reinier de Graaf /ID# 205811	Delft
Netherlands	Universitair Medisch Centrum Groningen /ID# 205162	Groningen
New Zealand	Greenlane Clinical Centre /ID# 205664	Epsom	Auckland
Portugal	CCA Braga - Hospital de Braga /ID# 205854	Braga
Portugal	Centro Hospitalar de Leiria, EPE /ID# 209906	Leiria
Portugal	Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 205839	Lisboa
Portugal	Hospital CUF Descobertas /ID# 205431	Lisboa
Portugal	Centro Hospitalar Universitario de Sao Joao, EPE /ID# 205679	Porto
Portugal	CHP, EPE- Hospital Geral de Sa /ID# 205187	Porto
Singapore	Changi General Hospital /ID# 205223	Singapore
Singapore	KK Women's & Children Hospital /ID# 206693	Singapore
Singapore	National Skin Centre /ID# 205222	Singapore	Central Singapore
Singapore	National University Hospital /ID# 205224	Singapore
Singapore	Singapore General Hospital /ID# 205225	Singapore
Spain	Hospital Clinic de Barcelona /ID# 210564	Barcelona
Spain	Hospital Parc de Salut del Mar /ID# 204709	Barcelona
Spain	Hospital Universitario Reina Sofia /ID# 204712	Cordoba
Spain	Hospital Sant Joan de Deu /ID# 218047	Esplugues de Llobregat	Barcelona
Spain	Hospital Campus de la Salud /ID# 205544	Granada
Spain	Hospital General Universitario Gregorio Maranon /ID# 204380	Madrid
Spain	Hospital Infantil Universitario Nino Jesus /ID# 210437	Madrid
Spain	Hospital Universitario Infanta Leonor /ID# 204710	Madrid
Spain	Hospital Vital Alvarez Buylla /ID# 205770	Mieres	Asturias
Spain	Hospital General Universitario de Valencia /ID# 210565	Valencia
Taiwan	Taipei Medical University Shuang Ho Hospital /ID# 204804	New Taipei City
Taiwan	Chung Shan Medical University Hospital /ID# 205092	Taichung
Taiwan	National Taiwan University Hospital /ID# 204803	Taipei City
Taiwan	Linkou Chang Gung Memorial Ho /ID# 204783	Taoyuan City
United Kingdom	Barts Health NHS Trust /ID# 206491	London	London, City Of
United Kingdom	Northwick Park Hospital /ID# 205250	Middlesex	Harrow
United Kingdom	The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 204993	Newcastle Upon Tyne
United Kingdom	University Hospital Plymouth NHS Trust /ID# 204649	Plymouth
United Kingdom	University Hospital Southampton NHS Foundation Trust /ID# 205711	Southampton	Hampshire
United States	Georgia Pollens Clinical Research Centers, Inc /ID# 218567	Albany	Georgia
United States	University of New Mexico School of Medicine /ID# 206756	Albuquerque	New Mexico
United States	David Fivenson, MD, PLC /ID# 206903	Ann Arbor	Michigan
United States	University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 206895	Ann Arbor	Michigan
United States	Metroplex Dermatology /ID# 213307	Arlington	Texas
United States	Ideal Clinical Research Inc. /ID# 209880	Aventura	Florida
United States	Bellaire Dermatology /ID# 205470	Bellaire	Texas
United States	Bellingham Asthma Allergy and Immunology Clinic /ID# 210357	Bellingham	Washington
United States	Total Skin and Beauty Derm Ctr /ID# 205129	Birmingham	Alabama
United States	Skin Care Research, LLC /ID# 207099	Boca Raton	Florida
United States	Treasure Valley Medical Research /ID# 210298	Boise	Idaho
United States	Midflorida Clinical Research, Inc. /ID# 213700	Brandon	Florida
United States	New England Research Associates, LLC /ID# 206896	Bridgeport	Connecticut
United States	Fordham Dermatology /ID# 218508	Bronx	New York
United States	The Dermatology Clinic of Arkansas /ID# 218749	Bryant	Arkansas
United States	Great Lakes Clinical Trials /ID# 205830	Chicago	Illinois
United States	Clinical Research of West Florida, Inc /ID# 206146	Clearwater	Florida
United States	University Hospitals Case Medical Center /ID# 206639	Cleveland	Ohio
United States	Duplicate_Summit Medical Group /ID# 213863	Clifton	New Jersey
United States	Raga Clinical Studies, LLC. /ID# 206749	Crown Point	Indiana
United States	Center for Clinical Studies /ID# 213186	Cypress	Texas
United States	Dermatology Treatment and Research Center, PA /ID# 205473	Dallas	Texas
United States	Revival Research /ID# 208383	Doral	Florida
United States	Universal Axon Clinical Research /ID# 213703	Doral	Florida
United States	Encino Research Center /ID# 207472	Encino	California
United States	Epiphany Dermatology - Fort Worth /ID# 210073	Fort Worth	Texas
United States	Cyn3rgy Research /ID# 218064	Gresham	Oregon
United States	Ashira Dermatology /ID# 205512	Gurnee	Illinois
United States	Clinical Investigation Specialists, Inc. /ID# 206898	Gurnee	Illinois
United States	Skin Laser and Surgery Specialists of NY and NJ /ID# 206754	Hackensack	New Jersey
United States	Care Access Research /ID# 218476	Hoboken	New Jersey
United States	Hutchinson Clinic /ID# 205970	Hutchinson	Kansas
United States	University of California Irvine /ID# 205136	Irvine	California
United States	Clinical Research Solutions, LLC /ID# 218416	Jackson	Tennessee
United States	Clinical Investigation Specialist, Inc - Kenosha /ID# 215933	Kenosha	Wisconsin
United States	Innovative Clinical Research - Lafayette /ID# 208400	Lafayette	Colorado
United States	Styde Research, LLC /ID# 213469	Lewisville	Texas
United States	Allergy, Asthma & Immunology Associates, PC /ID# 218169	Lincoln	Nebraska
United States	Ark Clinical Research /ID# 218193	Long Beach	California
United States	Keck School of Medicine of USC /ID# 206971	Los Angeles	California
United States	Wallace Medical Group /ID# 205701	Los Angeles	California
United States	The Education & Research Foundation, Inc. /ID# 206900	Lynchburg	Virginia
United States	Marietta Dermatology Clinical Research /ID# 210317	Marietta	Georgia
United States	Awasty Research Network, LLC /ID# 206748	Marion	Ohio
United States	Velocity Clinical Research Hallandale Beach /ID# 207544	Medford	Oregon
United States	Lakes Research, LLC /ID# 209156	Miami	Florida
United States	Miami Dade Medical Research Institute /ID# 209413	Miami	Florida
United States	Floridian Clinical Research /ID# 207433	Miami Lakes	Florida
United States	Savin Medical Group, LLC /ID# 206902	Miami Lakes	Florida
United States	Stones River Dermatology /ID# 205178	Murfreesboro	Tennessee
United States	EPIC Medical Research /ID# 206382	Murray	Utah
United States	Advanced Research for Health Improvement /ID# 217987	Naples	Florida
United States	Advanced Research for Health Improvement /ID# 218003	Naples	Florida
United States	Arkansas Research Trials /ID# 218469	North Little Rock	Arkansas
United States	Skin Specialists, PC /ID# 205515	Omaha	Nebraska
United States	Child Hosp of Orange County,CA /ID# 205735	Orange	California
United States	Aspen Clinical Research /ID# 208399	Orem	Utah
United States	Complete Health Research /ID# 213459	Ormond Beach	Florida
United States	Palmtree Clinical Research Inc. /Id# 206184	Palm Springs	California
United States	Austin Institute for Clinical Research /ID# 206640	Pflugerville	Texas
United States	Arizona Research Center, Inc. /ID# 205795	Phoenix	Arizona
United States	Medical Dermatology Specialist /ID# 205516	Phoenix	Arizona
United States	Beacon Clinical Research, LLC /ID# 206894	Quincy	Massachusetts
United States	Derm Clin Res Ctr San Antonio /ID# 205469	San Antonio	Texas
United States	Rady Children's Hospital San Diego /ID# 208244	San Diego	California
United States	Agile Clinical Research Trials /ID# 218080	Sandy Springs	Georgia
United States	Southern California Derma. Inc /ID# 205734	Santa Ana	California
United States	Northshore University Health System Dermatology Clinical Trials Unit /ID# 205135	Skokie	Illinois
United States	Timber Lane Allergy & Asthma Research, LLC /ID# 206897	South Burlington	Vermont
United States	Precision Clinical Research /ID# 207364	Sunrise	Florida
United States	Clinical Research Trials of Florida, Inc. /ID# 206840	Tampa	Florida
United States	ForCare Clinical Research /ID# 205120	Tampa	Florida
United States	Continental Clinical Solutions /ID# 210327	Towson	Maryland
United States	Southside Dermatology /ID# 214451	Tulsa	Oklahoma
United States	Vital Prospects Clinical Research Institute, PC /ID# 205824	Tulsa	Oklahoma
United States	PMG Research of Wilmington LLC /ID# 205968	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Croatia,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Korea, Republic of,  Netherlands,  New Zealand,  Portugal,  Singapore,  Spain,  Taiwan,  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, no oozing or crusting; 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). 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	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). 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	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). 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	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 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). Worst 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.	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, no oozing or crusting;; 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). Worst 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.	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.	Week 16

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