A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

— AD Up  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03568318
• Other study ID #: M16-047
• Secondary ID: 2017-005126-37
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: August 9, 2018
• Est. completion date: November 16, 2030

Study information

• Verified date: October 2023
• 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 combined with topical corticosteroids (TCS) 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, a blinded Long-term Extension (LTE) Period after Week 260 to Week 524, and a 30-day follow-up visit. Participants who meet eligibility criteria in the Main Study will be randomly assigned in a 1:1:1 ratio to receive upadacitinib 15 mg, upadacitinib 30 mg, or placebo once daily, in combination with topical corticosteroids.

Upon completion of enrollment of 810 participants in the Main Study, a supplemental study will continue to enroll adolescent participants (Adolescent Sub-study) until a total of 180 adolescent participants are enrolled in the overall study (Main Study + Adolescent Sub-study).

Approximately 1000 participants from M16-045 or M18-891 and approximately 500 participants from M16-047 will have the opportunity to enroll into the blinded Long-Term Extension (LTE) period (Week 260 - Week 524) after reaching Week 260 in their respective studies.

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 (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] versus severe [vIGA-AD 4]) and by geographic region (US/Puerto Rico/Canada and Other).

At Week 16 of both 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, and participants originally randomized to upadacitinib will continue upadacitinib in the extension period at the same dose. For the Main Study, the re-randomization will be stratified by Eczema Area and Severity Index (EASI) 50 responder status (Yes/No), by geographic region (US/Puerto Rico/Canada, Japan, China, and Other) and by age (adolescent [ages 12 to 17] versus adult [ages 18 to 75]). 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).

Starting at Week 4, 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: Enrolling by invitation
• Enrollment: 1500
• Est. completion date: November 16, 2030
• Est. primary completion date: February 16, 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 Visit and subject meets Hanifin and Rajka criteria.

• Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI) = 16, validated Investigator's Global Assessment (vIGA) = 3, = 10% of body surface area (BSA) with AD involvement, and weekly average of daily Worst Pruritus numerical rating scale (NRS) = 4.

• 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 or topical calcineurin inhibitor OR documented systemic treatment for AD within 6 months prior to Baseline Visit

Exclusion Criteria:

• Prior exposure to any Janus kinase (JAK) inhibitor

• Unable or unwilling to discontinue current atopic dermatitis (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
Tablets taken orally once a day
• Upadacitinib
Tablets taken orally once a day
• Topical corticosteroids (TCS)
Topical corticosteroids will be applied in a stepdown regimen, starting with medium potency once daily to areas with active lesions until lesions are clear or almost clear, or for 3 consecutive weeks, whichever is shorter; then low potency topical corticosteroids once daily. If lesions return or persist, this step-down approach will be repeated until lesion resolution or evidence of local or systemic topical corticosteroids toxicity. Recommended TCS include triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment as medium potency topical corticosteroids and hydrocortisone 1% cream as low potency topical corticosteroid.

Locations

Country	Name	City	State
Australia	Fremantle Dermatology /ID# 205306	Fremantle	Western Australia
Australia	St George Dermatology & Skin Cancer Centre /ID# 204788	Kogarah	New South Wales
Australia	Royal North Shore Hospital /ID# 204639	St Leonards	New South Wales
Australia	Westmead Hospital /ID# 205682	Westmead	New South Wales
Australia	Veracity Clinical Research /ID# 204793	Woolloongabba	Queensland
Austria	Medizinische Universitaet Innsbruck /ID# 210897	Innsbruck	Tirol
Austria	Kepler Universitaetsklinikum GmbH /ID# 201075	Linz	Oberoesterreich
Austria	Ordensklinikum Linz GmbH Elisabethinen /ID# 209567	Linz	Oberoesterreich
Austria	Medizinische Universitaet Wien /ID# 201080	Vienna	Wien
Belgium	UZ Gent /ID# 202030	Gent	Oost-Vlaanderen
Belgium	UZ Brussel /ID# 203557	Jette	Bruxelles-Capitale
Belgium	IMTR - Grand Hopital de Charleroi /ID# 202029	Loverval
Belgium	UCL Saint-Luc /ID# 202028	Woluwe-Saint-Lambert	Bruxelles-Capitale
Canada	Dermatology Research Institute Inc. /ID# 200341	Calgary	Alberta
Canada	Kirk Barber Research, CA /ID# 200329	Calgary	Alberta
Canada	Alberta DermaSurgery Centre /ID# 205674	Edmonton	Alberta
Canada	Eastern Canada Cutaneous Resea /ID# 200335	Halifax	Nova Scotia
Canada	Lynderm Research Inc. /ID# 200338	Markham	Ontario
Canada	DermEdge Research Inc. /ID# 200337	Mississauga	Ontario
Canada	CHU Sainte-Justine /ID# 206013	Montreal	Quebec
Canada	The Centre for Clinical Trials /ID# 205404	Oakville	Ontario
Canada	Angela Montgomery Medicine Professional Corporation /ID# 212653	Ottawa	Ontario
Canada	SKIN Centre for Dermatology /ID# 200331	Peterborough	Ontario
Canada	Centre de recheche dermatologique du Quebec Metropolitain /ID# 205403	Québec	Quebec
Canada	The Center For Dermatology /ID# 205409	Richmond Hill	Ontario
Canada	Dre Angelique Gagne-Henley M.D. inc. /ID# 200330	Saint-Jerome	Quebec
Canada	Karma Clinical Trials /ID# 200339	St. John's	Newfoundland and Labrador
Canada	Research Toronto /ID# 205410	Toronto	Ontario
Canada	Toronto Research Centre /ID# 205411	Toronto	Ontario
Canada	XLR8 Medical Research /ID# 205405	Windsor	Ontario
China	Beijing Friendship Hospital /ID# 207434	Beijing
China	Chinese PLA General Hospital /ID# 206786	Beijing	Beijing
China	Xiangya Hospital Central South University /ID# 207510	Changsha
China	Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 206728	Guangzhou	Guangdong
China	The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 207132	Hangzhou	Zhejiang
China	The second Affiliated hospital of Zhejiang University school of Medicine /ID# 207442	Hangzhou	Zhejiang
China	Huashan Hospital of Fudan University /ID# 207437	Shanghai
China	The First Hospital of China Medical University /ID# 209840	Shenyang	Liaoning
China	Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 206669	Wuhan	Hubei
Czechia	Fakultni nemocnice Plzen /ID# 202044	Plzen
Czechia	Duplicate_Vseobecna Fakultni Nemocnice /ID# 205248	Prague
Czechia	Sanatorium profesora Arenbergera /ID# 202082	Praha
Czechia	Vseobecna fakultni nemocnice v Praze /ID# 202045	Praha
France	Hopital Saint-Andre /ID# 206129	Bordeaux
France	AP-HM - Hopital de la Timone /ID# 206128	Marseille CEDEX 05	Bouches-du-Rhone
France	Chu de Nice-Hopital L'Archet Ii /Id# 205780	Nice	Alpes-Maritimes
France	Polyclinique Courlancy /ID# 201537	Reims
France	CHRU Tours - Hopital Gatien de Clocheville /ID# 218209	Tours	Centre-Val De Loire
Germany	Universitaetsklinikum Bonn /ID# 202092	Bonn
Germany	Universitaetsklinikum Frankfurt /ID# 202095	Frankfurt am Main	Hessen
Germany	TFS Trial Form Support GmbH /ID# 202096	Hamburg
Germany	Medizinische Hochschule Hannover /ID# 202098	Hannover
Germany	Universitaetsklinik Heidelberg /ID# 202097	Heidelberg	Baden-Wuerttemberg
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202256	Kiel	Schleswig-Holstein
Germany	Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205194	Mainz
Germany	Universitaetsklinikum Muenster /ID# 202094	Muenster	Nordrhein-Westfalen
Germany	Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202093	Munich
Germany	CMS3 Company for Medical Study /ID# 205195	Selters	Rheinland-Pfalz
Greece	401 GSNA - 401 Army General Hospital /ID# 211963	Athens	Attiki
Greece	Children's Hosp P. A. Kyriakou /ID# 217573	Athens	Attiki
Greece	General Hospital Andreas Syggros /ID# 201123	Athens	Attiki
Greece	University General Hospital Attikon /ID# 201126	Athens	Attiki
Greece	Papageorgiou General Hospital Thessaloniki /ID# 202392	Stavroupoli (Thessalonikis)	Thessaloniki
Greece	Thessaloniki Hospital of Skin and Venereal Diseases /ID# 201124	Thessaloniki
Hong Kong	Prince of Wales Hospital /ID# 205152	Hong Kong
Hong Kong	Queen Mary Hospital /ID# 205146	Hong Kong
Hungary	Debreceni Egyetem Klinikai Kozpont /ID# 201765	Debrecen	Hajdu-Bihar
Hungary	Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 217866	Debrecen
Hungary	Oroshazi Korhaz /ID# 203525	Oroshaza	Bekes
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 204144	Szeged	Csongrad
Hungary	Allergo-Derm Bakos Kft. /ID# 205361	Szolnok
Ireland	South Infirmary Victoria University Hospital /ID# 201079	Cork
Ireland	St James Hospital /ID# 201118	Dublin 8	Dublin
Ireland	University Hospital Waterford /ID# 201253	Waterford
Israel	HaEmek Medical Center /ID# 201958	Afula
Israel	Soroka University Medical Center /ID# 206652	Be'er Sheva	HaDarom
Israel	Rabin Medical Center /ID# 201959	Petakh Tikva
Israel	The Chaim Sheba Medical Center /ID# 201611	Ramat Gan	Tel-Aviv
Israel	Tel Aviv Sourasky Medical Center /ID# 201608	Tel Aviv-Yafo	Tel-Aviv
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200690	Ancona
Italy	A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200742	Catania
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 200744	Milan
Italy	Azienda Ospedaliera Universitaria Federico II /ID# 200751	Napoli
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 203014	Rome	Lazio
Italy	Istituto Clinico Humanitas /ID# 200739	Rozzano	Milano
Japan	Hiramoto skin clinic /ID# 204048	Amagasaki-shi	Hyogo
Japan	Juntendo University Hospital /ID# 202888	Bunkyo-ku	Tokyo
Japan	Medical Corporation Matsuo Clinic /ID# 202312	Fukuoka-shi	Fukuoka
Japan	Osaka Habikino Medical Center /ID# 204243	Habikino-shi	Osaka
Japan	Tokai University Hachioji Hospital /ID# 201711	Hachioji-shi	Tokyo
Japan	Hiroshima University Hospital /ID# 201914	Hiroshima-shi	Hiroshima
Japan	Maruyama Dermatology Clinic /ID# 202350	Koto-ku	Tokyo
Japan	Kyoto University Hospital /ID# 201654	Kyoto-shi	Kyoto
Japan	University Hospital Kyoto Prefectural University of Medicine /ID#258604	Kyoto-shi	Kyoto
Japan	Chukyo Hospital /ID# 202311	Nagoya-shi	Aichi
Japan	National Hospital Organization Sagamihara National Hospital /ID# 201658	Sagamihara-shi	Kanagawa
Japan	Medical Corporation Kojinkai Sapporo Skin Clinic /ID#258665	Sapporo-shi	Hokkaido
Japan	Tohoku University Hospital /ID# 206322	Sendai-shi	Miyagi
Japan	Jichi Medical University Hospital /ID# 201913	Shimotsuke-shi	Tochigi
Japan	Yamate Dermatological Clinic /ID# 202130	Shinjuku-ku	Tokyo
Japan	Queens Square Medical Center dermatology allergology /ID# 203850	Yokohama-shi	Kanagawa
Netherlands	Academisch Medisch Centrum /ID# 202193	Amsterdam
Netherlands	Universitair Medisch Centrum Groningen /ID# 202195	Groningen
Netherlands	Erasmus Medisch Centrum /ID# 202196	Rotterdam	Zuid-Holland
Netherlands	Universitair Medisch Centrum Utrecht /ID# 202194	Utrecht
New Zealand	Clinical Trials NZ /ID# 205336	Hamilton
Norway	Haukeland University Hospital /ID# 201152	Bergen	Hordaland
Norway	Universitetssykehuset N-Norge, Harstad /ID# 201269	Harstad	Troms
Norway	Rikshospitalet OUS HF /ID# 201271	Oslo
Norway	Universitetssykehuset N-Norge, Tromso /ID# 201270	Tromso	Troms
Puerto Rico	Dr. Samuel Sanchez PSC /ID# 202002	Caguas
Puerto Rico	Clinical Research Puerto Rico /ID# 203644	San Juan
Puerto Rico	GCM Medical Group PSC - Hato Rey /ID# 202003	San Juan
Slovakia	Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 204372	Banska Bystrica
Slovakia	Univerzitna nemocnica Martin /ID# 203851	Martin
Slovakia	Fakultna nemocnica s poliklinikou Nove Zamky /ID# 204240	Nove Zamky
Slovakia	Fakultna nemocnica s poliklinikou J.A. Reimana Presov /ID# 204373	Presov
Spain	Hospital General Universitario Alicante /ID# 200873	Alicante
Spain	Hospital Santa Creu i Sant Pau /ID# 201325	Barcelona
Spain	Hospital Universitario 12 de Octubre /ID# 201135	Madrid
Spain	Hospital Universitario de la Princesa /ID# 201517	Madrid
Spain	Hospital Universitario La Paz /ID# 205438	Madrid
Spain	Hospital Universitario de Puerto Real /ID# 200875	Puerto Real	Cadiz
Sweden	Sahlgrenska University Hospital /ID# 201274	Gothenburg	Vastra Gotalands Lan
Sweden	Skane University Hospital Lund /ID# 201244	Lund	Skane Lan
Sweden	Karolinska University Hospital /ID# 201243	Stockholm
Sweden	Sodersjukhuset /ID# 201242	Stockholm
United Kingdom	NHS Tayside /ID# 202081	Dundee	Scotland
United Kingdom	NHS Greater Glasgow and Clyde /ID# 201374	Glasgow	Scotland
United Kingdom	Leeds Teaching Hospitals NHS Trust /ID# 201106	Leeds
United Kingdom	Barts Health NHS Trust /ID# 201044	London	London, City Of
United Kingdom	Guy's and St Thomas' NHS Foundation Trust /ID# 201193	London	London, City Of
United Kingdom	Guy's and St Thomas' NHS Foundation Trust /ID# 204642	London	London, City Of
United Kingdom	Oxford University Hospitals NHS Foundation Trust /ID# 202052	Oxford	Oxfordshire
United States	ORA, Inc. /ID# 202824	Andover	Massachusetts
United States	Arlington Research Center, Inc /ID# 200559	Arlington	Texas
United States	Duplicate_University of Colorado Anchutz Medical Campus /ID# 202822	Aurora	Colorado
United States	Bakersfield Derma & Skin Cance /ID# 200892	Bakersfield	California
United States	Mosaic Dermatology /ID# 200553	Beverly Hills	California
United States	Bexley Dermatology Research /ID# 200899	Bexley	Ohio
United States	ACCEL Research Sites /ID# 213364	Birmingham	Alabama
United States	Clinical Research Center AL /ID# 201865	Birmingham	Alabama
United States	Total Skin and Beauty Derm Ctr /ID# 200548	Birmingham	Alabama
United States	Clearlyderm Dermatology /ID# 207709	Boca Raton	Florida
United States	Skin Care Research, LLC /ID# 200812	Boca Raton	Florida
United States	Advanced Clinical Research at Treasure Valley Dermatology & Skin Cancer Center /ID# 203628	Boise	Idaho
United States	Beth Israel Deaconess Medical Center /ID# 200545	Boston	Massachusetts
United States	Tufts Medical Center /ID# 200570	Boston	Massachusetts
United States	Colorado Center for Dermatology, PLLC /ID# 203626	Centennial	Colorado
United States	Clin Res Inst of Michigan, LLC /ID# 208020	Chesterfield	Michigan
United States	Northwestern University Feinberg School of Medicine /ID# 201646	Chicago	Illinois
United States	Michigan Center for Research Company /ID# 200560	Clarkston	Michigan
United States	Clinical Research of West Florida, Inc /ID# 203643	Clearwater	Florida
United States	The Ohio State University /ID# 200542	Columbus	Ohio
United States	Florida Academic Centers Research and Education /ID# 200544	Coral Gables	Florida
United States	Psoriasis Treatment Center of Central New Jersey /ID# 200714	East Windsor	New Jersey
United States	Deaconess Clinic Downtown /ID# 201001	Evansville	Indiana
United States	Rivergate Dermatology & Skin Care Center /ID# 201698	Goodlettsville	Tennessee
United States	Center for Clinical Studies /ID# 200582	Houston	Texas
United States	Indiana University /ID# 200515	Indianapolis	Indiana
United States	University of California Irvine /ID# 200902	Irvine	California
United States	Dartmouth-Hitchcock Medical Center /ID# 200918	Lebanon	New Hampshire
United States	University of Wisconsin - Madison /ID# 204933	Madison	Wisconsin
United States	Advanced Dermatology and Skin Care Centre /ID# 213550	Mobile	Alabama
United States	Stones River Dermatology /ID# 204962	Murfreesboro	Tennessee
United States	Juva Skin and Laser Center /ID# 200997	New York	New York
United States	Eastern Virginia Med School /ID# 200994	Norfolk	Virginia
United States	Tory P Sullivan, MD PA /ID# 201174	North Miami Beach	Florida
United States	Skin Specialists, PC /ID# 200573	Omaha	Nebraska
United States	Park Avenue Dermatology, PA /ID# 201012	Orange Park	Florida
United States	Epiphany Dermatology of Kansas LLC /ID# 203026	Overland Park	Kansas
United States	Alliance Dermatology and MOHs Center, PC /ID#200540	Phoenix	Arizona
United States	Arizona Research Center, Inc. /ID# 200546	Phoenix	Arizona
United States	University of Pittsburgh MC /ID# 206057	Pittsburgh	Pennsylvania
United States	Oregon Dermatology and Research Center /ID# 200601	Portland	Oregon
United States	Rhode Island Hospital /ID# 200566	Providence	Rhode Island
United States	MediSearch Clinical Trials /ID# 201006	Saint Joseph	Missouri
United States	Advanced Clinical Research - Woseth Dermatology /ID# 213745	Salt Lake City	Utah
United States	Progressive Clinical Research /ID# 201582	San Antonio	Texas
United States	Therapeutics Clinical Research /ID# 200593	San Diego	California
United States	Clear Dermatology & Aesthetics Center /ID# 201257	Scottsdale	Arizona
United States	Dermatology Associates of Seattle /ID# 200717	Seattle	Washington
United States	Dermatology Physicians of Connecticut /ID# 201004	Shelton	Connecticut
United States	Northshore University Health System Dermatology Clinical Trials Unit /ID# 200556	Skokie	Illinois
United States	Stanford University /ID# 200597	Stanford	California
United States	Precision Clinical Research /ID# 208734	Sunrise	Florida
United States	J. Schwartz, MD, PLLC /ID# 202122	Troy	New York
United States	University of Arizona /ID# 201059	Tucson	Arizona
United States	Vital Prospects Clinical Research Institute, PC /ID# 200901	Tulsa	Oklahoma
United States	AAPRI Clinical Research /ID# 221134	Warwick	Rhode Island
United States	Center for Clinical Studies - Webster TX /ID# 203186	Webster	Texas
United States	Duplicate_Western States Clinical Research, Inc. /ID# 201702	Wheat Ridge	Colorado
United States	DuPage Medical Group /ID# 202065	Wheaton	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  China,  Czechia,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Netherlands,  New Zealand,  Norway,  Puerto Rico,  Slovakia,  Spain,  Sweden,  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 4	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 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 an EASI 90 Response at Week 4	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 4
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 from 0 [none], to 3 [severe]) for redness, thickness, scratching, and lichenification.; 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.; The percentage of participants with an EASI 100 response at Week 16 was pre-specified as a ranked secondary endpoint for participants in the Upadacitinib 30 mg + Topical Corticosteroids group versus Placebo + Topical Corticosteroids group only.	Baseline and Week 16
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: 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	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 4	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 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 an EASI 90 Response at Week 4	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 4
Secondary	Adolescents: Percentage of Participants Achieving an EASI 100 Response at Week 16	EASI is used to measure the extent 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. and the severity score is calculated as the sum of the intensity scores (scored from 0 [none], to 3 [severe]) for redness, thickness, scratching, and lichenification.; 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.; The percentage of participants with an EASI 100 response at Week 16 was pre-specified as a secondary endpoint for participants in the Upadacitinib 30 mg + TCS group versus Placebo + TCS group only.	Baseline and Week 16
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: 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

External Links

•   Related Info