Clinical trial NCT03568318: A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Upadacitinib
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-06-26
Enrollment: 1500
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline and Week 16
measure: 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
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16
timeFrame: Baseline (last available rolling average before the first dose of study drug) and Week 16
measure: Main Study: Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16
timeFrame: Baseline and Week 16
measure: Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4
timeFrame: Baseline (last available rolling average before the first dose of study drug) and Week 4
measure: Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 4
timeFrame: Baseline and Week 4
measure: Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 2
timeFrame: Baseline and Week 2
measure: Main Study: Percentage of Participants Achieving an EASI 90 Response at Week 4
timeFrame: Baseline and Week 4
measure: Main Study: Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16
timeFrame: Baseline and Week 16
measure: Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1
timeFrame: Baseline (last available rolling average before the first dose of study drug) and Week 1
measure: Main Study: Percent Change From Baseline in Worst Pruritus NRS at Week 16
timeFrame: Baseline (last available rolling average before the first dose of study drug) and Week 16
measure: Main Study: Percent Change From Baseline in EASI Score at Week 16
timeFrame: Baseline and Week 16
measure: Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 16
timeFrame: Baseline and Week 16
measure: Adolescents: Percentage of Participants Achieving a vIGA-AD of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16
timeFrame: Baseline and Week 16
measure: Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 16
timeFrame: Baseline (last available rolling average before the first dose of study drug) and Week 16
measure: Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 16
timeFrame: Baseline and Week 16
measure: Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4
timeFrame: Baseline (last available rolling average before the first dose of study drug) and Week 4
measure: Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 4
timeFrame: Baseline and Week 4
measure: Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 2
timeFrame: Baseline and Week 2
measure: Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 4
timeFrame: Baseline and Week 4
measure: Adolescents: Percentage of Participants Achieving an EASI 100 Response at Week 16
timeFrame: Baseline and Week 16
measure: Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1
timeFrame: Baseline (last available rolling average before the first dose of study drug) and Week 1
measure: Adolescents: Percent Change From Baseline in Worst Pruritus NRS at Week 16
timeFrame: Baseline (last available rolling average before the first dose of study drug) and Week 16
measure: Adolescents: Percent Change From Baseline in EASI Score at Week 16
timeFrame: Baseline and Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Derm Ctr /ID# 200548
state: Alabama
city: Birmingham
country: United States
facility: Clinical Research Center AL /ID# 201865
state: Alabama
city: Birmingham
country: United States
facility: ACCEL Research Sites /ID# 213364
state: Alabama
city: Mobile
country: United States
facility: Advanced Dermatology and Skin Care Centre /ID# 213550
state: Alabama
city: Phoenix
country: United States
facility: Alliance Dermatology and MOHs Center, PC /ID#200540
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center, Inc. /ID# 200546
state: Arizona
city: Scottsdale
country: United States
facility: Clear Dermatology & Aesthetics Center /ID# 201257
state: Arizona
city: Tucson
country: United States
facility: University of Arizona /ID# 201059
state: Arizona
city: Bakersfield
country: United States
facility: Bakersfield Derma & Skin Cance /ID# 200892
state: California
city: Beverly Hills
country: United States
facility: Mosaic Dermatology /ID# 200553
state: California
city: Irvine
country: United States
facility: University of California Irvine /ID# 200902
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research /ID# 200593
state: California
city: Stanford
country: United States
facility: Stanford University /ID# 200597
state: California
city: Aurora
country: United States
facility: Duplicate_University of Colorado Anchutz Medical Campus /ID# 202822
state: Colorado
city: Centennial
country: United States
facility: Colorado Center for Dermatology, PLLC /ID# 203626
state: Colorado
city: Wheat Ridge
country: United States
facility: Duplicate_Western States Clinical Research, Inc. /ID# 201702
state: Colorado
city: Shelton
country: United States
facility: Dermatology Physicians of Connecticut /ID# 201004
state: Connecticut
city: Boca Raton
country: United States
facility: Clearlyderm Dermatology /ID# 207709
state: Florida
city: Boca Raton
country: United States
facility: Skin Care Research, LLC /ID# 200812
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc /ID# 203643
state: Florida
city: Coral Gables
country: United States
facility: Florida Academic Centers Research and Education /ID# 200544
state: Florida
city: North Miami Beach
country: United States
facility: Tory P Sullivan, MD PA /ID# 201174
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology, PA /ID# 201012
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research /ID# 208734
state: Florida
city: Boise
country: United States
facility: Advanced Clinical Research at Treasure Valley Dermatology & Skin Cancer Center /ID# 203628
state: Idaho
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine /ID# 201646
state: Illinois
city: Skokie
country: United States
facility: Northshore University Health System Dermatology Clinical Trials Unit /ID# 200556
state: Illinois
city: Wheaton
country: United States
facility: DuPage Medical Group /ID# 202065
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic Downtown /ID# 201001
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University /ID# 200515
state: Indiana
city: Overland Park
country: United States
facility: Epiphany Dermatology of Kansas LLC /ID# 203026
state: Kansas
city: Andover
country: United States
facility: ORA, Inc. /ID# 202824
state: Massachusetts
city: Boston
country: United States
facility: Tufts Medical Center /ID# 200570
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center /ID# 200545
state: Massachusetts
city: Chesterfield
country: United States
facility: Clin Res Inst of Michigan, LLC /ID# 208020
state: Michigan
city: Clarkston
country: United States
facility: Michigan Center for Research Company /ID# 200560
state: Michigan
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials /ID# 201006
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists, PC /ID# 200573
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center /ID# 200918
state: New Hampshire
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey /ID# 200714
state: New Jersey
city: New York
country: United States
facility: Juva Skin and Laser Center /ID# 200997
state: New York
city: Troy
country: United States
facility: J. Schwartz, MD, PLLC /ID# 202122
state: New York
city: Bexley
country: United States
facility: Bexley Dermatology Research /ID# 200899
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University /ID# 200542
state: Ohio
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, PC /ID# 200901
state: Oklahoma
city: Portland
country: United States
facility: Oregon Dermatology and Research Center /ID# 200601
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh MC /ID# 206057
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital /ID# 200566
state: Rhode Island
city: Warwick
country: United States
facility: AAPRI Clinical Research /ID# 221134
state: Rhode Island
city: Goodlettsville
country: United States
facility: Rivergate Dermatology & Skin Care Center /ID# 201698
state: Tennessee
city: Murfreesboro
country: United States
facility: Stones River Dermatology /ID# 204962
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center, Inc /ID# 200559
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies /ID# 200582
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research /ID# 201582
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies - Webster TX /ID# 203186
state: Texas
city: Salt Lake City
country: United States
facility: Advanced Clinical Research - Woseth Dermatology /ID# 213745
state: Utah
city: Norfolk
country: United States
facility: Eastern Virginia Med School /ID# 200994
state: Virginia
city: Seattle
country: United States
facility: Dermatology Associates of Seattle /ID# 200717
state: Washington
city: Madison
country: United States
facility: University of Wisconsin - Madison /ID# 204933
state: Wisconsin
city: Kogarah
country: Australia
facility: St George Dermatology & Skin Cancer Centre /ID# 204788
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital /ID# 204639
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital /ID# 205682
state: New South Wales
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research /ID# 204793
state: Queensland
city: Fremantle
country: Australia
facility: Fremantle Dermatology /ID# 205306
state: Western Australia
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 209567
state: Oberoesterreich
city: Linz
country: Austria
facility: Kepler Universitaetsklinikum GmbH /ID# 201075
state: Oberoesterreich
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck /ID# 210897
state: Tirol
city: Vienna
country: Austria
facility: Medizinische Universitaet Wien /ID# 201080
state: Wien
city: Jette
country: Belgium
facility: UZ Brussel /ID# 203557
state: Bruxelles-Capitale
city: Woluwe-Saint-Lambert
country: Belgium
facility: UCL Saint-Luc /ID# 202028
state: Bruxelles-Capitale
city: Gent
country: Belgium
facility: UZ Gent /ID# 202030
state: Oost-Vlaanderen
city: Loverval
country: Belgium
facility: IMTR - Grand Hopital de Charleroi /ID# 202029
city: Calgary
country: Canada
facility: Kirk Barber Research, CA /ID# 200329
state: Alberta
city: Calgary
country: Canada
facility: Dermatology Research Institute Inc. /ID# 200341
state: Alberta
city: Edmonton
country: Canada
facility: Alberta DermaSurgery Centre /ID# 205674
state: Alberta
city: St. John's
country: Canada
facility: Karma Clinical Trials /ID# 200339
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Eastern Canada Cutaneous Resea /ID# 200335
state: Nova Scotia
city: Markham
country: Canada
facility: Lynderm Research Inc. /ID# 200338
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research Inc. /ID# 200337
state: Ontario
city: Oakville
country: Canada
facility: The Centre for Clinical Trials /ID# 205404
state: Ontario
city: Ottawa
country: Canada
facility: Angela Montgomery Medicine Professional Corporation /ID# 212653
state: Ontario
city: Peterborough
country: Canada
facility: SKIN Centre for Dermatology /ID# 200331
state: Ontario
city: Richmond Hill
country: Canada
facility: The Center For Dermatology /ID# 205409
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre /ID# 205411
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto /ID# 205410
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research /ID# 205405
state: Ontario
city: Montreal
country: Canada
facility: CHU Sainte-Justine /ID# 206013
state: Quebec
city: Québec
country: Canada
facility: Centre de recheche dermatologique du Quebec Metropolitain /ID# 205403
state: Quebec
city: Saint-Jerome
country: Canada
facility: Dre Angelique Gagne-Henley M.D. inc. /ID# 200330
state: Quebec
city: Beijing
country: China
facility: Chinese PLA General Hospital /ID# 206786
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 206728
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 206669
state: Hubei
city: Shenyang
country: China
facility: The First Hospital of China Medical University /ID# 209840
state: Liaoning
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 207132
state: Zhejiang
city: Hangzhou
country: China
facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 207442
state: Zhejiang
city: Beijing
country: China
facility: Beijing Friendship Hospital /ID# 207434
city: Changsha
country: China
facility: Xiangya Hospital Central South University /ID# 207510
city: Shanghai
country: China
facility: Huashan Hospital of Fudan University /ID# 207437
city: Plzen
country: Czechia
facility: Fakultni nemocnice Plzen /ID# 202044
city: Prague
country: Czechia
facility: Duplicate_Vseobecna Fakultni Nemocnice /ID# 205248
city: Praha
country: Czechia
facility: Sanatorium profesora Arenbergera /ID# 202082
city: Praha
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze /ID# 202045
city: Nice
country: France
facility: Chu de Nice-Hopital L'Archet Ii /Id# 205780
state: Alpes-Maritimes
city: Marseille CEDEX 05
country: France
facility: AP-HM - Hopital de la Timone /ID# 206128
state: Bouches-du-Rhone
city: Tours
country: France
facility: CHRU Tours - Hopital Gatien de Clocheville /ID# 218209
state: Centre-Val De Loire
city: Bordeaux
country: France
facility: Hopital Saint-Andre /ID# 206129
city: Reims
country: France
facility: Polyclinique Courlancy /ID# 201537
city: Heidelberg
country: Germany
facility: Universitaetsklinik Heidelberg /ID# 202097
state: Baden-Wuerttemberg
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt /ID# 202095
state: Hessen
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster /ID# 202094
state: Nordrhein-Westfalen
city: Selters
country: Germany
facility: CMS3 Company for Medical Study /ID# 205195
state: Rheinland-Pfalz
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202256
state: Schleswig-Holstein
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn /ID# 202092
city: Hamburg
country: Germany
facility: TFS Trial Form Support GmbH /ID# 202096
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover /ID# 202098
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205194
city: Munich
country: Germany
facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202093
city: Athens
country: Greece
facility: 401 GSNA - 401 Army General Hospital /ID# 211963
state: Attiki
city: Athens
country: Greece
facility: Children's Hosp P. A. Kyriakou /ID# 217573
state: Attiki
city: Athens
country: Greece
facility: University General Hospital Attikon /ID# 201126
state: Attiki
city: Athens
country: Greece
facility: General Hospital Andreas Syggros /ID# 201123
state: Attiki
city: Stavroupoli (Thessalonikis)
country: Greece
facility: Papageorgiou General Hospital Thessaloniki /ID# 202392
state: Thessaloniki
city: Thessaloniki
country: Greece
facility: Thessaloniki Hospital of Skin and Venereal Diseases /ID# 201124
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital /ID# 205152
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital /ID# 205146
city: Oroshaza
country: Hungary
facility: Oroshazi Korhaz /ID# 203525
state: Bekes
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 204144
state: Csongrad
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont /ID# 201765
state: Hajdu-Bihar
city: Debrecen
country: Hungary
facility: Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 217866
city: Szolnok
country: Hungary
facility: Allergo-Derm Bakos Kft. /ID# 205361
city: Dublin 8
country: Ireland
facility: St James Hospital /ID# 201118
state: Dublin
city: Cork
country: Ireland
facility: South Infirmary Victoria University Hospital /ID# 201079
city: Waterford
country: Ireland
facility: University Hospital Waterford /ID# 201253
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center /ID# 206652
state: HaDarom
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 201611
state: Tel-Aviv
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 201608
state: Tel-Aviv
city: Afula
country: Israel
facility: HaEmek Medical Center /ID# 201958
city: Petakh Tikva
country: Israel
facility: Rabin Medical Center /ID# 201959
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 203014
state: Lazio
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas /ID# 200739
state: Milano
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200690
city: Catania
country: Italy
facility: A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200742
city: Milan
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 200744
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II /ID# 200751
city: Nagoya-shi
country: Japan
facility: Chukyo Hospital /ID# 202311
state: Aichi
city: Fukuoka-shi
country: Japan
facility: Medical Corporation Matsuo Clinic /ID# 202312
state: Fukuoka
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital /ID# 201914
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Medical Corporation Kojinkai Sapporo Skin Clinic /ID#258665
state: Hokkaido
city: Amagasaki-shi
country: Japan
facility: Hiramoto skin clinic /ID# 204048
state: Hyogo
city: Sagamihara-shi
country: Japan
facility: National Hospital Organization Sagamihara National Hospital /ID# 201658
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Queens Square Medical Center dermatology allergology /ID# 203850
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine /ID#258604
state: Kyoto
city: Kyoto-shi
country: Japan
facility: Kyoto University Hospital /ID# 201654
state: Kyoto
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital /ID# 206322
state: Miyagi
city: Habikino-shi
country: Japan
facility: Osaka Habikino Medical Center /ID# 204243
state: Osaka
city: Shimotsuke-shi
country: Japan
facility: Jichi Medical University Hospital /ID# 201913
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital /ID# 202888
state: Tokyo
city: Hachioji-shi
country: Japan
facility: Tokai University Hachioji Hospital /ID# 201711
state: Tokyo
city: Koto-ku
country: Japan
facility: Maruyama Dermatology Clinic /ID# 202350
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Yamate Dermatological Clinic /ID# 202130
state: Tokyo
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum /ID# 202196
state: Zuid-Holland
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum /ID# 202193
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen /ID# 202195
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht /ID# 202194
city: Hamilton
country: New Zealand
facility: Clinical Trials NZ /ID# 205336
city: Bergen
country: Norway
facility: Haukeland University Hospital /ID# 201152
state: Hordaland
city: Harstad
country: Norway
facility: Universitetssykehuset N-Norge, Harstad /ID# 201269
state: Troms
city: Tromso
country: Norway
facility: Universitetssykehuset N-Norge, Tromso /ID# 201270
state: Troms
city: Oslo
country: Norway
facility: Rikshospitalet OUS HF /ID# 201271
city: Caguas
country: Puerto Rico
facility: Dr. Samuel Sanchez PSC /ID# 202002
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico /ID# 203644
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC - Hato Rey /ID# 202003
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 204372
city: Martin
country: Slovakia
facility: Univerzitna nemocnica Martin /ID# 203851
city: Nove Zamky
country: Slovakia
facility: Fakultna nemocnica s poliklinikou Nove Zamky /ID# 204240
city: Presov
country: Slovakia
facility: Fakultna nemocnica s poliklinikou J.A. Reimana Presov /ID# 204373
city: Puerto Real
country: Spain
facility: Hospital Universitario de Puerto Real /ID# 200875
state: Cadiz
city: Alicante
country: Spain
facility: Hospital General Universitario Alicante /ID# 200873
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau /ID# 201325
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa /ID# 201517
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 201135
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 205438
city: Lund
country: Sweden
facility: Skane University Hospital Lund /ID# 201244
state: Skane Lan
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital /ID# 201274
state: Vastra Gotalands Lan
city: Stockholm
country: Sweden
facility: Sodersjukhuset /ID# 201242
city: Stockholm
country: Sweden
facility: Karolinska University Hospital /ID# 201243
city: London
country: United Kingdom
facility: Barts Health NHS Trust /ID# 201044
state: London, City Of
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust /ID# 201193
state: London, City Of
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust /ID# 204642
state: London, City Of
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust /ID# 202052
state: Oxfordshire
city: Dundee
country: United Kingdom
facility: NHS Tayside /ID# 202081
state: Scotland
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde /ID# 201374
state: Scotland
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust /ID# 201106
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
citation: Silverberg JI, Simpson EL, Calimlim BM, Litcher-Kelly L, Li X, Sun X, Leshem YA. Determining Severity Strata for Three Atopic Dermatitis Patient-Reported Outcome Questionnaires: Defining Severity Score Ranges for the Worst Pruritus Numerical Rating Scale and the Atopic Dermatitis Symptom and Impact Scales (ADerm-SS and ADerm-IS). Dermatol Ther (Heidelb). 2022 Dec;12(12):2817-2827. doi: 10.1007/s13555-022-00836-5. Epub 2022 Nov 4.
citation: Mendes-Bastos P, Ladizinski B, Guttman-Yassky E, Jiang P, Liu J, Prajapati VH, Simpson EL, Vigna N, Teixeira HD, Barbarot S. Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis: A post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials. J Am Acad Dermatol. 2022 Oct;87(4):784-791. doi: 10.1016/j.jaad.2022.06.012. Epub 2022 Jun 15.
citation: Reich K, Teixeira HD, de Bruin-Weller M, Bieber T, Soong W, Kabashima K, Werfel T, Zeng J, Huang X, Hu X, Hendrickson BA, Ladizinski B, Chu AD, Silverberg JI. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021 Jun 5;397(10290):2169-2181. doi: 10.1016/S0140-6736(21)00589-4. Epub 2021 May 21.