Clinical trial NCT03569293: Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Upadacitinib
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-06-26
Enrollment: 912
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 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, and a 30-day follow-up visit.

Participants who meet eligibility criteria in the main study will be randomized in a 1:1:1 ratio to receive a daily oral dose of upadacitinib 30 mg or upadacitinib 15 mg or matching placebo. Upon completion of enrollment of 810 participants in the main study, a supplemental study will continue to enroll adolescents (adolescent sub-study) until a total of 180 adolescent participants are enrolled in the overall study (main study + adolescent sub-study).

Randomization for the main study will be stratified by baseline disease severity (validated Investigator Global Assessment scale for Atopic Dermatitis \[vIGA-AD\] score of moderate \[3\] versus severe \[4\]), by geographic region (United States \[US\]/Puerto Rico/Canada, Japan, China, and Other), and by age (adolescent \[ages 12 to 17\] versus adult \[ages 18 to 75\]). The separate randomization for the adolescent sub-study will be stratified by baseline disease severity (moderate \[vIGA-AD 3\] vs. severe \[vIGA-AD 4\]) and by geographic region (US/Puerto Rico/Canada and Other).

At Week 16 of the main study and the adolescent sub-study, participants in the placebo group will be re-randomized in a 1:1 ratio to receive daily oral doses of upadacitinib 30 mg or upadacitinib 15 mg in the blinded extension period. In the main study the re-randomization at Week 16 will be stratified by Week 16 50% improvement in Eczema Area and Severity Index \[EASI 50\] responder \[yes/no\], geographic region \[US/Puerto Rico/Canada, China \[Mainland\], Japan, and other\], and age group \[adolescent/adult\]. For the adolescent sub-study, the re-randomization will be stratified by EASI 50 responder (Yes/No) and by geographic region (US/Puerto Rico/Canada and Other).

Participants originally randomized to upadacitinib will continue upadacitinib in the extension period at the same dose.

Starting at the Week 4 visit, rescue treatment for AD may be provided at the discretion of the investigator if medically necessary.

The Primary Analysis for the main study will be conducted after all ongoing participants have completed Week 16. In addition, a Primary Analysis for the adolescent population (including the adolescent participants from the main study and the adolescent sub-study) will be conducted after all ongoing adolescent participants have completed Week 16.

Eligibility criteria: Inclusion Criteria:

* Body weight of ≥ 40 kg at Baseline Visit for participants between ≥ 12 and \< 18 years of age
* Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years before Baseline Visit and subject meets Hanifin and Rajka criteria.
* Active moderate to severe AD defined by:

  * Eczema Area and Severity Index (EASI) score ≥ 16 at the Screening and Baseline Visits;
  * Validated Investigator's Global Assessment (vIGA) score ≥ 3 at the Screening and Baseline Visits;
  * ≥ 10% Body surface area (BSA) of AD involvement at the Screening and Baseline Visits;
  * Baseline weekly average of daily Worst Pruritus NRS ≥ 4.
* Candidate for systemic therapy or have recently required systemic therapy for AD
* Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days before the Baseline Visit.
* Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months before Baseline Visit

Exclusion Criteria:

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

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 2
timeFrame: Baseline and Week 2
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: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 2
timeFrame: Baseline and Day 2
measure: Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 3
timeFrame: Baseline and Day 3
measure: Main Study: Percentage of Participants Experiencing a Flare During the Double-blind Treatment Period
timeFrame: From first dose of study drug to Week 16
measure: 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
timeFrame: Baseline (last available rolling average before the first dose of study drug) and Week 16
measure: 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
timeFrame: Baseline (last available rolling average before the first dose of study drug) and Week 16
measure: 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
timeFrame: Baseline and Week 16
measure: Main Study: Percentage of Participants Achieving a Reduction of ≥ 11 Points From Baseline in ADerm-IS Emotional State Domain Score at Week 16
timeFrame: Baseline and Week 16
measure: Main Study: Percentage of Participants Achieving a Reduction of ≥ 14 Points From Baseline in in ADerm-IS Daily Activities Domain Score at Week 16
timeFrame: Baseline and Week 16
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: 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: Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Week 16
timeFrame: Baseline and Week 16
measure: Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
timeFrame: Baseline and Week 16
measure: Main Study: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16
timeFrame: Baseline and Week 16
measure: 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
timeFrame: Baseline and Week 16
measure: Main Study: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16
timeFrame: 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 2
timeFrame: Baseline and Week 2
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: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 2
timeFrame: Baseline and Day 2
measure: Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 3
timeFrame: Baseline and Day 3
measure: Adolescents: Percentage of Participants Experiencing a Flare During the Double-blind Treatment Period
timeFrame: From first dose of study drug to Week 16
measure: Adolescents: Percentage of Participants Achieving a Reduction of ≥ 12 Points From Baseline in ADerm-IS Sleep Domain Score 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 a Reduction of ≥ 4 Points From Baseline in ADerm-SS Skin Pain Score 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 a Reduction of ≥ 28 Points From Baseline in ADerm-SS TSS-7 at Week 16
timeFrame: Baseline and Week 16
measure: Adolescents: Percentage of Participants Achieving a Reduction of ≥ 11 Points From Baseline in ADerm-IS Emotional State Domain Score at Week 16
timeFrame: Baseline and Week 16
measure: Adolescents: Percentage of Participants Achieving a Reduction of ≥ 14 Points From Baseline in ADerm-IS Daily Activities Domain Score at Week 16
timeFrame: Baseline and Week 16
measure: Adolescents: Percentage of Participants Achieving an EASI 100 Response at Week 16
timeFrame: Baseline and Week 16
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
measure: Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in POEM Total Score at Week 16
timeFrame: Baseline and Week 16
measure: Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in DLQI Score at Week 16
timeFrame: Baseline and Week 16
measure: Adolescents: Percent Change From Baseline in SCORAD Score at Week 16
timeFrame: Baseline and Week 16
measure: Adolescents: Percentage of Participants Achieving HADS-A Score and HADS-D Score of < 8 at Week 16
timeFrame: Baseline and Week 16
measure: Adolescents: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16
timeFrame: Baseline and Week 16
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Alliance Dermatology and MOHs /ID# 200375
state: Arizona
city: Scottsdale
country: United States
facility: Clear Dermatology & Aesthetics Center /ID# 201256
state: Arizona
city: Bakersfield
country: United States
facility: Bakersfield Derma & Skin Cance /ID# 200433
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology /ID# 201910
state: California
city: Los Angeles
country: United States
facility: California Allergy and Asthma Medical Group /ID# 200727
state: California
city: Mission Viejo
country: United States
facility: Allergy & Asthma Associates of Southern California /ID# 200733
state: California
city: Newport Beach
country: United States
facility: Dermatology Clinical Trials /ID# 205876
state: California
city: Sacramento
country: United States
facility: UC Davis /ID# 203622
state: California
city: San Francisco
country: United States
facility: Synergy Dermatology /ID# 200842
state: California
city: San Luis Obispo
country: United States
facility: San Luis Derm and Laser Clinic /ID# 200372
state: California
city: Stanford
country: United States
facility: Stanford University /ID# 200440
state: California
city: Walnut Creek
country: United States
facility: Care Access Research - Walnut Creek /ID# 200940
state: California
city: Shelton
country: United States
facility: Dermatology Physicians of Connecticut /ID# 200928
state: Connecticut
city: Washington
country: United States
facility: Foxhall Research Center /ID# 213682
state: District of Columbia
city: Washington
country: United States
facility: Duplicate_George Washington Univ Med /ID# 200364
state: District of Columbia
city: Boca Raton
country: United States
facility: Clearlyderm Dermatology /ID# 208371
state: Florida
city: Boca Raton
country: United States
facility: Skin Care Research, LLC /ID# 200811
state: Florida
city: Clearwater
country: United States
facility: Olympian Clinical Research /ID# 202914
state: Florida
city: Lake City
country: United States
facility: Multi-Speciality Research Associates /ID# 213254
state: Florida
city: Margate
country: United States
facility: GSI Clinical Research, LLC /ID# 200849
state: Florida
city: Miami
country: United States
facility: Florida International Rsrch cr /ID# 218507
state: Florida
city: North Miami Beach
country: United States
facility: Tory P Sullivan, MD PA /ID# 200671
state: Florida
city: Ormond Beach
country: United States
facility: Leavitt Medical Associates of Florida /ID# 200880
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research /ID# 209002
state: Florida
city: West Palm Beach
country: United States
facility: Integrated Clinical Research LLC /ID# 200900
state: Florida
city: Champaign
country: United States
facility: Christie Clinic, LLC /ID# 200427
state: Illinois
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine /ID# 201644
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin, LLC /ID# 200366
state: Indiana
city: South Bend
country: United States
facility: The South Bend Clinic Center /ID# 200371
state: Indiana
city: Covington
country: United States
facility: Clinical Trials Management, LLC - Covington /ID# 212658
state: Louisiana
city: Metairie
country: United States
facility: Clinical Trials Management, LLC - Metairie /ID# 212659
state: Louisiana
city: Beverly
country: United States
facility: Northeast Dermatology /ID# 201338
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital /ID# 200474
state: Massachusetts
city: Quincy
country: United States
facility: Integrated Dermatology of Massachusetts, LLC /ID# 209468
state: Massachusetts
city: Chesterfield
country: United States
facility: Clin Res Inst of Michigan, LLC /ID# 208019
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical Center /ID# 204191
state: Michigan
city: Kirksville
country: United States
facility: Cleaver Dermatology /ID# 202825
state: Missouri
city: Omaha
country: United States
facility: Advanced Dermatology of the Midlands /ID# 201689
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Consortium /ID# 200734
state: Nevada
city: Portsmouth
country: United States
facility: AllCutis Research Inc /ID# 200981
state: New Hampshire
city: Bronx
country: United States
facility: Montefiore Medical Center /ID# 200456
state: New York
city: Kew Gardens
country: United States
facility: Forest Hills Dermatology Group /ID# 209244
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai /ID# 200370
state: New York
city: Troy
country: United States
facility: J. Schwartz, MD, PLLC /ID# 202121
state: New York
city: Cleveland
country: United States
facility: Velocity clinical research /ID# 202653
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute (LHSI) /ID# 212676
state: Oklahoma
city: Oklahoma City
country: United States
facility: Newton Clinical Research /ID# 204169
state: Oklahoma
city: Portland
country: United States
facility: Oregon Medical Res Center PC /ID# 200428
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University /ID# 200992
state: Oregon
city: Hazleton
country: United States
facility: Dermdox Dermatology Centers, PC /ID# 213782
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners, LLC /ID# 200460
state: Rhode Island
city: Charleston
country: United States
facility: Coastal Clinical Research Center of the Carolinas /ID# 200402
state: South Carolina
city: Arlington
country: United States
facility: Arlington Research Center, Inc /ID# 200391
state: Texas
city: Austin
country: United States
facility: Orion Clinical Research /ID# 204703
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates, PL /ID# 200705
state: Texas
city: Dallas
country: United States
facility: Menter Dermatology Res Inst /ID# 200390
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies - Webster TX /ID# 203185
state: Texas
city: Spokane
country: United States
facility: Dermatology Specialists of Spokane /ID# 202068
state: Washington
city: La Plata
country: Argentina
facility: Framingham Centro Medico /ID# 202688
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Instituto de Neumonología y Dermatología /ID# 203444
state: Ciuadad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Psoriahue Med Interdisciplinar /ID# 202451
state: Ciuadad Autonoma De Buenos Aires
city: Phillip
country: Australia
facility: Woden Dermatology /ID# 205799
state: Australian Capital Territory
city: Darlinghurst
country: Australia
facility: Holdsworth House Medical Practice /ID# 211236
state: New South Wales
city: Hectorville
country: Australia
facility: North Eastern Health Specialists /ID# 205802
state: South Australia
city: Carlton
country: Australia
facility: Skin Health Institute Inc /ID# 204791
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Dermatology /ID# 205305
state: Western Australia
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Centre of the Republic of Srpska /ID# 202666
state: Republika Srpska
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Centre of the Republic of Srpska /ID# 202667
state: Republika Srpska
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinical Center University of Sarajevo /ID# 202668
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinical Center University of Sarajevo /ID# 202669
city: Sofiya
country: Bulgaria
facility: UMHAT Alexandrovska EAD /ID# 201519
state: Sofia
city: Pleven
country: Bulgaria
facility: UMHAT Dr Georgi Stranski EAD /ID# 201521
city: Stara Zagora
country: Bulgaria
facility: UMHAT Professor Stoyan Kirkovich /ID# 201522
city: Calgary
country: Canada
facility: Kirk Barber Research, CA /ID# 200324
state: Alberta
city: Calgary
country: Canada
facility: Dermatology Research Institute Inc. /ID# 200318
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc. /ID# 200311
state: British Columbia
city: Surrey
country: Canada
facility: Enverus Medical Research /ID# 200307
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research /ID# 200323
state: Manitoba
city: Fredericton
country: Canada
facility: Dr. Irina Turchin PC Inc. /ID# 200322
state: New Brunswick
city: St. John's
country: Canada
facility: Karma Clinical Trials /ID# 200316
state: Newfoundland and Labrador
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - McMaster University Medical Centre /ID# 200313
state: Ontario
city: London
country: Canada
facility: Dr. Wei Jing Loo Medicine Prof /ID# 206051
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc. /ID# 200315
state: Ontario
city: Ottawa
country: Canada
facility: Dermatology Ottawa Research Centre /ID# 200319
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research /ID# 200317
state: Ontario
city: Montreal
country: Canada
facility: Dr. David Gratton Dermat Inc. /ID# 200309
state: Quebec
city: Montréal
country: Canada
facility: Innovaderm Research Inc. /ID# 200320
state: Quebec
city: Saint-Jerome
country: Canada
facility: Dre Angelique Gagne-Henley M.D. inc. /ID# 200326
state: Quebec
city: Beijing
country: China
facility: Peking University People's Hospital /ID# 202549
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital /ID# 202612
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 208597
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 202548
state: Guangdong
city: Shenyang
country: China
facility: The First Hospital of China Medical University /ID# 202615
state: Liaoning
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 202554
state: Shanghai
city: Hangzhou
country: China
facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 202608
state: Zhejiang
city: Beijing
country: China
facility: Beijing Friendship Hospital /ID# 202601
city: Shanghai
country: China
facility: Huashan Hospital of Fudan University /ID# 205760
city: Wuhan
country: China
facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 208598
city: Medellin
country: Colombia
facility: Clinisalud del sur /ID# 218100
state: Antioquia
city: Rionegro
country: Colombia
facility: Fundacion Hospital San Vicente de Paul - Rionegro /ID# 202043
state: Antioquia
city: Barranquilla
country: Colombia
facility: Ctr Int de Reum del Caribe SAS /ID# 201620
state: Atlantico
city: Monteria
country: Colombia
facility: Fundacion Centro de Excelencia en Enfermedades Cronicas no Transmisibles - FUNCE /ID# 201905
state: Cordoba
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Zagreb /ID# 201879
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Klinika za dječje bolesti Zagreb /ID# 203151
state: Grad Zagreb
city: Osijek
country: Croatia
facility: Duplicate_Klinicki bolnicki centar Osijek /ID# 201523
state: Osjecko-baranjska Zupanija
city: Rijeka
country: Croatia
facility: Klinicki bolnicki centar Rijeka /ID# 217423
state: Primorsko-goranska Zupanija
city: Split
country: Croatia
facility: Klinicki bolnicki centar Split /ID# 201527
state: Splitsko-dalmatinska Zupanija
city: Copenhagen NV
country: Denmark
facility: Bispebjerg and Frederiksberg Hospital /ID# 200979
state: Hovedstaden
city: Hellerup
country: Denmark
facility: Herlev and Gentofte Hospital /ID# 200736
state: Hovedstaden
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital /ID# 200737
state: Midtjylland
city: Mustamäe Linnaosa
country: Estonia
facility: North Estonia Medical Centre /ID# 200951
state: Harjumaa
city: Tallinn
country: Estonia
facility: Confido Private Medical Clinic /ID# 200846
state: Harjumaa
city: Tartu Linn
country: Estonia
facility: Tartu University Hospital /ID# 200847
state: Tartumaa
city: Turku
country: Finland
facility: Mehiläinen Neo /ID# 201116
state: Varsinais-Suomi
city: Kuopio
country: Finland
facility: Kuopio University Hospital /ID# 202449
city: Tampere
country: Finland
facility: Terveystalo Tampere /ID# 201117
city: Pierre Benite CEDEX
country: France
facility: HCL - Hôpital Lyon Sud /ID# 201529
state: Auvergne-Rhone-Alpes
city: Nantes
country: France
facility: CHU de Nantes, Hotel Dieu -HME /ID# 206377
state: Pays-de-la-Loire
city: Le Mans CEDEX 9
country: France
facility: Centre Hospitalier du Mans /ID# 205991
state: Sarthe
city: Lille Cedex
country: France
facility: Hopital Saint Vincent de Paul /ID# 218253
city: Martigues
country: France
facility: Le Bateau BLanc /ID# 206833
city: Paris
country: France
facility: AP-HP - Hopital Necker /ID# 218364
city: Rouen
country: France
facility: Hôpital Charles-Nicolle /ID# 201525
city: Toulouse
country: France
facility: CHU Toulouse - Hopital Larrey /ID# 201528
city: Munich
country: Germany
facility: Duplicate_Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202087
state: Bayern
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt /ID# 202089
state: Hessen
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster /ID# 202085
state: Nordrhein-Westfalen
city: Selters
country: Germany
facility: CMS3 Company for Medical Study /ID# 205193
state: Rheinland-Pfalz
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202255
state: Schleswig-Holstein
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn /ID# 202086
city: Hamburg
country: Germany
facility: TFS Trial Form Support GmbH /ID# 202083
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover /ID# 202091
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205192
city: Rome
country: Italy
facility: Fondazione PTV Policlinico Tor Vergata /ID# 201136
state: Roma
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200692
city: Bologna
country: Italy
facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 200746
city: Catania
country: Italy
facility: A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200741
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II /ID# 200750
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 200695
city: Nagakute-shi
country: Japan
facility: Aichi Medical University Hospital /ID# 202833
state: Aichi
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital /ID# 201309
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers /ID# 202891
state: Fukuoka
city: Gifu-shi
country: Japan
facility: Gifu University Hospital /ID# 201760
state: Gifu
city: Ogaki-shi
country: Japan
facility: Ogaki Municipal Hospital /ID# 203463
state: Gifu
city: Obihiro-shi
country: Japan
facility: Takagi Dermatology Clinic /ID# 201238
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Medical Cooperation Kojinkai Sapporo Skin Clinic /ID# 201239
state: Hokkaido
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine /ID# 201876
state: Kyoto
city: Sakai-shi
country: Japan
facility: Kume Clinic /ID# 201912
state: Osaka
city: Shinagawa-ku
country: Japan
facility: NTT Medical Center Tokyo /ID# 201759
state: Tokyo
city: Chuo-shi
country: Japan
facility: University of Yamanashi Hospital /ID# 204174
state: Yamanashi
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun /ID# 204375
state: Perak
city: Division Pantai Barat Utara
country: Malaysia
facility: Queen Elizabeth Hospital /ID# 204379
state: Sabah
city: Batu Caves
country: Malaysia
facility: Hospital Selayang /ID# 204378
state: Selangor
city: Hamilton
country: New Zealand
facility: Clinical Trials NZ /ID# 205335
city: Carolina
country: Puerto Rico
facility: Cruz-Santana, Carolina, PR /ID# 201096
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation /ID# 201821
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico /ID# 203309
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina /ID# 205860
city: Cluj Napoca
country: Romania
facility: Cabinet Medical de Dermatovenerologie Dr. Remus Orasan /ID# 205862
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Dermatovenerologic Dispensary /ID# 201996
state: Chelyabinskaya Oblast
city: Krasnodar
country: Russian Federation
facility: Clinical Dermatovenerology Dispensary /ID# 203439
state: Krasnodarskiy Kray
city: Saratov
country: Russian Federation
facility: Saratov State Medical University n.a. V.I. Razumovskiy /ID# 201595
state: Saratovskaya Oblast
city: Yekaterinburg
country: Russian Federation
facility: Ural Research Institute of dermatovenerology and immunopathology /ID# 201593
state: Sverdlovskaya Oblast
city: Moscow
country: Russian Federation
facility: National Medical Research Center for Children's Health /ID# 203440
city: Basel
country: Switzerland
facility: Universitätsspital Basel /ID# 201599
state: Basel-Stadt
city: Genève
country: Switzerland
facility: Hôpitaux Universitaires Genève /ID# 201600
state: Geneve
city: Lausanne
country: Switzerland
facility: CHUV, Centre hospitalier universitaire vaudois /ID# 200910
state: Vaud
city: Lausanne
country: Switzerland
facility: CHUV, Centre hospitalier universitaire vaudois /ID# 206505
state: Vaud
city: Bern
country: Switzerland
facility: Inselspital, Universitätsspital Bern /ID# 201598
city: Melikgazi
country: Turkey
facility: Erciyes University Medical Fac /ID# 204098
state: Kayseri
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Medicine /ID# 204099
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 204100
city: Yenimahalle
country: Turkey
facility: Gazi Universitesi Tip Fakultes /ID# 204176
city: Zaporizhzhya
country: Ukraine
facility: Military Hospital of Military-Medical Clinical Center of Southern Region /ID# 201962
state: Zaporizka Oblast
city: Rivne
country: Ukraine
facility: ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 210504
city: Isleworth
country: United Kingdom
facility: West Middlesex University Hospital /ID# 202273
state: London, City Of
city: London
country: United Kingdom
facility: Barts Health NHS Trust /ID# 201043
state: London, City Of
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust /ID# 201192
state: London, City Of
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHS Foundation Trust9 /ID# 201971
city: Salford
country: United Kingdom
facility: Northern Care Alliance NHS Group /ID# 201194
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
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: Simpson EL, Papp KA, Blauvelt A, Chu CY, Hong HC, Katoh N, Calimlim BM, Thyssen JP, Chiou AS, Bissonnette R, Stein Gold LF, Wegzyn C, Hu X, Liu M, Liu J, Tenorio AR, Chu AD, Guttman-Yassky E. Efficacy and Safety of Upadacitinib in Patients With Moderate to Severe Atopic Dermatitis: Analysis of Follow-up Data From the Measure Up 1 and Measure Up 2 Randomized Clinical Trials. JAMA Dermatol. 2022 Apr 1;158(4):404-413. doi: 10.1001/jamadermatol.2022.0029.
citation: Guttman-Yassky E, Teixeira HD, Simpson EL, Papp KA, Pangan AL, Blauvelt A, Thaci D, Chu CY, Hong HC, Katoh N, Paller AS, Calimlim B, Gu Y, Hu X, Liu M, Yang Y, Liu J, Tenorio AR, Chu AD, Irvine AD. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. Lancet. 2021 Jun 5;397(10290):2151-2168. doi: 10.1016/S0140-6736(21)00588-2. Epub 2021 May 21.