Clinical trial NCT06012240: A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata
Official title: A Phase 3 Randomized, Placebo-controlled, Double-blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Severe Alopecia Areata
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Alopecia Areata
Keywords: Alopecia Areata
Upadacitinib
Rinvoq
ABT-494
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-08-25
Enrollment: 1399
Sex: ALL
Minimum age (years): 12
Maximum age (years): 63
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the head and face, but hair loss can happen on any part of the body. The purpose of this study is to assess how safe, effective, and tolerable upadacitinib is in adolescent and adult participants with severe AA.

Upadacitinib is an approved drug being investigated for the treatment of AA. In Study 1 and Study 2 Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. In Study 1 and Study 2 Period B, participants originally randomized to upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will either remain on placebo in Period B, or be randomized in 1 of 2 groups, based off of their Severity of Alopecia Tool (SALT) score. Participants who complete Study 1 or Study 2, can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. Around 1500 participants with severe AA will be enrolled in the study at approximately 240 sites worldwide.

Participants will receive oral tablets of either upadacitinib or placebo once daily for up to 160 weeks with the potential of being re-randomized into a different treatment group at Weeks 24 and 52. Participants will be followed up for up to 30 days after last study drug dose.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria: Inclusion Criteria:

* Adult individuals must be \< 64 years old at Baseline Visit. Where permitted outside United States (US)/European Union (EU), adolescent individuals who are at least 12 years old at Screening may participate.
* Diagnosis of severe alopecia areata (AA) with Severity of Alopecia Tool (SALT) score \>= 50 scalp hair loss at Screening and Baseline.
* Severe AA with no spontaneous scalp hair regrowth over the past 6 months.
* Current episode of AA of less than 8 years.

Exclusion Criteria:

* Current diagnosis of primarily diffuse type of AA.
* Current diagnosis of other types of alopecia that would interfere with evaluation of AA, including but not limited to female pattern hair loss, male pattern hair loss (androgenetic alopecia) Stage III or greater based on Hamilton-Norwood classification, traction alopecia, lichen planopilaris (LPP), discoid lupus, frontal fibrosing alopecia (FFA), central centrifugal cicatricial alopecia (CCCA), folliculitis decalvans, trichotillomania, and telogen effluvium.
* Diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that would interfere with evaluation of AA as determined by the investigator, including but not limited to seborrheic dermatitis, scalp psoriasis, atopic dermatitis (AD), and tinea capitis.

Primary outcomes:
measure: Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20
timeFrame: Week 24
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 164 weeks
Secondary outcomes:
measure: Achievement of SALT score <= 20 for the Comparison of Upadacitinib Dose A QD Versus Placebo
timeFrame: Week 24
measure: Percentage of Participants with the Achievement of SALT Score <= 10
timeFrame: Up to Week 24
measure: Percentage of Participants with the Achievement of SALT Score <= 20
timeFrame: Up to Week 12
measure: Percentage of Participants with the Achievement of Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss of 0 or 1
timeFrame: Baseline to Week 24
measure: Percentage of Participants with the Achievement of ClinRO Measure for Eyelash Hair Loss of 0 or 1
timeFrame: Baseline to Week 24
measure: Percentage of Participants with the Achievement of SALT 75
timeFrame: Baseline to Week 24
measure: Percentage of Participants with the Achievement of SALT 90
timeFrame: Baseline to Week 24
measure: Percent Change from Baseline in SALT Score
timeFrame: Baseline to Week 24
measure: Percentage of Participants with the Achievement of Patients' Global Impression of Change of Alopecia Areata (PaGIC-AA) Score of 1 "Much Better" or 2 "Moderately Better"
timeFrame: Up to Week 24
measure: Percentage of Participants with the Achievement of Patient-Reported Outcome (PRO) for Scalp Hair Assessment 0/1 with ≥ 2-Point Improvement (Reduction)
timeFrame: Baseline to Week 24
measure: Change from Baseline in Alopecia Areata Symptom Impact Scale (AASIS) Interference Subscale Score
timeFrame: Week 24
measure: Change from Baseline in AASIS Symptoms Subscale Score
timeFrame: Week 24
measure: Change from Baseline in Skindex-16 AA Emotions Domain Scores
timeFrame: Week 24
measure: Change from Baseline in Skindex-16 AA Functioning Domain Scores
timeFrame: Week 24
measure: Achievement of Hospital Anxiety and Depression Scale (HADS)-Anxiety < 8 and HADS-Depression < 8 at Week 24 Among Participants with HADS-A >= 8 or HADS-D >= 8 at Baseline
timeFrame: Baseline to Week 24
measure: Percentage of Participants with the Achievement of SALT Score 0
timeFrame: Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center /ID# 259539
state: Alabama
city: Glendale
country: United States
facility: Advanced Research Associates - Glendale /ID# 259108
state: Arizona
city: Phoenix
country: United States
facility: Southwest Skin Specialists /ID# 258234
state: Arizona
city: Phoenix
country: United States
facility: Alliance Dermatology and Mohs Center /ID# 258111
state: Arizona
city: Fort Smith
country: United States
facility: Johnson Dermatology Clinic /ID# 259103
state: Arkansas
city: Encino
country: United States
facility: Joseph Raoof Md,Inc /Id# 258031
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology /ID# 259220
state: California
city: Irvine
country: United States
facility: University of California Irvine /ID# 259096
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates /ID# 258033
state: California
city: Redwood City
country: United States
facility: Stanford University School of Medicine - Redwood City /ID# 259542
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research /ID# 258114
state: California
city: Sacramento
country: United States
facility: University of California Davis Health /ID# 258112
state: California
city: Thousand Oaks
country: United States
facility: Clinical Trials Research Institute /ID# 258021
state: California
city: Boca Raton
country: United States
facility: Skin Care Research Boca Raton /ID# 258012
state: Florida
city: Brandon
country: United States
facility: Apex Clinical Trials /ID# 259205
state: Florida
city: Coral Gables
country: United States
facility: Florida Academic Dermatology Center /ID# 259353
state: Florida
city: Coral Gables
country: United States
facility: Skin Research Institute LLC /ID# 259207
state: Florida
city: Doral
country: United States
facility: Revival Research /ID# 259213
state: Florida
city: Hollywood
country: United States
facility: Skin Care Research - Hollywood /ID# 259210
state: Florida
city: Margate
country: United States
facility: GSI Clinical Research, LLC /ID# 259352
state: Florida
city: Margate
country: United States
facility: Life Clinical Trials /ID# 259358
state: Florida
city: Miami
country: United States
facility: Lenus Research and Medical Group /ID# 259356
state: Florida
city: Sanford
country: United States
facility: International Clinical Research - Sanford /ID# 259547
state: Florida
city: Tamarac
country: United States
facility: FWD Clinical Research /ID# 266687
state: Florida
city: Tampa
country: United States
facility: Advanced Clinical Research Institute /ID# 259204
state: Florida
city: Tampa
country: United States
facility: Avita Clinical Research /ID# 258011
state: Florida
city: Dawsonville
country: United States
facility: Cleaver Medical Group Dermatology /ID# 259801
state: Georgia
city: Marietta
country: United States
facility: Marietta Dermatology /ID# 259818
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine /ID# 259555
state: Illinois
city: Skokie
country: United States
facility: NorthShore University HealthSystem - Skokie /ID# 266684
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital /ID# 259827
state: Indiana
city: Leawood
country: United States
facility: U.S. Dermatology Partners Leawood /ID# 259203
state: Kansas
city: New Orleans
country: United States
facility: Tulane University School of Medicine /ID# 259799
state: Louisiana
city: Marriottsville
country: United States
facility: Care Access /ID# 268453
state: Maryland
city: Boston
country: United States
facility: MetroBoston Clinical Partners /ID# 259559
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center /ID# 260484
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group - Bay City /ID# 259100
state: Michigan
city: Canton
country: United States
facility: Hamzavi Dermatology - Canton /ID# 260115
state: Michigan
city: Chesterfield
country: United States
facility: Clin Res Inst of Michigan, LLC /ID# 259802
state: Michigan
city: Clarkston
country: United States
facility: Clarkston Dermatology /ID# 258018
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical Center - New Center One /ID# 258067
state: Michigan
city: Minneapolis
country: United States
facility: M Health Fairview University of Minnesota Medical Center - East Bank /ID# 260122
state: Minnesota
city: New Brighton
country: United States
facility: Minnesota Clinical Study Center /ID# 259218
state: Minnesota
city: Lee's Summit
country: United States
facility: Dermatology and Skin Center of Lees Summit /ID# 259206
state: Missouri
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC /ID# 259354
state: Nebraska
city: Omaha
country: United States
facility: Skin Specialists /ID# 259237
state: Nebraska
city: Reno
country: United States
facility: Skin Cancer and Dermatology Institute - Reno /ID# 259208
state: Nevada
city: New City
country: United States
facility: The Skin Center Dermatology Group /ID# 266748
state: New York
city: New York
country: United States
facility: Schweiger Dermatology, P.C. /ID# 258007
state: New York
city: New York
country: United States
facility: Schweiger Dermatology, P.C. /ID# 259531
state: New York
city: New York
country: United States
facility: Equity Medical, LLC /ID# 266680
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai /ID# 259808
state: New York
city: New York
country: United States
facility: Sadick Research Group LLC /ID# 266790
state: New York
city: Huntersville
country: United States
facility: Piedmont Plastic Surgery and Dermatology /ID# 258206
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic - Cleveland /ID# 258113
state: Ohio
city: Columbus
country: United States
facility: Remington-Davis Clinical Research /ID# 258106
state: Ohio
city: Mason
country: United States
facility: Dermatologists of Southwest Ohio, Inc /ID# 260116
state: Ohio
city: Springfield
country: United States
facility: Dermatologist of Central States (DOCS) Clinical Research - Springfield /ID# 266746
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology and Research Center /ID# 258243
state: Oregon
city: Portland
country: United States
facility: Oregon Medical Research Center /ID# 258107
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center /ID# 266681
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina /ID# 259828
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts /ID# 266678
state: South Dakota
city: Murfreesboro
country: United States
facility: International Clinical Research - Tennessee LLC /ID# 259552
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center, Inc /ID# 258028
state: Texas
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates /ID# 259360
state: Texas
city: Cedar Park
country: United States
facility: U.S. Dermatology Partners - Cedar Park /ID# 259367
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center /ID# 259357
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates, PLLC /ID# 259349
state: Texas
city: Dallas
country: United States
facility: Reveal Research Institute, Dallas /ID# 259361
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies - Houston - Northwest Freeway /ID# 258036
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research /ID# 259365
state: Texas
city: Sugar Land
country: United States
facility: Complete Dermatology /ID# 258025
state: Texas
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Buenos Aires Skin /ID# 258297
state: Ciudad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Instituto de Neumonologia y Dermatologia /ID# 258640
state: Ciudad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Psoriahue Med Interdisciplinar /ID# 258641
state: Ciudad Autonoma De Buenos Aires
city: Córdoba
country: Argentina
facility: Instituto De Investigaciones Clínicas Córdoba /ID# 260244
state: Cordoba
city: Buenos Aires
country: Argentina
facility: Centro de Investigacion y Prevencion Cardiovascular (CIPREC) /ID# 258639
city: Darlinghurst
country: Australia
facility: Momentum Clinical Research /ID# 258571
state: New South Wales
city: Kogarah
country: Australia
facility: St George Dermatology & Skin Cancer Centre /ID# 258567
state: New South Wales
city: Coorparoo
country: Australia
facility: Cornerstone Dermatology /ID# 258769
state: Queensland
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research /ID# 258566
state: Queensland
city: Carlton
country: Australia
facility: Skin Health Institute Inc /ID# 258570
state: Victoria
city: East Melbourne
country: Australia
facility: Sinclair Dermatology - Melbourne /ID# 258565
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital /ID# 258770
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Dermatology /ID# 260207
state: Western Australia
city: Anderlecht
country: Belgium
facility: Universite Libre de Bruxelles - Hopital Erasme /ID# 257314
state: Bruxelles-Capitale
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel /ID# 257325
state: Bruxelles-Capitale
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires UCL Saint-Luc /ID# 257320
state: Bruxelles-Capitale
city: Liège
country: Belgium
facility: CHU de Liège /ID# 257316
state: Liege
city: Gent
country: Belgium
facility: UZ Gent /ID# 257317
state: Oost-Vlaanderen
city: Torhout
country: Belgium
facility: AZ Delta - campus Torhout /ID# 257321
state: West-Vlaanderen
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre /ID# 258045
state: Rio Grande Do Sul
city: Botucatu
country: Brazil
facility: Upeclin Fmb - Unesp /Id# 258046
state: Sao Paulo
city: Campinas
country: Brazil
facility: Hospital e Maternidade Celso Pierro - PUC-Campinas /ID# 258105
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Brasil de Pesquisa Clinica S.A - IBPClin /ID# 258750
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz /ID# 258104
city: Sofiya
country: Bulgaria
facility: Diagnostic Consultative Center Aleksandrovska /ID# 257049
state: Sofia
city: Plovdiv
country: Bulgaria
facility: UMHAT Sveti Georgi /ID# 257548
city: Sofia
country: Bulgaria
facility: Ambulatory for Specialized Medical Care for skin and venereal diseases /ID# 257047
city: Sofiya
country: Bulgaria
facility: Diagnostic consultative center Focus-5 /ID# 257048
city: Sofiya
country: Bulgaria
facility: XX Diagnostic consultative center Sofia EOOD /ID# 257273
city: Stara Zagora
country: Bulgaria
facility: UMHAT Professor Stoyan Kirkovich /ID# 257051
city: Calgary
country: Canada
facility: Dermatology Research Institute - Blackfoot Trail /ID# 258818
state: Alberta
city: Calgary
country: Canada
facility: Beacon Dermatology Inc /ID# 258817
state: Alberta
city: Edmonton
country: Canada
facility: Rejuvenation Dermatology - Edmonton Downtown /ID# 258816
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc. /ID# 258814
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research /ID# 258819
state: Manitoba
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Center /ID# 258820
state: Ontario
city: Hamilton
country: Canada
facility: Leader Research /ID# 267028
state: Ontario
city: Markham
country: Canada
facility: Lynde Institute for Dermatology /ID# 258815
state: Ontario
city: Ottawa
country: Canada
facility: JRB Research /ID# 259248
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology /ID# 258813
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology Clinic & Research Centre /ID# 267026
state: Ontario
city: Sudbury
country: Canada
facility: Medicor Research Inc /ID# 258810
state: Ontario
city: Waterloo
country: Canada
facility: Private Practice - Dr. Kim Papp Clinical Research /ID# 259249
state: Ontario
city: Montréal
country: Canada
facility: Innovaderm Research Inc. /ID# 258812
state: Quebec
city: Québec
country: Canada
facility: Centre de Recherche dermatologique du Quebec Metropolitain /ID# 258811
state: Quebec
city: St-Jérôme
country: Canada
facility: Private Practice - Dr. Angelique Gagne-Henley /ID# 267027
state: Quebec
city: Independencia
country: Chile
facility: Fundacion Innovacion Cardiovascular /ID# 259313
state: Region Metropolitana De Santiago
city: Las Condes
country: Chile
facility: Centro Medico Skin Med SPA /ID# 259314
state: Region Metropolitana Santiago
city: Santiago
country: Chile
facility: Centro Internacional de Estudios Clinicos - CIEC /ID# 259312
state: Region Metropolitana Santiago
city: Vitacura
country: Chile
facility: Clinica Dermacross /ID# 259311
state: Region Metropolitana Santiago
city: Beijing
country: China
facility: Beijing Chaoyang Hospital,Capital Medical University /ID# 258912
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital /ID# 258941
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital /ID# 258940
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital Affiliated To Capital Medical University /ID# 266715
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University /ID# 260254
state: Chongqing
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University /ID# 257367
state: Guangdong
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University /ID# 257118
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University /ID# 258663
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University /ID# 258485
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital /ID# 258208
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital /ID# 258060
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital - Tongji Medical College /ID# 266737
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University /ID# 260260
state: Hubei
city: Nanchang
country: China
facility: Dermatology Hospital of Jiangxi Provincial /ID# 259488
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University /ID# 257496
state: Jilin
city: Xi'an
country: China
facility: Second Affiliated Hospital of Xian Jiaotong University /ID# 257497
state: Shaanxi
city: Jinan
country: China
facility: Dermatology Hospital Affiliated to Shandong First Medical University /ID# 267520
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University /ID# 257758
state: Shanghai
city: Taiyuan
country: China
facility: First Affiliated Hospital of Shanxi Medical University /ID# 259647
state: Shanxi
city: Chengdu
country: China
facility: Chengdu Second Municipal People's Hospital /ID# 259492
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital, Sichuan University /ID# 259560
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital /ID# 259525
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 257260
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 257119
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University /ID# 257739
state: Zhejiang
city: Zagreb
country: Croatia
facility: DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 257151
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Zagreb /ID# 257630
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Poliklinika Solmed /ID# 257651
state: Grad Zagreb
city: Split
country: Croatia
facility: Klinicki Bolnicki Centar (KBC) Split /ID# 257632
state: Splitsko-dalmatinska Zupanija
city: Rijeka
country: Croatia
facility: Specialty hospital Medico /ID# 257629
city: Nice
country: France
facility: Chu de Nice-Hopital Larchet Ii /Id# 256978
state: Alpes-Maritimes
city: Rennes
country: France
facility: Hopital Ponchaillou /ID# 257520
state: Bretagne
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-Andre /ID# 257519
state: Gironde
city: Reims
country: France
facility: Polyclinique Courlancy /ID# 256977
state: Marne
city: Nantes
country: France
facility: CHU de Nantes, Hotel Dieu -HME /ID# 256982
state: Pays-de-la-Loire
city: Lyon
country: France
facility: HCL - Hopital Edouard Herriot /ID# 256983
state: Rhone
city: Brest
country: France
facility: CHRU de Brest - Hopital Morvan /ID# 256979
city: Paris
country: France
facility: Centre de Sante Sabouraud /ID# 257213
city: Rouen
country: France
facility: Hôpital Charles-Nicolle /ID# 256981
city: Toulouse
country: France
facility: CHU Toulouse - Hopital Larrey /ID# 256980
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim /ID# 257741
state: Niedersachsen
city: Düsseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf /ID# 257307
state: Nordrhein-Westfalen
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster /ID# 257306
state: Nordrhein-Westfalen
city: Lübeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 257305
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 257310
city: Munich
country: Germany
facility: Klinikum rechts der Isar /ID# 257609
city: Athens
country: Greece
facility: General Hospital Andreas Syggros /ID# 257259
state: Attiki
city: Athens
country: Greece
facility: General Hospital Andreas Syggros /ID# 257262
state: Attiki
city: Thessaloniki
country: Greece
facility: Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 257263
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital /ID# 257258
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Varmegyei Oktatokorhaz /ID# 257472
state: Bacs-Kiskun
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 257468
state: Baranya
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 258552
state: Csongrad
city: Debrecen
country: Hungary
facility: Debreceni Egyetem-Klinikai Kozpont /ID# 257465
state: Hajdu-Bihar
city: Debrecen
country: Hungary
facility: DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 257469
city: Kecskemet
country: Hungary
facility: Bagoly Egeszseghaz (Meditres Kft.) /ID# 258032
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 257770
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 257771
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hebrew University /ID# 257946
state: Yerushalayim
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 257769
city: Petah Tikva
country: Israel
facility: Rabin Medical Center /ID# 257772
city: Bologna
country: Italy
facility: IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 257499
state: Emilia-Romagna
city: Florence
country: Italy
facility: AZIENDA USL TOSCANA CENTRO - Ospedale Piero Palagi /ID# 257501
state: Firenze
city: L'Aquila
country: Italy
facility: Presidio Ospedaliero San Salvatore /ID# 257506
state: L Aquila
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas /ID# 257500
state: Lombardia
city: Naples
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II /ID# 257504
state: Napoli
city: Naples
country: Italy
facility: Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 258585
state: Napoli
city: Rome
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 257502
state: Roma
city: Rome
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 257513
state: Roma
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 257505
state: Roma
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia /ID# 257508
city: Catania
country: Italy
facility: AOU Policlinico G. Rodolico - San Marco /ID# 257507
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 257503
city: Kurume-shi
country: Japan
facility: Kurume University Hospital /ID# 257255
state: Fukuoka
city: Sagamihara-shi
country: Japan
facility: Kitasato University Hospital /ID# 257285
state: Kanagawa
city: Niigata-shi
country: Japan
facility: Niigata University Medical & Dental Hospital /ID# 259425
state: Niigata
city: Osaka-shi
country: Japan
facility: Osaka Metropolitan University Hospital /ID# 257256
state: Osaka
city: Hamamatsu
country: Japan
facility: Hamamatsu University School Of Medicine University Hospital /ID# 257253
state: Shizuoka
city: Mitaka-shi
country: Japan
facility: Kyorin University Hospital - Mitaka Campus /ID# 257283
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital /ID# 258132
state: Tokyo
city: Ube-shi
country: Japan
facility: Yamaguchi University Hospital /ID# 257252
state: Yamaguchi
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital /ID# 257910
state: Busan Gwang Yeogsi
city: 중구
country: Korea, Republic of
facility: Kyungpook National University Hospital /ID# 257908
state: Daegu Gwang Yeogsi
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital /ID# 267151
state: Daejeon Gwang Yeogsi
city: Dongjak-gu
country: Korea, Republic of
facility: Chungang University Hospital /ID# 267155
state: Gyeonggido
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital /ID# 257906
state: Gyeonggido
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital /ID# 257904
state: Incheon Gwang Yeogsi
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital /ID# 267154
state: Jeonrabugdo
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 257903
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center /ID# 257900
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong /ID# 257907
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangdong Sacred Heart Hospital /ID# 257905
city: Epsom
country: New Zealand
facility: Greenlane Clinical Centre /ID# 258563
state: Auckland
city: Hamilton
country: New Zealand
facility: Clinical Trials New Zealand /ID# 258564
state: Waikato
city: Auckland
country: New Zealand
facility: Aotearoa Clinical Trials /ID# 258562
city: Wellington
country: New Zealand
facility: P3 Research Ltd /ID# 259846
city: Osielsko
country: Poland
facility: Dermodent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski /ID# 258242
state: Kujawsko-pomorskie
city: Torun
country: Poland
facility: MICS Centrum Medyczne Torun /ID# 257740
state: Kujawsko-pomorskie
city: Krakow
country: Poland
facility: Specjalistyczny Gabinet Dermatologiczny Aplikacyjno Badawczy /ID# 257534
state: Malopolskie
city: Warsaw
country: Poland
facility: Royalderm Agnieszka Nawrocka /ID# 257536
state: Mazowieckie
city: Warszawa
country: Poland
facility: Klinika Osipowicz & Turkowski sp.z.o.o /ID# 257598
state: Mazowieckie
city: Bialystok
country: Poland
facility: Osteo Medic s.c. Artur Racewicz Jerzy Supronik /ID# 257531
state: Podlaskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 257535
state: Pomorskie
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita /ID# 257916
state: Slaskie
city: Elblag
country: Poland
facility: Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 257537
state: Warminsko-mazurskie
city: Cracow
country: Poland
facility: Centrum Medyczne ALL-MED Badania Kliniczne /ID# 257590
city: Almada
country: Portugal
facility: Unidade Local de Saude de Almada-Seixal, EPE /ID# 257425
city: Lisboa
country: Portugal
facility: Hospital CUF Descobertas /ID# 257419
city: Porto
country: Portugal
facility: Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 258554
city: Bayamon
country: Puerto Rico
facility: Santa Cruz Behavioral (SCB) Research Center /ID# 259350
city: Caguas
country: Puerto Rico
facility: Dr. Samuel Sanchez PSC /ID# 259359
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico /ID# 259355
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC /ID# 258013
city: San Juan
country: Puerto Rico
facility: Mindful Medical Research /ID# 260113
city: Bratislava
country: Slovakia
facility: Derma therapy spol /ID# 257595
state: Bratislavsky Kraj
city: Presov
country: Slovakia
facility: Fakultna nemocnica s poliklinikou J.A. Reimana Presov /ID# 257593
state: Presovsky Kraj
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava, Nemocnica Stare mesto /ID# 257594
city: Topolcany
country: Slovakia
facility: Kaderma Majtan s.r.o. /ID# 257596
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge /ID# 257332
state: Barcelona
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia /ID# 257035
state: Cordoba
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada /ID# 257334
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau /ID# 257034
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 257333
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset /ID# 257036
city: Solna
country: Sweden
facility: Karolinska University Hospital Solna /ID# 257094
state: Stockholms Lan
city: Stockholm
country: Sweden
facility: Diagnostiskt Centrum Hud /ID# 257229
state: Stockholms Lan
city: Mölndal
country: Sweden
facility: CTC GoCo /ID# 257714
state: Vastra Gotalands Lan
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital /ID# 258726
state: Kaohsiung
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 257407
state: Taipei
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital /ID# 257409
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hosp /ID# 257413
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital /ID# 258725
city: Ankara
country: Turkey
facility: Gulhane Egitim ve Arastirma Hastanesi /ID# 257509
city: Ankara
country: Turkey
facility: Ankara City Hospital /ID# 257417
city: Gaziantep
country: Turkey
facility: Gaziantep Universitesi /ID# 257418
city: Istanbul
country: Turkey
facility: Bagcilar Medipol Mega Universite Hastanesi /ID# 257449
city: Kayseri
country: Turkey
facility: Erciyes University Medical Faculty /ID# 259034
city: High Wycombe
country: United Kingdom
facility: Velocity Clinical Research Ltd /ID# 257925
state: Buckinghamshire
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital /ID# 257912
state: East Sussex
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hospital /ID# 257953
state: Gloucestershire
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital /ID# 259128
state: Greater London
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust /ID# 257948
state: Oxfordshire
city: Harrow
country: United Kingdom
facility: London North West University Healthcare NHS Trust /ID# 257914
city: Salford
country: United Kingdom
facility: Northern Care Alliance NHS Group /ID# 257952
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: