Clinical trial NCT05889182: A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy
Official title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis Suppurativa
Upadacitinib
ABT-494
Rinvoq
STEP-UP HS
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-06-05
Enrollment: 1328
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions in the axilla (underarm), inguinal (groin) and anogenital (anal/genital) regions. This study will assess how safe and effective upadacitinib is in treating adult and adolescent participants with moderate to severe HS who have failed to respond to or are intolerant of anti-tumor necrosis factor (TNF) therapy. Adverse events and change in disease activity will be assessed.

Upadacitinib is an approved drug for ulcerative colitis, atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of HS. This study is "double-blinded", meaning that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo. This study is comprised of 3 periods. In Period 1, participants are randomized into 2 groups called treatment arms where each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. In Period 2, participants are placed into 6 different groups depending on their placement and results in Period 1. Period 3 is the long-term extension period where participants will continue treatment from Period 2. Approximately 1328 adult and adolescent participants diagnosed with HS will be enrolled in approximately 300 sites worldwide.

Participants will receive oral tablets of upadacitinib or placebo once daily for 36 weeks in Period 1 and Period 2. Eligible participants from Period 1 and Period 2 will enter Period 3 and receive oral tablets of upadacitinib or placebo once daily for 68 weeks. Participants will be followed up for approximately 30 days.

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


Eligibility criteria: Inclusion Criteria:

* Diagnosis of hidradenitis suppurativa (HS) for at least 6 months prior to Baseline, as determined by the investigator (i.e., through medical history and interview of participant).
* Documented history of previous use of \>= 1 tumor necrosis factor (TNF) inhibitor for HS for at least 12 weeks and/or 1 approved non-anti-TNF biologic therapy for HS for at least 16 weeks characterized by inadequate response or for any duration characterized by intolerance as determined by the investigator.
* Participant must have a total abscess and inflammatory nodule (AN) count of \>= 5 at Baseline.
* HS lesions must be present in at least 2 distinct anatomic areas at Baseline.
* At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.
* Draining fistula count of \<= 20 at Baseline.

Exclusion Criteria:

* History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit.
* Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug or be currently enrolled in another interventional clinical study. Investigational drugs are also prohibited during the study.
* Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 (e.g., rituximab) within 12 months prior to Baseline or until B cell count returns to normal level or pre-treatment level.
* Use of prescription topical therapies (including topical antibiotics) that can also be used to treat HS within 14 days prior to the Baseline visit.
* Received any systemic (including oral) antibiotic treatment for HS or any other chronic inflammatory disorder within 14 days prior to the Baseline visit.

Primary outcomes:
measure: Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 50
timeFrame: Baseline to Week 16
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Approximately Week 108
Secondary outcomes:
measure: Change from Baseline in Draining Fistula Count
timeFrame: Baseline to Week 16
measure: Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75
timeFrame: Baseline to Week 16
measure: Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 4 Among Participants with NRS ≥ 3 at Baseline
timeFrame: Baseline to Week 4
measure: Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA)
timeFrame: Baseline to Week 16
measure: Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA)
timeFrame: Baseline to Week 16
measure: Change from Baseline in Dermatology Life Quality Index (DLQI) for Adult Participants and Adolescent Participants Age ≥16 Years Old and Older
timeFrame: Baseline to Week 16
measure: Change from Baseline in Hidradenitis Suppurativa (HS)-Related Odor, Based on Hidradenitis Suppurativa Symptom Assessment (HSSA) Question 8
timeFrame: Baseline to Week 16
measure: Change from Baseline in the Patient's Global Assessment of Hidradenitis Suppurativa (HS)-Related Skin Pain NRS
timeFrame: Baseline to Week 8
measure: Occurrence of Hidradenitis Suppurativa (HS) Flare During Period 1
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Dermatology & Skin Health Center /ID# 254876
state: Alabama
city: Phoenix
country: United States
facility: Medical Dermatology Specialists /ID# 254226
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic - Scottsdale /ID# 254388
state: Arizona
city: Tucson
country: United States
facility: Banner University Medicine Dermatology /ID# 255853
state: Arizona
city: Fayetteville
country: United States
facility: Clinical Trials Institute - Northwest Arkansas /ID# 254924
state: Arkansas
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research /ID# 254238
state: Arkansas
city: North Little Rock
country: United States
facility: Arkansas Research Trials /ID# 254233
state: Arkansas
city: Rogers
country: United States
facility: NW Arkansas Clinical Trials Center /ID# 254311
state: Arkansas
city: Encino
country: United States
facility: Private Practice - Dr. Tooraj Raoof /ID# 254374
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates /ID# 254846
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research /ID# 254930
state: California
city: Sacramento
country: United States
facility: University of California Davis Health /ID# 254229
state: California
city: San Diego
country: United States
facility: Medderm Associates /ID# 253800
state: California
city: Thousand Oaks
country: United States
facility: Clinical Trials Research Institute /ID# 254466
state: California
city: Farmington
country: United States
facility: UConn Health Main /ID# 254507
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine /ID# 254586
state: Connecticut
city: Boca Raton
country: United States
facility: Skin Care Research Boca Raton /ID# 253814
state: Florida
city: Brandon
country: United States
facility: Apex Clinical Trials /ID# 255756
state: Florida
city: Coral Gables
country: United States
facility: Florida Academic Dermatology Center /ID# 254011
state: Florida
city: Hollywood
country: United States
facility: Skin Care Research - Hollywood /ID# 254508
state: Florida
city: Margate
country: United States
facility: Life Clinical Trials /ID# 258613
state: Florida
city: Tampa
country: United States
facility: Skin Care Research - Tampa /ID# 256440
state: Florida
city: Tampa
country: United States
facility: Advanced Clinical Research Institute /ID# 253746
state: Florida
city: Tampa
country: United States
facility: Avita Clinical Research /ID# 254471
state: Florida
city: Columbus
country: United States
facility: Centricity Research /ID# 255470
state: Georgia
city: Boise
country: United States
facility: Treasure Valley Medical Research /ID# 255208
state: Idaho
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine /ID# 254503
state: Illinois
city: Chicago
country: United States
facility: DeNova Research /ID# 254372
state: Illinois
city: Skokie
country: United States
facility: NorthShore University HealthSystem - Skokie /ID# 254389
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin, LLC /ID# 254390
state: Indiana
city: West Lafayette
country: United States
facility: Options Research Group /ID# 254537
state: Indiana
city: Leawood
country: United States
facility: U.S. Dermatology Partners Leawood /ID# 255838
state: Kansas
city: Bowling Green
country: United States
facility: Equity Medical, LLC /ID# 271140
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital /ID# 261093
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center /ID# 253811
state: Massachusetts
city: Quincy
country: United States
facility: Beacon Clinical Research, LLC /ID# 254419
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center /ID# 258839
state: Massachusetts
city: Canton
country: United States
facility: Hamzavi Dermatology - Canton /ID# 275856
state: Michigan
city: Waterford
country: United States
facility: Michigan Dermatology Institute /ID# 254468
state: Michigan
city: Kirksville
country: United States
facility: Cleaver Dermatology /ID# 254391
state: Missouri
city: Lee's Summit
country: United States
facility: Dermatology and Skin Center of Lees Summit /ID# 257546
state: Missouri
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials /ID# 254392
state: Missouri
city: Saint Louis
country: United States
facility: SSM Health Saint Louis University Hospital /ID# 256437
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine - St. Louis /ID# 254506
state: Missouri
city: Las Vegas
country: United States
facility: Vivida Dermatology- Flamingo /ID# 254227
state: Nevada
city: Las Vegas
country: United States
facility: Las Vegas Dermatology /ID# 272421
state: Nevada
city: Reno
country: United States
facility: Skin Cancer and Dermatology Institute - Reno /ID# 254410
state: Nevada
city: New Hyde Park
country: United States
facility: NorthWell Health - Dermatology /ID# 254704
state: New York
city: New York
country: United States
facility: Schweiger Dermatology, P.C. /ID# 254232
state: New York
city: Charlotte
country: United States
facility: Onsite Clinical Solutions /ID# 254854
state: North Carolina
city: Durham
country: United States
facility: Duke University (School of Medicine) /ID# 256898
state: North Carolina
city: Columbus
country: United States
facility: ClinOhio Research Services /ID# 254851
state: Ohio
city: Mason
country: United States
facility: Dermatologists of Southwest Ohio, Inc /ID# 254297
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Institute of Oklahoma City /ID# 253791
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University /ID# 254929
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center /ID# 254925
state: Pennsylvania
city: Philadelphia
country: United States
facility: Paddington Testing Co., Inc. /ID# 254394
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC /ID# 255308
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina /ID# 272569
state: South Carolina
city: Knoxville
country: United States
facility: Dermatology Associates of Knoxville /ID# 261082
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center, Inc /ID# 253805
state: Texas
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates /ID# 253797
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center /ID# 253795
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates, PLLC /ID# 253810
state: Texas
city: Dallas
country: United States
facility: HRMD Research Dallas /ID# 255256
state: Texas
city: Grapevine
country: United States
facility: Dallas Fort Worth Clinical Research Associates (DFWCRA) /ID# 256438
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates-Houston /ID# 254228
state: Texas
city: Plano
country: United States
facility: Texas Dermatology Research Center, LLC /ID# 254928
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies Webster TX /ID# 254242
state: Texas
city: Murray
country: United States
facility: University of Utah /ID# 254452
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia - Dermatology /ID# 254535
state: Virginia
city: Lynchburg
country: United States
facility: The Education & Research Foundation, Inc. /ID# 254852
state: Virginia
city: Norfolk
country: United States
facility: Virginia Clinical Research /ID# 254538
state: Virginia
city: Mill Creek
country: United States
facility: North Sound Dermatology /ID# 254554
state: Washington
city: Spokane
country: United States
facility: Premier Clinical Research /ID# 254847
state: Washington
city: Pilar
country: Argentina
facility: Hospital Universitario Austral /ID# 254904
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Buenos Aires Skin /ID# 255299
state: Ciudad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Instituto de Neumonologia y Dermatologia /ID# 254903
state: Ciudad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Psoriahue Med Interdisciplinar /ID# 257202
state: Ciudad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Consultorios Reumatologicos Pampa /ID# 255555
state: Ciudad Autonoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro de Investigacion y Prevencion Cardiovascular (CIPREC) /ID# 255474
city: Caba
country: Argentina
facility: Hospital Italiano /ID# 254905
city: Phillip
country: Australia
facility: Paratus Clinical Research Woden /ID# 254670
state: Australian Capital Territory
city: Darlinghurst
country: Australia
facility: Momentum Clinical Research /ID# 254411
state: New South Wales
city: Carlton
country: Australia
facility: Skin Health Institute Inc /ID# 254416
state: Victoria
city: East Melbourne
country: Australia
facility: Sinclair Dermatology - Melbourne /ID# 254412
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital /ID# 254414
state: Victoria
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 253458
state: Oberoesterreich
city: Graz
country: Austria
facility: Medizinische Universitaet Graz /ID# 253448
state: Steiermark
city: Vienna
country: Austria
facility: Medizinische Universitaet Wien /ID# 254096
state: Wien
city: Anderlecht
country: Belgium
facility: Universite Libre de Bruxelles - Hopital Erasme /ID# 254082
state: Bruxelles-Capitale
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires UCL Saint-Luc /ID# 254087
state: Bruxelles-Capitale
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel /ID# 254223
state: Bruxelles-Capitale
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi - Les Viviers /ID# 254091
state: Hainaut
city: Liège
country: Belgium
facility: CHU de Liège /ID# 254085
state: Liege
city: Gent
country: Belgium
facility: UZ Gent /ID# 254090
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 254089
state: Vlaams-Brabant
city: Macaé
country: Brazil
facility: Instituto de Pesquisa e Ensino CLIGEDIMUNO - IPEC /ID# 254369
state: Rio De Janeiro
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento /ID# 254366
state: Rio Grande Do Sul
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 254367
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Centro de Desenvolvimento em Estudos Clinicos Brasil - CDEC /ID# 254368
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 254370
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda University Hospital EAD /ID# 253331
city: Sofia
country: Bulgaria
facility: Ambulatory for Specialized Medical Care for skin and venereal diseases /ID# 253329
city: Sofiya
country: Bulgaria
facility: Diagnostic consultative center Focus-5 /ID# 253327
city: Stara Zagora
country: Bulgaria
facility: UMHAT Professor Stoyan Kirkovich /ID# 253328
city: Calgary
country: Canada
facility: Dermatology Research Institute - Blackfoot Trail /ID# 261413
state: Alberta
city: Calgary
country: Canada
facility: Beacon Dermatology Inc /ID# 254564
state: Alberta
city: Edmonton
country: Canada
facility: Rejuvenation Dermatology - Edmonton Downtown /ID# 254715
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc. /ID# 254378
state: British Columbia
city: Surrey
country: Canada
facility: Enverus Medical Research /ID# 254380
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research /ID# 254117
state: Manitoba
city: St. John's
country: Canada
facility: Karma Clinical Trials /ID# 254120
state: Newfoundland and Labrador
city: Hamilton
country: Canada
facility: LEADER Research /ID# 254379
state: Ontario
city: London
country: Canada
facility: DermEffects /ID# 254116
state: Ontario
city: Markham
country: Canada
facility: Lynde Institute for Dermatology /ID# 254713
state: Ontario
city: Newmarket
country: Canada
facility: Ryan Clinical Research Inc /ID# 254714
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology Clinic and Research Centre /ID# 254115
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto /ID# 255273
state: Ontario
city: Montreal
country: Canada
facility: CHU Sainte-Justine /ID# 254118
state: Quebec
city: Saint-Jerome
country: Canada
facility: Dre Angelique Gagne-Henley M.D. inc. /ID# 255632
state: Quebec
city: Saskatoon
country: Canada
facility: SkinSense Dermatology /ID# 254119
state: Saskatchewan
city: Quebec
country: Canada
facility: Diex Recherche Quebec Inc. /ID# 254381
city: Independencia
country: Chile
facility: Fundacion Innovacion Cardiovascular /ID# 254561
state: Region Metropolitana De Santiago
city: Las Condes
country: Chile
facility: Centro Medico Skin Med SPA /ID# 254560
state: Region Metropolitana Santiago
city: Santiago
country: Chile
facility: Centro Internacional de Estudios Clinicos - CIEC /ID# 254559
state: Region Metropolitana Santiago
city: Vitacura
country: Chile
facility: Clinica Dermacross /ID# 254558
state: Region Metropolitana Santiago
city: Medellin
country: Colombia
facility: Clinisalud del sur /ID# 254797
state: Antioquia
city: Medellín
country: Colombia
facility: IPS Suramericana SAS - IPS Sura San Diego /ID# 255064
state: Antioquia
city: Barranquilla
country: Colombia
facility: Centro Integral de Reumatología del Caribe SAS - Circaribe SAS /ID# 255278
state: Atlantico
city: Bogotá
country: Colombia
facility: Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 254796
state: Cundinamarca
city: Zagreb
country: Croatia
facility: DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 253587
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Zagreb /ID# 253786
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Klinika za dječje bolesti Zagreb /ID# 253588
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Poliklinika Solmed /ID# 254732
state: Grad Zagreb
city: Split
country: Croatia
facility: Klinicki Bolnicki Centar (KBC) Split /ID# 253789
state: Splitsko-dalmatinska Zupanija
city: Ivanic-Grad
country: Croatia
facility: Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 253586
state: Zagrebacka Zupanija
city: Rijeka
country: Croatia
facility: Specialty hospital Medico /ID# 254731
city: Karlovy Vary
country: Czechia
facility: Karlovarska Krajska Nemocnice - Karlovy Vary /ID# 253456
city: Prague
country: Czechia
facility: Duplicate_Fakultni Nemocnice v Motole /ID# 253455
city: Praha
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady /ID# 253454
city: Tampere
country: Finland
facility: Terveystalo Tampere /ID# 253968
state: Pirkanmaa
city: Oulu
country: Finland
facility: Oulun yliopistollinen sairaala /ID# 253969
state: Pohjois-Pohjanmaa
city: Nice
country: France
facility: Chu de Nice-Hopital L'Archet Ii /Id# 253504
state: Alpes-Maritimes
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-Andre /ID# 254139
state: Gironde
city: Antony
country: France
facility: Hopital Prive d'Antony /ID# 253501
state: Ile-de-France
city: Reims
country: France
facility: Polyclinique Courlancy /ID# 254680
state: Marne
city: Nantes
country: France
facility: CHU de Nantes, Hotel Dieu -HME /ID# 254114
state: Pays-de-la-Loire
city: Lyon
country: France
facility: HCL - Hopital Edouard Herriot /ID# 253500
state: Rhone
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen /ID# 254804
state: Bayern
city: Bramsche
country: Germany
facility: Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 254510
state: Niedersachsen
city: Mainz
country: Germany
facility: Universitaetsmedizin Mainz /ID# 272596
state: Rheinland-Pfalz
city: Merzig
country: Germany
facility: HMS GmbH Zimmer /ID# 272614
state: Saarland
city: Berlin
country: Germany
facility: Havelklinik /ID# 254194
city: Bochum
country: Germany
facility: Klinikum Ruhr Univ Bochum /ID# 253690
city: Magdeburg
country: Germany
facility: Magdeburger Company for Medical Studies & Services GmbH /ID# 255151
city: Mainz
country: Germany
facility: Dermatologie Quist-BAG Dres. med. Quist PartG /ID# 253691
city: Munich
country: Germany
facility: Klinik am Biederstein /ID# 254195
city: Regensburg
country: Germany
facility: Universitaetsklinikum Regensburg /ID# 253692
city: Athens
country: Greece
facility: 401 GSNA - 401 Army General Hospital /ID# 253499
state: Attiki
city: Athens
country: Greece
facility: University General Hospital Attikon /ID# 253495
state: Attiki
city: Athens
country: Greece
facility: General Hospital Andreas Syggros /ID# 253498
state: Attiki
city: Thessaloniki
country: Greece
facility: Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 253497
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital /ID# 253496
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 253753
state: Baranya
city: Debrecen
country: Hungary
facility: Debreceni Egyetem-Klinikai Kozpont /ID# 253637
state: Hajdu-Bihar
city: Kaposvár
country: Hungary
facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 253913
state: Somogy
city: Szombathely
country: Hungary
facility: Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 254377
state: Vas
city: Budapest
country: Hungary
facility: Csalogany Orvosi Kozpont /ID# 255063
city: Budapest
country: Hungary
facility: Duplicate_Obudai Egeszsegugyi Centrum Kft. /ID# 256366
city: Debrecen
country: Hungary
facility: DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 253638
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem /ID# 255142
city: Dublin 8
country: Ireland
facility: St James Hospital /ID# 253973
state: Dublin
city: Cork
country: Ireland
facility: South Infirmary Victoria University Hospital /ID# 253975
city: Dublin
country: Ireland
facility: University College Dublin /ID# 253971
city: Galway
country: Ireland
facility: University Hospital Galway /ID# 253976
city: Waterford
country: Ireland
facility: Waterford Regional Hospital /ID# 254038
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 254406
state: H_efa
city: Safed
country: Israel
facility: ZIV Medical Center /ID# 254403
state: HaTsafon
city: Ramat Gan
country: Israel
facility: Sheba Medical Center /ID# 254545
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 254404
state: Tel-Aviv
city: Petah Tikva
country: Israel
facility: Rabin Medical Center /ID# 254405
city: Cona
country: Italy
facility: Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale S.Anna /ID# 254496
state: Ferrara
city: Florence
country: Italy
facility: AZIENDA USL TOSCANA CENTRO - Ospedale Piero Palagi /ID# 254495
state: Firenze
city: Rome
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 254498
state: Roma
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 254500
state: Roma
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia /ID# 254875
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 254502
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena /ID# 254874
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana /ID# 254501
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital /ID# 254729
state: Fukuoka
city: Nishinomiya-shi
country: Japan
facility: Meiwa Hospital /ID# 254728
state: Hyogo
city: Tsukuba-shi
country: Japan
facility: University of Tsukuba Hospital /ID# 254638
state: Ibaraki
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine /ID# 254481
state: Kyoto
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital /ID# 254598
state: Miyagi
city: Nakagami-gun
country: Japan
facility: University of the Ryukyus Hospital /ID# 254517
state: Okinawa
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital /ID# 254574
state: Osaka
city: Otsu
country: Japan
facility: Shiga University of Medical Science Hospital /ID# 254215
state: Shiga
city: Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital /ID# 254637
state: Tokyo
city: Minato-ku
country: Japan
facility: Toranomon Hospital /ID# 253819
state: Tokyo
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital /ID# 254128
state: Gyeonggido
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center /ID# 254026
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 254027
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: SoonChunHyang University Seoul Hospital /ID# 254025
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital /ID# 254127
state: Seoul Teugbyeolsi
city: Vilnius
country: Lithuania
facility: Inlita - Santara KTC /ID# 253917
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos /ID# 253916
city: Monterrey
country: Mexico
facility: Eukarya PharmaSite, SC /ID# 254658
state: Nuevo Leon
city: Mexico City
country: Mexico
facility: Cryptex Investigacion Clinica S.A de C.V /ID# 256066
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis /ID# 253567
state: Noord-Brabant
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen /ID# 253571
city: Epsom
country: New Zealand
facility: Greenlane Clinical Centre /ID# 254351
state: Auckland
city: Hamilton
country: New Zealand
facility: Clinical Trials New Zealand /ID# 254352
state: Waikato
city: Lisboa
country: Portugal
facility: Hospital CUF Descobertas /ID# 254323
city: Lisbon
country: Portugal
facility: Centro Hospitalar de Lisboa Central /ID# 254325
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 254322
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 254324
city: Caguas
country: Puerto Rico
facility: Dr. Samuel Sanchez PSC /ID# 253948
city: Carolina
country: Puerto Rico
facility: Alma M. Cruz Santana, MD-Private practice /ID# 253951
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital and Research Centre /ID# 255279
state: Ar Riyad
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz Medical City- National Guard Hospital /ID# 255280
state: Ar Riyad
city: Jeddah
country: Saudi Arabia
facility: King Faisal Specialist Hospital /ID# 255539
state: Makkah
city: Riyadh
country: Saudi Arabia
facility: King Saud University Med City /ID# 255282
city: Singapore
country: Singapore
facility: National Skin Centre /ID# 255242
state: Central Singapore
city: Singapore
country: Singapore
facility: National University Hospital /ID# 254943
city: Bratislava
country: Slovakia
facility: Univerzitná nemocnica Bratislava - Nemocnica Ružinov /ID# 254157
state: Bratislavsky Kraj
city: Košice
country: Slovakia
facility: Univerzitna nemocnica L. Pasteura Kosice /ID# 254136
state: Kosicky Kraj
city: Nove Zamky
country: Slovakia
facility: Fakultna nemocnica s poliklinikou Nove Zamky /ID# 254155
state: Nitriansky Kraj
city: Martin
country: Slovakia
facility: Univerzitna nemocnica Martin /ID# 254153
state: Zilinsky Kraj
city: Trnava
country: Slovakia
facility: Fakultna nemocnica Trnava /ID# 254137
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge /ID# 254982
state: Barcelona
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda /ID# 253924
state: Madrid
city: Manises
country: Spain
facility: Hospital de Manises /ID# 253867
state: Valencia
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau /ID# 253869
city: Barcelona
country: Spain
facility: Hospital General de Granollers /ID# 253873
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves /ID# 253870
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal /ID# 253871
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe /ID# 253868
city: Solna
country: Sweden
facility: Karolinska University Hospital Solna /ID# 254808
state: Stockholms Lan
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset /ID# 254807
state: Vastra Gotalands Lan
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen /ID# 255243
state: Sankt Gallen
city: Zurich
country: Switzerland
facility: University Hospital Zurich /ID# 254642
state: Zuerich
city: Bern
country: Switzerland
facility: Inselspital, Universitaetsspital Bern /ID# 254736
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital /ID# 254031
state: Kaohsiung
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 254030
state: Taipei
city: Changhua City, Changhua County
country: Taiwan
facility: Changhua Christian Hospital /ID# 254032
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital /ID# 254033
city: Ankara
country: Turkey
facility: Gulhane Egitim ve Arastirma Hastanesi /ID# 253919
city: Bayraklı
country: Turkey
facility: Izmir Sehir Hastanesi /ID# 265465
city: Bursa
country: Turkey
facility: Uludag University Medical Faculty /ID# 253806
city: Istanbul
country: Turkey
facility: Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 253824
city: Kayseri
country: Turkey
facility: Erciyes University Medical Faculty /ID# 253804
city: Samsun
country: Turkey
facility: Ondokuz Mayis Universitesi /ID# 254034
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital /ID# 254190
state: Greater London
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust /ID# 254531
state: Hampshire
city: Coventry
country: United Kingdom
facility: UH Coventry & Warwickshire /ID# 256909
state: Warwickshire
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust /ID# 254616
state: West Yorkshire
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol /ID# 261505
city: Salford
country: United Kingdom
facility: Northern Care Alliance NHS Group /ID# 256910
city: Tooting
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust /ID# 256803
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: