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

Status: Recruiting
Location: See all (267) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 and Study 4 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 and Study 4 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, Study 2 or Study 4, 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 280 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
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 63
Healthy Volunteers: f
View:

• 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 in Study 1 and Study 2. Adolescent individuals in the US who are at least 12 years old at Screening may participate in Study 4.

• 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.

Locations
United States
Alabama
Total Skin and Beauty Dermatology Center /ID# 259539
ACTIVE_NOT_RECRUITING
Birmingham
Arkansas
Johnson Dermatology Clinic /ID# 259103
ACTIVE_NOT_RECRUITING
Fort Smith
Arizona
Duplicate_Advanced Research Associates - Glendale /ID# 259108
COMPLETED
Glendale
Alliance Dermatology and Mohs Center /ID# 258111
ACTIVE_NOT_RECRUITING
Phoenix
Southwest Skin Specialists /ID# 258234
COMPLETED
Phoenix
California
Duplicate_JOSEPH RAOOF MD,INC /ID# 258031
COMPLETED
Encino
First OC Dermatology /ID# 259220
RECRUITING
Fountain Valley
University of California Irvine /ID# 259096
ACTIVE_NOT_RECRUITING
Irvine
Dermatology Research Associates /ID# 258033
RECRUITING
Los Angeles
Stanford University School of Medicine - Redwood City /ID# 259542
RECRUITING
Redwood City
Integrative Skin Science and Research /ID# 258114
RECRUITING
Sacramento
University of California Davis Health /ID# 258112
RECRUITING
Sacramento
Clinical Trials Research Institute /ID# 258021
RECRUITING
Thousand Oaks
Florida
Skin Care Research Boca Raton /ID# 258012
RECRUITING
Boca Raton
Apex Clinical Trials /ID# 259205
ACTIVE_NOT_RECRUITING
Brandon
Florida Academic Dermatology Center /ID# 259353
ACTIVE_NOT_RECRUITING
Coral Gables
Skin Research Institute LLC /ID# 259207
COMPLETED
Coral Gables
Revival Research /ID# 259213
ACTIVE_NOT_RECRUITING
Doral
Skin Care Research - Hollywood /ID# 259210
RECRUITING
Hollywood
GSI Clinical Research, LLC /ID# 259352
RECRUITING
Margate
Life Clinical Trials /ID# 259358
ACTIVE_NOT_RECRUITING
Margate
Lenus Research and Medical Group /ID# 259356
RECRUITING
Miami
International Clinical Research - Sanford /ID# 259547
ACTIVE_NOT_RECRUITING
Sanford
FWD Clinical Research /ID# 266687
COMPLETED
Tamarac
Advanced Clinical Research Institute /ID# 259204
RECRUITING
Tampa
Avita Clinical Research /ID# 258011
COMPLETED
Tampa
Georgia
Cleaver Medical Group Dermatology /ID# 259801
ACTIVE_NOT_RECRUITING
Dawsonville
Marietta Dermatology /ID# 259818
ACTIVE_NOT_RECRUITING
Marietta
Illinois
Northwestern University Feinberg School of Medicine /ID# 259555
ACTIVE_NOT_RECRUITING
Chicago
NorthShore University HealthSystem - Skokie /ID# 266684
ACTIVE_NOT_RECRUITING
Skokie
Indiana
Indiana University Health University Hospital /ID# 259827
RECRUITING
Indianapolis
Kansas
U.S. Dermatology Partners Leawood /ID# 259203
COMPLETED
Leawood
Louisiana
Tulane University School of Medicine /ID# 259799
RECRUITING
New Orleans
Massachusetts
MetroBoston Clinical Partners /ID# 259559
ACTIVE_NOT_RECRUITING
Boston
Lahey Hospital & Medical Center /ID# 260484
COMPLETED
Burlington
Maryland
Care Access /ID# 268453
ACTIVE_NOT_RECRUITING
Marriottsville
Michigan
Great Lakes Research Group - Bay City /ID# 259100
COMPLETED
Bay City
Hamzavi Dermatology - Canton /ID# 260115
COMPLETED
Canton
Clin Res Inst of Michigan, LLC /ID# 259802
ACTIVE_NOT_RECRUITING
Chesterfield
Clarkston Dermatology /ID# 258018
RECRUITING
Clarkston
Henry Ford Medical Center - New Center One /ID# 258067
ACTIVE_NOT_RECRUITING
Detroit
Minnesota
M Health Fairview University of Minnesota Medical Center - East Bank /ID# 260122
ACTIVE_NOT_RECRUITING
Minneapolis
Minnesota Clinical Study Center /ID# 259218
COMPLETED
New Brighton
Missouri
Dermatology and Skin Center of Lees Summit /ID# 259206
COMPLETED
Lee's Summit
North Carolina
Piedmont Plastic Surgery and Dermatology /ID# 258206
COMPLETED
Huntersville
Nebraska
Physician Research Collaboration, LLC /ID# 259354
ACTIVE_NOT_RECRUITING
Lincoln
Skin Specialists /ID# 259237
RECRUITING
Omaha
Nevada
Skin Cancer and Dermatology Institute - Reno /ID# 259208
RECRUITING
Reno
New York
The Skin Center Dermatology Group /ID# 266748
ACTIVE_NOT_RECRUITING
New City
Equity Medical, LLC /ID# 266680
RECRUITING
New York
Icahn School of Medicine at Mount Sinai /ID# 259808
ACTIVE_NOT_RECRUITING
New York
Sadick Research Group LLC /ID# 266790
RECRUITING
New York
Schweiger Dermatology, P.C. /ID# 258007
COMPLETED
New York
Schweiger Dermatology, P.C. /ID# 259531
COMPLETED
New York
Ohio
Cleveland Clinic - Cleveland /ID# 258113
RECRUITING
Cleveland
Remington-Davis Clinical Research /ID# 258106
ACTIVE_NOT_RECRUITING
Columbus
Dermatologists of Southwest Ohio, Inc /ID# 260116
RECRUITING
Mason
Dermatologist of Central States (DOCS) Clinical Research - Springfield /ID# 266746
COMPLETED
Springfield
Oregon
Oregon Dermatology and Research Center /ID# 258243
RECRUITING
Portland
Oregon Medical Research Center /ID# 258107
ACTIVE_NOT_RECRUITING
Portland
Pennsylvania
University of Pittsburgh Medical Center /ID# 266681
ACTIVE_NOT_RECRUITING
Pittsburgh
South Carolina
Medical University of South Carolina /ID# 259828
ACTIVE_NOT_RECRUITING
Charleston
South Dakota
Health Concepts /ID# 266678
ACTIVE_NOT_RECRUITING
Rapid City
Tennessee
International Clinical Research - Tennessee LLC /ID# 259552
RECRUITING
Murfreesboro
Texas
Arlington Research Center, Inc /ID# 258028
RECRUITING
Arlington
Bellaire Dermatology Associates /ID# 259360
RECRUITING
Bellaire
U.S. Dermatology Partners - Cedar Park /ID# 259367
RECRUITING
Cedar Park
Dermatology Treatment and Research Center /ID# 259357
RECRUITING
Dallas
Modern Research Associates, PLLC /ID# 259349
ACTIVE_NOT_RECRUITING
Dallas
Reveal Research Institute - Dallas /ID# 259361
COMPLETED
Dallas
Center for Clinical Studies - Houston - Northwest Freeway /ID# 258036
ACTIVE_NOT_RECRUITING
Houston
Progressive Clinical Research /ID# 259365
ACTIVE_NOT_RECRUITING
San Antonio
Complete Dermatology /ID# 258025
ACTIVE_NOT_RECRUITING
Sugar Land
Other Locations
Argentina
Centro de Investigacion y Prevencion Cardiovascular (CIPREC) /ID# 258639
ACTIVE_NOT_RECRUITING
Buenos Aires
Buenos Aires Skin /ID# 258297
ACTIVE_NOT_RECRUITING
Ciudad Autonoma De Buenos Aire
Instituto de Neumonologia y Dermatologia /ID# 258640
ACTIVE_NOT_RECRUITING
Ciudad Autonoma De Buenos Aire
Psoriahue Med Interdisciplinar /ID# 258641
ACTIVE_NOT_RECRUITING
Ciudad Autonoma De Buenos Aire
Instituto De Investigaciones Clínicas Córdoba /ID# 260244
ACTIVE_NOT_RECRUITING
Córdoba
Australia
Skin Health Institute Inc /ID# 258570
ACTIVE_NOT_RECRUITING
Carlton
Cornerstone Dermatology /ID# 258769
ACTIVE_NOT_RECRUITING
Coorparoo
Momentum Clinical Research /ID# 258571
ACTIVE_NOT_RECRUITING
Darlinghurst
Sinclair Dermatology - Melbourne /ID# 258565
ACTIVE_NOT_RECRUITING
East Melbourne
Fremantle Dermatology /ID# 260207
ACTIVE_NOT_RECRUITING
Fremantle
St George Dermatology & Skin Cancer Centre /ID# 258567
ACTIVE_NOT_RECRUITING
Kogarah
The Royal Melbourne Hospital /ID# 258770
ACTIVE_NOT_RECRUITING
Parkville
Veracity Clinical Research /ID# 258566
ACTIVE_NOT_RECRUITING
Woolloongabba
Belgium
Universite Libre de Bruxelles - Hopital Erasme /ID# 257314
RECRUITING
Anderlecht
Cliniques Universitaires UCL Saint-Luc /ID# 257320
RECRUITING
Brussels
UZ Gent /ID# 257317
RECRUITING
Ghent
Universitair Ziekenhuis Brussel /ID# 257325
RECRUITING
Jette
CHU de Liege /ID# 257316
RECRUITING
Liège
AZ Delta - campus Torhout /ID# 257321
ACTIVE_NOT_RECRUITING
Torhout
Brazil
Upeclin Fmb - Unesp /Id# 258046
ACTIVE_NOT_RECRUITING
Botucatu
Hospital e Maternidade Celso Pierro - PUC-Campinas /ID# 258105
ACTIVE_NOT_RECRUITING
Campinas
Irmandade da Santa Casa de Misericordia de Porto Alegre /ID# 258045
ACTIVE_NOT_RECRUITING
Porto Alegre
Instituto Brasil de Pesquisa Clinica S.A - IBPClin /ID# 258750
ACTIVE_NOT_RECRUITING
Rio De Janeiro
Hospital Alemao Oswaldo Cruz /ID# 258104
ACTIVE_NOT_RECRUITING
São Paulo
Bulgaria
UMHAT Sveti Georgi /ID# 257548
ACTIVE_NOT_RECRUITING
Plovdiv
Duplicate_Ambulatory for Specialized Medical Care-IPSMC-skin and venereal diseas /ID# 257047
COMPLETED
Sofia
Diagnosis - Consult Centre 20 - Sofia /ID# 257273
ACTIVE_NOT_RECRUITING
Sofiya
Diagnostic Consultative Center Aleksandrovska /ID# 257049
ACTIVE_NOT_RECRUITING
Sofiya
Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 257048
ACTIVE_NOT_RECRUITING
Sofiya
UMHAT Professor Stoyan Kirkovich /ID# 257051
ACTIVE_NOT_RECRUITING
Stara Zagora
Canada
SimcoDerm Medical and Surgical Dermatology Center /ID# 258820
ACTIVE_NOT_RECRUITING
Barrie
Beacon Dermatology Inc /ID# 258817
ACTIVE_NOT_RECRUITING
Calgary
Dermatology Research Institute - Blackfoot Trail /ID# 258818
ACTIVE_NOT_RECRUITING
Calgary
Rejuvenation Dermatology - Edmonton Downtown /ID# 258816
ACTIVE_NOT_RECRUITING
Edmonton
Medicor Research Inc /ID# 258810
ACTIVE_NOT_RECRUITING
Greater Sudbury
Leader Research /ID# 267028
ACTIVE_NOT_RECRUITING
Hamilton
Lynderm Research Inc /ID# 258815
ACTIVE_NOT_RECRUITING
Markham
Innovaderm Research Inc. /ID# 258812
ACTIVE_NOT_RECRUITING
Montreal
JRB Research /ID# 259248
ACTIVE_NOT_RECRUITING
Ottawa
SKiN Centre for Dermatology /ID# 258813
ACTIVE_NOT_RECRUITING
Peterborough
Centre de Recherche dermatologique du Quebec Metropolitain /ID# 258811
ACTIVE_NOT_RECRUITING
Québec
York Dermatology Clinic & Research Centre /ID# 267026
ACTIVE_NOT_RECRUITING
Richmond Hill
Private Practice - Dr. Angelique Gagne-Henley /ID# 267027
ACTIVE_NOT_RECRUITING
Saint-jérôme
Dr. Chih-ho Hong Medical Inc. /ID# 258814
ACTIVE_NOT_RECRUITING
Surrey
Private Practice - Dr. Kim Papp Clinical Research /ID# 259249
ACTIVE_NOT_RECRUITING
Waterloo
Wiseman Dermatology Research /ID# 258819
ACTIVE_NOT_RECRUITING
Winnipeg
Chile
Fundacion Innovacion Cardiovascular /ID# 259313
ACTIVE_NOT_RECRUITING
Independencia
Centro Medico Skin Med SPA /ID# 259314
ACTIVE_NOT_RECRUITING
Las Condes
Centro Internacional de Estudios Clinicos - CIEC /ID# 259312
ACTIVE_NOT_RECRUITING
Santiago
Clinica Dermacross /ID# 259311
ACTIVE_NOT_RECRUITING
Vitacura
China
Beijing Chaoyang Hospital,Capital Medical University /ID# 258912
RECRUITING
Beijing
Beijing Tongren Hospital Affiliated To Capital Medical University /ID# 266715
ACTIVE_NOT_RECRUITING
Beijing
China-Japan Friendship Hospital /ID# 258941
ACTIVE_NOT_RECRUITING
Beijing
Peking University People's Hospital /ID# 258940
RECRUITING
Beijing
The First Hospital of Jilin University /ID# 257496
RECRUITING
Changchun
Chengdu Second Municipal People's Hospital /ID# 259492
ACTIVE_NOT_RECRUITING
Chengdu
West China Hospital, Sichuan University /ID# 259560
ACTIVE_NOT_RECRUITING
Chengdu
The Second Affiliated Hospital of Chongqing Medical University /ID# 260254
ACTIVE_NOT_RECRUITING
Chongqing
Dermatology Hospital of Southern Medical University /ID# 257118
ACTIVE_NOT_RECRUITING
Guangzhou
The First Affiliated Hospital Of Guangzhou Medical University /ID# 258663
ACTIVE_NOT_RECRUITING
Guangzhou
The First Affiliated Hospital, Sun Yat-sen University /ID# 257367
ACTIVE_NOT_RECRUITING
Guangzhou
Zhujiang Hospital of Southern Medical University /ID# 258485
ACTIVE_NOT_RECRUITING
Guangzhou
Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 257119
ACTIVE_NOT_RECRUITING
Hangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 257260
ACTIVE_NOT_RECRUITING
Hangzhou
Shandong Dermatological Hospital /ID# 267520
RECRUITING
Jinan
Dermatology Hospital of Jiangxi Provincial /ID# 259488
ACTIVE_NOT_RECRUITING
Nanchang
Huashan Hospital, Fudan University /ID# 257758
ACTIVE_NOT_RECRUITING
Shanghai
Shenzhen People's Hospital /ID# 258208
ACTIVE_NOT_RECRUITING
Shenzhen
Shenzhen Second Peoples Hospital /ID# 258060
ACTIVE_NOT_RECRUITING
Shenzhen
First Affiliated Hospital of Shanxi Medical University /ID# 259647
ACTIVE_NOT_RECRUITING
Taiyuan
Tianjin Medical University General Hospital /ID# 259525
ACTIVE_NOT_RECRUITING
Tianjin
The First Affiliated Hospital of Wenzhou Medical University /ID# 257739
ACTIVE_NOT_RECRUITING
Wenzhou
Renmin Hospital of Wuhan University /ID# 260260
ACTIVE_NOT_RECRUITING
Wuhan
Union Hospital - Tongji Medical College /ID# 266737
RECRUITING
Wuhan
Second Affiliated Hospital of Xian Jiaotong University /ID# 257497
ACTIVE_NOT_RECRUITING
Xi'an
Croatia
Specialty Hospital Medico /ID# 257629
ACTIVE_NOT_RECRUITING
Rijeka
Klinicki Bolnicki Centar (KBC) Split /ID# 257632
ACTIVE_NOT_RECRUITING
Split
DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 257151
ACTIVE_NOT_RECRUITING
Zagreb
Klinicki bolnicki centar Zagreb /ID# 257630
ACTIVE_NOT_RECRUITING
Zagreb
Poliklinika Solmed /ID# 257651
ACTIVE_NOT_RECRUITING
Zagreb
France
Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-Andre /ID# 257519
ACTIVE_NOT_RECRUITING
Bordeaux
CHRU de Brest - Hopital Morvan /ID# 256979
ACTIVE_NOT_RECRUITING
Brest
HCL - Hopital Edouard Herriot /ID# 256983
ACTIVE_NOT_RECRUITING
Lyon
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 256982
ACTIVE_NOT_RECRUITING
Nantes
Chu de Nice-Hopital L'Archet Ii /Id# 256978
ACTIVE_NOT_RECRUITING
Nice
Centre de Sante Sabouraud /ID# 257213
ACTIVE_NOT_RECRUITING
Paris
Polyclinique Courlancy /ID# 256977
ACTIVE_NOT_RECRUITING
Reims
Hopital Ponchaillou /ID# 257520
RECRUITING
Rennes
Hôpital Charles-Nicolle /ID# 256981
ACTIVE_NOT_RECRUITING
Rouen
CHU Toulouse - Hopital Larrey /ID# 256980
ACTIVE_NOT_RECRUITING
Toulouse
Germany
Fachklinik Bad Bentheim /ID# 257741
RECRUITING
Bad Bentheim
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 257310
RECRUITING
Berlin
Universitaetsklinikum Duesseldorf /ID# 257307
ACTIVE_NOT_RECRUITING
Düsseldorf
Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 257305
ACTIVE_NOT_RECRUITING
Lübeck
Klinikum rechts der Isar /ID# 257609
RECRUITING
Munich
Universitaetsklinikum Muenster /ID# 257306
RECRUITING
Münster
Greece
General Hospital Andreas Syggros /ID# 257259
ACTIVE_NOT_RECRUITING
Athens
General Hospital Andreas Syggros /ID# 257262
ACTIVE_NOT_RECRUITING
Athens
Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 257263
ACTIVE_NOT_RECRUITING
Thessaloniki
Papageorgiou General Hospital /ID# 257258
ACTIVE_NOT_RECRUITING
Thessaloniki
Hungary
Debreceni Egyetem-Klinikai Kozpont /ID# 257465
RECRUITING
Debrecen
DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 257469
COMPLETED
Debrecen
Bacs-Kiskun Varmegyei Oktatokorhaz /ID# 257472
ACTIVE_NOT_RECRUITING
Kecskemét
Bagoly Egeszseghaz (Meditres Kft.) /ID# 258032
COMPLETED
Kecskemét
Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 257468
RECRUITING
Pécs
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 258552
ACTIVE_NOT_RECRUITING
Szeged
Israel
Rambam Health Care Campus /ID# 257769
ACTIVE_NOT_RECRUITING
Haifa
Hadassah Medical Center-Hebrew University /ID# 257946
ACTIVE_NOT_RECRUITING
Jerusalem
Rabin Medical Center /ID# 257772
COMPLETED
Petah Tikva
The Chaim Sheba Medical Center /ID# 257770
ACTIVE_NOT_RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center /ID# 257771
COMPLETED
Tel Aviv
Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 257499
ACTIVE_NOT_RECRUITING
Bologna
ASST degli Spedali Civili di Brescia /ID# 257508
ACTIVE_NOT_RECRUITING
Brescia
AOU Policlinico G. Rodolico - San Marco /ID# 257507
ACTIVE_NOT_RECRUITING
Catania
AZIENDA USL TOSCANA CENTRO - Ospedale Piero Palagi /ID# 257501
COMPLETED
Florence
ASL 1 Abruzzo - Ospedale regionale San Salvatore /ID# 257506
ACTIVE_NOT_RECRUITING
L’aquila
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 257503
ACTIVE_NOT_RECRUITING
Milan
Azienda Ospedaliera Universitaria Federico II /ID# 257504
ACTIVE_NOT_RECRUITING
Naples
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 258585
ACTIVE_NOT_RECRUITING
Naples
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 257502
COMPLETED
Rome
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 257513
ACTIVE_NOT_RECRUITING
Rome
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 257505
ACTIVE_NOT_RECRUITING
Rome
IRCCS Istituto Clinico Humanitas /ID# 257500
ACTIVE_NOT_RECRUITING
Rozzano
Japan
Hamamatsu University Hospital /ID# 257253
ACTIVE_NOT_RECRUITING
Hamamatsu
Kurume University Hospital /ID# 257255
ACTIVE_NOT_RECRUITING
Kurume-shi
Kyorin University Hospital /ID# 257283
ACTIVE_NOT_RECRUITING
Mitaka-shi
Niigata University Medical & Dental Hospital /ID# 259425
ACTIVE_NOT_RECRUITING
Niigata
Osaka Metropolitan University Hospital /ID# 257256
ACTIVE_NOT_RECRUITING
Osaka
Kitasato University Hospital /ID# 257285
ACTIVE_NOT_RECRUITING
Sagamihara-shi
Tokyo Medical University Hospital /ID# 258132
ACTIVE_NOT_RECRUITING
Shinjuku-ku
Yamaguchi University Hospital /ID# 257252
ACTIVE_NOT_RECRUITING
Ube-shi
New Zealand
Aotearoa Clinical Trials /ID# 258562
ACTIVE_NOT_RECRUITING
Auckland
Greenlane Clinical Centre /ID# 258563
ACTIVE_NOT_RECRUITING
Epsom
Clinical Trials New Zealand /ID# 258564
ACTIVE_NOT_RECRUITING
Hamilton
P3 Research Ltd /ID# 259846
ACTIVE_NOT_RECRUITING
Wellington
Poland
Osteo Medic s.c. Artur Racewicz Jerzy Supronik /ID# 257531
ACTIVE_NOT_RECRUITING
Bialystok
Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 257537
ACTIVE_NOT_RECRUITING
Elblag
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 257535
ACTIVE_NOT_RECRUITING
Gdansk
Centrum Medyczne Angelius Provita /ID# 257916
ACTIVE_NOT_RECRUITING
Katowice
Centrum Medyczne ALL-MED Badania Kliniczne /ID# 257590
ACTIVE_NOT_RECRUITING
Krakow
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno Badawczy /ID# 257534
ACTIVE_NOT_RECRUITING
Krakow
Dermodent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski /ID# 258242
COMPLETED
Osielsko
MICS Centrum Medyczne Torun / Nasz Lekarz Przychodnie Medyczne /ID# 257740
ACTIVE_NOT_RECRUITING
Torun
Klinika Osipowicz & Turkowski sp.z.o.o /ID# 257598
ACTIVE_NOT_RECRUITING
Warsaw
Royalderm Agnieszka Nawrocka /ID# 257536
ACTIVE_NOT_RECRUITING
Warsaw
Portugal
Unidade Local de Saude de Almada-Seixal, EPE /ID# 257425
ACTIVE_NOT_RECRUITING
Almada
Hospital CUF Descobertas /ID# 257419
ACTIVE_NOT_RECRUITING
Lisbon
Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 258554
ACTIVE_NOT_RECRUITING
Porto
Puerto Rico
Santa Cruz Behavioral (SCB) Research Center /ID# 259350
COMPLETED
Bayamón
Dr. Samuel Sanchez PSC /ID# 259359
ACTIVE_NOT_RECRUITING
Caguas
Clinical Research Puerto Rico /ID# 259355
ACTIVE_NOT_RECRUITING
San Juan
GCM Medical Group PSC /ID# 258013
ACTIVE_NOT_RECRUITING
San Juan
Mindful Medical Research /ID# 260113
COMPLETED
San Juan
Republic of Korea
Pusan National University Hospital /ID# 257910
ACTIVE_NOT_RECRUITING
Busan
Kyungpook National University Hospital /ID# 257908
ACTIVE_NOT_RECRUITING
Daegu
Chungnam National University Hospital /ID# 267151
ACTIVE_NOT_RECRUITING
Daejeon
Chungang University Hospital /ID# 267155
COMPLETED
Dongjak-gu
Inha University Hospital /ID# 257904
ACTIVE_NOT_RECRUITING
Incheon
Jeonbuk National University Hospital /ID# 267154
ACTIVE_NOT_RECRUITING
Jeonju
Seoul National University Bundang Hospital /ID# 257906
ACTIVE_NOT_RECRUITING
Seongnam-si
Hallym University Kangdong Sacred Heart Hospital /ID# 257905
ACTIVE_NOT_RECRUITING
Seoul
Konkuk University Medical Center /ID# 257900
ACTIVE_NOT_RECRUITING
Seoul
Kyung Hee University Hospital at Gangdong /ID# 257907
ACTIVE_NOT_RECRUITING
Seoul
Seoul National University Hospital /ID# 257903
ACTIVE_NOT_RECRUITING
Seoul
Slovakia
Derma therapy spol /ID# 257595
ACTIVE_NOT_RECRUITING
Bratislava
Univerzitna nemocnica Bratislava, Nemocnica Stare mesto /ID# 257594
ACTIVE_NOT_RECRUITING
Bratislava
Fakultna nemocnica s poliklinikou J.A. Reimana Presov /ID# 257593
ACTIVE_NOT_RECRUITING
Prešov
Kaderma Majtan s.r.o. /ID# 257596
ACTIVE_NOT_RECRUITING
Topoľčany
Spain
Hospital Santa Creu i Sant Pau /ID# 257034
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Universitario Reina Sofia /ID# 257035
COMPLETED
Córdoba
Hospital Universitario de Fuenlabrada /ID# 257334
ACTIVE_NOT_RECRUITING
Fuenlabrada
Hospital Universitari de Bellvitge /ID# 257332
ACTIVE_NOT_RECRUITING
L'hospitalet De Llobregat
Hospital Universitario La Paz /ID# 257333
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario Dr. Peset /ID# 257036
RECRUITING
Valencia
Sweden
CTC GoCo /ID# 257714
ACTIVE_NOT_RECRUITING
Mölndal
Karolinska University Hospital Solna /ID# 257094
ACTIVE_NOT_RECRUITING
Solna
Diagnostiskt Centrum Hud /ID# 257229
ACTIVE_NOT_RECRUITING
Stockholm
Taiwan
Kaohsiung Chang Gung Memorial Hospital /ID# 258726
ACTIVE_NOT_RECRUITING
Kaohsiung City
National Cheng Kung University Hospital /ID# 257409
ACTIVE_NOT_RECRUITING
Tainan City
Taipei Veterans General Hosp /ID# 257413
ACTIVE_NOT_RECRUITING
Taipei
National Taiwan University Hospital /ID# 257407
ACTIVE_NOT_RECRUITING
Taipei City
Linkou Chang Gung Memorial Hospital /ID# 258725
ACTIVE_NOT_RECRUITING
Taoyuan
Turkey
Ankara City Hospital /ID# 257417
ACTIVE_NOT_RECRUITING
Ankara
Gulhane Egitim ve Arastirma Hastanesi /ID# 257509
ACTIVE_NOT_RECRUITING
Ankara
Gaziantep Universitesi /ID# 257418
ACTIVE_NOT_RECRUITING
Gaziantep
Bagcilar Medipol Mega Universite Hastanesi /ID# 257449
ACTIVE_NOT_RECRUITING
Istanbul
Erciyes University Medical Faculty /ID# 259034
ACTIVE_NOT_RECRUITING
Kayseri
United Kingdom
Royal Sussex County Hospital /ID# 257912
ACTIVE_NOT_RECRUITING
Brighton
Gloucestershire Royal Hospital /ID# 257953
ACTIVE_NOT_RECRUITING
Gloucester
London North West University Healthcare NHS Trust /ID# 257914
ACTIVE_NOT_RECRUITING
Harrow
Velocity Clinical Research Ltd /ID# 257925
ACTIVE_NOT_RECRUITING
High Wycombe
Chelsea and Westminster Hospital /ID# 259128
ACTIVE_NOT_RECRUITING
London
Oxford University Hospitals NHS Foundation Trust /ID# 257948
ACTIVE_NOT_RECRUITING
Oxford
Northern Care Alliance NHS Group /ID# 257952
ACTIVE_NOT_RECRUITING
Salford
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2023-10-11
Estimated Completion Date: 2028-01
Participants
Target number of participants: 1500
Treatments
Experimental: Study 1: Group 1 Upadacitinib Dose A
Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.
Experimental: Study 1: Group 2 Upadacitinib Dose B
Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.
Experimental: Study 1: Group 3 Placebo
Participants will receive matching placebo once daily for 24 weeks in Period A.
Experimental: Study 1: Group 4 Upadacitinib Dose A
Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.
Experimental: Study 1: Group 5 Upadacitinib Dose B
Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.
Experimental: Study 1: Group 6 Placebo
Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160.
Experimental: Study 2: Group 1 Upadacitinib Dose A
Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.
Experimental: Study 2: Group 2 Upadacitinib Dose B
Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.
Experimental: Study 2: Group 3 Placebo
Participants will receive matching placebo once daily for 24 weeks in Period A.
Experimental: Study 2: Group 4 Upadacitinib Dose A
Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.
Experimental: Study 2: Group 5 Upadacitinib Dose B
Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.
Experimental: Study 2: Group 6 Placebo
Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160.
Experimental: Study 3: Group 1 Upadacitinib Dose B (SALT > 20)
Participants receiving upadacitinib Dose A with a SALT score \> 20 at Week 52 (end of Period B) of Study 1 or Study 2 will dose escalate to upadacitinib Dose B once daily for 108 weeks.
Experimental: Study 3: Group 2 Upadacitinib Dose A (SALT ≤ 20)
Participants receiving upadacitinib Dose A with a SALT score ≤ 20 at Week 52 (end of Period B) of Study 1 or Study 2 will remain on upadacitinib Dose A once daily for 108 weeks.
Experimental: Study 3: Group 3 Upadacitinib Dose B (Non-Sustained)
Participants who end Period B on upadacitinib Dose B with a with a SALT score \> 20 at Week 40 or Week 52 of Study 1 or Study 2 will remain on upadacitinib Dose B once daily for 108 weeks.
Experimental: Study 3: Group 4 Upadacitinib Dose B (Sustained)
Participants who end Period B on upadacitinib Dose B with a with a SALT score ≤ 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose B once daily for 108 weeks.
Experimental: Study 3: Group 5 Upadacitinib Dose A (Sustained)
Participants who end Period B on upadacitinib Dose B with a with a SALT score ≤ 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose A once daily for 108 weeks.
Experimental: Study 4: Group 1 Upadacitinib Dose A
US only adolescent participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.
Experimental: Study 4: Group 2 Upadacitinib Dose B
US only adolescent participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.
Experimental: Study 4: Group 3 Placebo
US only adolescent participants will receive matching placebo once daily for 24 weeks in Period A.
Experimental: Study 4: Group 4 Upadacitinib Dose A
Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.
Experimental: Study 4: Group 5 Upadacitinib Dose B
Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.
Experimental: Study 4: Group 6 Placebo
Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov