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
Status: Active_not_recruiting
Location: See all (282) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
Cahaba Dermatology & Skin Health Center /ID# 254876
Birmingham
Arkansas
Clinical Trials Institute - Northwest Arkansas /ID# 254924
Fayetteville
Burke Pharmaceutical Research /ID# 254238
Hot Springs
Arkansas Research Trials /ID# 254233
North Little Rock
NW Arkansas Clinical Trials Center /ID# 254311
Rogers
Arizona
Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272564
Fountain Hills
Medical Dermatology Specialists /ID# 254226
Phoenix
Mayo Clinic - Scottsdale /ID# 254388
Scottsdale
Banner University Medicine Dermatology /ID# 255853
Tucson
California
Private Practice - Dr. Tooraj Raoof /ID# 254374
Encino
Marvel Clinical Research /ID# 276228
Huntington Beach
Dermatology Research Associates /ID# 254846
Los Angeles
NorCal Clinical Research /ID# 274219
Rocklin
Integrative Skin Science and Research /ID# 254930
Sacramento
University of California Davis Health /ID# 254229
Sacramento
Medderm Associates /ID# 253800
San Diego
Clinical Trials Research Institute /ID# 254466
Thousand Oaks
Connecticut
UConn Health Main /ID# 254507
Farmington
Yale University School of Medicine /ID# 254586
New Haven
Florida
Skin Care Research Boca Raton /ID# 253814
Boca Raton
Apex Clinical Trials /ID# 255756
Brandon
Florida Academic Dermatology Center /ID# 254011
Coral Gables
Dermatology Associates of the Palm Beaches /ID# 275950
Delray Beach
Skin Care Research - Hollywood /ID# 254508
Hollywood
Life Clinical Trials - N State Rd - Margate /ID# 258613
Margate
Advanced Clinical Research Institute - Tampa /ID# 253746
Tampa
Avita Clinical Research /ID# 254471
Tampa
Skin Care Research - Tampa /ID# 256440
Tampa
Georgia
Centricity Research - Columbus /ID# 255470
Columbus
Idaho
Treasure Valley Medical Research /ID# 255208
Boise
Illinois
DeNova Research /ID# 254372
Chicago
Northwestern University Feinberg School of Medicine /ID# 254503
Chicago
NorthShore University HealthSystem - Skokie /ID# 254389
Skokie
Indiana
Dawes Fretzin /ID# 254390
Indianapolis
Options Research Group /ID# 254537
West Lafayette
Kansas
U.S. Dermatology Partners Leawood /ID# 255838
Leawood
Kentucky
Equity Medical, LLC /ID# 271140
Bowling Green
Massachusetts
Beth Israel Deaconess Medical Center /ID# 253811
Boston
Massachusetts General Hospital /ID# 261093
Boston
Beacon Clinical Research, LLC /ID# 254419
Quincy
UMass Memorial Medical Center - Lake Avenue North /ID# 258839
Worcester
Michigan
The Derm Institute Of West Michigan /ID# 275948
Caledonia
Hamzavi Dermatology - Canton /ID# 275856
Canton
Michigan Center for Medical Research - Clarkston /ID# 275860
Clarkston
Michigan Dermatology Institute /ID# 254468
Waterford
Missouri
Cleaver Dermatology /ID# 254391
Kirksville
Dermatology and Skin Center of Lees Summit /ID# 257546
Lee's Summit
MediSearch Clinical Trials /ID# 254392
Saint Joseph
SSM Health Saint Louis University Hospital /ID# 256437
St Louis
Washington University School of Medicine - St. Louis /ID# 254506
St Louis
North Carolina
Onsite Clinical Solutions - Community House Rd - Charlotte /ID# 254854
Charlotte
Duke University Medical Center /ID# 256898
Durham
Nevada
Las Vegas Dermatology /ID# 272421
Las Vegas
Vivida Dermatology- Flamingo /ID# 254227
Las Vegas
Skin Cancer and Dermatology Institute - Reno /ID# 254410
Reno
New York
Empire Dermatology /ID# 276241
East Syracuse
NorthWell Health - Dermatology /ID# 254704
New Hyde Park
Private Practice - Dr. Bobby Buka /ID# 276371
New York
Schweiger Dermatology, P.C. /ID# 254232
New York
Ohio
Apex Clinical Research Center, LLC /ID# 275956
Canton
ClinOhio Research Services /ID# 254851
Columbus
Dermatologists of Southwest Ohio, Inc /ID# 254297
Mason
Dermatology Partners - Medina /ID# 275939
Medina
Oklahoma
Lynn Institute of Oklahoma City /ID# 253791
Oklahoma City
Oregon
Oregon Health and Science University /ID# 254929
Portland
Pennsylvania
Penn State Milton S. Hershey Medical Center /ID# 254925
Hershey
Clinical Research of Philadelphia, LLC /ID# 255308
Philadelphia
Paddington Testing Co., Inc. /ID# 254394
Philadelphia
South Carolina
Medical University of South Carolina /ID# 272569
Charleston
Tennessee
Dermatology Associates of Knoxville /ID# 261082
Knoxville
Texas
Arlington Research Center, Inc /ID# 253805
Arlington
Bellaire Dermatology Associates /ID# 253797
Bellaire
Dermatology Treatment and Research Center /ID# 253795
Dallas
HRMD Research Dallas /ID# 255256
Dallas
Modern Research Associates /ID# 253810
Dallas
Dallas Fort Worth Clinical Research Associates (DFWCRA) /ID# 256438
Grapevine
Suzanne Bruce and Associates-Houston /ID# 254228
Houston
Texas Dermatology Research Center /ID# 254928
Plano
Center for Clinical Studies Webster /ID# 254242
Webster
Utah
Cope Family Medicine - Ogden Clinic /ID# 276227
Bountiful
University of Utah - Murray /ID# 254452
Murray
Springville Dermatology - Springville /ID# 276225
Springville
Virginia
University of Virginia - Dermatology /ID# 254535
Charlottesville
The Education & Research Foundation, Inc. /ID# 254852
Lynchburg
Virginia Clinical Research /ID# 254538
Norfolk
Washington
Frontier Dermatology /ID# 254554
Mill Creek
Premier Clinical Research /ID# 254847
Spokane
Other Locations
Argentina
Ciprec (Centro De Investigacion Y Prevencion Cardiovascular) - Barrio Norte /ID# 255474
Buenos Aires
Hospital Italiano /ID# 254905
Caba
Buenos Aires Skin /ID# 255299
Ciudad Autonoma De Buenos Aire
Consultorios Reumatologicos Pampa /ID# 255555
Ciudad Autonoma De Buenos Aire
Instituto de Neumonologia y Dermatologia /ID# 254903
Ciudad Autonoma De Buenos Aire
Psoriahue Med Interdisciplinar /ID# 257202
Ciudad Autonoma De Buenos Aire
Hospital Universitario Austral /ID# 254904
Pilar
Australia
Skin Health Institute Inc /ID# 254416
Carlton
Momentum Clinical Research /ID# 254411
Darlinghurst
Sinclair Dermatology - Melbourne /ID# 254412
East Melbourne
The Alfred Hospital /ID# 254414
Melbourne
Paratus Clinical Research Woden /ID# 254670
Phillip
Austria
Medizinische Universitaet Graz /ID# 253448
Graz
Duplicate_Ordensklinikum Linz GmbH Elisabethinen /ID# 253458
Linz
Medizinische Universitaet Wien /ID# 254096
Vienna
Belgium
Universite Libre de Bruxelles - Hopital Erasme /ID# 254082
Anderlecht
Cliniques Universitaires UCL Saint-Luc /ID# 254087
Brussels
Grand Hopital de Charleroi - Les Viviers /ID# 254091
Charleroi
UZ Gent /ID# 254090
Ghent
Universitair Ziekenhuis Brussel /ID# 254223
Jette
Universitair Ziekenhuis Leuven /ID# 254089
Leuven
CHU de Liege /ID# 254085
Liège
Brazil
Hospital e Maternidade Celso Pierro - PUC-Campinas /ID# 275811
Campinas
Instituto de Pesquisa e Ensino CLIGEDIMUNO - IPEC /ID# 254369
Macaé
Hospital Moinhos de Vento /ID# 254366
Porto Alegre
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 254367
Ribeirão Preto
Instituto Brasil de Pesquisa Clinica S.A - IBPClin /ID# 275810
Rio De Janeiro
Centro de Desenvolvimento em Estudos Clinicos Brasil - CDEC /ID# 254368
São Paulo
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 254370
São Paulo
Bulgaria
Acibadem City Clinic Tokuda University Hospital EAD /ID# 253331
Sofia
Ambulatory for Specialized Medical Care-IPSMC-skin and venereal diseases /ID# 253329
Sofiya
Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 253327
Sofiya
UMHAT Professor Stoyan Kirkovich /ID# 253328
Stara Zagora
Canada
Beacon Dermatology /ID# 254564
Calgary
Dermatology Research Institute - Blackfoot Trail /ID# 261413
Calgary
Alberta Dermasurgery Centre /ID# 275945
Edmonton
Rejuvenation Dermatology - Edmonton Downtown /ID# 254715
Edmonton
LEADER Research /ID# 254379
Hamilton
DermEffects /ID# 254116
London
Lynderm Research Inc /ID# 254713
Markham
Derm Care Clinic /ID# 276065
Mississauga
CHU Sainte-Justine /ID# 254118
Montreal
Ryan Clinical Research Inc /ID# 254714
Newmarket
Diex Recherche Quebec Inc. /ID# 254381
Québec
Care Clinic - Red Deer - Taylor Drive /ID# 276063
Red Deer
York Dermatology Clinic and Research Centre /ID# 254115
Richmond Hill
Dre Angelique Gagne-Henley M.D. inc. /ID# 255632
Saint-jérôme
SkinSense Dermatology /ID# 254119
Saskatoon
Karma Clinical Trials /ID# 254120
St. John's
Dr. Chih-ho Hong Medical Inc. /ID# 254378
Surrey
Enverus Medical Research /ID# 254380
Surrey
Research Toronto /ID# 255273
Toronto
Wiseman Dermatology Research /ID# 254117
Winnipeg
Chile
Fundacion Innovacion Cardiovascular /ID# 254561
Independencia
Centro Medico Skin Med SPA /ID# 254560
Las Condes
Centro Internacional de Estudios Clinicos - CIEC /ID# 254559
Santiago
Clinica Dermacross /ID# 254558
Vitacura
Colombia
Centro Integral de Reumatologia del Caribe SAS - Circaribe SAS /ID# 255278
Barranquilla
Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 254796
Bogotá
Clinica De Inmunologia Y Genetica (Cige) /ID# 254797
Medellín
IPS Suramericana SAS - IPS Sura San Diego /ID# 255064
Medellín
Croatia
Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 253586
Ivanić-grad
Specialty Hospital Medico /ID# 254731
Rijeka
Klinicki Bolnicki Centar Split /ID# 253789
Split
DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 253587
Zagreb
Klinicki bolnicki centar Zagreb /ID# 253786
Zagreb
Klinika za dječje bolesti Zagreb /ID# 253588
Zagreb
Poliklinika Solmed /ID# 254732
Zagreb
Finland
Oulun yliopistollinen sairaala /ID# 253969
Oulu
Terveystalo Tampere /ID# 253968
Tampere
France
Hopital Prive d'Antony /ID# 253501
Antony
Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-Andre /ID# 254139
Bordeaux
HCL - Hopital Edouard Herriot /ID# 253500
Lyon
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 254114
Nantes
Chu de Nice-Hopital Larchet Ii /Id# 253504
Nice
Polyclinique Courlancy /ID# 254680
Reims
Germany
Fachklinik - Bad Bentheim /ID# 275537
Bad Bentheim
Havelklinik /ID# 254194
Berlin
Klinikum Ruhr Univ Bochum /ID# 253690
Bochum
Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 254510
Bramsche
Universitaetsklinikum Duesseldorf /ID# 253711
Düsseldorf
Universitaetsklinikum Erlangen /ID# 254804
Erlangen
Universitaetsklinikum Frankfurt /ID# 253683
Frankfurt Am Main
Universitaetsklinikum Freiburg /ID# 275746
Freiburg Im Breisgau
Magdeburger Company for Medical Studies & Services GmbH /ID# 255151
Magdeburg
Dermatologie Quist-BAG Dres. med. Quist PartG /ID# 253691
Mainz
Universitaetsmedizin Mainz /ID# 272596
Mainz
Hautmedizin Saar Science /ID# 272614
Merzig
Klinik am Biederstein /ID# 254195
Munich
Universitaetsklinikum Regensburg /ID# 253692
Regensburg
Universitaetsklinikum Wuerzburg /ID# 275599
Würzburg
Greece
401 GSNA - 401 Army General Hospital /ID# 253499
Athens
General Hospital Andreas Syggros /ID# 253498
Athens
University General Hospital Attikon /ID# 253495
Chaïdári
Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 253497
Thessaloniki
Papageorgiou General Hospital /ID# 253496
Thessaloniki
Hungary
Csalogany Orvosi Kozpont /ID# 255063
Budapest
Duplicate_Obudai Egeszsegugyi Centrum Kft. /ID# 256366
Budapest
Semmelweis Egyetem /ID# 276162
Budapest
Debreceni Egyetem-Klinikai Kozpont /ID# 253637
Debrecen
DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 253638
Debrecen
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 253913
Kaposvár
Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 253753
Pécs
Szegedi Tudomanyegyetem /ID# 255142
Szeged
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 254377
Szombathely
Ireland
South Infirmary Victoria University Hospital /ID# 253975
Cork
St James Hospital /ID# 253973
Dublin
University College Dublin /ID# 253971
Dublin
University Hospital Galway /ID# 253976
Galway
Waterford Regional Hospital /ID# 254038
Waterford
Israel
Rambam Health Care Campus /ID# 254406
Haifa
Rabin Medical Center. /ID# 254405
Petah Tikva
Sheba Medical Center /ID# 254545
Ramat Gan
ZIV Medical Center /ID# 254403
Safed
Tel Aviv Sourasky Medical Center /ID# 254404
Tel Aviv
Italy
ASST degli Spedali Civili di Brescia /ID# 254875
Brescia
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale S.Anna /ID# 254496
Cona
AZIENDA USL TOSCANA CENTRO - Ospedale Piero Palagi /ID# 254495
Florence
ASL 1 Abruzzo - Ospedale regionale San Salvatore /ID# 276045
L’aquila
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 254502
Milan
Azienda Ospedaliero-Universitaria di Modena /ID# 254874
Modena
Azienda Ospedaliero Universitaria Pisana /ID# 254501
Pisa
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 254498
Rome
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 254500
Rome
Japan
Fukuoka University Hospital /ID# 254729
Fukuoka
University of the Ryukyus Hospital /ID# 254517
Ginowan-shi
Nihon University Itabashi Hospital /ID# 254637
Itabashi-ku
University Hospital Kyoto Prefectural University of Medicine /ID# 254481
Kyoto
Toranomon Hospital /ID# 253819
Minato-ku
Meiwa Hospital /ID# 254728
Nishinomiya-shi
Shiga University of Medical Science Hospital /ID# 254215
Ōtsu
Kindai University Hospital /ID# 254574
Sakai-shi
Tohoku University Hospital /ID# 254598
Sendai
University of Tsukuba Hospital /ID# 254638
Tsukuba
Lithuania
Inlita - Santara KTC /ID# 253917
Vilnius
Vilnius University Hospital Santaros Klinikos /ID# 253916
Vilnius
Mexico
Grupo Clinico Catei Sociedad Civil /Id# 254657
Guadalajara
Cryptex Investigacion Clinica S.A de C.V /ID# 256066
Mexico City
Eukarya PharmaSite, SC /ID# 254658
Monterrey
Netherlands
Amphia Ziekenhuis /ID# 253567
Breda
Universitair Medisch Centrum Groningen /ID# 253571
Groningen
New Zealand
Greenlane Clinical Centre /ID# 254351
Epsom
Clinical Trials New Zealand /ID# 254352
Hamilton
Portugal
Centro Hospitalar de Lisboa Central - Lisbon /ID# 254325
Lisbon
Hospital CUF Descobertas /ID# 254323
Lisbon
Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 254322
Porto
Unidade Local de Saude Sao Joao /ID# 254324
Porto
Puerto Rico
Dr. Samuel Sanchez PSC /ID# 253948
Caguas
Alma M. Cruz Santana, MD-Private practice /ID# 253951
Carolina
Republic of Korea
Korea University Ansan Hospital /ID# 254128
Ansan-si
CHA Bundang Medical Center /ID# 254026
Seongnam
Hallym University Kangnam Sacred Heart Hospital /ID# 254127
Seoul
Seoul National University Hospital /ID# 254027
Seoul
SoonChunHyang University Seoul Hospital /ID# 254025
Seoul
Saudi Arabia
King Faisal Specialist Hospital /ID# 255539
Jeddah
King Abdulaziz Medical City- National Guard Hospital /ID# 255280
Riyadh
King Faisal Specialist Hospital and Research Centre /ID# 255279
Riyadh
King Saud University Med City /ID# 255282
Riyadh
Singapore
National Skin Centre /ID# 255242
Singapore
National University Hospital /ID# 254943
Singapore
Slovakia
Univerzitna nemocnica Bratislava - Nemocnica Ruzinov /ID# 254157
Bratislava
Univerzitna nemocnica L. Pasteura Kosice /ID# 254136
Košice
Univerzitna nemocnica Martin /ID# 254153
Martin
Fakultna nemocnica s poliklinikou Nove Zamky /ID# 254155
Nové Zámky
Fakultna nemocnica Trnava /ID# 254137
Trnava
Spain
Hospital General de Granollers /ID# 253873
Barcelona
Hospital Santa Creu i Sant Pau /ID# 253869
Barcelona
Hospital Universitario Virgen de las Nieves /ID# 253870
Granada
Hospital Universitari de Bellvitge /ID# 254982
L'hospitalet De Llobregat
Hospital Universitario Ramon y Cajal /ID# 253871
Madrid
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 253924
Majadahonda
Hospital de Manises /ID# 253867
Manises
Hospital Universitario y Politecnico La Fe /ID# 253868
Valencia
Sweden
Sahlgrenska Universitetssjukhuset /ID# 254807
Gothenburg
Karolinska University Hospital Solna /ID# 254808
Solna
Switzerland
Inselspital, Universitaetsspital Bern /ID# 254736
Bern
Kantonsspital St. Gallen /ID# 255243
Sankt Gallen
University Hospital Zurich /ID# 254642
Zurich
Taiwan
Changhua Christian Hospital /ID# 254032
Changhua City, Changhua County
Kaohsiung Chang Gung Memorial Hospital /ID# 254031
Kaohsiung City
National Taiwan University Hospital /ID# 254030
Taipei
Linkou Chang Gung Memorial Hospital /ID# 254033
Taoyuan City
Turkey
Gulhane Egitim ve Arastirma Hastanesi /ID# 253919
Ankara
Izmir Sehir Hastanesi /ID# 265465
Bayraklı
Uludag University Medical Faculty /ID# 253806
Bursa
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 253824
Istanbul
Erciyes University Medical Faculty /ID# 253804
Kayseri
Ondokuz Mayis Universitesi /ID# 254034
Samsun
United Kingdom
University Hospitals Bristol /ID# 261505
Bristol
UH Coventry & Warwickshire /ID# 256909
Coventry
Leeds Teaching Hospitals NHS Trust /ID# 254616
Leeds
Chelsea and Westminster Hospital /ID# 254190
London
St George University Hospitals NHS Foundation Trust /ID# 256803
London
Northern Care Alliance NHS Group /ID# 256910
Salford
University Hospital Southampton NHS Foundation Trust /ID# 254531
Southampton
Time Frame
Start Date: 2023-06-21
Completion Date: 2028-09
Participants
Target number of participants: 1328
Treatments
Experimental: Period 1: Upadacitinib Dose A
Participants will receive Upadicitinib Dose A once daily for 16 weeks.
Placebo_comparator: Period 1: Placebo
Participants will receive Placebo once daily for 16 weeks.
Experimental: Period 2: Group 1 - Upadacitinib Dose A
Participants who were randomized to placebo in Period 1 who did not achieve HiSCR 50 (clinical non-responder, CNR) at Week 16 will receive Upadacitinib Dose A once daily for 20 weeks.
Placebo_comparator: Period 2: Group 2 - Placebo
Participants who were randomized to placebo in Period 1 who achieve HiSCR 50 (clinical responder, CR) at Week 16 will continue to receive placebo once daily for 20 weeks.
Experimental: Period 2: Group 3 - Upadacitinib Dose A
Participants who were randomized to upadacitinib Dose A in Period 1 who did not achieve HiSCR 50 (CNR) at Week 16 will continue to receive upadacitinib Dose A once daily for 20 weeks.
Experimental: Period 2: Group 4 - Upadacitinib Dose A
Participants who were randomized to upadacitinib Dose A in Period 1 who achieve HiSCR 50 (CR) at Week 16 will receive upadacitinib Dose A once daily for 20 weeks.
Experimental: Period 2: Group 5 - Upadacitinib Dose B
Participants who were randomized to upadacitinib Dose A in Period 1 who achieve HiSCR 50 (CR) at Week 16 will receive upadacitinib Dose B once daily for 20 weeks.
Experimental: Period 2: Group 6 - Placebo
Participants who were randomized to upadacitinib Dose A in Period 1 who achieve HiSCR 50 (CR) at Week 16 will receive placebo once daily for 20 weeks.
Experimental: Period 3: Long-Term Extension
Eligible participants will continue to receive upadacitinib or placebo for 68 weeks. Participants will be followed-up for approximately 30 days.
Related Therapeutic Areas
Sponsors
Leads: AbbVie