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
Step-Up HS
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
2 other identifiers
interventional
1,328
36 countries
280
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2023
Longer than P75 for phase_3
280 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2023
CompletedFirst Posted
Study publicly available on registry
June 5, 2023
CompletedStudy Start
First participant enrolled
June 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
March 4, 2026
March 1, 2026
4.7 years
May 26, 2023
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 50
HiSCR 50 is defined as at least a 50% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.
Baseline to Week 16
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Up to Approximately Week 108
Secondary Outcomes (9)
Change from Baseline in Draining Fistula Count
Baseline to Week 16
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75
Baseline to Week 16
Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 4 Among Participants with NRS ≥ 3 at Baseline
Baseline to Week 4
Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA)
Baseline to Week 16
Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA)
Baseline to Week 16
- +4 more secondary outcomes
Study Arms (9)
Period 1: Upadacitinib Dose A
EXPERIMENTALParticipants will receive Upadicitinib Dose A once daily for 16 weeks.
Period 1: Placebo
PLACEBO COMPARATORParticipants will receive Placebo once daily for 16 weeks.
Period 2: Group 1 - Upadacitinib Dose A
EXPERIMENTALParticipants 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.
Period 2: Group 2 - Placebo
PLACEBO COMPARATORParticipants 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.
Period 2: Group 3 - Upadacitinib Dose A
EXPERIMENTALParticipants 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.
Period 2: Group 4 - Upadacitinib Dose A
EXPERIMENTALParticipants 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.
Period 2: Group 5 - Upadacitinib Dose B
EXPERIMENTALParticipants 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.
Period 2: Group 6 - Placebo
EXPERIMENTALParticipants 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.
Period 3: Long-Term Extension
EXPERIMENTALEligible participants will continue to receive upadacitinib or placebo for 68 weeks. Participants will be followed-up for approximately 30 days.
Interventions
Oral Tablets
Oral Tablets
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (285)
Cahaba Dermatology & Skin Health Center /ID# 254876
Birmingham, Alabama, 35244, United States
Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272564
Fountain Hills, Arizona, 85268, United States
Medical Dermatology Specialists /ID# 254226
Phoenix, Arizona, 85006, United States
Mayo Clinic - Scottsdale /ID# 254388
Scottsdale, Arizona, 85259-5452, United States
Banner University Medicine Dermatology /ID# 255853
Tucson, Arizona, 85718-1407, United States
Clinical Trials Institute - Northwest Arkansas /ID# 254924
Fayetteville, Arkansas, 72703, United States
Burke Pharmaceutical Research /ID# 254238
Hot Springs, Arkansas, 71913-6404, United States
Arkansas Research Trials /ID# 254233
North Little Rock, Arkansas, 72217, United States
NW Arkansas Clinical Trials Center /ID# 254311
Rogers, Arkansas, 72758, United States
Private Practice - Dr. Tooraj Raoof /ID# 254374
Encino, California, 91436, United States
Marvel Clinical Research /ID# 276228
Huntington Beach, California, 92647, United States
Dermatology Research Associates /ID# 254846
Los Angeles, California, 90045, United States
NorCal Clinical Research /ID# 274219
Rocklin, California, 95765, United States
Integrative Skin Science and Research /ID# 254930
Sacramento, California, 95815, United States
University of California Davis Health /ID# 254229
Sacramento, California, 95817, United States
Medderm Associates /ID# 253800
San Diego, California, 92103, United States
Clinical Trials Research Institute /ID# 254466
Thousand Oaks, California, 91320-2130, United States
UConn Health Main /ID# 254507
Farmington, Connecticut, 06032, United States
Yale University School of Medicine /ID# 254586
New Haven, Connecticut, 06510, United States
Skin Care Research Boca Raton /ID# 253814
Boca Raton, Florida, 33486-2269, United States
Apex Clinical Trials /ID# 255756
Brandon, Florida, 33511, United States
Florida Academic Dermatology Center /ID# 254011
Coral Gables, Florida, 33134-5755, United States
Dermatology Associates of the Palm Beaches /ID# 275950
Delray Beach, Florida, 33445, United States
Skin Care Research - Hollywood /ID# 254508
Hollywood, Florida, 33021-6748, United States
Life Clinical Trials /ID# 258613
Margate, Florida, 33063, United States
Skin Care Research - Tampa /ID# 256440
Tampa, Florida, 33607-6438, United States
Advanced Clinical Research Institute /ID# 253746
Tampa, Florida, 33607, United States
Avita Clinical Research /ID# 254471
Tampa, Florida, 33613-1825, United States
Centricity Research /ID# 255470
Columbus, Georgia, 31904-2954, United States
Treasure Valley Medical Research /ID# 255208
Boise, Idaho, 83706, United States
DeNova Research /ID# 254372
Chicago, Illinois, 60610, United States
Northwestern University Feinberg School of Medicine /ID# 254503
Chicago, Illinois, 60611-2927, United States
NorthShore University HealthSystem - Skokie /ID# 254389
Skokie, Illinois, 60077, United States
Dawes Fretzin, LLC /ID# 254390
Indianapolis, Indiana, 46256, United States
Options Research Group /ID# 254537
West Lafayette, Indiana, 47906, United States
U.S. Dermatology Partners Leawood /ID# 255838
Leawood, Kansas, 66211-1453, United States
Equity Medical, LLC /ID# 271140
Bowling Green, Kentucky, 42104, United States
Massachusetts General Hospital /ID# 261093
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center /ID# 253811
Boston, Massachusetts, 02215-5400, United States
Beacon Clinical Research, LLC /ID# 254419
Quincy, Massachusetts, 02169, United States
UMass Memorial Medical Center /ID# 258839
Worcester, Massachusetts, 01605, United States
The Derm Institute Of West Michigan /ID# 275948
Caledonia, Michigan, 49316, United States
Hamzavi Dermatology - Canton /ID# 275856
Canton, Michigan, 48187, United States
Michigan Center for Medical Research /ID# 275860
Clarkston, Michigan, 48346, United States
Michigan Dermatology Institute /ID# 254468
Waterford, Michigan, 48328, United States
Cleaver Dermatology /ID# 254391
Kirksville, Missouri, 63501-5362, United States
Dermatology and Skin Center of Lees Summit /ID# 257546
Lee's Summit, Missouri, 64064-2301, United States
MediSearch Clinical Trials /ID# 254392
Saint Joseph, Missouri, 64506, United States
SSM Health Saint Louis University Hospital /ID# 256437
St Louis, Missouri, 63104, United States
Washington University School of Medicine - St. Louis /ID# 254506
St Louis, Missouri, 63130, United States
Vivida Dermatology- Flamingo /ID# 254227
Las Vegas, Nevada, 89119-5190, United States
Las Vegas Dermatology /ID# 272421
Las Vegas, Nevada, 89144, United States
Skin Cancer and Dermatology Institute - Reno /ID# 254410
Reno, Nevada, 89509, United States
Empire Dermatology /ID# 276241
East Syracuse, New York, 13057, United States
NorthWell Health - Dermatology /ID# 254704
New Hyde Park, New York, 11042-2058, United States
Schweiger Dermatology, P.C. /ID# 254232
New York, New York, 07044-2946, United States
Private Practice - Dr. Bobby Buka /ID# 276371
New York, New York, 10012, United States
Onsite Clinical Solutions /ID# 254854
Charlotte, North Carolina, 28277-3816, United States
Duke University Medical Center /ID# 256898
Durham, North Carolina, 27710, United States
Apex Clinical Research Center, LLC /ID# 275956
Canton, Ohio, 44718, United States
ClinOhio Research Services /ID# 254851
Columbus, Ohio, 43213-4440, United States
Dermatologists of Southwest Ohio, Inc /ID# 254297
Mason, Ohio, 45040-4520, United States
Dermatology Partners - Medina /ID# 275939
Medina, Ohio, 44256, United States
Lynn Institute of Oklahoma City /ID# 253791
Oklahoma City, Oklahoma, 73112, United States
Oregon Health and Science University /ID# 254929
Portland, Oregon, 97239, United States
Penn State Milton S. Hershey Medical Center /ID# 254925
Hershey, Pennsylvania, 17033-2360, United States
Paddington Testing Co., Inc. /ID# 254394
Philadelphia, Pennsylvania, 19103, United States
Clinical Research of Philadelphia, LLC /ID# 255308
Philadelphia, Pennsylvania, 19114, United States
Medical University of South Carolina /ID# 272569
Charleston, South Carolina, 29425, United States
Dermatology Associates of Knoxville /ID# 261082
Knoxville, Tennessee, 37917, United States
Arlington Research Center, Inc /ID# 253805
Arlington, Texas, 76011, United States
Bellaire Dermatology Associates /ID# 253797
Bellaire, Texas, 77401, United States
Dermatology Treatment and Research Center /ID# 253795
Dallas, Texas, 75230, United States
Modern Research Associates, PLLC /ID# 253810
Dallas, Texas, 75231, United States
HRMD Research Dallas /ID# 255256
Dallas, Texas, 75240-6246, United States
Dallas Fort Worth Clinical Research Associates (DFWCRA) /ID# 256438
Grapevine, Texas, 76051-3580, United States
Suzanne Bruce and Associates-Houston /ID# 254228
Houston, Texas, 77056, United States
Texas Dermatology Research Center, LLC /ID# 254928
Plano, Texas, 75025, United States
Center for Clinical Studies Webster TX /ID# 254242
Webster, Texas, 77598, United States
Cope Family Medicine - Ogden Clinic /ID# 276227
Bountiful, Utah, 84010, United States
University of Utah /ID# 254452
Murray, Utah, 84107, United States
Springville Dermatology - Springville /ID# 276225
Springville, Utah, 84663, United States
University of Virginia - Dermatology /ID# 254535
Charlottesville, Virginia, 22903, United States
The Education & Research Foundation, Inc. /ID# 254852
Lynchburg, Virginia, 24501-1403, United States
Virginia Clinical Research /ID# 254538
Norfolk, Virginia, 23507, United States
Frontier Dermatology /ID# 254554
Mill Creek, Washington, 98012, United States
Premier Clinical Research /ID# 254847
Spokane, Washington, 99202, United States
Hospital Universitario Austral /ID# 254904
Pilar, Buenos Aires, 1629, Argentina
Buenos Aires Skin /ID# 255299
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1055, Argentina
Instituto de Neumonologia y Dermatologia /ID# 254903
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1425, Argentina
Psoriahue Med Interdisciplinar /ID# 257202
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1425, Argentina
Consultorios Reumatologicos Pampa /ID# 255555
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1428, Argentina
Centro de Investigacion y Prevencion Cardiovascular (CIPREC) /ID# 255474
Buenos Aires, 1061, Argentina
Hospital Italiano /ID# 254905
CABA, C1199ABB, Argentina
Paratus Clinical Research Woden /ID# 254670
Phillip, Australian Capital Territory, 2606, Australia
Momentum Clinical Research /ID# 254411
Darlinghurst, New South Wales, 2010, Australia
Skin Health Institute Inc /ID# 254416
Carlton, Victoria, 3053, Australia
Sinclair Dermatology - Melbourne /ID# 254412
East Melbourne, Victoria, 3002, Australia
The Alfred Hospital /ID# 254414
Melbourne, Victoria, 3004, Australia
Medizinische Universitaet Graz /ID# 253448
Graz, Styria, 8010, Austria
Duplicate_Ordensklinikum Linz GmbH Elisabethinen /ID# 253458
Linz, Upper Austria, 4010, Austria
Medizinische Universitaet Wien /ID# 254096
Vienna, Vienna, 1090, Austria
Universite Libre de Bruxelles - Hopital Erasme /ID# 254082
Anderlecht, Brussels Capital, 1070, Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 254087
Brussels, Brussels Capital, 1200, Belgium
Universitair Ziekenhuis Brussel /ID# 254223
Jette, Brussels Capital, 1090, Belgium
Grand Hôpital de Charleroi - Les Viviers /ID# 254091
Charleroi, Hainaut, 6280, Belgium
UZ Gent /ID# 254090
Ghent, Oost-Vlaanderen, 9000, Belgium
Universitair Ziekenhuis Leuven /ID# 254089
Leuven, Vlaams-Brabant, 3000, Belgium
CHU de Liege /ID# 254085
Liège, 4000, Belgium
Instituto de Pesquisa e Ensino CLIGEDIMUNO - IPEC /ID# 254369
Macaé, Rio de Janeiro, 27910-190, Brazil
Hospital Moinhos de Vento /ID# 254366
Porto Alegre, Rio Grande do Sul, 90035-001, Brazil
Hospital e Maternidade Celso Pierro - PUC-Campinas /ID# 275811
Campinas, São Paulo, 13034-685, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 254367
Ribeirão Preto, São Paulo, 14049-900, Brazil
Centro de Desenvolvimento em Estudos Clinicos Brasil - CDEC /ID# 254368
São Paulo, São Paulo, 04020-060, Brazil
Instituto Brasil de Pesquisa Clinica S.A - IBPClin /ID# 275810
Rio de Janeiro, 20241-180, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 254370
São Paulo, 05403-000, Brazil
Ambulatory for Specialized Medical Care-IPSMC-skin and venereal diseases /ID# 253329
Sofiya, Sofia, 1407, Bulgaria
Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 253327
Sofiya, Sofia, 1463, Bulgaria
Acibadem City Clinic Tokuda University Hospital EAD /ID# 253331
Sofia, 1407, Bulgaria
UMHAT Professor Stoyan Kirkovich /ID# 253328
Stara Zagora, 6000, Bulgaria
Dermatology Research Institute - Blackfoot Trail /ID# 261413
Calgary, Alberta, T2J 7E1, Canada
Beacon Dermatology Inc /ID# 254564
Calgary, Alberta, T3A 2N1, Canada
Rejuvenation Dermatology - Edmonton Downtown /ID# 254715
Edmonton, Alberta, T5J 3S9, Canada
Alberta Dermasurgery Centre /ID# 275945
Edmonton, Alberta, T6G 1C3, Canada
Care Clinic - Red Deer - Taylor Drive /ID# 276063
Red Deer, Alberta, T4P 1K4, Canada
Dr. Chih-ho Hong Medical Inc. /ID# 254378
Surrey, British Columbia, V3R 6A7, Canada
Enverus Medical Research /ID# 254380
Surrey, British Columbia, V3V 0C6, Canada
Wiseman Dermatology Research /ID# 254117
Winnipeg, Manitoba, R3M 3Z4, Canada
Karma Clinical Trials /ID# 254120
St. John's, Newfoundland and Labrador, A1A 4Y3, Canada
LEADER Research /ID# 254379
Hamilton, Ontario, L8L 3C3, Canada
DermEffects /ID# 254116
London, Ontario, N6H 5L5, Canada
Lynderm Research Inc /ID# 254713
Markham, Ontario, L3P 1X2, Canada
Derm Care Clinic /ID# 276065
Mississauga, Ontario, L4W 0C2, Canada
Ryan Clinical Research Inc /ID# 254714
Newmarket, Ontario, L3Y 5G8, Canada
York Dermatology Clinic & Research Centre /ID# 254115
Richmond Hill, Ontario, L4C 9M7, Canada
Research Toronto /ID# 255273
Toronto, Ontario, M4W 2N4, Canada
CHU Sainte-Justine /ID# 254118
Montreal, Quebec, H3T 1C5, Canada
Dre Angelique Gagne-Henley M.D. inc. /ID# 255632
Saint-Jérôme, Quebec, J7Z 7E2, Canada
SkinSense Dermatology /ID# 254119
Saskatoon, Saskatchewan, S7K 0H6, Canada
Diex Recherche Quebec Inc. /ID# 254381
Québec, G1V 4T3, Canada
Centro Medico Skin Med SPA /ID# 254560
Las Condes, Region Metropolitana Santiago, 7580206, Chile
Centro Internacional de Estudios Clinicos - CIEC /ID# 254559
Santiago, Region Metropolitana Santiago, 8420383, Chile
Clinica Dermacross /ID# 254558
Vitacura, Region Metropolitana Santiago, 7640881, Chile
Fundacion Innovacion Cardiovascular /ID# 254561
Independencia, Santiago Metropolitan, 8380465, Chile
IPS Suramericana SAS - IPS Sura San Diego /ID# 255064
Medellín, Antioquia, 050016, Colombia
Centro de Inmunología y Genética CIGE SAS /ID# 254797
Medellín, Antioquia, 055422, Colombia
Centro Integral de Reumatología del Caribe SAS - Circaribe SAS /ID# 255278
Barranquilla, Atlántico, 80002, Colombia
Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 254796
Bogotá, Cundinamarca, 110221, Colombia
DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 253587
Zagreb, City of Zagreb, 10000, Croatia
Klinicki bolnicki centar Zagreb /ID# 253786
Zagreb, City of Zagreb, 10000, Croatia
Klinika za dječje bolesti Zagreb /ID# 253588
Zagreb, City of Zagreb, 10000, Croatia
Poliklinika Solmed /ID# 254732
Zagreb, City of Zagreb, 10000, Croatia
Specialty Hospital Medico /ID# 254731
Rijeka, Primorje-Gorski Kotar County, 51000, Croatia
Klinicki Bolnicki Centar (KBC) Split /ID# 253789
Split, Split-Dalmatia County, 21000, Croatia
Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 253586
Ivanić-Grad, Zagreb County, 10310, Croatia
Karlovarska Krajska Nemocnice - Karlovy Vary /ID# 253456
Karlovy Vary, 360 01, Czechia
Fakultni nemocnice Kralovske Vinohrady /ID# 253454
Prague, 100 34, Czechia
Duplicate_Fakultni Nemocnice v Motole /ID# 253455
Prague, 150 00, Czechia
Oulun yliopistollinen sairaala /ID# 253969
Oulu, North Ostrobothnia, 90220, Finland
Terveystalo Tampere /ID# 253968
Tampere, Pirkanmaa, 33100, Finland
Chu de Nice-Hopital Larchet Ii /Id# 253504
Nice, Alpes-Maritimes, 06202, France
Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-Andre /ID# 254139
Bordeaux, Gironde, 33000, France
Polyclinique Courlancy /ID# 254680
Reims, Marne, 51100, France
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 254114
Nantes, Pays de la Loire Region, 44000, France
HCL - Hopital Edouard Herriot /ID# 253500
Lyon, Rhone, 69003, France
Hopital Prive d'Antony /ID# 253501
Antony, Île-de-France Region, 92160, France
Universitaetsklinikum Freiburg /ID# 275746
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Universitaetsklinikum Erlangen /ID# 254804
Erlangen, Bavaria, 91054, Germany
Universitaetsklinikum Wuerzburg /ID# 275599
Würzburg, Bavaria, 97080, Germany
Universitaetsklinikum Frankfurt /ID# 253683
Frankfurt am Main, Hesse, 60590, Germany
Fachklinik Bad Bentheim /ID# 275537
Bad Bentheim, Lower Saxony, 48455, Germany
Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 254510
Bramsche, Lower Saxony, 49565, Germany
Universitaetsklinikum Duesseldorf /ID# 253711
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Universitaetsmedizin Mainz /ID# 272596
Mainz, Rhineland-Palatinate, 55131, Germany
HMS GmbH Zimmer /ID# 272614
Merzig, Saarland, 66663, Germany
Havelklinik /ID# 254194
Berlin, 13595, Germany
Klinikum Ruhr Univ Bochum /ID# 253690
Bochum, 44791, Germany
Magdeburger Company for Medical Studies & Services GmbH /ID# 255151
Magdeburg, 39104, Germany
Dermatologie Quist-BAG Dres. med. Quist PartG /ID# 253691
Mainz, 55128, Germany
Klinik am Biederstein /ID# 254195
Munich, 80802, Germany
Universitaetsklinikum Regensburg /ID# 253692
Regensburg, 93042, Germany
401 GSNA - 401 Army General Hospital /ID# 253499
Athens, Attica, 11527, Greece
University General Hospital Attikon /ID# 253495
Athens, Attica, 12462, Greece
General Hospital Andreas Syggros /ID# 253498
Athens, Attica, 16121, Greece
Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 253497
Thessaloniki, 54643, Greece
Papageorgiou General Hospital /ID# 253496
Thessaloniki, 56429, Greece
Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 253753
Pécs, Baranya, 7624, Hungary
Debreceni Egyetem-Klinikai Kozpont /ID# 253637
Debrecen, Hajdú-Bihar, 4032, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 253913
Kaposvár, Somogy County, 7400, Hungary
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 254377
Szombathely, Vas County, 9700, Hungary
Csalogany Orvosi Kozpont /ID# 255063
Budapest, 1027, Hungary
Duplicate_Obudai Egeszsegugyi Centrum Kft. /ID# 256366
Budapest, 1036, Hungary
Semmelweis Egyetem /ID# 276162
Budapest, 1085, Hungary
DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 253638
Debrecen, 4031, Hungary
Szegedi Tudomanyegyetem /ID# 255142
Szeged, 6720, Hungary
St James Hospital /ID# 253973
Dublin, Dublin, D08 NHY1, Ireland
South Infirmary Victoria University Hospital /ID# 253975
Cork, T12 X23H, Ireland
University College Dublin /ID# 253971
Dublin, D07 A8NN, Ireland
University Hospital Galway /ID# 253976
Galway, H91 YR71, Ireland
Waterford Regional Hospital /ID# 254038
Waterford, X91 ER8E, Ireland
ZIV Medical Center /ID# 254403
Safed, Northern District, 13100, Israel
Sheba Medical Center /ID# 254545
Ramat Gan, Tel Aviv, 52621, Israel
Tel Aviv Sourasky Medical Center /ID# 254404
Tel Aviv, Tel Aviv, 6423906, Israel
Rambam Health Care Campus /ID# 254406
Haifa, 3109601, Israel
Rabin Medical Center. /ID# 254405
Petah Tikva, 4941492, Israel
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale S.Anna /ID# 254496
Cona, Ferrara, 44124, Italy
AZIENDA USL TOSCANA CENTRO - Ospedale Piero Palagi /ID# 254495
Florence, Firenze, 50122, Italy
ASL 1 Abruzzo - Ospedale regionale San Salvatore /ID# 276045
L’Aquila, L Aquila, 67100, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 254498
Rome, Roma, 00133, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 254500
Rome, Roma, 00168, Italy
ASST degli Spedali Civili di Brescia /ID# 254875
Brescia, 25123, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 254502
Milan, 20122, Italy
Azienda Ospedaliero-Universitaria di Modena /ID# 254874
Modena, 41124, Italy
Azienda Ospedaliero Universitaria Pisana /ID# 254501
Pisa, 56126, Italy
Fukuoka University Hospital /ID# 254729
Fukuoka, Fukuoka, 814-0180, Japan
Meiwa Hospital /ID# 254728
Nishinomiya-shi, Hyōgo, 663-8186, Japan
University of Tsukuba Hospital /ID# 254638
Tsukuba, Ibaraki, 305-8576, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 254481
Kyoto, Kyoto, 602-8566, Japan
Tohoku University Hospital /ID# 254598
Sendai, Miyagi, 9808574, Japan
University of the Ryukyus Hospital /ID# 254517
Ginowan-shi, Okinawa, 901-2725, Japan
Kindai University Hospital /ID# 254574
Sakai-shi, Osaka, 590-0197, Japan
Shiga University of Medical Science Hospital /ID# 254215
Ōtsu, Shiga, 520-2192, Japan
Nihon University Itabashi Hospital /ID# 254637
Itabashi-ku, Tokyo, 173-8610, Japan
Toranomon Hospital /ID# 253819
Minato-ku, Tokyo, 105-8470, Japan
Inlita - Santara KTC /ID# 253917
Vilnius, 08406, Lithuania
Vilnius University Hospital Santaros Klinikos /ID# 253916
Vilnius, 08661, Lithuania
Grupo Clinico Catei Sociedad Civil /Id# 254657
Guadalajara, Jalisco, 44657, Mexico
Eukarya PharmaSite, SC /ID# 254658
Monterrey, Nuevo León, 64718, Mexico
Cryptex Investigacion Clinica S.A de C.V /ID# 256066
Mexico City, 06100, Mexico
Amphia Ziekenhuis /ID# 253567
Breda, North Brabant, 4818 CK, Netherlands
Universitair Medisch Centrum Groningen /ID# 253571
Groningen, 9713 GZ, Netherlands
Greenlane Clinical Centre /ID# 254351
Epsom, Auckland, 1051, New Zealand
Clinical Trials New Zealand /ID# 254352
Hamilton, Waikato Region, 3204, New Zealand
Centro Hospitalar de Lisboa Central /ID# 254325
Lisbon, 1169-050, Portugal
Hospital CUF Descobertas /ID# 254323
Lisbon, 1998-018, Portugal
Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 254322
Porto, 4099-001, Portugal
Unidade Local de Saude Sao Joao, EPE /ID# 254324
Porto, 4200-319, Portugal
Dr. Samuel Sanchez PSC /ID# 253948
Caguas, 00727, Puerto Rico
Alma M. Cruz Santana, MD-Private practice /ID# 253951
Carolina, 00985, Puerto Rico
King Faisal Specialist Hospital /ID# 255539
Jeddah, Mecca Region, 23433, Saudi Arabia
King Faisal Specialist Hospital and Research Centre /ID# 255279
Riyadh, Riyadh Region, 11211, Saudi Arabia
King Abdulaziz Medical City- National Guard Hospital /ID# 255280
Riyadh, Riyadh Region, 11426, Saudi Arabia
King Saud University Med City /ID# 255282
Riyadh, 12372, Saudi Arabia
National Skin Centre /ID# 255242
Singapore, Central Singapore, 308205, Singapore
National University Hospital /ID# 254943
Singapore, 119074, Singapore
Univerzitná nemocnica Bratislava - Nemocnica Ružinov /ID# 254157
Bratislava, Bratislava Region, 821 01, Slovakia
Univerzitna nemocnica L. Pasteura Kosice /ID# 254136
Košice, Košice Region, 040 01, Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky /ID# 254155
Nové Zámky, Nitra Region, 940 34, Slovakia
Fakultna nemocnica Trnava /ID# 254137
Trnava, 917 02, Slovakia
Univerzitna nemocnica Martin /ID# 254153
Martin, Žilina Region, 036 01, Slovakia
Korea University Ansan Hospital /ID# 254128
Ansan-si, Gyeonggido, 15355, South Korea
CHA Bundang Medical Center /ID# 254026
Seongnam, Gyeonggido, 13496, South Korea
Seoul National University Hospital /ID# 254027
Seoul, Seoul Teugbyeolsi, 03080, South Korea
SoonChunHyang University Seoul Hospital /ID# 254025
Seoul, Seoul Teugbyeolsi, 04401, South Korea
Hallym University Kangnam Sacred Heart Hospital /ID# 254127
Seoul, Seoul Teugbyeolsi, 07441, South Korea
Hospital Universitari de Bellvitge /ID# 254982
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 253924
Majadahonda, Madrid, 28222, Spain
Hospital de Manises /ID# 253867
Manises, Valencia, 46940, Spain
Hospital Santa Creu i Sant Pau /ID# 253869
Barcelona, 08041, Spain
Hospital General de Granollers /ID# 253873
Barcelona, 08042, Spain
Hospital Universitario Virgen de las Nieves /ID# 253870
Granada, 18014, Spain
Hospital Universitario Ramon y Cajal /ID# 253871
Madrid, 28034, Spain
Hospital Universitario y Politecnico La Fe /ID# 253868
Valencia, 46026, Spain
Karolinska University Hospital Solna /ID# 254808
Solna, Stockholm County, 171 64, Sweden
Sahlgrenska Universitetssjukhuset /ID# 254807
Gothenburg, Västra Götaland County, 413 46, Sweden
Kantonsspital St. Gallen /ID# 255243
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
University Hospital Zurich /ID# 254642
Zurich, Canton of Zurich, 8091, Switzerland
Inselspital, Universitaetsspital Bern /ID# 254736
Bern, 3010, Switzerland
Kaohsiung Chang Gung Memorial Hospital /ID# 254031
Kaohsiung City, Kaohsiung, 833, Taiwan
National Taiwan University Hospital /ID# 254030
Taipei City, Taipei, 100, Taiwan
Changhua Christian Hospital /ID# 254032
Changhua City, Changhua County, 50006, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 254033
Taoyuan, 333, Taiwan
Gulhane Egitim ve Arastirma Hastanesi /ID# 253919
Ankara, Antalya, 06010, Turkey (Türkiye)
Izmir Sehir Hastanesi /ID# 265465
Bayraklı, 35540, Turkey (Türkiye)
Uludag University Medical Faculty /ID# 253806
Bursa, 16059, Turkey (Türkiye)
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 253824
Istanbul, 34098, Turkey (Türkiye)
Erciyes University Medical Faculty /ID# 253804
Kayseri, 38039, Turkey (Türkiye)
Ondokuz Mayis Universitesi /ID# 254034
Samsun, 55139, Turkey (Türkiye)
Chelsea and Westminster Hospital /ID# 254190
London, Greater London, SW10 9NH, United Kingdom
St George University Hospitals NHS Foundation Trust /ID# 256803
London, Greater London, SW17 0QT, United Kingdom
University Hospital Southampton NHS Foundation Trust /ID# 254531
Southampton, Hampshire, SO16 6YD, United Kingdom
UH Coventry & Warwickshire /ID# 256909
Coventry, Warwickshire, CV2 2DX, United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 254616
Leeds, West Yorkshire, LS9 7TF, United Kingdom
University Hospitals Bristol /ID# 261505
Bristol, BS1 3NU, United Kingdom
Northern Care Alliance NHS Group /ID# 256910
Salford, M6 8HD, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2023
First Posted
June 5, 2023
Study Start
June 21, 2023
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2028
Last Updated
March 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.