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)

March 2, 2026 updated by: AbbVie

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

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.

Study Overview

Status

Recruiting

Conditions

Hidradenitis Suppurativa

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1328

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: ABBVIE CALL CENTER
Phone Number: 844-663-3742
Email: abbvieclinicaltrials@abbvie.com

Study Locations

Argentina
- - Buenos Aires, Argentina, 1061
    - Recruiting
    - Centro de Investigacion y Prevencion Cardiovascular (CIPREC) /ID# 255474
  - CABA, Argentina, C1199ABB
    - Recruiting
    - Hospital Italiano /ID# 254905
- Buenos Aires
  - Pilar, Buenos Aires, Argentina, 1629
    - Recruiting
    - Hospital Universitario Austral /ID# 254904
- Buenos Aires F.D.
  - Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1055
    - Recruiting
    - Buenos Aires Skin /ID# 255299
  - Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1425
    - Recruiting
    - Instituto de Neumonologia y Dermatologia /ID# 254903
  - Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1425
    - Recruiting
    - Psoriahue Med Interdisciplinar /ID# 257202
  - Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1428
    - Recruiting
    - Consultorios Reumatologicos Pampa /ID# 255555
Australia
- Australian Capital Territory
  - Phillip, Australian Capital Territory, Australia, 2606
    - Recruiting
    - Paratus Clinical Research Woden /ID# 254670
- New South Wales
  - Darlinghurst, New South Wales, Australia, 2010
    - Recruiting
    - Momentum Clinical Research /ID# 254411
- Victoria
  - Carlton, Victoria, Australia, 3053
    - Recruiting
    - Skin Health Institute Inc /ID# 254416
  - East Melbourne, Victoria, Australia, 3002
    - Recruiting
    - Sinclair Dermatology - Melbourne /ID# 254412
  - Melbourne, Victoria, Australia, 3004
    - Recruiting
    - The Alfred Hospital /ID# 254414
Austria
- Styria
  - Graz, Styria, Austria, 8010
    - Recruiting
    - Medizinische Universitaet Graz /ID# 253448
- Upper Austria
  - Linz, Upper Austria, Austria, 4010
    - Completed
    - Duplicate_Ordensklinikum Linz GmbH Elisabethinen /ID# 253458
- Vienna
  - Vienna, Vienna, Austria, 1090
    - Recruiting
    - Medizinische Universitaet Wien /ID# 254096
Belgium
- - Liège, Belgium, 4000
    - Recruiting
    - CHU de Liege /ID# 254085
- Brussels Capital
  - Anderlecht, Brussels Capital, Belgium, 1070
    - Recruiting
    - Universite Libre de Bruxelles - Hopital Erasme /ID# 254082
  - Brussels, Brussels Capital, Belgium, 1200
    - Recruiting
    - Cliniques Universitaires UCL Saint-Luc /ID# 254087
  - Jette, Brussels Capital, Belgium, 1090
    - Recruiting
    - Universitair Ziekenhuis Brussel /ID# 254223
- Hainaut
  - Charleroi, Hainaut, Belgium, 6280
    - Recruiting
    - Grand Hôpital de Charleroi - Les Viviers /ID# 254091
- Oost-Vlaanderen
  - Ghent, Oost-Vlaanderen, Belgium, 9000
    - Recruiting
    - UZ Gent /ID# 254090
- Vlaams-Brabant
  - Leuven, Vlaams-Brabant, Belgium, 3000
    - Recruiting
    - Universitair Ziekenhuis Leuven /ID# 254089
Brazil
- - Rio de Janeiro, Brazil, 20241-180
    - Recruiting
    - Instituto Brasil de Pesquisa Clinica S.A - IBPClin /ID# 275810
  - São Paulo, Brazil, 05403-000
    - Recruiting
    - Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 254370
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
    - Recruiting
    - Hospital Moinhos de Vento /ID# 254366
- Rio de Janeiro
  - Macaé, Rio de Janeiro, Brazil, 27910-190
    - Recruiting
    - Instituto de Pesquisa e Ensino CLIGEDIMUNO - IPEC /ID# 254369
- São Paulo
  - Campinas, São Paulo, Brazil, 13034-685
    - Recruiting
    - Hospital e Maternidade Celso Pierro - PUC-Campinas /ID# 275811
  - Ribeirão Preto, São Paulo, Brazil, 14049-900
    - Recruiting
    - Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 254367
  - São Paulo, São Paulo, Brazil, 04020-060
    - Recruiting
    - Centro de Desenvolvimento em Estudos Clinicos Brasil - CDEC /ID# 254368
Bulgaria
- - Sofia, Bulgaria, 1407
    - Completed
    - Acibadem City Clinic Tokuda University Hospital EAD /ID# 253331
  - Stara Zagora, Bulgaria, 6000
    - Recruiting
    - UMHAT Professor Stoyan Kirkovich /ID# 253328
- Sofia
  - Sofiya, Sofia, Bulgaria, 1407
    - Recruiting
    - Ambulatory for Specialized Medical Care-IPSMC-skin and venereal diseases /ID# 253329
  - Sofiya, Sofia, Bulgaria, 1463
    - Recruiting
    - Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 253327
Canada
- - Québec, Canada, G1V 4T3
    - Recruiting
    - Diex Recherche Quebec Inc. /ID# 254381
- Alberta
  - Calgary, Alberta, Canada, T2J 7E1
    - Recruiting
    - Dermatology Research Institute - Blackfoot Trail /ID# 261413
  - Calgary, Alberta, Canada, T3A 2N1
    - Recruiting
    - Beacon Dermatology Inc /ID# 254564
  - Edmonton, Alberta, Canada, T5J 3S9
    - Recruiting
    - Rejuvenation Dermatology - Edmonton Downtown /ID# 254715
  - Edmonton, Alberta, Canada, T6G 1C3
    - Recruiting
    - Alberta Dermasurgery Centre /ID# 275945
  - Red Deer, Alberta, Canada, T4P 1K4
    - Recruiting
    - Care Clinic - Red Deer - Taylor Drive /ID# 276063
- British Columbia
  - Surrey, British Columbia, Canada, V3R 6A7
    - Recruiting
    - Dr. Chih-ho Hong Medical Inc. /ID# 254378
  - Surrey, British Columbia, Canada, V3V 0C6
    - Recruiting
    - Enverus Medical Research /ID# 254380
- Manitoba
  - Winnipeg, Manitoba, Canada, R3M 3Z4
    - Recruiting
    - Wiseman Dermatology Research /ID# 254117
- Newfoundland and Labrador
  - St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
    - Recruiting
    - Karma Clinical Trials /ID# 254120
- Ontario
  - Hamilton, Ontario, Canada, L8L 3C3
    - Recruiting
    - LEADER Research /ID# 254379
  - London, Ontario, Canada, N6H 5L5
    - Recruiting
    - DermEffects /ID# 254116
  - Markham, Ontario, Canada, L3P 1X2
    - Recruiting
    - Lynderm Research Inc /ID# 254713
  - Mississauga, Ontario, Canada, L4W 0C2
    - Recruiting
    - Derm Care Clinic /ID# 276065
  - Newmarket, Ontario, Canada, L3Y 5G8
    - Recruiting
    - Ryan Clinical Research Inc /ID# 254714
  - Richmond Hill, Ontario, Canada, L4C 9M7
    - Recruiting
    - York Dermatology Clinic & Research Centre /ID# 254115
  - Toronto, Ontario, Canada, M4W 2N4
    - Recruiting
    - Research Toronto /ID# 255273
- Quebec
  - Montreal, Quebec, Canada, H3T 1C5
    - Recruiting
    - CHU Sainte-Justine /ID# 254118
  - Saint-Jérôme, Quebec, Canada, J7Z 7E2
    - Recruiting
    - Dre Angelique Gagne-Henley M.D. inc. /ID# 255632
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7K 0H6
    - Recruiting
    - SkinSense Dermatology /ID# 254119
Chile
- Region Metropolitana Santiago
  - Las Condes, Region Metropolitana Santiago, Chile, 7580206
    - Recruiting
    - Centro Medico Skin Med SPA /ID# 254560
  - Santiago, Region Metropolitana Santiago, Chile, 8420383
    - Recruiting
    - Centro Internacional de Estudios Clinicos - CIEC /ID# 254559
  - Vitacura, Region Metropolitana Santiago, Chile, 7640881
    - Recruiting
    - Clinica Dermacross /ID# 254558
- Santiago Metropolitan
  - Independencia, Santiago Metropolitan, Chile, 8380465
    - Recruiting
    - Fundacion Innovacion Cardiovascular /ID# 254561
Colombia
- Antioquia
  - Medellín, Antioquia, Colombia, 050016
    - Recruiting
    - IPS Suramericana SAS - IPS Sura San Diego /ID# 255064
  - Medellín, Antioquia, Colombia, 055422
    - Recruiting
    - Centro de Inmunología y Genética CIGE SAS /ID# 254797
- Atlántico
  - Barranquilla, Atlántico, Colombia, 80002
    - Recruiting
    - Centro Integral de Reumatología del Caribe SAS - Circaribe SAS /ID# 255278
- Cundinamarca
  - Bogotá, Cundinamarca, Colombia, 110221
    - Recruiting
    - Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 254796
Croatia
- City of Zagreb
  - Zagreb, City of Zagreb, Croatia, 10000
    - Completed
    - DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 253587
  - Zagreb, City of Zagreb, Croatia, 10000
    - Recruiting
    - Klinicki bolnicki centar Zagreb /ID# 253786
  - Zagreb, City of Zagreb, Croatia, 10000
    - Recruiting
    - Klinika za dječje bolesti Zagreb /ID# 253588
  - Zagreb, City of Zagreb, Croatia, 10000
    - Recruiting
    - Poliklinika Solmed /ID# 254732
- Primorje-Gorski Kotar County
  - Rijeka, Primorje-Gorski Kotar County, Croatia, 51000
    - Recruiting
    - Specialty Hospital Medico /ID# 254731
- Split-Dalmatia County
  - Split, Split-Dalmatia County, Croatia, 21000
    - Recruiting
    - Klinicki Bolnicki Centar (KBC) Split /ID# 253789
- Zagreb County
  - Ivanić-Grad, Zagreb County, Croatia, 10310
    - Recruiting
    - Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 253586
Czechia
- - Karlovy Vary, Czechia, 360 01
    - Recruiting
    - Karlovarska Krajska Nemocnice - Karlovy Vary /ID# 253456
  - Prague, Czechia, 150 00
    - Recruiting
    - Duplicate_Fakultni Nemocnice v Motole /ID# 253455
  - Prague, Czechia, 100 34
    - Recruiting
    - Fakultni nemocnice Kralovske Vinohrady /ID# 253454
Finland
- North Ostrobothnia
  - Oulu, North Ostrobothnia, Finland, 90220
    - Recruiting
    - Oulun yliopistollinen sairaala /ID# 253969
- Pirkanmaa
  - Tampere, Pirkanmaa, Finland, 33100
    - Recruiting
    - Terveystalo Tampere /ID# 253968
France
- Alpes-Maritimes
  - Nice, Alpes-Maritimes, France, 06202
    - Recruiting
    - Chu de Nice-Hopital Larchet Ii /Id# 253504
- Gironde
  - Bordeaux, Gironde, France, 33000
    - Recruiting
    - Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-Andre /ID# 254139
- Marne
  - Reims, Marne, France, 51100
    - Recruiting
    - Polyclinique Courlancy /ID# 254680
- Pays de la Loire Region
  - Nantes, Pays de la Loire Region, France, 44000
    - Recruiting
    - Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 254114
- Rhone
  - Lyon, Rhone, France, 69003
    - Recruiting
    - HCL - Hopital Edouard Herriot /ID# 253500
- Île-de-France Region
  - Antony, Île-de-France Region, France, 92160
    - Recruiting
    - Hopital Prive d'Antony /ID# 253501
Germany
- - Berlin, Germany, 13595
    - Recruiting
    - Havelklinik /ID# 254194
  - Bochum, Germany, 44791
    - Recruiting
    - Klinikum Ruhr Univ Bochum /ID# 253690
  - Magdeburg, Germany, 39104
    - Completed
    - Magdeburger Company for Medical Studies & Services GmbH /ID# 255151
  - Mainz, Germany, 55128
    - Recruiting
    - Dermatologie Quist-BAG Dres. med. Quist PartG /ID# 253691
  - Munich, Germany, 80802
    - Recruiting
    - Klinik am Biederstein /ID# 254195
  - Regensburg, Germany, 93042
    - Recruiting
    - Universitaetsklinikum Regensburg /ID# 253692
- Baden-Wurttemberg
  - Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
    - Recruiting
    - Universitaetsklinikum Freiburg /ID# 275746
- Bavaria
  - Erlangen, Bavaria, Germany, 91054
    - Recruiting
    - Universitaetsklinikum Erlangen /ID# 254804
  - Würzburg, Bavaria, Germany, 97080
    - Recruiting
    - Universitaetsklinikum Wuerzburg /ID# 275599
    - Contact:
      
      Site Coordinator
      
      Phone Number: +4993120126722
- Hesse
  - Frankfurt am Main, Hesse, Germany, 60590
    - Recruiting
    - Universitaetsklinikum Frankfurt /ID# 253683
- Lower Saxony
  - Bad Bentheim, Lower Saxony, Germany, 48455
    - Recruiting
    - Fachklinik Bad Bentheim /ID# 275537
  - Bramsche, Lower Saxony, Germany, 49565
    - Completed
    - Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 254510
- North Rhine-Westphalia
  - Düsseldorf, North Rhine-Westphalia, Germany, 40225
    - Recruiting
    - Universitaetsklinikum Duesseldorf /ID# 253711
    - Contact:
      
      Site Coordinator
      
      Phone Number: +492118117775
- Rhineland-Palatinate
  - Mainz, Rhineland-Palatinate, Germany, 55131
    - Recruiting
    - Universitaetsmedizin Mainz /ID# 272596
- Saarland
  - Merzig, Saarland, Germany, 66663
    - Recruiting
    - HMS GmbH Zimmer /ID# 272614
Greece
- - Thessaloniki, Greece, 56429
    - Recruiting
    - Papageorgiou General Hospital /ID# 253496
  - Thessaloniki, Greece, 54643
    - Recruiting
    - Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 253497
- Attica
  - Athens, Attica, Greece, 11527
    - Completed
    - 401 GSNA - 401 Army General Hospital /ID# 253499
  - Athens, Attica, Greece, 12462
    - Recruiting
    - University General Hospital Attikon /ID# 253495
  - Athens, Attica, Greece, 16121
    - Recruiting
    - General Hospital Andreas Syggros /ID# 253498
Hungary
- - Budapest, Hungary, 1036
    - Completed
    - Duplicate_Obudai Egeszsegugyi Centrum Kft. /ID# 256366
  - Budapest, Hungary, 1027
    - Completed
    - Csalogany Orvosi Kozpont /ID# 255063
  - Budapest, Hungary, 1085
    - Recruiting
    - Semmelweis Egyetem /ID# 276162
  - Debrecen, Hungary, 4031
    - Recruiting
    - DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 253638
  - Szeged, Hungary, 6720
    - Recruiting
    - Szegedi Tudomanyegyetem /ID# 255142
- Baranya
  - Pécs, Baranya, Hungary, 7624
    - Recruiting
    - Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 253753
- Hajdú-Bihar
  - Debrecen, Hajdú-Bihar, Hungary, 4032
    - Recruiting
    - Debreceni Egyetem-Klinikai Kozpont /ID# 253637
- Somogy County
  - Kaposvár, Somogy County, Hungary, 7400
    - Recruiting
    - Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 253913
- Vas County
  - Szombathely, Vas County, Hungary, 9700
    - Recruiting
    - Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 254377
Ireland
- - Cork, Ireland, T12 X23H
    - Recruiting
    - South Infirmary Victoria University Hospital /ID# 253975
  - Dublin, Ireland, D07 A8NN
    - Recruiting
    - University College Dublin /ID# 253971
  - Galway, Ireland, H91 YR71
    - Recruiting
    - University Hospital Galway /ID# 253976
  - Waterford, Ireland, X91 ER8E
    - Recruiting
    - Waterford Regional Hospital /ID# 254038
- Dublin
  - Dublin, Dublin, Ireland, D08 NHY1
    - Recruiting
    - St James Hospital /ID# 253973
Israel
- - Haifa, Israel, 3109601
    - Recruiting
    - Rambam Health Care Campus /ID# 254406
  - Petah Tikva, Israel, 4941492
    - Completed
    - Rabin Medical Center. /ID# 254405
- Northern District
  - Safed, Northern District, Israel, 13100
    - Recruiting
    - ZIV Medical Center /ID# 254403
- Tel Aviv
  - Ramat Gan, Tel Aviv, Israel, 52621
    - Completed
    - Sheba Medical Center /ID# 254545
  - Tel Aviv, Tel Aviv, Israel, 6423906
    - Recruiting
    - Tel Aviv Sourasky Medical Center /ID# 254404
Italy
- - Brescia, Italy, 25123
    - Recruiting
    - ASST degli Spedali Civili di Brescia /ID# 254875
  - Milan, Italy, 20122
    - Recruiting
    - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 254502
  - Modena, Italy, 41124
    - Recruiting
    - Azienda Ospedaliero-Universitaria di Modena /ID# 254874
  - Pisa, Italy, 56126
    - Recruiting
    - Azienda Ospedaliero Universitaria Pisana /ID# 254501
- Ferrara
  - Cona, Ferrara, Italy, 44124
    - Recruiting
    - Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale S.Anna /ID# 254496
- Firenze
  - Florence, Firenze, Italy, 50122
    - Recruiting
    - AZIENDA USL TOSCANA CENTRO - Ospedale Piero Palagi /ID# 254495
- L Aquila
  - L’Aquila, L Aquila, Italy, 67100
    - Recruiting
    - ASL 1 Abruzzo - Ospedale regionale San Salvatore /ID# 276045
- Roma
  - Rome, Roma, Italy, 00133
    - Recruiting
    - Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 254498
  - Rome, Roma, Italy, 00168
    - Recruiting
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 254500
Japan
- Fukuoka
  - Fukuoka, Fukuoka, Japan, 814-0180
    - Recruiting
    - Fukuoka University Hospital /ID# 254729
- Hyōgo
  - Nishinomiya-shi, Hyōgo, Japan, 663-8186
    - Completed
    - Meiwa Hospital /ID# 254728
- Ibaraki
  - Tsukuba, Ibaraki, Japan, 305-8576
    - Recruiting
    - University of Tsukuba Hospital /ID# 254638
- Kyoto
  - Kyoto, Kyoto, Japan, 602-8566
    - Recruiting
    - University Hospital Kyoto Prefectural University of Medicine /ID# 254481
- Miyagi
  - Sendai, Miyagi, Japan, 9808574
    - Recruiting
    - Tohoku University Hospital /ID# 254598
- Okinawa
  - Ginowan-shi, Okinawa, Japan, 901-2725
    - Recruiting
    - University of the Ryukyus Hospital /ID# 254517
- Osaka
  - Sakai-shi, Osaka, Japan, 590-0197
    - Recruiting
    - Kindai University Hospital /ID# 254574
- Shiga
  - Ōtsu, Shiga, Japan, 520-2192
    - Recruiting
    - Shiga University of Medical Science Hospital /ID# 254215
- Tokyo
  - Itabashi-ku, Tokyo, Japan, 173-8610
    - Recruiting
    - Nihon University Itabashi Hospital /ID# 254637
  - Minato-ku, Tokyo, Japan, 105-8470
    - Recruiting
    - Toranomon Hospital /ID# 253819
Lithuania
- - Vilnius, Lithuania, 08406
    - Recruiting
    - Inlita - Santara KTC /ID# 253917
  - Vilnius, Lithuania, 08661
    - Recruiting
    - Vilnius University Hospital Santaros Klinikos /ID# 253916
Mexico
- - Mexico City, Mexico, 06100
    - Recruiting
    - Cryptex Investigacion Clinica S.A de C.V /ID# 256066
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44657
    - Recruiting
    - Grupo Clinico Catei Sociedad Civil /Id# 254657
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64718
    - Recruiting
    - Eukarya PharmaSite, SC /ID# 254658
Netherlands
- - Groningen, Netherlands, 9713 GZ
    - Recruiting
    - Universitair Medisch Centrum Groningen /ID# 253571
- North Brabant
  - Breda, North Brabant, Netherlands, 4818 CK
    - Recruiting
    - Amphia Ziekenhuis /ID# 253567
New Zealand
- Auckland
  - Epsom, Auckland, New Zealand, 1051
    - Recruiting
    - Greenlane Clinical Centre /ID# 254351
- Waikato Region
  - Hamilton, Waikato Region, New Zealand, 3204
    - Recruiting
    - Clinical Trials New Zealand /ID# 254352
Portugal
- - Lisbon, Portugal, 1169-050
    - Recruiting
    - Centro Hospitalar de Lisboa Central /ID# 254325
  - Lisbon, Portugal, 1998-018
    - Recruiting
    - Hospital CUF Descobertas /ID# 254323
  - Porto, Portugal, 4099-001
    - Recruiting
    - Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 254322
  - Porto, Portugal, 4200-319
    - Recruiting
    - Unidade Local de Saude Sao Joao, EPE /ID# 254324
Puerto Rico
- - Caguas, Puerto Rico, 00727
    - Recruiting
    - Dr. Samuel Sanchez PSC /ID# 253948
    - Contact:
      
      Site Coordinator
      
      Phone Number: 787-429-6644
  - Carolina, Puerto Rico, 00985
    - Recruiting
    - Alma M. Cruz Santana, MD-Private practice /ID# 253951
    - Contact:
      
      Site Coordinator
      
      Phone Number: 787-769-1954
Saudi Arabia
- - Riyadh, Saudi Arabia, 12372
    - Recruiting
    - King Saud University Med City /ID# 255282
- Mecca Region
  - Jeddah, Mecca Region, Saudi Arabia, 23433
    - Recruiting
    - King Faisal Specialist Hospital /ID# 255539
- Riyadh Region
  - Riyadh, Riyadh Region, Saudi Arabia, 11211
    - Recruiting
    - King Faisal Specialist Hospital and Research Centre /ID# 255279
  - Riyadh, Riyadh Region, Saudi Arabia, 11426
    - Recruiting
    - King Abdulaziz Medical City- National Guard Hospital /ID# 255280
Singapore
- - Singapore, Singapore, 119074
    - Recruiting
    - National University Hospital /ID# 254943
- Central Singapore
  - Singapore, Central Singapore, Singapore, 308205
    - Recruiting
    - National Skin Centre /ID# 255242
Slovakia
- - Trnava, Slovakia, 917 02
    - Recruiting
    - Fakultna nemocnica Trnava /ID# 254137
- Bratislava Region
  - Bratislava, Bratislava Region, Slovakia, 821 01
    - Recruiting
    - Univerzitná nemocnica Bratislava - Nemocnica Ružinov /ID# 254157
- Košice Region
  - Košice, Košice Region, Slovakia, 040 01
    - Recruiting
    - Univerzitna nemocnica L. Pasteura Kosice /ID# 254136
- Nitra Region
  - Nové Zámky, Nitra Region, Slovakia, 940 34
    - Recruiting
    - Fakultna nemocnica s poliklinikou Nove Zamky /ID# 254155
- Žilina Region
  - Martin, Žilina Region, Slovakia, 036 01
    - Recruiting
    - Univerzitna nemocnica Martin /ID# 254153
South Korea
- Gyeonggido
  - Ansan-si, Gyeonggido, South Korea, 15355
    - Recruiting
    - Korea University Ansan Hospital /ID# 254128
  - Seongnam, Gyeonggido, South Korea, 13496
    - Recruiting
    - CHA Bundang Medical Center /ID# 254026
- Seoul Teugbyeolsi
  - Seoul, Seoul Teugbyeolsi, South Korea, 03080
    - Recruiting
    - Seoul National University Hospital /ID# 254027
  - Seoul, Seoul Teugbyeolsi, South Korea, 04401
    - Recruiting
    - SoonChunHyang University Seoul Hospital /ID# 254025
  - Seoul, Seoul Teugbyeolsi, South Korea, 07441
    - Recruiting
    - Hallym University Kangnam Sacred Heart Hospital /ID# 254127
Spain
- - Barcelona, Spain, 08042
    - Recruiting
    - Hospital General de Granollers /ID# 253873
  - Barcelona, Spain, 08041
    - Recruiting
    - Hospital Santa Creu i Sant Pau /ID# 253869
  - Granada, Spain, 18014
    - Recruiting
    - Hospital Universitario Virgen de las Nieves /ID# 253870
  - Madrid, Spain, 28034
    - Recruiting
    - Hospital Universitario Ramon y Cajal /ID# 253871
  - Valencia, Spain, 46026
    - Recruiting
    - Hospital Universitario y Politecnico La Fe /ID# 253868
    - Contact:
      
      Site Coordinator
      
      Phone Number: 961 24 40 00
- Barcelona
  - L'Hospitalet de Llobregat, Barcelona, Spain, 08907
    - Recruiting
    - Hospital Universitari de Bellvitge /ID# 254982
- Madrid
  - Majadahonda, Madrid, Spain, 28222
    - Completed
    - Hospital Universitario Puerta de Hierro - Majadahonda /ID# 253924
- Valencia
  - Manises, Valencia, Spain, 46940
    - Recruiting
    - Hospital de Manises /ID# 253867
Sweden
- Stockholm County
  - Solna, Stockholm County, Sweden, 171 64
    - Recruiting
    - Karolinska University Hospital Solna /ID# 254808
- Västra Götaland County
  - Gothenburg, Västra Götaland County, Sweden, 413 46
    - Recruiting
    - Sahlgrenska Universitetssjukhuset /ID# 254807
Switzerland
- - Bern, Switzerland, 3010
    - Recruiting
    - Inselspital, Universitaetsspital Bern /ID# 254736
- Canton of St. Gallen
  - Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
    - Recruiting
    - Kantonsspital St. Gallen /ID# 255243
    - Contact:
      
      Site Coordinator
      
      Phone Number: +41 71 494 19 95
- Canton of Zurich
  - Zurich, Canton of Zurich, Switzerland, 8091
    - Recruiting
    - University Hospital Zurich /ID# 254642
Taiwan
- - Changhua City, Changhua County, Taiwan, 50006
    - Recruiting
    - Changhua Christian Hospital /ID# 254032
  - Taoyuan, Taiwan, 333
    - Recruiting
    - Linkou Chang Gung Memorial Hospital /ID# 254033
- Kaohsiung
  - Kaohsiung City, Kaohsiung, Taiwan, 833
    - Recruiting
    - Kaohsiung Chang Gung Memorial Hospital /ID# 254031
- Taipei
  - Taipei City, Taipei, Taiwan, 100
    - Recruiting
    - National Taiwan University Hospital /ID# 254030
Turkey (Türkiye)
- - Bayraklı, Turkey (Türkiye), 35540
    - Recruiting
    - Izmir Sehir Hastanesi /ID# 265465
  - Bursa, Turkey (Türkiye), 16059
    - Recruiting
    - Uludag University Medical Faculty /ID# 253806
  - Istanbul, Turkey (Türkiye), 34098
    - Recruiting
    - Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 253824
  - Kayseri, Turkey (Türkiye), 38039
    - Recruiting
    - Erciyes University Medical Faculty /ID# 253804
  - Samsun, Turkey (Türkiye), 55139
    - Recruiting
    - Ondokuz Mayis Universitesi /ID# 254034
- Antalya
  - Ankara, Antalya, Turkey (Türkiye), 06010
    - Recruiting
    - Gulhane Egitim ve Arastirma Hastanesi /ID# 253919
United Kingdom
- - Bristol, United Kingdom, BS1 3NU
    - Recruiting
    - University Hospitals Bristol /ID# 261505
  - Salford, United Kingdom, M6 8HD
    - Recruiting
    - Northern Care Alliance NHS Group /ID# 256910
- Greater London
  - London, Greater London, United Kingdom, SW10 9NH
    - Recruiting
    - Chelsea and Westminster Hospital /ID# 254190
  - London, Greater London, United Kingdom, SW17 0QT
    - Recruiting
    - St George University Hospitals NHS Foundation Trust /ID# 256803
- Hampshire
  - Southampton, Hampshire, United Kingdom, SO16 6YD
    - Recruiting
    - University Hospital Southampton NHS Foundation Trust /ID# 254531
- Warwickshire
  - Coventry, Warwickshire, United Kingdom, CV2 2DX
    - Recruiting
    - UH Coventry & Warwickshire /ID# 256909
- West Yorkshire
  - Leeds, West Yorkshire, United Kingdom, LS9 7TF
    - Recruiting
    - Leeds Teaching Hospitals NHS Trust /ID# 254616
United States
- Alabama
  - Birmingham, Alabama, United States, 35244
    - Recruiting
    - Cahaba Dermatology & Skin Health Center /ID# 254876
    - Contact:
      
      Site Coordinator
      
      Phone Number: 205-778-1564
- Arizona
  - Fountain Hills, Arizona, United States, 85268
    - Recruiting
    - Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272564
  - Phoenix, Arizona, United States, 85006
    - Recruiting
    - Medical Dermatology Specialists /ID# 254226
    - Contact:
      
      Site Coordinator
      
      Phone Number: 602-354-5770
  - Scottsdale, Arizona, United States, 85259-5452
    - Recruiting
    - Mayo Clinic - Scottsdale /ID# 254388
  - Tucson, Arizona, United States, 85718-1407
    - Recruiting
    - Banner University Medicine Dermatology /ID# 255853
    - Contact:
      
      Site Coordinator
      
      Phone Number: 520-694-1828
- Arkansas
  - Fayetteville, Arkansas, United States, 72703
    - Recruiting
    - Clinical Trials Institute - Northwest Arkansas /ID# 254924
    - Contact:
      
      Site Coordinator
      
      Phone Number: 479-544-3483
  - Hot Springs, Arkansas, United States, 71913-6404
    - Recruiting
    - Burke Pharmaceutical Research /ID# 254238
    - Contact:
      
      Site Coordinator
      
      Phone Number: 501-620-4449
  - North Little Rock, Arkansas, United States, 72217
    - Recruiting
    - Arkansas Research Trials /ID# 254233
  - Rogers, Arkansas, United States, 72758
    - Recruiting
    - NW Arkansas Clinical Trials Center /ID# 254311
- California
  - Encino, California, United States, 91436
    - Recruiting
    - Private Practice - Dr. Tooraj Raoof /ID# 254374
    - Contact:
      
      Site Coordinator
      
      Phone Number: 818-714-1431
  - Huntington Beach, California, United States, 92647
    - Recruiting
    - Marvel Clinical Research /ID# 276228
  - Los Angeles, California, United States, 90045
    - Recruiting
    - Dermatology Research Associates /ID# 254846
    - Contact:
      
      Site Coordinator
      
      Phone Number: 310-337-7171
  - Rocklin, California, United States, 95765
    - Recruiting
    - NorCal Clinical Research /ID# 274219
  - Sacramento, California, United States, 95815
    - Recruiting
    - Integrative Skin Science and Research /ID# 254930
    - Contact:
      
      Site Coordinator
      
      Phone Number: (916) 524-1216
  - Sacramento, California, United States, 95817
    - Recruiting
    - University of California Davis Health /ID# 254229
  - San Diego, California, United States, 92103
    - Completed
    - Medderm Associates /ID# 253800
  - Thousand Oaks, California, United States, 91320-2130
    - Recruiting
    - Clinical Trials Research Institute /ID# 254466
    - Contact:
      
      Site Coordinator
      
      Phone Number: 805-298-7021
- Connecticut
  - Farmington, Connecticut, United States, 06032
    - Recruiting
    - UConn Health Main /ID# 254507
    - Contact:
      
      Site Coordinator
      
      Phone Number: 860-679-3475
  - New Haven, Connecticut, United States, 06510
    - Recruiting
    - Yale University School of Medicine /ID# 254586
- Florida
  - Boca Raton, Florida, United States, 33486-2269
    - Recruiting
    - Skin Care Research Boca Raton /ID# 253814
    - Contact:
      
      Site Coordinator
      
      Phone Number: +1-561-948-3116
  - Brandon, Florida, United States, 33511
    - Recruiting
    - Apex Clinical Trials /ID# 255756
    - Contact:
      
      Site Coordinator
      
      Phone Number: +1-813-321-1786
  - Coral Gables, Florida, United States, 33134-5755
    - Recruiting
    - Florida Academic Dermatology Center /ID# 254011
    - Contact:
      
      Site Coordinator
      
      Phone Number: 954-743-0747
  - Delray Beach, Florida, United States, 33445
    - Recruiting
    - Dermatology Associates of the Palm Beaches /ID# 275950
  - Hollywood, Florida, United States, 33021-6748
    - Recruiting
    - Skin Care Research - Hollywood /ID# 254508
    - Contact:
      
      Site Coordinator
      
      Phone Number: +1-561-948-3116
  - Margate, Florida, United States, 33063
    - Recruiting
    - Life Clinical Trials /ID# 258613
    - Contact:
      
      Site Coordinator
      
      Phone Number: 954-752-7552 ex: 416
  - Tampa, Florida, United States, 33607-6438
    - Recruiting
    - Skin Care Research - Tampa /ID# 256440
    - Contact:
      
      Site Coordinator
      
      Phone Number: 561-948-3116
  - Tampa, Florida, United States, 33607
    - Recruiting
    - Advanced Clinical Research Institute /ID# 253746
    - Contact:
      
      Site Coordinator
      
      Phone Number: +1-813-879-7546
  - Tampa, Florida, United States, 33613-1825
    - Completed
    - Avita Clinical Research /ID# 254471
- Georgia
  - Columbus, Georgia, United States, 31904-2954
    - Recruiting
    - Centricity Research /ID# 255470
    - Contact:
      
      Site Coordinator
      
      Phone Number: 706-321-0495
- Idaho
  - Boise, Idaho, United States, 83706
    - Recruiting
    - Treasure Valley Medical Research /ID# 255208
- Illinois
  - Chicago, Illinois, United States, 60611-2927
    - Recruiting
    - Northwestern University Feinberg School of Medicine /ID# 254503
  - Chicago, Illinois, United States, 60610
    - Recruiting
    - DeNova Research /ID# 254372
  - Skokie, Illinois, United States, 60077
    - Recruiting
    - NorthShore University HealthSystem - Skokie /ID# 254389
- Indiana
  - Indianapolis, Indiana, United States, 46256
    - Recruiting
    - Dawes Fretzin, LLC /ID# 254390
    - Contact:
      
      Site Coordinator
      
      Phone Number: 317-516-5030 X102
  - West Lafayette, Indiana, United States, 47906
    - Recruiting
    - Options Research Group /ID# 254537
- Kansas
  - Leawood, Kansas, United States, 66211-1453
    - Recruiting
    - U.S. Dermatology Partners Leawood /ID# 255838
    - Contact:
      
      Site Coordinator
      
      Phone Number: 913-451-7546
- Kentucky
  - Bowling Green, Kentucky, United States, 42104
    - Recruiting
    - Equity Medical, LLC /ID# 271140
- Massachusetts
  - Boston, Massachusetts, United States, 02215-5400
    - Recruiting
    - Beth Israel Deaconess Medical Center /ID# 253811
    - Contact:
      
      Site Coordinator
      
      Phone Number: 6176675834
  - Boston, Massachusetts, United States, 02114
    - Recruiting
    - Massachusetts General Hospital /ID# 261093
  - Quincy, Massachusetts, United States, 02169
    - Recruiting
    - Beacon Clinical Research, LLC /ID# 254419
    - Contact:
      
      Site Coordinator
      
      Phone Number: 774-462-6610
  - Worcester, Massachusetts, United States, 01605
    - Recruiting
    - UMass Memorial Medical Center /ID# 258839
- Michigan
  - Caledonia, Michigan, United States, 49316
    - Recruiting
    - The Derm Institute Of West Michigan /ID# 275948
  - Canton, Michigan, United States, 48187
    - Recruiting
    - Hamzavi Dermatology - Canton /ID# 275856
  - Clarkston, Michigan, United States, 48346
    - Recruiting
    - Michigan Center for Medical Research /ID# 275860
    - Contact:
      
      Site Coordinator
      
      Phone Number: 248.620.3376 opt. 3
  - Waterford, Michigan, United States, 48328
    - Recruiting
    - Michigan Dermatology Institute /ID# 254468
- Missouri
  - Kirksville, Missouri, United States, 63501-5362
    - Recruiting
    - Cleaver Dermatology /ID# 254391
  - Lee's Summit, Missouri, United States, 64064-2301
    - Recruiting
    - Dermatology and Skin Center of Lees Summit /ID# 257546
    - Contact:
      
      Site Coordinator
      
      Phone Number: 913-451-7546 X2431
  - Saint Joseph, Missouri, United States, 64506
    - Recruiting
    - MediSearch Clinical Trials /ID# 254392
    - Contact:
      
      Site Coordinator
      
      Phone Number: 816-364-1515
  - St Louis, Missouri, United States, 63104
    - Recruiting
    - SSM Health Saint Louis University Hospital /ID# 256437
  - St Louis, Missouri, United States, 63130
    - Recruiting
    - Washington University School of Medicine - St. Louis /ID# 254506
- Nevada
  - Las Vegas, Nevada, United States, 89119-5190
    - Recruiting
    - Vivida Dermatology- Flamingo /ID# 254227
  - Las Vegas, Nevada, United States, 89144
    - Recruiting
    - Las Vegas Dermatology /ID# 272421
    - Contact:
      
      Site Coordinator
      
      Phone Number: (702) 456-3120
  - Reno, Nevada, United States, 89509
    - Recruiting
    - Skin Cancer and Dermatology Institute - Reno /ID# 254410
- New York
  - East Syracuse, New York, United States, 13057
    - Recruiting
    - Empire Dermatology /ID# 276241
  - New Hyde Park, New York, United States, 11042-2058
    - Recruiting
    - NorthWell Health - Dermatology /ID# 254704
    - Contact:
      
      Site Coordinator
      
      Phone Number: 516-881-7026
  - New York, New York, United States, 10012
    - Recruiting
    - Private Practice - Dr. Bobby Buka /ID# 276371
    - Contact:
      
      Site Coordinator
      
      Phone Number: 212-385-3700Ext 1208
      
      Email: jjeter@thedermspecs.com
  - New York, New York, United States, 07044-2946
    - Completed
    - Schweiger Dermatology, P.C. /ID# 254232
- North Carolina
  - Charlotte, North Carolina, United States, 28277-3816
    - Recruiting
    - Onsite Clinical Solutions /ID# 254854
  - Durham, North Carolina, United States, 27710
    - Recruiting
    - Duke University Medical Center /ID# 256898
- Ohio
  - Canton, Ohio, United States, 44718
    - Recruiting
    - Apex Clinical Research Center, LLC /ID# 275956
  - Columbus, Ohio, United States, 43213-4440
    - Recruiting
    - ClinOhio Research Services /ID# 254851
  - Mason, Ohio, United States, 45040-4520
    - Recruiting
    - Dermatologists of Southwest Ohio, Inc /ID# 254297
    - Contact:
      
      Site Coordinator
      
      Phone Number: 513-701-5526
  - Medina, Ohio, United States, 44256
    - Recruiting
    - Dermatology Partners - Medina /ID# 275939
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73112
    - Recruiting
    - Lynn Institute of Oklahoma City /ID# 253791
    - Contact:
      
      Site Coordinator
      
      Phone Number: (405) 602-3916
- Oregon
  - Portland, Oregon, United States, 97239
    - Recruiting
    - Oregon Health and Science University /ID# 254929
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033-2360
    - Recruiting
    - Penn State Milton S. Hershey Medical Center /ID# 254925
  - Philadelphia, Pennsylvania, United States, 19114
    - Recruiting
    - Clinical Research of Philadelphia, LLC /ID# 255308
    - Contact:
      
      Site Coordinator
      
      Phone Number: 215-676-6696
  - Philadelphia, Pennsylvania, United States, 19103
    - Completed
    - Paddington Testing Co., Inc. /ID# 254394
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Recruiting
    - Medical University of South Carolina /ID# 272569
    - Contact:
      
      Site Coordinator
      
      Phone Number: 858-792-9784
- Tennessee
  - Knoxville, Tennessee, United States, 37917
    - Recruiting
    - Dermatology Associates of Knoxville /ID# 261082
    - Contact:
      
      Site Coordinator
      
      Phone Number: 865-524-2547 x 4725
- Texas
  - Arlington, Texas, United States, 76011
    - Recruiting
    - Arlington Research Center, Inc /ID# 253805
    - Contact:
      
      Site Coordinator
      
      Phone Number: 817-795-7546
  - Bellaire, Texas, United States, 77401
    - Recruiting
    - Bellaire Dermatology Associates /ID# 253797
    - Contact:
      
      Site Coordinator
      
      Phone Number: 832-331-7070
  - Dallas, Texas, United States, 75231
    - Recruiting
    - Modern Research Associates, PLLC /ID# 253810
    - Contact:
      
      Site Coordinator
      
      Phone Number: 214-361-2008
  - Dallas, Texas, United States, 75240-6246
    - Recruiting
    - HRMD Research Dallas /ID# 255256
  - Dallas, Texas, United States, 75230
    - Completed
    - Dermatology Treatment and Research Center /ID# 253795
  - Grapevine, Texas, United States, 76051-3580
    - Completed
    - Dallas Fort Worth Clinical Research Associates (DFWCRA) /ID# 256438
  - Houston, Texas, United States, 77056
    - Completed
    - Suzanne Bruce and Associates-Houston /ID# 254228
  - Plano, Texas, United States, 75025
    - Recruiting
    - Texas Dermatology Research Center, LLC /ID# 254928
  - Webster, Texas, United States, 77598
    - Recruiting
    - Center for Clinical Studies Webster TX /ID# 254242
    - Contact:
      
      Site Coordinator
      
      Phone Number: 281-343-3300
- Utah
  - Bountiful, Utah, United States, 84010
    - Recruiting
    - Cope Family Medicine - Ogden Clinic /ID# 276227
  - Murray, Utah, United States, 84107
    - Recruiting
    - University of Utah /ID# 254452
    - Contact:
      
      Site Coordinator
      
      Phone Number: 801-213-0353
  - Springville, Utah, United States, 84663
    - Recruiting
    - Springville Dermatology - Springville /ID# 276225
- Virginia
  - Charlottesville, Virginia, United States, 22903
    - Recruiting
    - University of Virginia - Dermatology /ID# 254535
    - Contact:
      
      Site Coordinator
      
      Phone Number: 434-924-5115
  - Lynchburg, Virginia, United States, 24501-1403
    - Recruiting
    - The Education & Research Foundation, Inc. /ID# 254852
    - Contact:
      
      Site Coordinator
      
      Phone Number: 434-847-8400
  - Norfolk, Virginia, United States, 23507
    - Recruiting
    - Virginia Clinical Research /ID# 254538
    - Contact:
      
      Site Coordinator
      
      Phone Number: 757-625-0151
- Washington
  - Mill Creek, Washington, United States, 98012
    - Recruiting
    - Frontier Dermatology /ID# 254554
    - Contact:
      
      Site Coordinator
      
      Phone Number: 425-275-4404
  - Spokane, Washington, United States, 99202
    - Completed
    - Premier Clinical Research /ID# 254847

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Period 1: Upadacitinib Dose A Participants will receive Upadicitinib Dose A once daily for 16 weeks.	Drug: Upadacitinib Oral Tablets Other Names: RINVOQ ABT-494
Placebo Comparator: Period 1: Placebo Participants will receive Placebo once daily for 16 weeks.	Drug: Placebo Oral Tablets
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.	Drug: Upadacitinib Oral Tablets Other Names: RINVOQ ABT-494
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.	Drug: Placebo Oral Tablets
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.	Drug: Upadacitinib Oral Tablets Other Names: RINVOQ ABT-494
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.	Drug: Upadacitinib Oral Tablets Other Names: RINVOQ ABT-494
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.	Drug: Upadacitinib Oral Tablets Other Names: RINVOQ ABT-494
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.	Drug: Placebo Oral Tablets
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.	Drug: Upadacitinib Oral Tablets Other Names: RINVOQ ABT-494 Drug: Placebo Oral Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 50 Time Frame: Baseline to Week 16	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) Time Frame: Up to Approximately Week 108	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75 Time Frame: Baseline to Week 16	HiSCR 75 is defined as at least a 75% 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
Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA) Time Frame: Baseline to Week 16	The HSSA (24-hour recall) is a 9-item PRO questionnaire developed to assess the primary symptoms of HS in the 7 consecutive days prior to assessments. Each item of the HSSA is scored on an 11-point (0 to 10) NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.	Baseline to Week 16
Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA) Time Frame: Baseline to Week 16	The HSIA is an 18-item PRO questionnaire developed to assess the impact of HS on the daily lives of subjects in the 7 days prior to the assessment. Items 1 - 16 of the HSIA are scored on a 0 to 10 NRS, where 0 represents no impact and 10 represents extreme impact.	Baseline to Week 16
Change from Baseline in Hidradenitis Suppurativa (HS)-Related Odor, Based on Hidradenitis Suppurativa Symptom Assessment (HSSA) Question 8 Time Frame: Baseline to Week 16	The HSSA (24-hour recall) is a 9-item PRO questionnaire developed to assess the primary symptoms of HS in the 7 consecutive days prior to assessments. Each item of the HSSA is scored on an 11-point (0 to 10) NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.	Baseline to Week 16
Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 4 Among Participants with NRS ≥ 3 at Baseline Time Frame: Baseline to Week 4	Achievement will be considered at least a 30% reduction and at least 2 units reduction from Baseline in the Participant's Global Assessment (PGA) of HS-related skin pain NRS based on worst skin pain in a 24-hour recall period (maximal daily pain). The PGA Skin Pain is an 11-point numerical rating scale with ratings for the item ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine).	Baseline to Week 4
Change from Baseline in Draining Fistula Count Time Frame: Baseline to Week 16	Change from baseline in draining fistula count.	Baseline to Week 16
Change from Baseline in Dermatology Life Quality Index (DLQI) for Adult Participants and Adolescent Participants Age ≥16 Years Old and Older Time Frame: Baseline to Week 16	The DLQI and the CDLQI are both 10-item questionnaires used to assess the impact of hidradenitis suppurativa (HS) disease symptoms and treatment on quality of life that consists of 10 questions scored on a 4-point scale where 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much.	Baseline to Week 16
Change from Baseline in the Patient's Global Assessment of Hidradenitis Suppurativa (HS)-Related Skin Pain NRS Time Frame: Baseline to Week 8	The PGA Skin Pain is an 11-point numerical rating scale with ratings for the item ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) that is used to assess the worst pain due to HS. Patients are asked to respond to the item based on a recall period of "the last 24 hours	Baseline to Week 8
Occurrence of Hidradenitis Suppurativa (HS) Flare During Period 1 Time Frame: Baseline to Week 16	Defined as at least one occurrence of a ≥ 25% increase in AN count, with a minimum absolute increase of 2 relative to Baseline.	Baseline to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2023

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

May 26, 2023

First Submitted That Met QC Criteria

May 26, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

M23-698
2023-503661-28-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

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Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

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Study Locations

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Ages Eligible for Study

Accepts Healthy Volunteers

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How is the study designed?

Design Details

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Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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Clinical Trials on Upadacitinib

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