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)

August 18, 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1328

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1061
        • Ciprec (Centro De Investigacion Y Prevencion Cardiovascular) - Barrio Norte /ID# 255474
      • CABA, Argentina, C1199ABB
        • Hospital Italiano /ID# 254905
    • Buenos Aires
      • Pilar, Buenos Aires, Argentina, 1629
        • Hospital Universitario Austral /ID# 254904
    • Buenos Aires F.D.
      • Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1055
        • Buenos Aires Skin /ID# 255299
      • Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1425
        • Instituto de Neumonologia y Dermatologia /ID# 254903
      • Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1425
        • Psoriahue Med Interdisciplinar /ID# 257202
      • Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1428
        • Consultorios Reumatologicos Pampa /ID# 255555
  • Australia
    • Australian Capital Territory
      • Phillip, Australian Capital Territory, Australia, 2606
        • Paratus Clinical Research Woden /ID# 254670
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Momentum Clinical Research /ID# 254411
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • Skin Health Institute Inc /ID# 254416
      • East Melbourne, Victoria, Australia, 3002
        • Sinclair Dermatology - Melbourne /ID# 254412
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital /ID# 254414
  • Austria
    • State of Vienna
      • Vienna, State of Vienna, Austria, 1090
        • Medizinische Universitaet Wien /ID# 254096
    • Styria
      • Graz, Styria, Austria, 8010
        • Medizinische Universitaet Graz /ID# 253448
    • Upper Austria
      • Linz, Upper Austria, Austria, 4010
        • Duplicate_Ordensklinikum Linz GmbH Elisabethinen /ID# 253458
  • Belgium
      • Liège, Belgium, 4000
        • CHU de Liege /ID# 254085
    • Brussels Capital
      • Anderlecht, Brussels Capital, Belgium, 1070
        • Universite Libre de Bruxelles - Hopital Erasme /ID# 254082
      • Brussels, Brussels Capital, Belgium, 1200
        • Cliniques Universitaires UCL Saint-Luc /ID# 254087
      • Jette, Brussels Capital, Belgium, 1090
        • Universitair Ziekenhuis Brussel /ID# 254223
    • Hainaut
      • Charleroi, Hainaut, Belgium, 6280
        • Grand Hopital de Charleroi - Les Viviers /ID# 254091
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent /ID# 254090
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Universitair Ziekenhuis Leuven /ID# 254089
  • Brazil
      • Rio de Janeiro, Brazil, 20241-180
        • Instituto Brasil de Pesquisa Clinica S.A - IBPClin /ID# 275810
      • São Paulo, Brazil, 05403-000
        • 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
        • Hospital Moinhos de Vento /ID# 254366
    • Rio de Janeiro
      • Macaé, Rio de Janeiro, Brazil, 27910-190
        • Instituto de Pesquisa e Ensino CLIGEDIMUNO - IPEC /ID# 254369
    • São Paulo
      • Campinas, São Paulo, Brazil, 13034-685
        • Hospital e Maternidade Celso Pierro - PUC-Campinas /ID# 275811
      • Ribeirão Preto, São Paulo, Brazil, 14049-900
        • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 254367
      • São Paulo, São Paulo, Brazil, 04020-060
        • Centro de Desenvolvimento em Estudos Clinicos Brasil - CDEC /ID# 254368
  • Bulgaria
      • Sofia, Bulgaria, 1407
        • Acibadem City Clinic Tokuda University Hospital EAD /ID# 253331
      • Stara Zagora, Bulgaria, 6000
        • UMHAT Professor Stoyan Kirkovich /ID# 253328
    • Sofia
      • Sofiya, Sofia, Bulgaria, 1407
        • Ambulatory for Specialized Medical Care-IPSMC-skin and venereal diseases /ID# 253329
      • Sofiya, Sofia, Bulgaria, 1463
        • Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 253327
  • Canada
      • Québec, Canada, G1V 4T3
        • Diex Recherche Quebec Inc. /ID# 254381
    • Alberta
      • Calgary, Alberta, Canada, T2J 7E1
        • Dermatology Research Institute - Blackfoot Trail /ID# 261413
      • Calgary, Alberta, Canada, T3A 2N1
        • Beacon Dermatology /ID# 254564
      • Edmonton, Alberta, Canada, T5J 3S9
        • Rejuvenation Dermatology - Edmonton Downtown /ID# 254715
      • Edmonton, Alberta, Canada, T6G 1C3
        • Alberta Dermasurgery Centre /ID# 275945
      • Red Deer, Alberta, Canada, T4P 1K4
        • Care Clinic - Red Deer - Taylor Drive /ID# 276063
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • Dr. Chih-ho Hong Medical Inc. /ID# 254378
      • Surrey, British Columbia, Canada, V3V 0C6
        • Enverus Medical Research /ID# 254380
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3Z4
        • Wiseman Dermatology Research /ID# 254117
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
        • Karma Clinical Trials /ID# 254120
    • Ontario
      • Hamilton, Ontario, Canada, L8L 3C3
        • LEADER Research /ID# 254379
      • London, Ontario, Canada, N6H 5L5
        • DermEffects /ID# 254116
      • Markham, Ontario, Canada, L3P 1X2
        • Lynderm Research Inc /ID# 254713
      • Mississauga, Ontario, Canada, L4W 0C2
        • Derm Care Clinic /ID# 276065
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Ryan Clinical Research Inc /ID# 254714
      • Richmond Hill, Ontario, Canada, L4C 9M7
        • York Dermatology Clinic and Research Centre /ID# 254115
      • Toronto, Ontario, Canada, M4W 2N4
        • Research Toronto /ID# 255273
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • CHU Sainte-Justine /ID# 254118
      • Saint-Jérôme, Quebec, Canada, J7Z 7E2
        • Dre Angelique Gagne-Henley M.D. inc. /ID# 255632
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
        • SkinSense Dermatology /ID# 254119
  • Chile
    • Region Metropolitana Santiago
      • Las Condes, Region Metropolitana Santiago, Chile, 7580206
        • Centro Medico Skin Med SPA /ID# 254560
      • Santiago, Region Metropolitana Santiago, Chile, 8420383
        • Centro Internacional de Estudios Clinicos - CIEC /ID# 254559
      • Vitacura, Region Metropolitana Santiago, Chile, 7640881
        • Clinica Dermacross /ID# 254558
    • Santiago Metropolitan
      • Independencia, Santiago Metropolitan, Chile, 8380465
        • Fundacion Innovacion Cardiovascular /ID# 254561
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050012
        • Clinica De Inmunologia Y Genetica (Cige) /ID# 254797
      • Medellín, Antioquia, Colombia, 050016
        • IPS Suramericana SAS - IPS Sura San Diego /ID# 255064
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 80002
        • Centro Integral de Reumatologia del Caribe SAS - Circaribe SAS /ID# 255278
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia, 110221
        • Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 254796
  • Croatia
    • City of Zagreb
      • Zagreb, City of Zagreb, Croatia, 10000
        • DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 253587
      • Zagreb, City of Zagreb, Croatia, 10000
        • Klinicki bolnicki centar Zagreb /ID# 253786
      • Zagreb, City of Zagreb, Croatia, 10000
        • Klinika za dječje bolesti Zagreb /ID# 253588
      • Zagreb, City of Zagreb, Croatia, 10000
        • Poliklinika Solmed /ID# 254732
    • Primorje-Gorski Kotar County
      • Rijeka, Primorje-Gorski Kotar County, Croatia, 51000
        • Specialty Hospital Medico /ID# 254731
    • Split-Dalmatia County
      • Split, Split-Dalmatia County, Croatia, 21000
        • Klinicki Bolnicki Centar Split /ID# 253789
    • Zagreb County
      • Ivanić-Grad, Zagreb County, Croatia, 10310
        • Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 253586
  • Czechia
      • Karlovy Vary, Czechia, 360 01
        • Karlovarska Krajska Nemocnice - Karlovy Vary /ID# 253456
      • Prague, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady /ID# 253454
    • Praha 5
      • Prague, Praha 5, Czechia, 150 06
        • Fakultni nemocnice Motol a Homolka /ID# 253455
  • Finland
    • North Ostrobothnia
      • Oulu, North Ostrobothnia, Finland, 90220
        • Oulun yliopistollinen sairaala /ID# 253969
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33100
        • Terveystalo Tampere /ID# 253968
  • France
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06202
        • Chu de Nice-Hopital Larchet Ii /Id# 253504
    • Gironde
      • Bordeaux, Gironde, France, 33000
        • Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-Andre /ID# 254139
    • Marne
      • Reims, Marne, France, 51100
        • Polyclinique Courlancy /ID# 254680
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, France, 44000
        • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 254114
    • Rhone
      • Lyon, Rhone, France, 69003
        • HCL - Hopital Edouard Herriot /ID# 253500
    • Île-de-France Region
      • Antony, Île-de-France Region, France, 92160
        • Hopital Prive d'Antony /ID# 253501
  • Germany
      • Berlin, Germany, 13595
        • Havelklinik /ID# 254194
      • Bochum, Germany, 44791
        • Klinikum Ruhr Univ Bochum /ID# 253690
      • Magdeburg, Germany, 39104
        • Magdeburger Company for Medical Studies & Services GmbH /ID# 255151
      • Mainz, Germany, 55128
        • Dermatologie Quist-BAG Dres. med. Quist PartG /ID# 253691
      • Munich, Germany, 80802
        • Klinik am Biederstein /ID# 254195
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
        • Universitaetsklinikum Freiburg /ID# 275746
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Universitaetsklinikum Erlangen /ID# 254804
      • Regensburg, Bavaria, Germany, 93042
        • Universitaetsklinikum Regensburg /ID# 253692
      • Würzburg, Bavaria, Germany, 97080
        • Universitaetsklinikum Wuerzburg /ID# 275599
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • Universitaetsklinikum Frankfurt /ID# 253683
    • Lower Saxony
      • Bad Bentheim, Lower Saxony, Germany, 48455
        • Fachklinik - Bad Bentheim /ID# 275537
      • Bramsche, Lower Saxony, Germany, 49565
        • Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 254510
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Universitaetsklinikum Duesseldorf /ID# 253711
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Universitaetsmedizin Mainz /ID# 272596
    • Saarland
      • Merzig, Saarland, Germany, 66663
        • Hautmedizin Saar Science /ID# 272614
  • Greece
      • Thessaloniki, Greece, 54643
        • Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 253497
      • Thessaloniki, Greece, 56429
        • Papageorgiou General Hospital /ID# 253496
    • Attica
      • Athens, Attica, Greece, 11527
        • 401 GSNA - 401 Army General Hospital /ID# 253499
      • Athens, Attica, Greece, 16121
        • General Hospital Andreas Syggros /ID# 253498
      • Chaïdári, Attica, Greece, 12462
        • University General Hospital Attikon /ID# 253495
  • Hungary
      • Budapest, Hungary, 1027
        • Csalogany Orvosi Kozpont /ID# 255063
      • Budapest, Hungary, 1036
        • Duplicate_Obudai Egeszsegugyi Centrum Kft. /ID# 256366
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem /ID# 276162
      • Debrecen, Hungary, 4031
        • DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 253638
    • Baranya
      • Pécs, Baranya, Hungary, 7624
        • Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 253753
    • Csongrád megye
      • Szeged, Csongrád megye, Hungary, 6720
        • Szegedi Tudomanyegyetem /ID# 255142
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Debreceni Egyetem-Klinikai Kozpont /ID# 253637
    • Somogy County
      • Kaposvár, Somogy County, Hungary, 7400
        • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 253913
    • Vas County
      • Szombathely, Vas County, Hungary, 9700
        • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 254377
  • Ireland
      • Cork, Ireland, T12 X23H
        • South Infirmary Victoria University Hospital /ID# 253975
      • Dublin, Ireland, D07 A8NN
        • University College Dublin /ID# 253971
      • Galway, Ireland, H91 YR71
        • University Hospital Galway /ID# 253976
      • Waterford, Ireland, X91 ER8E
        • Waterford Regional Hospital /ID# 254038
    • Dublin
      • Dublin, Dublin, Ireland, D08 NHY1
        • St James Hospital /ID# 253973
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus /ID# 254406
    • Central District
      • Petah Tikva, Central District, Israel, 4941492
        • Rabin Medical Center. /ID# 254405
    • Northern District
      • Safed, Northern District, Israel, 13100
        • ZIV Medical Center /ID# 254403
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israel, 52621
        • Sheba Medical Center /ID# 254545
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center /ID# 254404
  • Italy
      • Brescia, Italy, 25123
        • ASST degli Spedali Civili di Brescia /ID# 254875
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 254502
      • Modena, Italy, 41124
        • Azienda Ospedaliero-Universitaria di Modena /ID# 254874
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana /ID# 254501
    • Ferrara
      • Cona, Ferrara, Italy, 44124
        • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale S.Anna /ID# 254496
    • Firenze
      • Florence, Firenze, Italy, 50122
        • AZIENDA USL TOSCANA CENTRO - Ospedale Piero Palagi /ID# 254495
    • L Aquila
      • L’Aquila, L Aquila, Italy, 67100
        • ASL 1 Abruzzo - Ospedale regionale San Salvatore /ID# 276045
    • Roma
      • Rome, Roma, Italy, 00133
        • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 254498
      • Rome, Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 254500
  • Japan
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital /ID# 254729
    • Hyōgo
      • Nishinomiya-shi, Hyōgo, Japan, 663-8186
        • Meiwa Hospital /ID# 254728
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 305-8576
        • University of Tsukuba Hospital /ID# 254638
    • Kyoto
      • Kyoto, Kyoto, Japan, 602-8566
        • University Hospital Kyoto Prefectural University of Medicine /ID# 254481
    • Miyagi
      • Sendai, Miyagi, Japan, 9808574
        • Tohoku University Hospital /ID# 254598
    • Okinawa
      • Ginowan-shi, Okinawa, Japan, 901-2725
        • University of the Ryukyus Hospital /ID# 254517
    • Osaka
      • Sakai-shi, Osaka, Japan, 590-0197
        • Kindai University Hospital /ID# 254574
    • Shiga
      • Ōtsu, Shiga, Japan, 520-2192
        • Shiga University of Medical Science Hospital /ID# 254215
    • Tokyo
      • Itabashi-ku, Tokyo, Japan, 173-8610
        • Nihon University Itabashi Hospital /ID# 254637
      • Minato-ku, Tokyo, Japan, 105-8470
        • Toranomon Hospital /ID# 253819
  • Lithuania
      • Vilnius, Lithuania, 08406
        • Inlita - Santara KTC /ID# 253917
      • Vilnius, Lithuania, 08661
        • Vilnius University Hospital Santaros Klinikos /ID# 253916
  • Mexico
      • Mexico City, Mexico, 06100
        • Cryptex Investigacion Clinica S.A de C.V /ID# 256066
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44657
        • Grupo Clinico Catei Sociedad Civil /Id# 254657
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64718
        • Eukarya PharmaSite, SC /ID# 254658
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Universitair Medisch Centrum Groningen /ID# 253571
    • North Brabant
      • Breda, North Brabant, Netherlands, 4818 CK
        • Amphia Ziekenhuis /ID# 253567
  • New Zealand
    • Auckland
      • Epsom, Auckland, New Zealand, 1051
        • Greenlane Clinical Centre /ID# 254351
    • Waikato Region
      • Hamilton, Waikato Region, New Zealand, 3204
        • Clinical Trials New Zealand /ID# 254352
  • Portugal
      • Lisbon, Portugal, 1998-018
        • Hospital CUF Descobertas /ID# 254323
      • Porto, Portugal, 4099-001
        • Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 254322
      • Porto, Portugal, 4200-319
        • Unidade Local de Saude Sao Joao /ID# 254324
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1169-050
        • Centro Hospitalar de Lisboa Central - Lisbon /ID# 254325
  • Puerto Rico
      • Caguas, Puerto Rico, 00727
        • Dr. Samuel Sanchez PSC /ID# 253948
      • Carolina, Puerto Rico, 00985
        • Alma M. Cruz Santana, MD-Private practice /ID# 253951
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 12372
        • King Saud University Med City /ID# 255282
    • Mecca Region
      • Jeddah, Mecca Region, Saudi Arabia, 23433
        • King Faisal Specialist Hospital /ID# 255539
    • Riyadh Region
      • Riyadh, Riyadh Region, Saudi Arabia, 11211
        • King Faisal Specialist Hospital and Research Centre /ID# 255279
      • Riyadh, Riyadh Region, Saudi Arabia, 11426
        • King Abdulaziz Medical City- National Guard Hospital /ID# 255280
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital /ID# 254943
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 308205
        • National Skin Centre /ID# 255242
  • Slovakia
      • Trnava, Slovakia, 917 02
        • Fakultna nemocnica Trnava /ID# 254137
    • Bratislava Region
      • Bratislava, Bratislava Region, Slovakia, 821 01
        • Univerzitna nemocnica Bratislava - Nemocnica Ruzinov /ID# 254157
    • Košice Region
      • Košice, Košice Region, Slovakia, 040 01
        • Univerzitna nemocnica L. Pasteura Kosice /ID# 254136
    • Nitra Region
      • Nové Zámky, Nitra Region, Slovakia, 940 34
        • Fakultna nemocnica s poliklinikou Nove Zamky /ID# 254155
    • Žilina Region
      • Martin, Žilina Region, Slovakia, 036 01
        • Univerzitna nemocnica Martin /ID# 254153
  • South Korea
    • Gyeonggido
      • Ansan-si, Gyeonggido, South Korea, 15355
        • Korea University Ansan Hospital /ID# 254128
      • Seongnam, Gyeonggido, South Korea, 13496
        • CHA Bundang Medical Center /ID# 254026
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 03080
        • Seoul National University Hospital /ID# 254027
      • Seoul, Seoul Teugbyeolsi, South Korea, 04401
        • SoonChunHyang University Seoul Hospital /ID# 254025
      • Seoul, Seoul Teugbyeolsi, South Korea, 07441
        • Hallym University Kangnam Sacred Heart Hospital /ID# 254127
  • Spain
      • Barcelona, Spain, 08041
        • Hospital Santa Creu i Sant Pau /ID# 253869
      • Barcelona, Spain, 08042
        • Hospital General de Granollers /ID# 253873
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves /ID# 253870
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal /ID# 253871
      • Valencia, Spain, 46026
        • Hospital Universitario y Politecnico La Fe /ID# 253868
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge /ID# 254982
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 253924
    • Valencia
      • Manises, Valencia, Spain, 46940
        • Hospital de Manises /ID# 253867
  • Sweden
    • Stockholm County
      • Solna, Stockholm County, Sweden, 171 64
        • Karolinska University Hospital Solna /ID# 254808
    • Västra Götaland County
      • Gothenburg, Västra Götaland County, Sweden, 413 46
        • Sahlgrenska Universitetssjukhuset /ID# 254807
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital, Universitaetsspital Bern /ID# 254736
    • Canton of St. Gallen
      • Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen /ID# 255243
    • Canton of Zurich
      • Zurich, Canton of Zurich, Switzerland, 8091
        • University Hospital Zurich /ID# 254642
  • Taiwan
      • Changhua City, Changhua County, Taiwan, 50006
        • Changhua Christian Hospital /ID# 254032
      • Kaohsiung City, Taiwan, 833
        • Kaohsiung Chang Gung Memorial Hospital /ID# 254031
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital /ID# 254030
      • Taoyuan City, Taiwan, 333
        • Linkou Chang Gung Memorial Hospital /ID# 254033
  • Turkey (Türkiye)
      • Bayraklı, Turkey (Türkiye), 35540
        • Izmir Sehir Hastanesi /ID# 265465
      • Bursa, Turkey (Türkiye), 16059
        • Uludag University Medical Faculty /ID# 253806
      • Istanbul, Turkey (Türkiye), 34098
        • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 253824
      • Kayseri, Turkey (Türkiye), 38039
        • Erciyes University Medical Faculty /ID# 253804
      • Samsun, Turkey (Türkiye), 55139
        • Ondokuz Mayis Universitesi /ID# 254034
    • Antalya
      • Ankara, Antalya, Turkey (Türkiye), 06010
        • Gulhane Egitim ve Arastirma Hastanesi /ID# 253919
  • United Kingdom
      • Bristol, United Kingdom, BS1 3NU
        • University Hospitals Bristol /ID# 261505
      • Salford, United Kingdom, M6 8HD
        • Northern Care Alliance NHS Group /ID# 256910
    • Greater London
      • London, Greater London, United Kingdom, SW10 9NH
        • Chelsea and Westminster Hospital /ID# 254190
      • London, Greater London, United Kingdom, SW17 0QT
        • St George University Hospitals NHS Foundation Trust /ID# 256803
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust /ID# 254531
    • Warwickshire
      • Coventry, Warwickshire, United Kingdom, CV2 2DX
        • UH Coventry & Warwickshire /ID# 256909
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
        • Leeds Teaching Hospitals NHS Trust /ID# 254616
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Cahaba Dermatology & Skin Health Center /ID# 254876
    • Arizona
      • Fountain Hills, Arizona, United States, 85268
        • Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272564
      • Phoenix, Arizona, United States, 85006
        • Medical Dermatology Specialists /ID# 254226
      • Scottsdale, Arizona, United States, 85259-5452
        • Mayo Clinic - Scottsdale /ID# 254388
      • Tucson, Arizona, United States, 85718-1407
        • Banner University Medicine Dermatology /ID# 255853
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Clinical Trials Institute - Northwest Arkansas /ID# 254924
      • Hot Springs, Arkansas, United States, 71913-6404
        • Burke Pharmaceutical Research /ID# 254238
      • North Little Rock, Arkansas, United States, 72217
        • Arkansas Research Trials /ID# 254233
      • Rogers, Arkansas, United States, 72758
        • NW Arkansas Clinical Trials Center /ID# 254311
    • California
      • Encino, California, United States, 91436
        • Private Practice - Dr. Tooraj Raoof /ID# 254374
      • Huntington Beach, California, United States, 92647
        • Marvel Clinical Research /ID# 276228
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates /ID# 254846
      • Rocklin, California, United States, 95765
        • NorCal Clinical Research /ID# 274219
      • Sacramento, California, United States, 95815
        • Integrative Skin Science and Research /ID# 254930
      • Sacramento, California, United States, 95817
        • University of California Davis Health /ID# 254229
      • San Diego, California, United States, 92103
        • Medderm Associates /ID# 253800
      • Thousand Oaks, California, United States, 91320-2130
        • Clinical Trials Research Institute /ID# 254466
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • UConn Health Main /ID# 254507
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine /ID# 254586
    • Florida
      • Boca Raton, Florida, United States, 33486-2269
        • Skin Care Research Boca Raton /ID# 253814
      • Brandon, Florida, United States, 33511
        • Apex Clinical Trials /ID# 255756
      • Coral Gables, Florida, United States, 33134-5755
        • Florida Academic Dermatology Center /ID# 254011
      • Delray Beach, Florida, United States, 33445
        • Dermatology Associates of the Palm Beaches /ID# 275950
      • Hollywood, Florida, United States, 33021-6748
        • Skin Care Research - Hollywood /ID# 254508
      • Margate, Florida, United States, 33063
        • Life Clinical Trials - N State Rd - Margate /ID# 258613
      • Tampa, Florida, United States, 33607-6438
        • Skin Care Research - Tampa /ID# 256440
      • Tampa, Florida, United States, 33607
        • Advanced Clinical Research Institute - Tampa /ID# 253746
      • Tampa, Florida, United States, 33613-1825
        • Avita Clinical Research /ID# 254471
    • Georgia
      • Columbus, Georgia, United States, 31904-2954
        • Centricity Research - Columbus /ID# 255470
    • Idaho
      • Boise, Idaho, United States, 83706
        • Treasure Valley Medical Research /ID# 255208
    • Illinois
      • Chicago, Illinois, United States, 60610
        • DeNova Research /ID# 254372
      • Chicago, Illinois, United States, 60611-2927
        • Northwestern University Feinberg School of Medicine /ID# 254503
      • Skokie, Illinois, United States, 60077
        • NorthShore University HealthSystem - Skokie /ID# 254389
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Dawes Fretzin /ID# 254390
      • West Lafayette, Indiana, United States, 47906
        • Options Research Group /ID# 254537
    • Kansas
      • Leawood, Kansas, United States, 66211-1453
        • U.S. Dermatology Partners Leawood /ID# 255838
    • Kentucky
      • Bowling Green, Kentucky, United States, 42104
        • Equity Medical, LLC /ID# 271140
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital /ID# 261093
      • Boston, Massachusetts, United States, 02215-5400
        • Beth Israel Deaconess Medical Center /ID# 253811
      • Quincy, Massachusetts, United States, 02169
        • Beacon Clinical Research, LLC /ID# 254419
      • Worcester, Massachusetts, United States, 01655
        • UMass Memorial Medical Center - Lake Avenue North /ID# 258839
    • Michigan
      • Caledonia, Michigan, United States, 49316
        • The Derm Institute Of West Michigan /ID# 275948
      • Canton, Michigan, United States, 48187
        • Hamzavi Dermatology - Canton /ID# 275856
      • Clarkston, Michigan, United States, 48346
        • Michigan Center for Medical Research - Clarkston /ID# 275860
      • Waterford, Michigan, United States, 48328
        • Michigan Dermatology Institute /ID# 254468
    • Missouri
      • Kirksville, Missouri, United States, 63501-5362
        • Cleaver Dermatology /ID# 254391
      • Lee's Summit, Missouri, United States, 64064-2301
        • Dermatology and Skin Center of Lees Summit /ID# 257546
      • Saint Joseph, Missouri, United States, 64506
        • MediSearch Clinical Trials /ID# 254392
      • St Louis, Missouri, United States, 63104
        • SSM Health Saint Louis University Hospital /ID# 256437
      • St Louis, Missouri, United States, 63130
        • Washington University School of Medicine - St. Louis /ID# 254506
    • Nevada
      • Las Vegas, Nevada, United States, 89119-5190
        • Vivida Dermatology- Flamingo /ID# 254227
      • Las Vegas, Nevada, United States, 89144
        • Las Vegas Dermatology /ID# 272421
      • Reno, Nevada, United States, 89509
        • Skin Cancer and Dermatology Institute - Reno /ID# 254410
    • New York
      • East Syracuse, New York, United States, 13057
        • Empire Dermatology /ID# 276241
      • New Hyde Park, New York, United States, 11042-2058
        • NorthWell Health - Dermatology /ID# 254704
      • New York, New York, United States, 07044-2946
        • Schweiger Dermatology, P.C. /ID# 254232
      • New York, New York, United States, 10012
        • Private Practice - Dr. Bobby Buka /ID# 276371
    • North Carolina
      • Charlotte, North Carolina, United States, 28277-3816
        • Onsite Clinical Solutions - Community House Rd - Charlotte /ID# 254854
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center /ID# 256898
    • Ohio
      • Canton, Ohio, United States, 44718
        • Apex Clinical Research Center, LLC /ID# 275956
      • Columbus, Ohio, United States, 43213-4440
        • ClinOhio Research Services /ID# 254851
      • Mason, Ohio, United States, 45040-4520
        • Dermatologists of Southwest Ohio, Inc /ID# 254297
      • Medina, Ohio, United States, 44256
        • Dermatology Partners - Medina /ID# 275939
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Institute of Oklahoma City /ID# 253791
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University /ID# 254929
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-2360
        • Penn State Milton S. Hershey Medical Center /ID# 254925
      • Philadelphia, Pennsylvania, United States, 19103
        • Paddington Testing Co., Inc. /ID# 254394
      • Philadelphia, Pennsylvania, United States, 19114
        • Clinical Research of Philadelphia, LLC /ID# 255308
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina /ID# 272569
    • Tennessee
      • Knoxville, Tennessee, United States, 37917
        • Dermatology Associates of Knoxville /ID# 261082
    • Texas
      • Arlington, Texas, United States, 76011
        • Arlington Research Center, Inc /ID# 253805
      • Bellaire, Texas, United States, 77401
        • Bellaire Dermatology Associates /ID# 253797
      • Dallas, Texas, United States, 75230
        • Dermatology Treatment and Research Center /ID# 253795
      • Dallas, Texas, United States, 75231
        • Modern Research Associates /ID# 253810
      • Dallas, Texas, United States, 75240-6246
        • HRMD Research Dallas /ID# 255256
      • Grapevine, Texas, United States, 76051-3580
        • Dallas Fort Worth Clinical Research Associates (DFWCRA) /ID# 256438
      • Houston, Texas, United States, 77056
        • Suzanne Bruce and Associates-Houston /ID# 254228
      • Plano, Texas, United States, 75025
        • Texas Dermatology Research Center /ID# 254928
      • Webster, Texas, United States, 77598
        • Center for Clinical Studies Webster /ID# 254242
    • Utah
      • Bountiful, Utah, United States, 84010
        • Cope Family Medicine - Ogden Clinic /ID# 276227
      • Murray, Utah, United States, 84107
        • University of Utah - Murray /ID# 254452
      • Springville, Utah, United States, 84663
        • Springville Dermatology - Springville /ID# 276225
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia - Dermatology /ID# 254535
      • Lynchburg, Virginia, United States, 24501-1403
        • The Education & Research Foundation, Inc. /ID# 254852
      • Norfolk, Virginia, United States, 23507
        • Virginia Clinical Research /ID# 254538
    • Washington
      • Mill Creek, Washington, United States, 98012
        • Frontier Dermatology /ID# 254554
      • Spokane, Washington, United States, 99202
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

No

product manufactured in and exported from the U.S.

No

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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