AzTrials
AzTrials

Hidradenitis SuppurativaPhase 3Step-Up HSNCT05889182

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

A Phase 3 study testing Upadacitinib in people with Hidradenitis Suppurativa, run by AbbVie at 285 sites in 37 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions in the axilla (underarm), inguinal (groin) and anogenital (anal/genital) regions. This study will assess how safe and effective upadacitinib is in treating adult and adolescent participants with moderate to severe HS who have… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Hidradenitis Suppurativa
What is being tested?
Upadacitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,328 participants
Where
285 sitesin 37 countries
Study dates
21 Jun 2023to Sep 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

285 sites in 37 countries.

285 sites in 37 countries

United States87 sites

  • Arlington Research Center, Inc /ID# 253805

    Arlington, Texas, 76011

  • Bellaire Dermatology Associates /ID# 253797

    Bellaire, Texas, 77401

  • Cahaba Dermatology & Skin Health Center /ID# 254876

    Birmingham, Alabama, 35244

  • Skin Care Research Boca Raton /ID# 253814

    Boca Raton, Florida, 33486-2269

  • Treasure Valley Medical Research /ID# 255208

    Boise, Idaho, 83706

  • Massachusetts General Hospital /ID# 261093

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center /ID# 253811

    Boston, Massachusetts, 02215-5400

  • Cope Family Medicine - Ogden Clinic /ID# 276227

    Bountiful, Utah, 84010

  • Equity Medical, LLC /ID# 271140

    Bowling Green, Kentucky, 42104

  • Apex Clinical Trials /ID# 255756

    Brandon, Florida, 33511

  • The Derm Institute Of West Michigan /ID# 275948

    Caledonia, Michigan, 49316

  • Hamzavi Dermatology - Canton /ID# 275856

    Canton, Michigan, 48187

  • Apex Clinical Research Center, LLC /ID# 275956

    Canton, Ohio, 44718

  • Medical University of South Carolina /ID# 272569

    Charleston, South Carolina, 29425

  • Onsite Clinical Solutions - Community House Rd - Charlotte /ID# 254854

    Charlotte, North Carolina, 28277-3816

  • University of Virginia - Dermatology /ID# 254535

    Charlottesville, Virginia, 22903

  • DeNova Research /ID# 254372

    Chicago, Illinois, 60610

  • Northwestern University Feinberg School of Medicine /ID# 254503

    Chicago, Illinois, 60611-2927

  • Michigan Center for Medical Research - Clarkston /ID# 275860

    Clarkston, Michigan, 48346

  • Centricity Research - Columbus /ID# 255470

    Columbus, Georgia, 31904-2954

  • ClinOhio Research Services /ID# 254851

    Columbus, Ohio, 43213-4440

  • Florida Academic Dermatology Center /ID# 254011

    Coral Gables, Florida, 33134-5755

  • Dermatology Treatment and Research Center /ID# 253795

    Dallas, Texas, 75230

  • Modern Research Associates /ID# 253810

    Dallas, Texas, 75231

  • HRMD Research Dallas /ID# 255256

    Dallas, Texas, 75240-6246

  • Dermatology Associates of the Palm Beaches /ID# 275950

    Delray Beach, Florida, 33445

  • Duke University Medical Center /ID# 256898

    Durham, North Carolina, 27710

  • Empire Dermatology /ID# 276241

    East Syracuse, New York, 13057

  • Private Practice - Dr. Tooraj Raoof /ID# 254374

    Encino, California, 91436

  • UConn Health Main /ID# 254507

    Farmington, Connecticut, 06032

  • Clinical Trials Institute - Northwest Arkansas /ID# 254924

    Fayetteville, Arkansas, 72703

  • Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272564

    Fountain Hills, Arizona, 85268

  • Dallas Fort Worth Clinical Research Associates (DFWCRA) /ID# 256438

    Grapevine, Texas, 76051-3580

  • Penn State Milton S. Hershey Medical Center /ID# 254925

    Hershey, Pennsylvania, 17033-2360

  • Skin Care Research - Hollywood /ID# 254508

    Hollywood, Florida, 33021-6748

  • Burke Pharmaceutical Research /ID# 254238

    Hot Springs, Arkansas, 71913-6404

  • Suzanne Bruce and Associates-Houston /ID# 254228

    Houston, Texas, 77056

  • Marvel Clinical Research /ID# 276228

    Huntington Beach, California, 92647

  • Dawes Fretzin /ID# 254390

    Indianapolis, Indiana, 46256

  • Cleaver Dermatology /ID# 254391

    Kirksville, Missouri, 63501-5362

  • Dermatology Associates of Knoxville /ID# 261082

    Knoxville, Tennessee, 37917

  • Vivida Dermatology- Flamingo /ID# 254227

    Las Vegas, Nevada, 89119-5190

  • Las Vegas Dermatology /ID# 272421

    Las Vegas, Nevada, 89144

  • U.S. Dermatology Partners Leawood /ID# 255838

    Leawood, Kansas, 66211-1453

  • Dermatology and Skin Center of Lees Summit /ID# 257546

    Lee's Summit, Missouri, 64064-2301

  • Dermatology Research Associates /ID# 254846

    Los Angeles, California, 90045

  • The Education & Research Foundation, Inc. /ID# 254852

    Lynchburg, Virginia, 24501-1403

  • Life Clinical Trials - N State Rd - Margate /ID# 258613

    Margate, Florida, 33063

  • Dermatologists of Southwest Ohio, Inc /ID# 254297

    Mason, Ohio, 45040-4520

  • Dermatology Partners - Medina /ID# 275939

    Medina, Ohio, 44256

  • Frontier Dermatology /ID# 254554

    Mill Creek, Washington, 98012

  • University of Utah - Murray /ID# 254452

    Murray, Utah, 84107

  • Yale University School of Medicine /ID# 254586

    New Haven, Connecticut, 06510

  • NorthWell Health - Dermatology /ID# 254704

    New Hyde Park, New York, 11042-2058

  • Schweiger Dermatology, P.C. /ID# 254232

    New York, New York, 07044-2946

  • Private Practice - Dr. Bobby Buka /ID# 276371

    New York, New York, 10012

  • Virginia Clinical Research /ID# 254538

    Norfolk, Virginia, 23507

  • Arkansas Research Trials /ID# 254233

    North Little Rock, Arkansas, 72217

  • Lynn Institute of Oklahoma City /ID# 253791

    Oklahoma City, Oklahoma, 73112

  • Paddington Testing Co., Inc. /ID# 254394

    Philadelphia, Pennsylvania, 19103

  • Clinical Research of Philadelphia, LLC /ID# 255308

    Philadelphia, Pennsylvania, 19114

  • Medical Dermatology Specialists /ID# 254226

    Phoenix, Arizona, 85006

  • Texas Dermatology Research Center /ID# 254928

    Plano, Texas, 75025

  • Oregon Health and Science University /ID# 254929

    Portland, Oregon, 97239

  • Beacon Clinical Research, LLC /ID# 254419

    Quincy, Massachusetts, 02169

  • Skin Cancer and Dermatology Institute - Reno /ID# 254410

    Reno, Nevada, 89509

  • NorCal Clinical Research /ID# 274219

    Rocklin, California, 95765

  • NW Arkansas Clinical Trials Center /ID# 254311

    Rogers, Arkansas, 72758

  • Integrative Skin Science and Research /ID# 254930

    Sacramento, California, 95815

  • University of California Davis Health /ID# 254229

    Sacramento, California, 95817

  • MediSearch Clinical Trials /ID# 254392

    Saint Joseph, Missouri, 64506

  • Medderm Associates /ID# 253800

    San Diego, California, 92103

  • Mayo Clinic - Scottsdale /ID# 254388

    Scottsdale, Arizona, 85259-5452

  • NorthShore University HealthSystem - Skokie /ID# 254389

    Skokie, Illinois, 60077

  • Premier Clinical Research /ID# 254847

    Spokane, Washington, 99202

  • Springville Dermatology - Springville /ID# 276225

    Springville, Utah, 84663

  • SSM Health Saint Louis University Hospital /ID# 256437

    St Louis, Missouri, 63104

  • Washington University School of Medicine - St. Louis /ID# 254506

    St Louis, Missouri, 63130

  • Skin Care Research - Tampa /ID# 256440

    Tampa, Florida, 33607-6438

  • Advanced Clinical Research Institute - Tampa /ID# 253746

    Tampa, Florida, 33607

  • Avita Clinical Research /ID# 254471

    Tampa, Florida, 33613-1825

  • Clinical Trials Research Institute /ID# 254466

    Thousand Oaks, California, 91320-2130

  • Banner University Medicine Dermatology /ID# 255853

    Tucson, Arizona, 85718-1407

  • Michigan Dermatology Institute /ID# 254468

    Waterford, Michigan, 48328

  • Center for Clinical Studies Webster /ID# 254242

    Webster, Texas, 77598

  • Options Research Group /ID# 254537

    West Lafayette, Indiana, 47906

  • UMass Memorial Medical Center - Lake Avenue North /ID# 258839

    Worcester, Massachusetts, 01655

Other trials in United States

Canada20 sites

  • Dermatology Research Institute - Blackfoot Trail /ID# 261413

    Calgary, Alberta, T2J 7E1

  • Beacon Dermatology /ID# 254564

    Calgary, Alberta, T3A 2N1

  • Rejuvenation Dermatology - Edmonton Downtown /ID# 254715

    Edmonton, Alberta, T5J 3S9

  • Alberta Dermasurgery Centre /ID# 275945

    Edmonton, Alberta, T6G 1C3

  • LEADER Research /ID# 254379

    Hamilton, Ontario, L8L 3C3

  • DermEffects /ID# 254116

    London, Ontario, N6H 5L5

  • Lynderm Research Inc /ID# 254713

    Markham, Ontario, L3P 1X2

  • Derm Care Clinic /ID# 276065

    Mississauga, Ontario, L4W 0C2

  • CHU Sainte-Justine /ID# 254118

    Montreal, Quebec, H3T 1C5

  • Ryan Clinical Research Inc /ID# 254714

    Newmarket, Ontario, L3Y 5G8

  • Diex Recherche Quebec Inc. /ID# 254381

    Québec, G1V 4T3

  • Care Clinic - Red Deer - Taylor Drive /ID# 276063

    Red Deer, Alberta, T4P 1K4

  • York Dermatology Clinic and Research Centre /ID# 254115

    Richmond Hill, Ontario, L4C 9M7

  • Dre Angelique Gagne-Henley M.D. inc. /ID# 255632

    Saint-Jérôme, Quebec, J7Z 7E2

  • SkinSense Dermatology /ID# 254119

    Saskatoon, Saskatchewan, S7K 0H6

  • Karma Clinical Trials /ID# 254120

    St. John's, Newfoundland and Labrador, A1A 4Y3

  • Dr. Chih-ho Hong Medical Inc. /ID# 254378

    Surrey, British Columbia, V3R 6A7

  • Enverus Medical Research /ID# 254380

    Surrey, British Columbia, V3V 0C6

  • Research Toronto /ID# 255273

    Toronto, Ontario, M4W 2N4

  • Wiseman Dermatology Research /ID# 254117

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

Germany15 sites

  • Fachklinik - Bad Bentheim /ID# 275537

    Bad Bentheim, Lower Saxony, 48455

  • Havelklinik /ID# 254194

    Berlin, 13595

  • Klinikum Ruhr Univ Bochum /ID# 253690

    Bochum, 44791

  • Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 254510

    Bramsche, Lower Saxony, 49565

  • Universitaetsklinikum Duesseldorf /ID# 253711

    Düsseldorf, North Rhine-Westphalia, 40225

  • Universitaetsklinikum Erlangen /ID# 254804

    Erlangen, Bavaria, 91054

  • Universitaetsklinikum Frankfurt /ID# 253683

    Frankfurt am Main, Hesse, 60590

  • Universitaetsklinikum Freiburg /ID# 275746

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Magdeburger Company for Medical Studies & Services GmbH /ID# 255151

    Magdeburg, 39104

  • Universitaetsmedizin Mainz /ID# 272596

    Mainz, Rhineland-Palatinate, 55131

  • Dermatologie Quist-BAG Dres. med. Quist PartG /ID# 253691

    Mainz, 55128

  • Hautmedizin Saar Science /ID# 272614

    Merzig, Saarland, 66663

  • Klinik am Biederstein /ID# 254195

    Munich, 80802

  • Universitaetsklinikum Regensburg /ID# 253692

    Regensburg, Bavaria, 93042

  • Universitaetsklinikum Wuerzburg /ID# 275599

    Würzburg, Bavaria, 97080

Other trials in Germany

Japan10 sites

  • Fukuoka University Hospital /ID# 254729

    Fukuoka, Fukuoka, 814-0180

  • University of the Ryukyus Hospital /ID# 254517

    Ginowan-shi, Okinawa, 901-2725

  • University Hospital Kyoto Prefectural University of Medicine /ID# 254481

    Kyoto, Kyoto, 602-8566

  • Toranomon Hospital /ID# 253819

    Minato-ku, Tokyo, 105-8470

  • Meiwa Hospital /ID# 254728

    Nishinomiya-shi, Hyōgo, 663-8186

  • Shiga University of Medical Science Hospital /ID# 254215

    Ōtsu, Shiga, 520-2192

  • Kindai University Hospital /ID# 254574

    Sakai-shi, Osaka, 590-0197

  • Tohoku University Hospital /ID# 254598

    Sendai, Miyagi, 9808574

  • Nihon University Itabashi Hospital /ID# 254637

    tabashi City, Tokyo, 173-8610

  • University of Tsukuba Hospital /ID# 254638

    Tsukuba, Ibaraki, 305-8576

Other trials in Japan

Hungary9 sites

  • Csalogany Orvosi Kozpont /ID# 255063

    Budapest, 1027

  • Duplicate_Obudai Egeszsegugyi Centrum Kft. /ID# 256366

    Budapest, 1036

  • Semmelweis Egyetem /ID# 276162

    Budapest, 1085

  • Debreceni Egyetem-Klinikai Kozpont /ID# 253637

    Debrecen, Hajdú-Bihar, 4032

  • DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 253638

    Debrecen, 4031

  • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 253913

    Kaposvár, Somogy County, 7400

  • Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 253753

    Pécs, Baranya, 7624

  • Szegedi Tudomanyegyetem /ID# 255142

    Szeged, Csongrád megye, 6720

  • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 254377

    Szombathely, Vas County, 9700

Other trials in Hungary

Italy9 sites

  • ASST degli Spedali Civili di Brescia /ID# 254875

    Brescia, 25123

  • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale S.Anna /ID# 254496

    Cona, Ferrara, 44124

  • AZIENDA USL TOSCANA CENTRO - Ospedale Piero Palagi /ID# 254495

    Florence, Firenze, 50122

  • ASL 1 Abruzzo - Ospedale regionale San Salvatore /ID# 276045

    L’Aquila, L Aquila, 67100

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 254502

    Milan, 20122

  • Azienda Ospedaliero-Universitaria di Modena /ID# 254874

    Modena, 41124

  • Azienda Ospedaliero Universitaria Pisana /ID# 254501

    Pisa, 56126

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 254498

    Rome, Roma, 00133

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 254500

    Rome, Roma, 00168

Other trials in Italy

Spain8 sites

  • Hospital Santa Creu i Sant Pau /ID# 253869

    Barcelona, 08041

  • Hospital General de Granollers /ID# 253873

    Barcelona, 08042

  • Hospital Universitario Virgen de las Nieves /ID# 253870

    Granada, 18014

  • Hospital Universitari de Bellvitge /ID# 254982

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario Ramon y Cajal /ID# 253871

    Madrid, 28034

  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 253924

    Majadahonda, Madrid, 28222

  • Hospital de Manises /ID# 253867

    Manises, Valencia, 46940

  • Hospital Universitario y Politecnico La Fe /ID# 253868

    Valencia, 46026

Other trials in Spain

Argentina7 sites

  • Ciprec (Centro De Investigacion Y Prevencion Cardiovascular) - Barrio Norte /ID# 255474

    Buenos Aires, 1061

  • Hospital Italiano /ID# 254905

    CABA, C1199ABB

  • Buenos Aires Skin /ID# 255299

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1055

  • Instituto de Neumonologia y Dermatologia /ID# 254903

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1425

  • Psoriahue Med Interdisciplinar /ID# 257202

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1425

  • Consultorios Reumatologicos Pampa /ID# 255555

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1428

  • Hospital Universitario Austral /ID# 254904

    Pilar, Buenos Aires, 1629

Other trials in Argentina

Belgium7 sites

  • Universite Libre de Bruxelles - Hopital Erasme /ID# 254082

    Anderlecht, Brussels Capital, 1070

  • Cliniques Universitaires UCL Saint-Luc /ID# 254087

    Brussels, Brussels Capital, 1200

  • Grand Hopital de Charleroi - Les Viviers /ID# 254091

    Charleroi, Hainaut, 6280

  • UZ Gent /ID# 254090

    Ghent, Oost-Vlaanderen, 9000

  • Universitair Ziekenhuis Brussel /ID# 254223

    Jette, Brussels Capital, 1090

  • Universitair Ziekenhuis Leuven /ID# 254089

    Leuven, Vlaams-Brabant, 3000

  • CHU de Liege /ID# 254085

    Liège, 4000

Other trials in Belgium

Brazil7 sites

  • Hospital e Maternidade Celso Pierro - PUC-Campinas /ID# 275811

    Campinas, São Paulo, 13034-685

  • Instituto de Pesquisa e Ensino CLIGEDIMUNO - IPEC /ID# 254369

    Macaé, Rio de Janeiro, 27910-190

  • Hospital Moinhos de Vento /ID# 254366

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 254367

    Ribeirão Preto, São Paulo, 14049-900

  • Instituto Brasil de Pesquisa Clinica S.A - IBPClin /ID# 275810

    Rio de Janeiro, 20241-180

  • Centro de Desenvolvimento em Estudos Clinicos Brasil - CDEC /ID# 254368

    São Paulo, São Paulo, 04020-060

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 254370

    São Paulo, 05403-000

Other trials in Brazil

Croatia7 sites

  • Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 253586

    Ivanić-Grad, Zagreb County, 10310

  • Specialty Hospital Medico /ID# 254731

    Rijeka, Primorje-Gorski Kotar County, 51000

  • Klinicki Bolnicki Centar Split /ID# 253789

    Split, Split-Dalmatia County, 21000

  • DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 253587

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Zagreb /ID# 253786

    Zagreb, City of Zagreb, 10000

  • Klinika za dječje bolesti Zagreb /ID# 253588

    Zagreb, City of Zagreb, 10000

  • Poliklinika Solmed /ID# 254732

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

United Kingdom7 sites

  • University Hospitals Bristol /ID# 261505

    Bristol, BS1 3NU

  • UH Coventry & Warwickshire /ID# 256909

    Coventry, Warwickshire, CV2 2DX

  • Leeds Teaching Hospitals NHS Trust /ID# 254616

    Leeds, West Yorkshire, LS9 7TF

  • Chelsea and Westminster Hospital /ID# 254190

    London, Greater London, SW10 9NH

  • St George University Hospitals NHS Foundation Trust /ID# 256803

    London, Greater London, SW17 0QT

  • Northern Care Alliance NHS Group /ID# 256910

    Salford, M6 8HD

  • University Hospital Southampton NHS Foundation Trust /ID# 254531

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

France6 sites

  • Hopital Prive d'Antony /ID# 253501

    Antony, Île-de-France Region, 92160

  • Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-Andre /ID# 254139

    Bordeaux, Gironde, 33000

  • HCL - Hopital Edouard Herriot /ID# 253500

    Lyon, Rhone, 69003

  • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 254114

    Nantes, Pays de la Loire Region, 44000

  • Chu de Nice-Hopital Larchet Ii /Id# 253504

    Nice, Alpes-Maritimes, 06202

  • Polyclinique Courlancy /ID# 254680

    Reims, Marne, 51100

Other trials in France

Turkey (Türkiye)6 sites

  • Gulhane Egitim ve Arastirma Hastanesi /ID# 253919

    Ankara, Antalya, 06010

  • Izmir Sehir Hastanesi /ID# 265465

    Bayraklı, 35540

  • Uludag University Medical Faculty /ID# 253806

    Bursa, 16059

  • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 253824

    Istanbul, 34098

  • Erciyes University Medical Faculty /ID# 253804

    Kayseri, 38039

  • Ondokuz Mayis Universitesi /ID# 254034

    Samsun, 55139

Other trials in Turkey (Türkiye)

Australia5 sites

  • Skin Health Institute Inc /ID# 254416

    Carlton, Victoria, 3053

  • Momentum Clinical Research /ID# 254411

    Darlinghurst, New South Wales, 2010

  • Sinclair Dermatology - Melbourne /ID# 254412

    East Melbourne, Victoria, 3002

  • The Alfred Hospital /ID# 254414

    Melbourne, Victoria, 3004

  • Paratus Clinical Research Woden /ID# 254670

    Phillip, Australian Capital Territory, 2606

Other trials in Australia

Greece5 sites

  • 401 GSNA - 401 Army General Hospital /ID# 253499

    Athens, Attica, 11527

  • General Hospital Andreas Syggros /ID# 253498

    Athens, Attica, 16121

  • University General Hospital Attikon /ID# 253495

    Chaïdári, Attica, 12462

  • Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 253497

    Thessaloniki, 54643

  • Papageorgiou General Hospital /ID# 253496

    Thessaloniki, 56429

Other trials in Greece

Ireland5 sites

  • South Infirmary Victoria University Hospital /ID# 253975

    Cork, T12 X23H

  • St James Hospital /ID# 253973

    Dublin, Dublin, D08 NHY1

  • University College Dublin /ID# 253971

    Dublin, D07 A8NN

  • University Hospital Galway /ID# 253976

    Galway, H91 YR71

  • Waterford Regional Hospital /ID# 254038

    Waterford, X91 ER8E

Other trials in Ireland

Israel5 sites

  • Rambam Health Care Campus /ID# 254406

    Haifa, 3109601

  • Rabin Medical Center. /ID# 254405

    Petah Tikva, Central District, 4941492

  • Sheba Medical Center /ID# 254545

    Ramat Gan, Tel Aviv, 52621

  • ZIV Medical Center /ID# 254403

    Safed, Northern District, 13100

  • Tel Aviv Sourasky Medical Center /ID# 254404

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Slovakia5 sites

  • Univerzitna nemocnica Bratislava - Nemocnica Ruzinov /ID# 254157

    Bratislava, Bratislava Region, 821 01

  • Univerzitna nemocnica L. Pasteura Kosice /ID# 254136

    Košice, Košice Region, 040 01

  • Univerzitna nemocnica Martin /ID# 254153

    Martin, Žilina Region, 036 01

  • Fakultna nemocnica s poliklinikou Nove Zamky /ID# 254155

    Nové Zámky, Nitra Region, 940 34

  • Fakultna nemocnica Trnava /ID# 254137

    Trnava, 917 02

Other trials in Slovakia

South Korea5 sites

  • Korea University Ansan Hospital /ID# 254128

    Ansan-si, Gyeonggido, 15355

  • CHA Bundang Medical Center /ID# 254026

    Seongnam, Gyeonggido, 13496

  • Seoul National University Hospital /ID# 254027

    Seoul, Seoul Teugbyeolsi, 03080

  • SoonChunHyang University Seoul Hospital /ID# 254025

    Seoul, Seoul Teugbyeolsi, 04401

  • Hallym University Kangnam Sacred Heart Hospital /ID# 254127

    Seoul, Seoul Teugbyeolsi, 07441

Other trials in South Korea

Bulgaria4 sites

  • Acibadem City Clinic Tokuda University Hospital EAD /ID# 253331

    Sofia, 1407

  • Ambulatory for Specialized Medical Care-IPSMC-skin and venereal diseases /ID# 253329

    Sofiya, Sofia, 1407

  • Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 253327

    Sofiya, Sofia, 1463

  • UMHAT Professor Stoyan Kirkovich /ID# 253328

    Stara Zagora, 6000

Other trials in Bulgaria

Chile4 sites

  • Fundacion Innovacion Cardiovascular /ID# 254561

    Independencia, Santiago Metropolitan, 8380465

  • Centro Medico Skin Med SPA /ID# 254560

    Las Condes, Region Metropolitana Santiago, 7580206

  • Centro Internacional de Estudios Clinicos - CIEC /ID# 254559

    Santiago, Region Metropolitana Santiago, 8420383

  • Clinica Dermacross /ID# 254558

    Vitacura, Region Metropolitana Santiago, 7640881

Other trials in Chile

Colombia4 sites

  • Centro Integral de Reumatologia del Caribe SAS - Circaribe SAS /ID# 255278

    Barranquilla, Atlántico, 80002

  • Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 254796

    Bogotá, Cundinamarca, 110221

  • Clinica De Inmunologia Y Genetica (Cige) /ID# 254797

    Medellín, Antioquia, 050012

  • IPS Suramericana SAS - IPS Sura San Diego /ID# 255064

    Medellín, Antioquia, 050016

Other trials in Colombia

Portugal4 sites

  • Centro Hospitalar de Lisboa Central - Lisbon /ID# 254325

    Lisbon, Lisbon District, 1169-050

  • Hospital CUF Descobertas /ID# 254323

    Lisbon, 1998-018

  • Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 254322

    Porto, 4099-001

  • Unidade Local de Saude Sao Joao /ID# 254324

    Porto, 4200-319

Other trials in Portugal

Saudi Arabia4 sites

  • King Faisal Specialist Hospital /ID# 255539

    Jeddah, Mecca Region, 23433

  • King Faisal Specialist Hospital and Research Centre /ID# 255279

    Riyadh, Riyadh Region, 11211

  • King Abdulaziz Medical City- National Guard Hospital /ID# 255280

    Riyadh, Riyadh Region, 11426

  • King Saud University Med City /ID# 255282

    Riyadh, 12372

Other trials in Saudi Arabia

Taiwan4 sites

  • Changhua Christian Hospital /ID# 254032

    Changhua City, Changhua County, 50006

  • Kaohsiung Chang Gung Memorial Hospital /ID# 254031

    Kaohsiung City, 833

  • National Taiwan University Hospital /ID# 254030

    Taipei, 100

  • Linkou Chang Gung Memorial Hospital /ID# 254033

    Taoyuan City, 333

Other trials in Taiwan

Austria3 sites

  • Medizinische Universitaet Graz /ID# 253448

    Graz, Styria, 8010

  • Duplicate_Ordensklinikum Linz GmbH Elisabethinen /ID# 253458

    Linz, Upper Austria, 4010

  • Medizinische Universitaet Wien /ID# 254096

    Vienna, State of Vienna, 1090

Other trials in Austria

Czechia3 sites

  • Karlovarska Krajska Nemocnice - Karlovy Vary /ID# 253456

    Karlovy Vary, 360 01

  • Fakultni nemocnice Motol a Homolka /ID# 253455

    Prague, Praha 5, 150 06

  • Fakultni nemocnice Kralovske Vinohrady /ID# 253454

    Prague, 100 34

Other trials in Czechia

Mexico3 sites

  • Grupo Clinico Catei Sociedad Civil /Id# 254657

    Guadalajara, Jalisco, 44657

  • Cryptex Investigacion Clinica S.A de C.V /ID# 256066

    Mexico City, 06100

  • Eukarya PharmaSite, SC /ID# 254658

    Monterrey, Nuevo León, 64718

Other trials in Mexico

Switzerland3 sites

  • Inselspital, Universitaetsspital Bern /ID# 254736

    Bern, 3010

  • Kantonsspital St. Gallen /ID# 255243

    Sankt Gallen, Canton of St. Gallen, 9007

  • University Hospital Zurich /ID# 254642

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Finland2 sites

  • Oulun yliopistollinen sairaala /ID# 253969

    Oulu, North Ostrobothnia, 90220

  • Terveystalo Tampere /ID# 253968

    Tampere, Pirkanmaa, 33100

Other trials in Finland

Lithuania2 sites

  • Inlita - Santara KTC /ID# 253917

    Vilnius, 08406

  • Vilnius University Hospital Santaros Klinikos /ID# 253916

    Vilnius, 08661

Other trials in Lithuania

Netherlands2 sites

  • Amphia Ziekenhuis /ID# 253567

    Breda, North Brabant, 4818 CK

  • Universitair Medisch Centrum Groningen /ID# 253571

    Groningen, 9713 GZ

Other trials in Netherlands

New Zealand2 sites

  • Greenlane Clinical Centre /ID# 254351

    Epsom, Auckland, 1051

  • Clinical Trials New Zealand /ID# 254352

    Hamilton, Waikato Region, 3204

Other trials in New Zealand

Puerto Rico2 sites

  • Dr. Samuel Sanchez PSC /ID# 253948

    Caguas, 00727

  • Alma M. Cruz Santana, MD-Private practice /ID# 253951

    Carolina, 00985

Other trials in Puerto Rico

Singapore2 sites

  • National Skin Centre /ID# 255242

    Singapore, Central Singapore, 308205

  • National University Hospital /ID# 254943

    Singapore, 119074

Other trials in Singapore

Sweden2 sites

  • Sahlgrenska Universitetssjukhuset /ID# 254807

    Gothenburg, Västra Götaland County, 413 46

  • Karolinska University Hospital Solna /ID# 254808

    Solna, Stockholm County, 171 64

Other trials in Sweden

About this study

Official title: 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.

Read more

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.

Being tested
Upadacitinib, Placebo
Keywords
Hidradenitis Suppurativa, Upadacitinib, ABT-494, Rinvoq, STEP-UP HS
Medical subject headings
Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UpadacitinibDrug

    Also called ABT-494, RINVOQ

    Oral Tablets

  • PlaceboDrug

    Oral Tablets

Study groups in NCT05889182
Study groupRoleWhat they receive
Period 1: Upadacitinib Dose AExperimentalParticipants will receive Upadicitinib Dose A once daily for 16 weeks.
Receives: Drug: Upadacitinib
Period 1: PlaceboPlacebo comparatorParticipants will receive Placebo once daily for 16 weeks.
Receives: Drug: Placebo
Period 2: Group 1 - Upadacitinib Dose AExperimentalParticipants 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.
Receives: Drug: Upadacitinib
Period 2: Group 2 - PlaceboPlacebo comparatorParticipants who were randomized to placebo in Period 1 who achieve HiSCR 50 (clinical responder, CR) at Week 16 will continue to receive placebo once daily for 20 weeks.
Receives: Drug: Placebo
Period 2: Group 3 - Upadacitinib Dose AExperimentalParticipants 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.
Receives: Drug: Upadacitinib
Period 2: Group 4 - Upadacitinib Dose AExperimentalParticipants 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.
Receives: Drug: Upadacitinib
Period 2: Group 5 - Upadacitinib Dose BExperimentalParticipants 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.
Receives: Drug: Upadacitinib
Period 2: Group 6 - PlaceboExperimentalParticipants 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.
Receives: Drug: Placebo
Period 3: Long-Term ExtensionExperimentalEligible participants will continue to receive upadacitinib or placebo for 68 weeks. Participants will be followed-up for approximately 30 days.
Receives: Drug: Upadacitinib; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 50

    HiSCR 50 is defined as at least a 50% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.

    Measured: Baseline to Week 16

  2. Number of Participants with Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

    Measured: Up to Approximately Week 108

Secondary outcomes (9)

  1. Change from Baseline in Draining Fistula Count

    Change from baseline in draining fistula count.

    Measured: Baseline to Week 16

  2. Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75

    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.

    Measured: Baseline to Week 16

  3. Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 4 Among Participants with NRS ≥ 3 at Baseline

    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).

    Measured: Baseline to Week 4

  4. Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA)

    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.

    Measured: Baseline to Week 16

  5. Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA)

    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.

    Measured: Baseline to Week 16

  6. Change from Baseline in Dermatology Life Quality Index (DLQI) for Adult Participants and Adolescent Participants Age ≥16 Years Old and Older

    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.

    Measured: Baseline to Week 16

  7. Change from Baseline in Hidradenitis Suppurativa (HS)-Related Odor, Based on Hidradenitis Suppurativa Symptom Assessment (HSSA) Question 8

    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.

    Measured: Baseline to Week 16

  8. Change from Baseline in the Patient's Global Assessment of Hidradenitis Suppurativa (HS)-Related Skin Pain NRS

    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

    Measured: Baseline to Week 8

  9. Occurrence of Hidradenitis Suppurativa (HS) Flare During Period 1

    Defined as at least one occurrence of a ≥ 25% increase in AN count, with a minimum absolute increase of 2 relative to Baseline.

    Measured: Baseline to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2023
  2. Study start21 Jun 2023
  3. Primary completionMar 2028 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,328 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05889182
Sponsor's protocol ID
M23-698
Other IDs
2023-503661-28-00, 2023
Acronym
Step-Up HS
Status last verified
Aug 2026
First submitted
26 May 2023
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Upadacitinib in people with Hidradenitis Suppurativa, run by AbbVie at 285 sites in 37 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 285 sites in United States, Canada, Germany, Japan, Hungary and 32 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 50 (time frame: Baseline to Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05889182.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in