AzTrials
AzTrials

Hidradenitis SuppurativaPhase 3IntrepidNCT06468228

A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa

A Phase 3 study testing Lutikizumab in people with Hidradenitis Suppurativa, run by AbbVie at 279 sites in 44 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 a chronic and often painful inflammatory skin disease which includes the forming of lumps, abscesses and scars in areas of the skin such as under the breasts, under armpits, inner thighs, groin and buttocks. 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?
Lutikizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,400 participants
Where
279 sitesin 44 countries
Study dates
27 Jun 2024to Dec 2026
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 moderate to severe HS for at least 6 months prior to Baseline as determined by the investigator (i.e., through medical history and interview of participant).
  • Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline
  • Hidradenitis suppurativa (HS) lesions present in at least two distinct anatomic areas at Baseline.
  • At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.

Who cannot join

  • Any evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • Confirmed positive anti-HIV antibody (HIV Ab) test.
  • Evidence of active tuberculosis or meets tuberculosis exclusionary parameter

Trial locations and contacts

279 sites in 44 countries.

279 sites in 44 countries

United States73 sites

  • Arlington Research Center, Inc /ID# 263895

    Arlington, Texas, 76011

  • Bellaire Dermatology Associates /ID# 263850

    Bellaire, Texas, 77401

  • Dermatology of Greater Columbus /ID# 263497

    Bexley, Ohio, 43209

  • Cahaba Dermatology & Skin Health Center /ID# 263795

    Birmingham, Alabama, 35244

  • Clearlyderm Dermatology - West Boca /ID# 265023

    Boca Raton, Florida, 33428

  • Treasure Valley Medical Research /ID# 263671

    Boise, Idaho, 83706

  • Beth Israel Deaconess Medical Center /ID# 263709

    Boston, Massachusetts, 02215

  • Equity Medical, LLC /ID# 268590

    Bowling Green, Kentucky, 42104

  • Apex Clinical Trials /ID# 263815

    Brandon, Florida, 33511

  • TrueBlue Clinical Research - Brandon /ID# 265041

    Brandon, Florida, 33511

  • Dermatology Trial Associates /ID# 264587

    Bryant, Arkansas, 72022

  • Hamzavi Dermatology - Canton /ID# 263538

    Canton, Michigan, 48187

  • Clinical Research Center of the Carolinas /ID# 263407

    Charleston, South Carolina, 29407

  • Medical University of South Carolina /ID# 263890

    Charleston, South Carolina, 29425

  • DeNova Research /ID# 264593

    Chicago, Illinois, 60610

  • Northwestern University Feinberg School of Medicine /ID# 265007

    Chicago, Illinois, 60611-2927

  • Michigan Center for Medical Research - Clarkston /ID# 263547

    Clarkston, Michigan, 48346

  • University Hospitals Cleveland Medical Center /ID# 263600

    Cleveland, Ohio, 44106

  • Michigan Center for Skin Care Research /ID# 267228

    Clinton Township, Michigan, 48038

  • Centricity Research Columbus Dermatology /ID# 266530

    Columbus, Georgia, 31904

  • The Ohio State University Wexner Medical Center - CarePoint East /ID# 263598

    Columbus, Ohio, 43203

  • Florida Academic Dermatology Center /ID# 263834

    Coral Gables, Florida, 33134-5755

  • Studies in Dermatology /ID# 263399

    Cypress, Texas, 77429

  • Reveal Research Institute - Dallas /ID# 267233

    Dallas, Texas, 75235

  • Cleaver Medical Group Dermatology /ID# 263845

    Dawsonville, Georgia, 30534

  • Private Practice - Dr. Tooraj Raoof /ID# 263756

    Encino, California, 91436

  • Direct Helpers Research Center /ID# 278343

    Hialeah, Florida, 33012

  • Skin Care Research - Hollywood /ID# 263805

    Hollywood, Florida, 33021-6748

  • Center for Clinical Studies - Houston - Binz Street /ID# 263378

    Houston, Texas, 77004

  • Dawes Fretzin /ID# 264601

    Indianapolis, Indiana, 46256

  • Vivida Dermatology- Flamingo /ID# 263716

    Las Vegas, Nevada, 89119-5190

  • Dermatology Partners of Leawood /ID# 263533

    Leawood, Kansas, 66211

  • Dartmouth Hitchcock Medical Center - Old Etna Road /ID# 263713

    Lebanon, New Hampshire, 03766

  • Dermatology and Skin Center of Lees Summit /ID# 263567

    Lee's Summit, Missouri, 64064-2301

  • Dermatology Research Associates - Los Angeles /ID# 263765

    Los Angeles, California, 90045

  • Dermatology Specialists Research (DS Research) - Kentucky /ID# 263343

    Louisville, Kentucky, 40241

  • Gsi Clinical Research /ID# 263827

    Margate, Florida, 33063-7011

  • Dermatologists of Southwest Ohio - Mason /ID# 263588

    Mason, Ohio, 45040

  • Apex Clinical Research Center /ID# 272787

    Mayfield Heights, Ohio, 44124

  • Sullivan Dermatology /ID# 263511

    Miami, Florida, 33162

  • Frontier Dermatology /ID# 278387

    Mill Creek, Washington, 98012

  • University of Utah - Murray /ID# 263818

    Murray, Utah, 84107

  • Yale University School of Medicine /ID# 263695

    New Haven, Connecticut, 06510

  • Tulane University School of Medicine /ID# 263899

    New Orleans, Louisiana, 70112

  • Mount Sinai Doctors - Dermatology /ID# 264602

    New York, New York, 10028

  • Virginia Clinical Research /ID# 264553

    Norfolk, Virginia, 23507

  • Arkansas Research Trials /ID# 263901

    North Little Rock, Arkansas, 72217

  • Vitalia Medical Research /ID# 278321

    North Palm Beach, Florida, 33408

  • Renstar Medical Research - Ocala - Northeast 1st Avenue /ID# 263842

    Ocala, Florida, 34470

  • Dermatology Partners - Philadelphia /ID# 264999

    Philadelphia, Pennsylvania, 19114

  • Medical Dermatology Specialists /ID# 263394

    Phoenix, Arizona, 85006

  • University of Pittsburgh Medical Center /ID# 264590

    Pittsburgh, Pennsylvania, 15213

  • Texas Dermatology Research Center /ID# 264488

    Plano, Texas, 75025

  • StracSkin /ID# 263387

    Portsmouth, New Hampshire, 03801

  • Stanford University School of Medicine - Redwood City /ID# 263711

    Redwood City, California, 94063

  • Norcal Clinical Research /ID# 279008

    Rocklin, California, 95765

  • Arlington Dermatology /ID# 263410

    Rolling Meadows, Illinois, 60008

  • Integrative Skin Science and Research /ID# 264600

    Sacramento, California, 95815

  • MediSearch Clinical Trials /ID# 263582

    Saint Joseph, Missouri, 64506

  • Texas Dermatology and Laser Specialists /ID# 263778

    San Antonio, Texas, 78218

  • Advanced Dermatology And Cosmetic Surgery - Spartanburg /ID# 267207

    Spartanburg, South Carolina, 29307

  • Dermatology Specialists of Spokane /ID# 264499

    Spokane, Washington, 99202

  • Skin Care Research - Tampa /ID# 263819

    Tampa, Florida, 33607-6438

  • Advanced Clinical Research Institute - Tampa /ID# 263808

    Tampa, Florida, 33607

  • University of South Florida /ID# 269624

    Tampa, Florida, 33612

  • Alliance Clinical Research of Tampa /ID# 264594

    Tampa, Florida, 33615

  • The Woodlands Dermatology Associates /ID# 266820

    The Woodlands, Texas, 77380

  • Clinical Trials Research Institute /ID# 263743

    Thousand Oaks, California, 91320

  • Banner University Medicine Dermatology /ID# 263557

    Tucson, Arizona, 85718-1407

  • Dermatology Associates of Tyler /ID# 265002

    Tyler, Texas, 75703

  • TruDerm Research /ID# 278217

    Wellington, Florida, 33449

  • Wake Forest University Health Sciences /ID# 264507

    Winston-Salem, North Carolina, 27104

  • UMass Memorial Medical Center - Lake Avenue North /ID# 274149

    Worcester, Massachusetts, 01655

Other trials in United States

Canada17 sites

  • Beacon Dermatology /ID# 264262

    Calgary, Alberta, T3A 2N1

  • Skin Health /ID# 267735

    Cobourg, Ontario, K9A 0Z4

  • Rejuvenation Dermatology - Edmonton Downtown /ID# 265963

    Edmonton, Alberta, T5J 3S9

  • Stratica Dermatology /ID# 265856

    Edmonton, Alberta, T5K 1X3

  • Brunswick Dermatology Center /ID# 264260

    Fredericton, New Brunswick, R3M 3Z4

  • Leader Research /ID# 266114

    Hamilton, Ontario, L8L 3C3

  • Interior Dermatology Centre - Probity - PPDS /ID# 266202

    Kelowna, British Columbia, V1W 4V5

  • DermEffects /ID# 265262

    London, Ontario, N6H 5L5

  • Derm Care Clinic /ID# 265261

    Mississauga, Ontario, L4W 0C2

  • Diex Recherche Quebec Inc. /ID# 265263

    Québec, G1V 4T3

  • Centre de Recherche Saint-Louis /ID# 265855

    Québec, G1W 4R4

  • York Dermatology Clinic and Research Centre /ID# 265265

    Richmond Hill, Ontario, L4C 9M7

  • Private Practice - Dr. Angelique Gagne-Henley /ID# 264263

    Saint-Jérôme, Quebec, J7Z 7E2

  • SkinSense Dermatology /ID# 265964

    Saskatoon, Saskatchewan, S7K 0H6

  • Karma Clinical Trials /ID# 265962

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

  • FACET Dermatology /ID# 265267

    Toronto, Ontario, M4C 1L1

  • Private Practice - Dr. Kim Papp Clinical Research /ID# 265266

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

Germany13 sites

  • Fachklinik - Bad Bentheim /ID# 263067

    Bad Bentheim, Lower Saxony, 48455

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 263076

    Berlin, 10117

  • Katholisches Klinikum Bochum /ID# 262976

    Bochum, North Rhine-Westphalia, 44805

  • Rosenpark Research /ID# 269202

    Darmstadt, Hesse, 64283

  • Universitaetsklinikum Erlangen /ID# 263075

    Erlangen, Bavaria, 91054

  • Universitaetsklinikum Freiburg /ID# 263659

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Hautarztpraxis Dr. Kirschner /ID# 263656

    Mainz, Rhineland-Palatinate, 55116

  • Beldio Research GmbH /ID# 263074

    Memmingen, Bavaria, 87700

  • Hautmedizin Saar Science /ID# 278634

    Merzig, Saarland, 66663

  • Universitaetsklinikum Muenster /ID# 263068

    Münster, North Rhine-Westphalia, 48149

  • Hautarztpraxis Mortazawi /ID# 271673

    Remscheid, North Rhine-Westphalia, 42897

  • Universitaetsmedizin Rostock /ID# 278301

    Rostock, Mecklenburg-Vorpommern, 18057

  • Universitaetsklinikum Tuebingen /ID# 271718

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Japan12 sites

  • Fukuoka University Hospital /ID# 263991

    Fukuoka, 814-0180

  • University of the Ryukyus Hospital /ID# 264605

    Ginowan-shi, Okinawa, 901-2725

  • Dokkyo Medical University Saitama Medical Center /ID# 265400

    Koshigaya, Saitama, 343-0845

  • University Hospital Kyoto Prefectural University of Medicine /ID# 264291

    Kyoto, Kyoto, 602-8566

  • Nagoya City University Hospital /ID# 263874

    Nagoya, Aichi-ken, 467-8602

  • Niigata University Medical and Dental Hospital /ID# 276568

    Niigata, Niigata, 951-8520

  • Takagi Dermatological Clinic /ID# 264810

    Obihiro-Shi, Hokkaido, 080-0013

  • Osaka Metropolitan University Hospital /ID# 265682

    Osaka, Osaka, 545-8586

  • Kindai University Hospital /ID# 264322

    Sakai-shi, Osaka, 590-0197

  • Iwate Medical University Hospital /ID# 273799

    Shiwa-gun, Iwate, 028-3695

  • Nihon University Itabashi Hospital /ID# 264661

    Tokyo, 173-8610

  • Fujita Health University Hospital /ID# 265440

    Toyoake, Aichi-ken, 470-1192

Other trials in Japan

South Korea9 sites

  • Korea University Ansan Hospital /ID# 264227

    Ansan-si, Gyeonggido, 15355

  • Pusan National University Hospital /ID# 271496

    Busan, Busan Gwang Yeogsi, 49241

  • SoonChunHyang University Hospital Cheonan /ID# 271320

    Cheonan-si, Chungcheongnam-do, 31151

  • CHA Bundang Medical Center /ID# 264225

    Seongnam, Gyeonggido, 13496

  • Yonsei University Health System Severance Hospital /ID# 271353

    Seoul, Seoul Teugbyeolsi, 03722

  • SoonChunHyang University Seoul Hospital /ID# 264224

    Seoul, Seoul Teugbyeolsi, 04401

  • Asan Medical Center /ID# 264228

    Seoul, Seoul Teugbyeolsi, 05505

  • Hallym University Kangnam Sacred Heart Hospital /ID# 264226

    Seoul, Seoul Teugbyeolsi, 07441

  • The Catholic University Of Korea Eunpyeong St. MaryS Hospital /ID# 271348

    Seoul, 03312

Other trials in South Korea

Poland8 sites

  • Oftalmika sp. z o.o. /ID# 263087

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-631

  • Centrum Medyczne Angelius Provita /ID# 277204

    Katowice, Silesian Voivodeship, 40-615

  • Specjalistyczny gabinet dermatologiczny Aplikacyjno-Badawczy Marek Brzewski, Paw /ID# 277221

    Krakow, Lesser Poland Voivodeship, 30-002

  • Centrum Nowoczesnych Terapii Dobry Lekarz sp.z.o.o. /ID# 263146

    Krakow, Lesser Poland Voivodeship, 31-011

  • DERMED Centrum Medyczne Sp. z o.o /ID# 263147

    Lodz, Łódź Voivodeship, 90-265

  • Santa Sp. z o..o. Santa Familia PTG Lodz /ID# 263181

    Lodz, Łódź Voivodeship, 90-302

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji /ID# 277307

    Warsaw, Masovian Voivodeship, 02-507

  • Klinika Ambroziak Dermatologia /ID# 263173

    Warsaw, Masovian Voivodeship, 02-953

Other trials in Poland

United Kingdom8 sites

  • Bristol Royal Infirmary /ID# 263937

    Bristol, BS2 8HW

  • Queen Margaret Hospital /ID# 264198

    Dunfermline, Fife, KY12 0SU

  • Gloucestershire Royal Hospital /ID# 265848

    Gloucester, Gloucestershire, GL1 3NN

  • Harrogate District Hospital /ID# 265632

    Harrogate, North Yorkshire, HG2 7SX

  • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 264121

    London, Greater London, E1 2ES

  • Royal Victoria Infirmary /ID# 273368

    Newcastle upon Tyne, NE1 4LP

  • Southlands Hospital /ID# 276976

    Shoreham-by-Sea, West Sussex, BN43 6TQ

  • Royal Cornwall Hospital /ID# 277507

    Truro, Cornwall, TR1 3LQ

Other trials in United Kingdom

Belgium7 sites

  • Universite Libre de Bruxelles - Hopital Erasme /ID# 263097

    Anderlecht, Brussels Capital, 1070

  • Cliniques Universitaires UCL Saint-Luc /ID# 263096

    Brussels, Brussels Capital, 1200

  • Grand Hopital de Charleroi - Les Viviers /ID# 263100

    Charleroi, Hainaut, 6280

  • UZ Gent /ID# 263099

    Ghent, Oost-Vlaanderen, 9000

  • Universitair Ziekenhuis Brussel /ID# 263101

    Jette, Brussels Capital, 1090

  • Universitair Ziekenhuis Leuven /ID# 263098

    Leuven, Vlaams-Brabant, 3000

  • CHU de Liege /ID# 263095

    Liège, 4000

Other trials in Belgium

Israel7 sites

  • Haemek Medical Center /ID# 267297

    Afula, Haifa District, 1834111

  • Rambam Health Care Campus- Haifa /ID# 262994

    Haifa, 3109601

  • Hadassah Medical Center-Hebrew University /ID# 262884

    Jerusalem, 91120

  • Galilee Medical Center /ID# 262995

    Nahariya, Northern District, 2210001

  • Rabin Medical Center /ID# 262992

    Petah Tikva, Central District, 4941492

  • The Chaim Sheba Medical Center /ID# 262993

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 266581

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Italy7 sites

  • AOU Policlinico G. Rodolico - San Marco /ID# 263469

    Catania, 95123

  • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale S.Anna /ID# 263474

    Cona, Ferrara, 44124

  • AZIENDA USL TOSCANA CENTRO - Ospedale Piero Palagi /ID# 263454

    Florence, Firenze, 50122

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 263471

    Milan, 20122

  • Azienda Ospedaliera Universitaria Federico II - Naples /ID# 263539

    Naples, Napoli, 80131

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 263473

    Rome, Roma, 00168

  • IRCCS Istituto Clinico Humanitas /ID# 263503

    Rozzano, Lombardy, 20089

Other trials in Italy

Bulgaria6 sites

  • Medical Center Cordis /ID# 262894

    Pleven, 5800

  • Acibadem City Clinic Tokuda Hospital /ID# 263300

    Sofiya, Sofia, 1407

  • Ambulatory for Specialized Medical Care-IPSMC-skin and venereal diseases /ID# 262891

    Sofiya, Sofia, 1407

  • Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 262893

    Sofiya, Sofia, 1463

  • Medical Center Hera /ID# 263010

    Sofiya, Sofia, 1510

  • UMHAT Professor Stoyan Kirkovich /ID# 262892

    Stara Zagora, 6000

Other trials in Bulgaria

France6 sites

  • Hopital Edouard Herriot /ID# 263456

    Lyon, Auvergne-Rhône-Alpes, 69003

  • Cabinet medical - Le bateau Blanc /ID# 263465

    Martigues, Provence-Alpes-Côte d'Azur Region, 13500

  • Groupe Hospitalier Paris Saint-Joseph /ID# 263996

    Paris, 75014

  • Polyclinique Courlancy /ID# 263313

    Reims, 51100

  • Centre Hospitalier Universitaire de Rouen (CHU)- Hopital Charles Nicolle /ID# 263995

    Rouen, Seine-Maritime, 76031

  • Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 263459

    St-Priest-en-Jarez, Pays de la Loire Region, 42270

Other trials in France

Spain6 sites

  • Hospital General Universitario Gregorio Maranon /ID# 262940

    Madrid, 28007

  • Hospital Universitario Virgen de la Victoria /ID# 262941

    Málaga, 29010

  • Hospital de Manises /ID# 262938

    Manises, Valencia, 46940

  • Hospital Universitari Parc Tauli /ID# 262942

    Sabadell, Barcelona, 08208

  • Hospital Universitario Marques de Valdecilla /ID# 263039

    Santander, Cantabria, 39008

  • Consorci Hospital General Universitario de Valencia /ID# 262944

    Valencia, 46014

Other trials in Spain

Taiwan6 sites

  • Kaohsiung Chang Gung Memorial Hospital /ID# 264619

    Kaohsiung City, 833

  • Taichung Veterans General Hospital /ID# 270741

    Taichung, 407

  • National Taiwan University Hospital /ID# 264618

    Taipei, 100

  • Mackay Memorial Hospital /ID# 263661

    Taipei, 104

  • Taipei Veterans General Hospital /ID# 265879

    Taipei, 112

  • Linkou Chang Gung Memorial Hospital /ID# 264620

    Taoyuan City, 333

Other trials in Taiwan

Australia5 sites

  • Momentum Clinical Research /ID# 263192

    Darlinghurst, New South Wales, 2010

  • Sinclair Dermatology - Melbourne /ID# 263121

    East Melbourne, Victoria, 3002

  • Premier Dermatology - Kogarah /ID# 263124

    Kogarah, New South Wales, 2217

  • Paratus Clinical Research Woden /ID# 263125

    Phillip, Australian Capital Territory, 2606

  • Veracity Clinical Research /ID# 263126

    Woolloongabba, Queensland, 4102

Other trials in Australia

Argentina4 sites

  • Buenos Aires Skin /ID# 264299

    Buenos Aires, 1055

  • Consultorios Reumatologicos Pampa /ID# 265911

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

  • Instituto De Investigaciones Clinicas Cordoba /ID# 264297

    Córdoba, 5000

  • Instituto de Especialidades de la Salud Rosario - Clinica del Torax /ID# 266132

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Bosnia and Herzegovina4 sites

  • University Clinical Centre of the Republic of Srpska /ID# 265905

    Banja Luka, Republika Srpska, 78000

  • University Clinical Centre of the Republic of Srpska /ID# 265909

    Banja Luka, Republika Srpska, 78000

  • Clinical Center University of Sarajevo - Bolnicka /ID# 265908

    Sarajevo, Federation of Bosnia and Herzegovina, 71000

  • University Clinical Center Tuzla /ID# 265906

    Tuzla, Federation of Bosnia and Herzegovina, 75000

Other trials in Bosnia and Herzegovina

Colombia4 sites

  • Centro Integral de Reumatologia del Caribe SAS - Circaribe SAS /ID# 265089

    Barranquilla, Atlántico, 80002

  • Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 265093

    Bogotá, Cundinamarca, 110221

  • Centro de Inmunologia y Genetica CIGE SAS /ID# 263793

    Medellín, Antioquia, 050012

  • Healthy Medical Center S.A.S /ID# 265091

    Zipaquirá, Cundinamarca, 250252

Other trials in Colombia

Croatia4 sites

  • Klinicki Bolnicki Centar Zagreb /ID# 263989

    Grad Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Osijek /ID# 265916

    Osijek, County of Osijek-Baranja, 31000

  • Specialty Hospital Medico /ID# 263922

    Rijeka, Primorje-Gorski Kotar County, 51000

  • Klinicki Bolnicki Centar Sestre Milosrdnice /ID# 265069

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Greece4 sites

  • General Hospital Andreas Syggros /ID# 263417

    Athens, Attica, 16121

  • University General Hospital Attikon /ID# 263413

    Chaïdári, Attica, 12462

  • Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 263416

    Thessaloniki, 54643

  • Papageorgiou General Hospital /ID# 263415

    Thessaloniki, 56429

Other trials in Greece

Hungary4 sites

  • Semmelweis Egyetem /ID# 263451

    Budapest, 1085

  • Debreceni Egyetem /ID# 263423

    Debrecen, 4032

  • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 263424

    Kaposvár, Somogy County, 7400

  • Pecsi Tudomanyegyetem /ID# 264120

    Pécs, Baranya, 7632

Other trials in Hungary

Ireland4 sites

  • South Infirmary Victoria University Hospital /ID# 265872

    Cork, T12 X23H

  • Our Lady of Lourdes Hospital - Drogheda /ID# 265893

    Drogheda, Louth, A92 VW28

  • University College Dublin /ID# 265875

    Dublin, D07 A8NN

  • Mater Misericordiae University Hospital /ID# 265914

    Dublin, D07 R2WY

Other trials in Ireland

Mexico4 sites

  • Grupo Clinico CATEI S C /ID# 265276

    Guadalajara, Jalisco, 44638

  • Cryptex Investigacion Clinica /ID# 265271

    Mexico City, Mexico City, 06100

  • Eukarya PharmaSite /ID# 265307

    Monterrey, Nuevo León, 64718

  • Sociedad de Metabolismo y Corazon S.C. /ID# 265915

    Veracruz, 91900

Other trials in Mexico

Portugal4 sites

  • Unidade Local de Saude do Alto Ave, EPE /ID# 265158

    Guimarães, Braga District, 4835-044

  • CUF Descobertas Hospital /ID# 263188

    Lisbon, Lisbon District, 1998-018

  • Unidade Local de Saude de Sao Jose, EPE /ID# 265155

    Lisbon, 1150-199

  • Unidade Local de Saude de Santo Antonio /ID# 265479

    Porto, 4099-003

Other trials in Portugal

Serbia4 sites

  • Military Medical Academy /ID# 263257

    Belgrade, Beograd, 11000

  • University Clinical Center Serbia /ID# 263256

    Belgrade, Beograd, 11000

  • University Clinical Center Kragujevac /ID# 264211

    Kragujevac, Sumadijski Okrug, 34000

  • University Clinical Center Vojvodina /ID# 263260

    Novi Sad, 21000

Other trials in Serbia

Slovakia4 sites

  • Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 263921

    Bratislava, Bratislava Region, 811 09

  • Univerzitna nemocnica L. Pasteura Kosice /ID# 263907

    Košice, Košice Region, 040 01

  • Fakultna nemocnica s poliklinikou Nove Zamky /ID# 265944

    Nové Zámky, Nitra Region, 940 34

  • Fakultna nemocnica Trnava /ID# 263905

    Trnava, 917 02

Other trials in Slovakia

South Africa4 sites

  • Life Chatsmed Garden Hospital /ID# 270237

    Chatsworth, KwaZulu-Natal, 4092

  • Ahmed Al-Kadi Private Hospital /ID# 262837

    Durban, KwaZulu-Natal, 4091

  • Global Clinical Trials /ID# 262839

    Pretoria, Gauteng, 0157

  • Dr Ahmed Ismail Manjra /ID# 262838

    Westville, KwaZulu-Natal, 3629

Other trials in South Africa

Switzerland4 sites

  • University Hospital Basel /ID# 264245

    Basel Town, Canton of Basel-City, 4031

  • Dermatology & Skin Care Clinic /ID# 264030

    Buochs, Canton of Nidwalden, 6374

  • Kantonsspital St.Gallen /ID# 264238

    Sankt Gallen, Canton of St. Gallen, 9007

  • University Hospital Zurich /ID# 266142

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Chile3 sites

  • Fundacion Innovacion Cardiovascular /ID# 264844

    Independencia, Santiago Metropolitan, 8380465

  • Centro Internacional de Estudios Clinicos - CIEC /ID# 266129

    Santiago, Region Metropolitana Santiago, 8420383

  • Clinica Dermacross /ID# 266127

    Vitacura, Region Metropolitana Santiago, 7640881

Other trials in Chile

Czechia3 sites

  • Karlovarska Krajska Nemocnice - Karlovy Vary /ID# 265354

    Karlovy Vary, 360 01

  • Fakultni nemocnice Ostrava /ID# 264041

    Ostrava, Ostrava-mesto, 708 52

  • Fakultni nemocnice Kralovske Vinohrady /ID# 264040

    Prague, 100 34

Other trials in Czechia

Denmark3 sites

  • Aarhus Universitetshospital - Skejby /ID# 265657

    Aarhus, Central Jutland, 8200

  • Herlev and Gentofte Hospital /ID# 265839

    Hellerup, Capital Region, 2900

  • Roskilde Sygehus /ID# 274895

    Roskilde, Region Sjælland, 4000

Other trials in Denmark

Norway3 sites

  • Oslo University Hospital - Rikshospitalet /ID# 265996

    Oslo, 0372

  • Stavanger Universitetssykehus /ID# 265997

    Stavanger, Rogaland, 4068

  • Universitetssykehuset I Nord-Norge /ID# 265992

    Tromsø, Troms, 9019

Other trials in Norway

Romania3 sites

  • Spitalul Clinic Colentina /ID# 263303

    Bucharest, Bucharest, 020125

  • Centrul Medical Euromed /ID# 263304

    Bucharest, 020762

  • Private Practice - Dr. Orasan Remus /ID# 263305

    Cluj-Napoca, Cluj, 400006

Other trials in Romania

Turkey (Türkiye)3 sites

  • Pamukkale University Medical Faculty Hospital /ID# 264734

    Chonai, Denizli, 20330

  • Gaziantep Universitesi /ID# 263048

    Gaziantep, 27310

  • Erciyes Universitesi Tip Fakultesi /ID# 263050

    Melikgazi, Kayseri, 38170

Other trials in Turkey (Türkiye)

Austria2 sites

  • Medizinische Universitaet Graz /ID# 263306

    Graz, Styria, 8010

  • Medizinische Universitaet Wien /ID# 264043

    Vienna, 1090

Other trials in Austria

Guatemala2 sites

  • Dermos S.A. /ID# 265857

    Guatemala City, 01015

  • Prosalud /Id# 266586

    Guatemala City, Zona 1

Other trials in Guatemala

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 277709

    Kaunas, 50161

  • Vilnius University Hospital Santaros Klinikos /ID# 277707

    Vilnius, 08661

Other trials in Lithuania

New Zealand2 sites

  • Greenlane Clinical Centre /ID# 263191

    Epsom, Auckland, 1051

  • Clinical Trials New Zealand /ID# 265432

    Hamilton, Waikato Region, 3204

Other trials in New Zealand

Puerto Rico2 sites

  • Private Practice - Dr. Alma Cruz /ID# 263204

    Carolina, 00985

  • Clinical Research Puerto Rico /ID# 263450

    San Juan, 00909-1711

Other trials in Puerto Rico

Saudi Arabia2 sites

  • King Abdulaziz Medical City /ID# 266121

    Jeddah, Mecca Region, 22384

  • King Saud University Med City /ID# 266120

    Riyadh, 12372

Other trials in Saudi Arabia

Singapore2 sites

  • National University Hospital /ID# 264673

    Singapore, 119074

  • National Skin Centre /ID# 264680

    Singapore, 308205

Other trials in Singapore

Slovenia2 sites

  • University Medical Centre Ljubljana /ID# 265720

    Ljubljana, 1000

  • University Medical Centre Maribor /ID# 265827

    Maribor, 2000

Other trials in Slovenia

Sweden2 sites

  • Universitetssjukhuset Orebro /ID# 265064

    Örebro, Örebro County, 701 85

  • Karolinska University Hospital Solna /ID# 264530

    Solna, Stockholm County, 171 64

Other trials in Sweden

Netherlands1 site

  • Erasmus Medisch Centrum /ID# 263377

    Rotterdam, South Holland, 3015 CE

Other trials in Netherlands

About this study

Official title: A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab in Adult and Adolescent Subjects With Moderate to Severe Hidradenitis Suppurativa

Hidradenitis suppurativa (HS) is a chronic and often painful inflammatory skin disease which includes the forming of lumps, abscesses and scars in areas of the skin such as under the breasts, under armpits, inner thighs, groin and buttocks. This study will compare lutikizumab versus placebo for the treatment of adult and adolescent participants with the signs and symptoms of moderate to severe HS .

Lutikizumab is an investigational drug being developed for the treatment of HS. During Period 1 of the study, participants will placed in 1 of 2 groups called treatment arms. There is a 1 in 2 chance that participants will be assigned to placebo. Around 1280 adult and adolescent participants with moderate to severe HS will be enrolled in the study at approximately 275 sites world wide. During Period 2, participants that were part of the lutikizumab treatment arm in Period 1 will be re-randomized to 1 of 2 lutikizumab treatment arms. Participants that were part of the Placebo arm in Period 1 will start Period 2 with an initiation of lutikizumab followed by a re-randomization to 1 of 2 lutikizumab treatment arms.

Read more

In Period 1, participants will receive subcutaneous injections of lutikizumab or placebo every week for 16 weeks. In Period 2, participants that were randomized to lutikizumab in Period 1 will receive subcutaneous injections of lutikizumab every week or every other week for 36-weeks. Participants that were randomized to the placebo arm in Period 1 will receive subcutaneous injections of lutikizumab every week for 16 weeks, then either every week or every other week for 20 weeks.

Period 3 is the Long Term Extentsion (LTE) and through Week 68, participants will continue to receive lutikizumab SC using the same assigned dosing regimen from the end of Period 2 for 16 weeks followed by open-label lutikizumab EOW for 140 weeks.

Participants in the US that complete Periods 1 \& 2 will have the option to enroll in a 156-week open-label Sub-Study that will assess the long term safety and efficacy of lutikizumab in a prefilled pen.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires and diaries.

Being tested
Lutikizumab, Placebo
Medical subject headings
Hidradenitis Suppurativa

What participants receive

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

  • LutikizumabDrug

    Also called ABT-981

    Subcutaneous injection

  • PlaceboDrug

    Subcutaneous injection

Study groups in NCT06468228
Study groupRoleWhat they receive
Period 1ExperimentalParticipants will be randomized to either Lutikizumab Dose B at baseline followed by Lutikizumab Dose A, or a matching placebo dose equivalent for both, every week through Week 16 .
Receives: Drug: Lutikizumab; Drug: Placebo
Period 2: Lutikizumab Every WeekExperimentalParticipants randomized to lutikizumab in Period 1 who complete Week 16 of the study will be re-randomized to lutikizumab Dose A through Week 52
Receives: Drug: Lutikizumab
Period 2: Lutikizumab Every Other WeekExperimentalParticipants randomized to lutikizumab in Period 1 who complete Week 16 of the study will be re-randomized to lutikizumab Dose A every other week though week 52
Receives: Drug: Lutikizumab; Drug: Placebo
Period 2: Placebo to Lutikizumab GroupExperimentalParticipants randomized to Placebo in Period 1 who complete Week 16 of the study will initiate lutikizumab with Dose B followed by Dose A every week.
Receives: Drug: Lutikizumab
Period 2: Placebo to Lutikizumab Group Every WeekExperimentalParticipants that were assigned Placebo in Period 1 and initiated lutikizumab in Period 2 will then be re-randomized to lutikizumab Dose A every week through Week 52
Receives: Drug: Lutikizumab
Period 2: Placebo to Lutikizumab Group Every Other WeekExperimentalThe participants that were assigned Placebo in Period 1 and initiated lutikizumab in Period 2 will then be re-randomized to lutikizumab Dose A every other week through Week 52
Receives: Drug: Lutikizumab; Drug: Placebo
Period 3: Open-label LutikizumabExperimentalStarting at Week 68 in Period 3, all participants will receive Open-label Lutikizumab every other week
Receives: Drug: Lutikizumab
Sub-Study: Lutikizumab Pre-Filled PenExperimentalLutikizumab solution for injection in prefilled pen (EOW) for 60 weeks, followed by lutikizumab solution for injection in prefilled syringes (EOW) for 96 weeks.
Receives: Drug: Lutikizumab

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) 75

    HiSCR 75 is defined as at least a 75% reduction from baseline 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: At 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 participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

    Measured: Up to Approximately Week 62

Secondary outcomes (12)

  1. Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3

    NRS 30 is defined as at least a 30% reduction and at least 1-unit reduction from Baseline in worst skin pain (maximal daily pain), as assessed by the Patient's Global Assessment (PGA) of Skin Pain.

    Measured: At Week 8

  2. Change from Baseline in Dermatology Life Quality Index (DLQI) among participants ≥ 16 years of age at Baseline

    DLQI (Dermatology Life Quality Index) assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 (no effect) to 30 (very large effect), with a higher score indicating a more impaired quality of life.

    Measured: At Week 16

  3. 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: At Week 16

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

    The HSSA (24-hour recall) is a 9-item PRO questionnaire developed to assess the primary symptoms of Hidradenitis Suppurativa (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: At Week 16

  5. Change from Baseline in number of Draining Fistulas Count among participants with at least 1 draining fistula at Baseline

    Measured: At Week 16

  6. Percentage of Participants Achieving HiSCR 90

    HiSCR 90 is defined as at least a 90% reduction from baseline 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: At Week 16

  7. Change from Baseline in the Patient's Global Assessment of HS-related Skin Pain (NRS)

    Measured: At Week 8

  8. Change from Baseline in HSSA

    The HSSA (24-hour recall) is a 9-item PRO questionnaire developed to assess the primary symptoms of Hidradenitis Suppurativa (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: At Week 16

  9. Change from Baseline in the Patient's Global Assessment of HS-related Odor (smell), based on the 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: At Week 16

  10. Percentage of Participants with an Occurrence of HS Flare in Period 1

    HS Flare is 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

  11. Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA) Emotional Domain

    Measured: At Week 16

  12. Change from Baseline in HSIA Mobility Domain

    Measured: at 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 posted21 Jun 2024
  2. Study start27 Jun 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06468228
Sponsor's protocol ID
M20-465
Other IDs
2024-510730-40-00
Acronym
Intrepid
Status last verified
Aug 2026
First submitted
17 Jun 2024
Last updated
2 Sep 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 data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lutikizumab in people with Hidradenitis Suppurativa, run by AbbVie at 279 sites in 44 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 4 inclusion and 3 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 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 279 sites in United States, Canada, Germany, Japan, South Korea and 39 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. 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) 75 (time frame: At 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 NCT06468228.

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 2 Sep 2026.

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