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

Last updated: March 25, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

3

Condition

Hidradenitis Suppurativa

Rosacea

Scalp Disorders

Treatment

Lutikizumab

Placebo

Clinical Study ID

NCT06468228
M20-465
2024-510730-40-00
  • Ages > 16
  • All Genders

Study 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. This study will compare lutikizumab versus placebo for the treatment of adult and adolescent participants with 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.

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

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of moderate to severe HS for at least 6 months prior to Baseline asdetermined by the investigator (i.e., through medical history and interview ofparticipant).

  • Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline

  • Hidradenitis suppurativa (HS) lesions present in at least two distinct anatomicareas at Baseline.

  • At least 1 anatomic area of HS involvement characterized as Hurley Stage II orhigher at Baseline.

Exclusion

Exclusion Criteria:

  • 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

Study Design

Total Participants: 1280
Treatment Group(s): 2
Primary Treatment: Lutikizumab
Phase: 3
Study Start date:
June 27, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Paratus Clinical Research Woden /ID# 263125

    Phillip, Australian Capital Territory 2606
    Australia

    Active - Recruiting

  • Momentum Clinical Research /ID# 263192

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • Premier Dermatology /ID# 263124

    Kogarah, New South Wales 2217
    Australia

    Active - Recruiting

  • Holdsworth House Medical Practice /ID# 263192

    Sydney, New South Wales 2010
    Australia

    Site Not Available

  • Veracity Clinical Research /ID# 263126

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Sinclair Dermatology - Melbourne /ID# 263121

    East Melbourne, Victoria 3002
    Australia

    Active - Recruiting

  • UZ Gent /ID# 263099

    Gent, Oost-Vlaanderen 9000
    Belgium

    Active - Recruiting

  • ASMC-IPSMC-Skin and Venereal Diseases /ID# 262891

    Sofiya, Sofia 1407
    Bulgaria

    Active - Recruiting

  • Medical Center Cordis /ID# 262894

    Pleven, 5800
    Bulgaria

    Active - Recruiting

  • Rejuvenation Dermatology - Edmonton Downtown /ID# 265963

    Edmonton, Alberta T5J 3S9
    Canada

    Active - Recruiting

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

    Kelowna, British Columbia V1W 4V5
    Canada

    Active - Recruiting

  • Brunswick Dermatology Center /ID# 264260

    Fredericton, New Brunswick R3M 3Z4
    Canada

    Active - Recruiting

  • Leader Research /ID# 266114

    Hamilton, Ontario L8L 3C3
    Canada

    Active - Recruiting

  • DermEffects /ID# 265262

    London, Ontario N6H 5L5
    Canada

    Active - Recruiting

  • Derm Care Clinic /ID# 265261

    Mississauga, Ontario L4W 0C2
    Canada

    Active - Recruiting

  • SKiN Centre for Dermatology /ID# 267735

    Peterborough, Ontario K9J 5K2
    Canada

    Active - Recruiting

  • York Dermatology Clinic & Research Centre /ID# 265265

    Richmond Hill, Ontario L4C 9M7
    Canada

    Active - Recruiting

  • FACET Dermatology /ID# 265267

    Toronto, Ontario M4C 1L1
    Canada

    Active - Recruiting

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

    Waterloo, Ontario N2J 1C4
    Canada

    Active - Recruiting

  • Centre de Recherche Saint-Louis /ID# 265855

    Québec, Quebec G1W 4R4
    Canada

    Active - Recruiting

  • Diex Recherche Québec /ID# 265263

    Québec, Quebec G1V 4T3
    Canada

    Active - Recruiting

  • Diex Recherche Québec Inc. /ID# 265263

    Québec, Quebec G1V 4T3
    Canada

    Active - Recruiting

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

    St-Jérôme, Quebec J7Z 7E2
    Canada

    Active - Recruiting

  • SkinSense Dermatology /ID# 265964

    Saskatoon, Saskatchewan S7K 0H6
    Canada

    Active - Recruiting

  • Herlev and Gentofte Hospital /ID# 265839

    Hellerup, Hovedstaden 2900
    Denmark

    Active - Recruiting

  • Universitaetsklinikum Tuebingen /ID# 271718

    Tübingen, Baden-Wuerttemberg 72076
    Germany

    Active - Recruiting

  • Beldio Research GmbH /ID# 263074

    Memmingen, Bayern 87700
    Germany

    Active - Recruiting

  • General Hospital Andreas Syggros /ID# 263417

    Athens, Attiki 16121
    Greece

    Active - Recruiting

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

    Thessaloniki, 54643
    Greece

    Active - Recruiting

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

    Drogheda, Louth A92 VW28
    Ireland

    Active - Recruiting

  • Mater Misericordiae University Hospital /ID# 265914

    Dublin, D07 R2WY
    Ireland

    Active - Recruiting

  • University College Dublin /ID# 265875

    Dublin, D07 A8NN
    Ireland

    Active - Recruiting

  • HaEmek Medical Center /ID# 267297

    Afula, H_efa 1834111
    Israel

    Active - Recruiting

  • Rambam Health Care Campus /ID# 262994

    Haifa, H_efa 3525408
    Israel

    Active - Recruiting

  • Rabin Medical Center /ID# 262992

    Petah Tikva, HaMerkaz 4941492
    Israel

    Active - Recruiting

  • Galilee Medical Center /ID# 262995

    Naharia, HaTsafon 2210001
    Israel

    Active - Recruiting

  • The Chaim Sheba Medical Center /ID# 262993

    Ramat Gan, Tel-Aviv 5265601
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center /ID# 266581

    Tel Aviv, Tel-Aviv 6423906
    Israel

    Active - Recruiting

  • Hadassah Medical Center-Hebrew University /ID# 262884

    Jerusalem, 91120
    Israel

    Active - Recruiting

  • Nagoya City University Hospital /ID# 263874

    Nagoya, Aichi 467-8602
    Japan

    Active - Recruiting

  • Fujita Health University Hospital /ID# 265440

    Toyoake, Aichi 470-1192
    Japan

    Active - Recruiting

  • Takagi Dermatological Clinic /ID# 264810

    Obihiro-Shi, Hokkaido 080-0013
    Japan

    Completed

  • Kyoto Prefectural University of Medicine /ID# 264291

    Kyoto-shi, Kyoto 602-8566
    Japan

    Active - Recruiting

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

    Kyoto-shi, Kyoto 602-8566
    Japan

    Active - Recruiting

  • University of the Ryukyus Hospital /ID# 264605

    Ginowan-shi, Okinawa 901-2725
    Japan

    Active - Recruiting

  • University of the Ryukyus Hospital /ID# 264605

    Nishihara, Okinawa 903-0215
    Japan

    Site Not Available

  • Osaka Metropolitan University Hospital /ID# 265682

    Osaka-shi, Osaka 545-8586
    Japan

    Active - Recruiting

  • Kindai University Hospital /ID# 264322

    Osakasayama-shi, Osaka 589-8511
    Japan

    Active - Recruiting

  • Dokkyo Medical University Saitama Medical Center /ID# 265400

    Koshigaya, Saitama 343-0845
    Japan

    Active - Recruiting

  • Fukuoka University Hospital /ID# 263991

    Fukuoka, 814-0180
    Japan

    Active - Recruiting

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

    Kyoto, 602-8566
    Japan

    Site Not Available

  • Nihon University Itabashi Hospital /ID# 264661

    Tokyo, 173-8610
    Japan

    Active - Recruiting

  • Korea University Ansan Hospital /ID# 264227

    Ansan-si, Gyeonggido 15355
    Korea, Republic of

    Active - Recruiting

  • CHA Bundang Medical Center /ID# 264225

    Seongnam, Gyeonggido 13496
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center /ID# 264228

    Seoul, Seoul Teugbyeolsi 05505
    Korea, Republic of

    Active - Recruiting

  • Hallym University Kangnam Sacred Heart Hospital /ID# 264226

    Seoul, Seoul Teugbyeolsi 07441
    Korea, Republic of

    Active - Recruiting

  • SoonChunHyang University Seoul Hospital /ID# 264224

    Seoul, Seoul Teugbyeolsi 04401
    Korea, Republic of

    Active - Recruiting

  • Clinical Trials New Zealand /ID# 265432

    Hamilton, Waikato 3204
    New Zealand

    Active - Recruiting

  • Greenlane Clinical Centre /ID# 263191

    Auckland, 1051
    New Zealand

    Active - Recruiting

  • Stavanger Universitetssykehus /ID# 265997

    Stavanger, Rogaland 4068
    Norway

    Active - Recruiting

  • Universitetssykehuset I Nord-Norge /ID# 265992

    Tromsø, Troms 9019
    Norway

    Active - Recruiting

  • Oslo University Hospital - Rikshospitalet /ID# 265996

    Oslo, 0372
    Norway

    Active - Recruiting

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

    Guimaraes, Braga 4835-044
    Portugal

    Active - Recruiting

  • CUF Descobertas Hospital /ID# 263188

    Lisbon, Lisboa 1998-018
    Portugal

    Active - Recruiting

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

    Lisboa, 1150-199
    Portugal

    Active - Recruiting

  • Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 265479

    Porto, 4099-003
    Portugal

    Active - Recruiting

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

    Carolina, 00985
    Puerto Rico

    Active - Recruiting

  • Clinical Research Puerto Rico /ID# 263450

    San Juan, 00909-1711
    Puerto Rico

    Active - Recruiting

  • Military Medical Academy /ID# 263257

    Belgrade, Beograd 11000
    Serbia

    Active - Recruiting

  • University Clinical Center Serbia /ID# 263256

    Belgrade, Beograd 11000
    Serbia

    Active - Recruiting

  • University Clinical Center Kragujevac /ID# 264211

    Kragujevac, Sumadijski Okrug 34000
    Serbia

    Active - Recruiting

  • University Clinical Center Vojvodina /ID# 263260

    Novi Sad, 21000
    Serbia

    Active - Recruiting

  • Fakultna nemocnica s poliklinikou Nove Zamky /ID# 265944

    Nové Zámky, Nitriansky Kraj 940 34
    Slovakia

    Active - Recruiting

  • University Medical Centre Ljubljana /ID# 265720

    Ljubljana, 1000
    Slovenia

    Active - Recruiting

  • University Medical Centre Maribor /ID# 265827

    Maribor, 2000
    Slovenia

    Active - Recruiting

  • Global Clinical Trials /ID# 262839

    Pretoria, Gauteng 0157
    South Africa

    Active - Recruiting

  • Life Chatsmed Garden Hospital /ID# 270237

    Chatsworth, Kwazulu-Natal 4092
    South Africa

    Active - Recruiting

  • Ahmed Al-Kadi Private Hospital /ID# 262837

    Durban, Kwazulu-Natal 4091
    South Africa

    Active - Recruiting

  • Dr Ahmed Ismail Manjra /ID# 262838

    Westville, Kwazulu-Natal 3629
    South Africa

    Active - Recruiting

  • Hospital Universitari Parc Tauli /ID# 262942

    Sabadell, Barcelona 08208
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañón /ID# 262940

    Madrid, 28007
    Spain

    Active - Recruiting

  • Consorci Hospital General Universitario de Valencia /ID# 262944

    Valencia, 46014
    Spain

    Active - Recruiting

  • Universitetssjukhuset Örebro /ID# 265064

    Örebro, 701 85
    Sweden

    Active - Recruiting

  • Dermatology & Skin Care Clinic /ID# 264030

    Buochs, Nidwalden 6374
    Switzerland

    Active - Recruiting

  • Kantonsspital St.Gallen /ID# 264238

    St. Gallen, Sankt Gallen 9007
    Switzerland

    Active - Recruiting

  • University Hospital Zurich /ID# 266142

    Zurich, Zuerich 8006
    Switzerland

    Active - Recruiting

  • Kaohsiung Chang Gung Memorial Hospital /ID# 264619

    Kaohsiung City, Kaohsiung 833
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital /ID# 264618

    Taipei City, Taipei 100
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital /ID# 270741

    Taichung, 407
    Taiwan

    Active - Recruiting

  • Mackay Memorial Hospital /ID# 263661

    Taipei City, 104
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital /ID# 265879

    Taipei City, 112
    Taiwan

    Active - Recruiting

  • Linkou Chang Gung Memorial Hospital /ID# 264620

    Taoyuan City, 333
    Taiwan

    Active - Recruiting

  • Barts Health NHS Trust /ID# 264121

    London, Greater London E1 2ES
    United Kingdom

    Active - Recruiting

  • Cahaba Dermatology & Skin Health Center /ID# 263795

    Birmingham, Alabama 35244
    United States

    Active - Recruiting

  • Medical Dermatology Specialists /ID# 263394

    Phoenix, Arizona 85006
    United States

    Active - Recruiting

  • Dermatology Trial Associates /ID# 264587

    Bryant, Arkansas 72022
    United States

    Active - Recruiting

  • Arkansas Research Trials /ID# 263901

    North Little Rock, Arkansas 72217
    United States

    Active - Recruiting

  • Joseph Raoof Md,Inc /Id# 263756

    Encino, California 91436
    United States

    Active - Recruiting

  • Dermatology Research Associates - Los Angeles /ID# 263765

    Los Angeles, California 90045
    United States

    Active - Recruiting

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

    Redwood City, California 94063-3132
    United States

    Active - Recruiting

  • Integrative Skin Science and Research /ID# 264600

    Sacramento, California 95815
    United States

    Active - Recruiting

  • Clinical Trials Research Institute /ID# 263743

    Thousand Oaks, California 91320
    United States

    Active - Recruiting

  • Clearlyderm Dermatology - West Boca /ID# 265023

    Boca Raton, Florida 33428
    United States

    Active - Recruiting

  • Apex Clinical Trials /ID# 263815

    Brandon, Florida 33511
    United States

    Active - Recruiting

  • TrueBlue Clinical Research /ID# 265041

    Brandon, Florida 33511
    United States

    Active - Recruiting

  • Skin Care Research - Hollywood /ID# 263805

    Hollywood, Florida 33021-6748
    United States

    Active - Recruiting

  • GSI Clinical Research, LLC /ID# 263827

    Margate, Florida 33063-7011
    United States

    Active - Recruiting

  • Ziaderm Research LLC /ID# 263511

    Miami, Florida 33162
    United States

    Active - Recruiting

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

    Ocala, Florida 34470
    United States

    Active - Recruiting

  • Advanced Clinical Research Institute /ID# 263808

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Alliance Clinical Research of Tampa /ID# 264594

    Tampa, Florida 33615
    United States

    Active - Recruiting

  • Skin Care Research - Tampa /ID# 263819

    Tampa, Florida 33607-6438
    United States

    Active - Recruiting

  • Centricity Research Columbus Dermatology /ID# 266530

    Columbus, Georgia 31904
    United States

    Active - Recruiting

  • Cleaver Medical Group Dermatology /ID# 263845

    Dawsonville, Georgia 30534
    United States

    Active - Recruiting

  • Treasure Valley Medical Research /ID# 263671

    Boise, Idaho 83706
    United States

    Active - Recruiting

  • Northwestern University Feinberg School of Medicine /ID# 265007

    Chicago, Illinois 60611-2927
    United States

    Active - Recruiting

  • Arlington Dermatology /ID# 263410

    Rolling Meadows, Illinois 60008
    United States

    Active - Recruiting

  • Dawes Fretzin, LLC /ID# 264601

    Indianapolis, Indiana 46256
    United States

    Active - Recruiting

  • Dermatology Partners of Leawood /ID# 263533

    Leawood, Kansas 66211
    United States

    Active - Recruiting

  • Equity Medical, LLC /ID# 268590

    Bowling Green, Kentucky 42104
    United States

    Active - Recruiting

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

    Louisville, Kentucky 40241
    United States

    Active - Recruiting

  • Hamzavi Dermatology - Canton /ID# 263538

    Canton, Michigan 48187
    United States

    Active - Recruiting

  • Michigan Center for Medical Research /ID# 263547

    Clarkston, Michigan 48346
    United States

    Active - Recruiting

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

    Lee's Summit, Missouri 64064-2301
    United States

    Active - Recruiting

  • MediSearch Clinical Trials /ID# 263582

    Saint Joseph, Missouri 64506
    United States

    Active - Recruiting

  • Vivida Dermatology- Flamingo /ID# 263716

    Las Vegas, Nevada 89119-5190
    United States

    Active - Recruiting

  • ActivMed Practice and Research, LLC /ID# 263387

    Portsmouth, New Hampshire 03801
    United States

    Active - Recruiting

  • ActivMed Practices & Research - Portsmouth /ID# 263387

    Portsmouth, New Hampshire 03801
    United States

    Active - Recruiting

  • Mount Sinai Doctors - Dermatology /ID# 264602

    New York, New York 10028
    United States

    Active - Recruiting

  • Atrium Health Wake Forest Baptist Medical Center /ID# 264507

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Dermatology of Greater Columbus /ID# 263497

    Bexley, Ohio 43209
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center /ID# 263600

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Ohio State Officenter Gahanna /ID# 263598

    Gahanna, Ohio 43230
    United States

    Active - Recruiting

  • Dermatologists of Southwest Ohio - Mason /ID# 263588

    Mason, Ohio 45040
    United States

    Active - Recruiting

  • Apex Clinical Research Center /ID# 272787

    Mayfield Heights, Ohio 44124
    United States

    Active - Recruiting

  • Dermatology Partners /ID# 264999

    Philadelphia, Pennsylvania 19114
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center /ID# 264590

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Clinical Research Center of the Carolinas /ID# 263407

    Charleston, South Carolina 29407
    United States

    Active - Recruiting

  • Medical University of South Carolina /ID# 263890

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • ADCS - Spartanburg /ID# 267207

    Spartanburg, South Carolina 29307
    United States

    Active - Recruiting

  • Arlington Research Center, Inc /ID# 263895

    Arlington, Texas 76011
    United States

    Active - Recruiting

  • Bellaire Dermatology Associates /ID# 263850

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Studies in Dermatology LLC /ID# 263399

    Cypress, Texas 77429
    United States

    Active - Recruiting

  • Reveal Research Institute, Dallas /ID# 267233

    Dallas, Texas 75235-2519
    United States

    Active - Recruiting

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

    Houston, Texas 77004
    United States

    Active - Recruiting

  • Texas Dermatology Research Center /ID# 264488

    Plano, Texas 75025
    United States

    Active - Recruiting

  • Texas Dermatology and Laser Specialists /ID# 263778

    San Antonio, Texas 78218
    United States

    Active - Recruiting

  • Dermatology Associates of Tyler /ID# 265002

    Tyler, Texas 75703
    United States

    Active - Recruiting

  • University of Utah /ID# 263818

    Murray, Utah 84107
    United States

    Active - Recruiting

  • Virginia Clinical Research /ID# 264553

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

  • Virginia Clinical Research, Inc. /ID# 264553

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • Dermatology Specialists of Spokane /ID# 264499

    Spokane, Washington 99202
    United States

    Active - Recruiting

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