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

June 1, 2026 updated by: AbbVie

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1400

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1055
        • Buenos Aires Skin /ID# 264299
    • Buenos Aires F.D.
      • Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1428
        • Consultorios Reumatologicos Pampa /ID# 265911
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, 5000
        • Instituto De Investigaciones Clínicas Córdoba /ID# 264297
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Instituto de Especialidades de la Salud Rosario - Clinica del Torax /ID# 266132
  • Australia
    • Australian Capital Territory
      • Phillip, Australian Capital Territory, Australia, 2606
        • Paratus Clinical Research Woden /ID# 263125
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Momentum Clinical Research /ID# 263192
      • Kogarah, New South Wales, Australia, 2217
        • Premier Dermatology - Kogarah /ID# 263124
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Veracity Clinical Research /ID# 263126
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Sinclair Dermatology - Melbourne /ID# 263121
  • Austria
      • Vienna, Austria, 1090
        • Medizinische Universitaet Wien /ID# 264043
    • Styria
      • Graz, Styria, Austria, 8010
        • Medizinische Universitaet Graz /ID# 263306
  • Belgium
      • Liège, Belgium, 4000
        • CHU de Liege /ID# 263095
    • Brussels Capital
      • Anderlecht, Brussels Capital, Belgium, 1070
        • Universite Libre de Bruxelles - Hopital Erasme /ID# 263097
      • Brussels, Brussels Capital, Belgium, 1200
        • Cliniques Universitaires UCL Saint-Luc /ID# 263096
      • Jette, Brussels Capital, Belgium, 1090
        • Universitair Ziekenhuis Brussel /ID# 263101
    • Hainaut
      • Charleroi, Hainaut, Belgium, 6280
        • Grand Hopital de Charleroi - Les Viviers /ID# 263100
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent /ID# 263099
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Universitair Ziekenhuis Leuven /ID# 263098
  • Bosnia and Herzegovina
    • Federation of Bosnia and Herzegovina
      • Sarajevo, Federation of Bosnia and Herzegovina, Bosnia and Herzegovina, 71000
        • Clinical Center University of Sarajevo - Bolnicka /ID# 265908
      • Tuzla, Federation of Bosnia and Herzegovina, Bosnia and Herzegovina, 75000
        • University Clinical Center Tuzla /ID# 265906
    • Republika Srpska
      • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
        • University Clinical Centre of the Republic of Srpska /ID# 265905
      • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
        • University Clinical Centre of the Republic of Srpska /ID# 265909
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Medical Center Cordis /ID# 262894
      • Stara Zagora, Bulgaria, 6000
        • UMHAT Professor Stoyan Kirkovich /ID# 262892
    • Sofia
      • Sofiya, Sofia, Bulgaria, 1407
        • Acibadem City Clinic Tokuda Hospital /ID# 263300
      • Sofiya, Sofia, Bulgaria, 1407
        • Ambulatory for Specialized Medical Care-IPSMC-skin and venereal diseases /ID# 262891
      • Sofiya, Sofia, Bulgaria, 1463
        • Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 262893
      • Sofiya, Sofia, Bulgaria, 1510
        • Medical Center Hera EOOD /ID# 263010
  • Canada
      • Québec, Canada, G1V 4T3
        • Diex Recherche Quebec Inc. /ID# 265263
    • Alberta
      • Calgary, Alberta, Canada, T3A 2N1
        • Beacon Dermatology Inc /ID# 264262
      • Edmonton, Alberta, Canada, T5J 3S9
        • Rejuvenation Dermatology - Edmonton Downtown /ID# 265963
      • Edmonton, Alberta, Canada, T5K 1X3
        • Stratica Dermatology /ID# 265856
    • British Columbia
      • Kelowna, British Columbia, Canada, V1W 4V5
        • Interior Dermatology Centre - Probity - PPDS /ID# 266202
    • New Brunswick
      • Fredericton, New Brunswick, Canada, R3M 3Z4
        • Brunswick Dermatology Center /ID# 264260
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
        • Karma Clinical Trials /ID# 265962
    • Ontario
      • Cobourg, Ontario, Canada, K9A 0Z4
        • Skin Health /ID# 267735
      • Hamilton, Ontario, Canada, L8L 3C3
        • Leader Research /ID# 266114
      • London, Ontario, Canada, N6H 5L5
        • DermEffects /ID# 265262
      • Mississauga, Ontario, Canada, L4W 0C2
        • Derm Care Clinic /ID# 265261
      • Richmond Hill, Ontario, Canada, L4C 9M7
        • York Dermatology Clinic & Research Centre /ID# 265265
      • Toronto, Ontario, Canada, M4C 1L1
        • FACET Dermatology /ID# 265267
      • Waterloo, Ontario, Canada, N2J 1C4
        • Private Practice - Dr. Kim Papp Clinical Research /ID# 265266
    • Quebec
      • Québec, Quebec, Canada, G1W 4R4
        • Centre de Recherche Saint-Louis /ID# 265855
      • Saint-Jérôme, Quebec, Canada, J7Z 7E2
        • Private Practice - Dr. Angelique Gagne-Henley /ID# 264263
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
        • SkinSense Dermatology /ID# 265964
  • Chile
    • Region Metropolitana Santiago
      • Santiago, Region Metropolitana Santiago, Chile, 8420383
        • Centro Internacional de Estudios Clinicos - CIEC /ID# 266129
      • Vitacura, Region Metropolitana Santiago, Chile, 7640881
        • Clinica Dermacross /ID# 266127
    • Santiago Metropolitan
      • Independencia, Santiago Metropolitan, Chile, 8380465
        • Fundacion Innovacion Cardiovascular /ID# 264844
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050012
        • Centro de Inmunología y Genética CIGE SAS /ID# 263793
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 80002
        • Centro Integral de Reumatología del Caribe SAS - Circaribe SAS /ID# 265089
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia, 110221
        • Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 265093
      • Zipaquirá, Cundinamarca, Colombia, 250252
        • Healthy Medical Center S.A.S /ID# 265091
  • Croatia
    • City of Zagreb
      • Grad Zagreb, City of Zagreb, Croatia, 10000
        • Klinicki Bolnicki Centar Zagreb /ID# 263989
      • Zagreb, City of Zagreb, Croatia, 10000
        • Klinicki Bolnicki Centar Sestre Milosrdnice /ID# 265069
    • County of Osijek-Baranja
      • Osijek, County of Osijek-Baranja, Croatia, 31000
        • Klinicki bolnicki centar Osijek /ID# 265916
    • Primorje-Gorski Kotar County
      • Rijeka, Primorje-Gorski Kotar County, Croatia, 51000
        • Specialty Hospital Medico /ID# 263922
  • Czechia
      • Karlovy Vary, Czechia, 360 01
        • Karlovarska Krajska Nemocnice - Karlovy Vary /ID# 265354
      • Prague, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady /ID# 264040
    • Ostrava-mesto
      • Ostrava, Ostrava-mesto, Czechia, 708 52
        • Fakultni nemocnice Ostrava /ID# 264041
  • Denmark
    • Capital Region
      • Hellerup, Capital Region, Denmark, 2900
        • Herlev and Gentofte Hospital /ID# 265839
    • Central Jutland
      • Aarhus, Central Jutland, Denmark, 8200
        • Aarhus Universitetshospital - Skejby /ID# 265657
    • Region Sjælland
      • Roskilde, Region Sjælland, Denmark, 4000
        • Roskilde Sygehus /ID# 274895
  • France
      • Paris, France, 75014
        • Groupe Hospitalier Paris Saint-Joseph /ID# 263996
      • Reims, France, 51100
        • Polyclinique Courlancy /ID# 263313
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, France, 69003
        • Hopital Edouard Herriot /ID# 263456
    • Pays de la Loire Region
      • St-Priest-en-Jarez, Pays de la Loire Region, France, 42270
        • Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 263459
    • Provence-Alpes-Côte d'Azur Region
      • Martigues, Provence-Alpes-Côte d'Azur Region, France, 13500
        • Cabinet medical - Le bateau Blanc /ID# 263465
    • Seine-Maritime
      • Rouen, Seine-Maritime, France, 76031
        • Centre Hospitalier Universitaire de Rouen (CHU)- Hopital Charles Nicolle /ID# 263995
  • Germany
      • Berlin, Germany, 10117
        • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 263076
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
        • Universitaetsklinikum Freiburg /ID# 263659
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Universitaetsklinikum Tuebingen /ID# 271718
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Universitaetsklinikum Erlangen /ID# 263075
      • Memmingen, Bavaria, Germany, 87700
        • Beldio Research GmbH /ID# 263074
    • Hesse
      • Darmstadt, Hesse, Germany, 64283
        • Rosenpark Research /ID# 269202
    • Lower Saxony
      • Bad Bentheim, Lower Saxony, Germany, 48455
        • Fachklinik - Bad Bentheim /ID# 263067
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany, 18057
        • Universitaetsmedizin Rostock /ID# 278301
    • North Rhine-Westphalia
      • Bochum, North Rhine-Westphalia, Germany, 44805
        • Katholisches Klinikum Bochum /ID# 262976
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Universitaetsklinikum Muenster /ID# 263068
      • Remscheid, North Rhine-Westphalia, Germany, 42897
        • Hautarztpraxis Mortazawi /ID# 271673
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55116
        • Hautarztpraxis Dr. Kirschner /ID# 263656
    • Saarland
      • Merzig, Saarland, Germany, 66663
        • HMS GmbH Zimmer /ID# 278634
  • Greece
      • Thessaloniki, Greece, 54643
        • Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 263416
      • Thessaloniki, Greece, 56429
        • Papageorgiou General Hospital /ID# 263415
    • Attica
      • Athens, Attica, Greece, 12462
        • University General Hospital Attikon /ID# 263413
      • Athens, Attica, Greece, 16121
        • General Hospital Andreas Syggros /ID# 263417
  • Guatemala
      • Guatemala City, Guatemala, 01015
        • Dermos S.A. /ID# 265857
      • Guatemala City, Guatemala, Zona 1
        • Prosalud /Id# 266586
  • Hungary
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem /ID# 263451
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem /ID# 263423
    • Baranya
      • Pécs, Baranya, Hungary, 7632
        • Pecsi Tudomanyegyetem /ID# 264120
    • Somogy County
      • Kaposvár, Somogy County, Hungary, 7400
        • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 263424
  • Ireland
      • Cork, Ireland, T12 X23H
        • South Infirmary Victoria University Hospital /ID# 265872
      • Dublin, Ireland, D07 A8NN
        • University College Dublin /ID# 265875
      • Dublin, Ireland, D07 R2WY
        • Mater Misericordiae University Hospital /ID# 265914
    • Louth
      • Drogheda, Louth, Ireland, A92 VW28
        • Our Lady of Lourdes Hospital - Drogheda /ID# 265893
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus- Haifa /ID# 262994
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center-Hebrew University /ID# 262884
    • Central District
      • Petah Tikva, Central District, Israel, 4941492
        • Rabin Medical Center /ID# 262992
    • Haifa District
      • Afula, Haifa District, Israel, 1834111
        • HaEmek Medical Center /ID# 267297
    • Northern District
      • Nahariya, Northern District, Israel, 2210001
        • Galilee Medical Center /ID# 262995
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israel, 5265601
        • The Chaim Sheba Medical Center /ID# 262993
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center /ID# 266581
  • Italy
      • Catania, Italy, 95123
        • AOU Policlinico G. Rodolico - San Marco /ID# 263469
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 263471
    • Ferrara
      • Cona, Ferrara, Italy, 44124
        • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale S.Anna /ID# 263474
    • Firenze
      • Florence, Firenze, Italy, 50122
        • AZIENDA USL TOSCANA CENTRO - Ospedale Piero Palagi /ID# 263454
    • Lombardy
      • Rozzano, Lombardy, Italy, 20089
        • IRCCS Istituto Clinico Humanitas /ID# 263503
    • Napoli
      • Naples, Napoli, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico II - Naples /ID# 263539
    • Roma
      • Rome, Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 263473
  • Japan
      • Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital /ID# 263991
      • Tokyo, Japan, 173-8610
        • Nihon University Itabashi Hospital /ID# 264661
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Nagoya City University Hospital /ID# 263874
      • Toyoake, Aichi-ken, Japan, 470-1192
        • Fujita Health University Hospital /ID# 265440
    • Hokkaido
      • Obihiro-Shi, Hokkaido, Japan, 080-0013
        • Takagi Dermatological Clinic /ID# 264810
    • Iwate
      • Shiwa-gun, Iwate, Japan, 028-3695
        • Iwate Medical University Hospital /ID# 273799
    • Kyoto
      • Kyoto, Kyoto, Japan, 602-8566
        • University Hospital Kyoto Prefectural University of Medicine /ID# 264291
    • Niigata
      • Niigata, Niigata, Japan, 951-8520
        • Niigata University Medical and Dental Hospital /ID# 276568
    • Okinawa
      • Ginowan-shi, Okinawa, Japan, 901-2725
        • University of the Ryukyus Hospital /ID# 264605
    • Osaka
      • Osaka, Osaka, Japan, 545-8586
        • Osaka Metropolitan University Hospital /ID# 265682
      • Sakai-shi, Osaka, Japan, 590-0197
        • Kindai University Hospital /ID# 264322
    • Saitama
      • Koshigaya, Saitama, Japan, 343-0845
        • Dokkyo Medical University Saitama Medical Center /ID# 265400
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 277709
      • Vilnius, Lithuania, 08661
        • Vilnius University Hospital Santaros Klinikos /ID# 277707
  • Mexico
      • Veracruz, Mexico, 91900
        • Sociedad de Metabolismo y Corazon S.C. /ID# 265915
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44638
        • Grupo Clinico CATEI S C /ID# 265276
    • Mexico City
      • Mexico City, Mexico City, Mexico, 06100
        • Cryptex Investigacion Clinica /ID# 265271
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64718
        • Eukarya PharmaSite /ID# 265307
  • Netherlands
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015 CE
        • Erasmus Medisch Centrum /ID# 263377
  • New Zealand
    • Auckland
      • Epsom, Auckland, New Zealand, 1051
        • Greenlane Clinical Centre /ID# 263191
    • Waikato Region
      • Hamilton, Waikato Region, New Zealand, 3204
        • Clinical Trials New Zealand /ID# 265432
  • Norway
      • Oslo, Norway, 0372
        • Oslo University Hospital - Rikshospitalet /ID# 265996
    • Rogaland
      • Stavanger, Rogaland, Norway, 4068
        • Stavanger Universitetssykehus /ID# 265997
    • Troms
      • Tromsø, Troms, Norway, 9019
        • Universitetssykehuset I Nord-Norge /ID# 265992
  • Poland
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-631
        • Oftalmika sp. z o.o. /ID# 263087
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-002
        • Specjalistyczny gabinet dermatologiczny Aplikacyjno-Badawczy Marek Brzewski, Paw /ID# 277221
      • Krakow, Lesser Poland Voivodeship, Poland, 31-011
        • Centrum Nowoczesnych Terapii Dobry Lekarz sp.z.o.o. /ID# 263146
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-507
        • Panstwowy Instytut Medyczny Mswia /Id# 277307
      • Warsaw, Masovian Voivodeship, Poland, 02-953
        • Klinika Ambroziak Dermatologia /ID# 263173
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-615
        • Centrum Medyczne Angelius Provita /ID# 277204
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 90-265
        • DERMED Centrum Medyczne Sp. z o.o /ID# 263147
      • Lodz, Łódź Voivodeship, Poland, 90-302
        • Santa Sp. z o..o. Santa Familia PTG Lodz /ID# 263181
  • Portugal
      • Lisbon, Portugal, 1150-199
        • Unidade Local de Saude de Sao Jose, EPE /ID# 265155
      • Porto, Portugal, 4099-003
        • Unidade Local de Saude de Santo Antonio /ID# 265479
    • Braga District
      • Guimarães, Braga District, Portugal, 4835-044
        • Unidade Local de Saude do Alto Ave, EPE /ID# 265158
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1998-018
        • CUF Descobertas Hospital /ID# 263188
  • Puerto Rico
      • Carolina, Puerto Rico, 00985
        • Private Practice - Dr. Alma Cruz /ID# 263204
      • San Juan, Puerto Rico, 00909-1711
        • Clinical Research Puerto Rico /ID# 263450
  • Romania
      • Bucharest, Romania, 020762
        • Centrul Medical Euromed /ID# 263304
    • Bucharest
      • Bucharest, Bucharest, Romania, 020125
        • Spitalul Clinic Colentina /ID# 263303
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400006
        • Private Practice - Dr. Orasan Remus /ID# 263305
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 12372
        • King Saud University Med City /ID# 266120
    • Mecca Region
      • Jeddah, Mecca Region, Saudi Arabia, 22384
        • King Abdulaziz Medical City /ID# 266121
  • Serbia
      • Novi Sad, Serbia, 21000
        • University Clinical Center Vojvodina /ID# 263260
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Military Medical Academy /ID# 263257
      • Belgrade, Beograd, Serbia, 11000
        • University Clinical Center Serbia /ID# 263256
    • Sumadijski Okrug
      • Kragujevac, Sumadijski Okrug, Serbia, 34000
        • University Clinical Center Kragujevac /ID# 264211
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital /ID# 264673
      • Singapore, Singapore, 308205
        • National Skin Centre /ID# 264680
  • Slovakia
      • Trnava, Slovakia, 917 02
        • Fakultna nemocnica Trnava /ID# 263905
    • Bratislava Region
      • Bratislava, Bratislava Region, Slovakia, 811 09
        • Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 263921
    • Košice Region
      • Košice, Košice Region, Slovakia, 040 11
        • Detska Fakultna Nemocnica Kosice /ID# 263907
    • Nitra Region
      • Nové Zámky, Nitra Region, Slovakia, 940 34
        • Fakultna nemocnica s poliklinikou Nove Zamky /ID# 265944
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Medical Centre Ljubljana /ID# 265720
      • Maribor, Slovenia, 2000
        • University Medical Centre Maribor /ID# 265827
  • South Africa
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0157
        • Global Clinical Trials /ID# 262839
    • KwaZulu-Natal
      • Chatsworth, KwaZulu-Natal, South Africa, 4092
        • Life Chatsmed Garden Hospital /ID# 270237
      • Durban, KwaZulu-Natal, South Africa, 4091
        • Ahmed Al-Kadi Private Hospital /ID# 262837
      • Westville, KwaZulu-Natal, South Africa, 3629
        • Dr Ahmed Ismail Manjra /ID# 262838
  • South Korea
      • Seoul, South Korea, 03312
        • The Catholic University Of Korea, Eunpyeong St. Mary'S Hospital /ID# 271348
    • Busan Gwang Yeogsi
      • Busan, Busan Gwang Yeogsi, South Korea, 49241
        • Pusan National University Hospital /ID# 271496
    • Chungcheongnam-do
      • Cheonan-si, Chungcheongnam-do, South Korea, 31151
        • SoonChunHyang University Hospital Cheonan /ID# 271320
    • Gyeonggido
      • Ansan-si, Gyeonggido, South Korea, 15355
        • Korea University Ansan Hospital /ID# 264227
      • Seongnam, Gyeonggido, South Korea, 13496
        • CHA Bundang Medical Center /ID# 264225
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 03722
        • Yonsei University Health System Severance Hospital /ID# 271353
      • Seoul, Seoul Teugbyeolsi, South Korea, 04401
        • SoonChunHyang University Seoul Hospital /ID# 264224
      • Seoul, Seoul Teugbyeolsi, South Korea, 05505
        • Asan Medical Center /ID# 264228
      • Seoul, Seoul Teugbyeolsi, South Korea, 07441
        • Hallym University Kangnam Sacred Heart Hospital /ID# 264226
  • Spain
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon /ID# 262940
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria /ID# 262941
      • Valencia, Spain, 46014
        • Consorci Hospital General Universitario de Valencia /ID# 262944
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Hospital Universitari Parc Tauli /ID# 262942
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla /ID# 263039
    • Valencia
      • Manises, Valencia, Spain, 46940
        • Hospital de Manises /ID# 262938
  • Sweden
    • Stockholm County
      • Solna, Stockholm County, Sweden, 171 64
        • Karolinska University Hospital Solna /ID# 264530
    • Örebro County
      • Örebro, Örebro County, Sweden, 701 85
        • Universitetssjukhuset Orebro /ID# 265064
  • Switzerland
    • Canton of Basel-City
      • Basel Town, Canton of Basel-City, Switzerland, 4031
        • University Hospital Basel /ID# 264245
    • Canton of Nidwalden
      • Buochs, Canton of Nidwalden, Switzerland, 6374
        • Dermatology & Skin Care Clinic /ID# 264030
    • Canton of St. Gallen
      • Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
        • Kantonsspital St.Gallen /ID# 264238
    • Canton of Zurich
      • Zurich, Canton of Zurich, Switzerland, 8091
        • University Hospital Zurich /ID# 266142
  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Kaohsiung Chang Gung Memorial Hospital /ID# 264619
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital /ID# 270741
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital /ID# 264618
      • Taipei, Taiwan, 104
        • Mackay Memorial Hospital /ID# 263661
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital /ID# 265879
      • Taoyuan City, Taiwan, 333
        • Linkou Chang Gung Memorial Hospital /ID# 264620
  • Turkey (Türkiye)
      • Gaziantep, Turkey (Türkiye), 27310
        • Gaziantep Universitesi /ID# 263048
    • Denizli
      • Chonai, Denizli, Turkey (Türkiye), 20330
        • Pamukkale University Medical Faculty Hospital /ID# 264734
    • Kayseri
      • Melikgazi, Kayseri, Turkey (Türkiye), 38170
        • Erciyes Üniversitesi Tip Fakültesi /ID# 263050
  • United Kingdom
      • Bristol, United Kingdom, BS2 8HW
        • Bristol Royal Infirmary /ID# 263937
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary /ID# 273368
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LQ
        • Royal Cornwall Hospital /ID# 277507
    • Fife
      • Dunfermline, Fife, United Kingdom, KY12 0SU
        • Queen Margaret Hospital /ID# 264198
    • Gloucestershire
      • Gloucester, Gloucestershire, United Kingdom, GL1 3NN
        • Gloucestershire Royal Hospital /ID# 265848
    • Greater London
      • London, Greater London, United Kingdom, E1 2ES
        • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 264121
    • North Yorkshire
      • Harrogate, North Yorkshire, United Kingdom, HG2 7SX
        • Harrogate District Hospital /ID# 265632
    • West Sussex
      • Shoreham-by-Sea, West Sussex, United Kingdom, BN43 6TQ
        • Southlands Hospital /ID# 276976
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Cahaba Dermatology & Skin Health Center /ID# 263795
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Medical Dermatology Specialists /ID# 263394
      • Tucson, Arizona, United States, 85718-1407
        • Banner University Medicine Dermatology /ID# 263557
    • Arkansas
      • Bryant, Arkansas, United States, 72022
        • Dermatology Trial Associates /ID# 264587
      • North Little Rock, Arkansas, United States, 72217
        • Arkansas Research Trials /ID# 263901
    • California
      • Encino, California, United States, 91436
        • Private Practice - Dr. Tooraj Raoof /ID# 263756
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates - Los Angeles /ID# 263765
      • Redwood City, California, United States, 94063
        • Stanford University School of Medicine - Redwood City /ID# 263711
      • Rocklin, California, United States, 95765
        • Norcal Clinical Research /ID# 279008
      • Sacramento, California, United States, 95815
        • Integrative Skin Science and Research /ID# 264600
      • Thousand Oaks, California, United States, 91320
        • Clinical Trials Research Institute /ID# 263743
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine /ID# 263695
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Clearlyderm Dermatology - West Boca /ID# 265023
      • Brandon, Florida, United States, 33511
        • Apex Clinical Trials /ID# 263815
      • Brandon, Florida, United States, 33511
        • TrueBlue Clinical Research - Brandon /ID# 265041
      • Coral Gables, Florida, United States, 33134-5755
        • Florida Academic Dermatology Center /ID# 263834
      • Hialeah, Florida, United States, 33012
        • Direct Helpers Research Center /ID# 278343
      • Hollywood, Florida, United States, 33021-6748
        • Skin Care Research - Hollywood /ID# 263805
      • Margate, Florida, United States, 33063-7011
        • GSI Clinical Research, LLC /ID# 263827
      • Miami, Florida, United States, 33162
        • Sullivan Dermatology /ID# 263511
      • North Palm Beach, Florida, United States, 33408
        • Vitalia Medical Research /ID# 278321
      • Ocala, Florida, United States, 34470
        • Renstar Medical Research - Ocala - Northeast 1st Avenue /ID# 263842
      • Tampa, Florida, United States, 33607-6438
        • Skin Care Research - Tampa /ID# 263819
      • Tampa, Florida, United States, 33607
        • Advanced Clinical Research Institute - Tampa /ID# 263808
      • Tampa, Florida, United States, 33612
        • University of South Florida /ID# 269624
      • Tampa, Florida, United States, 33615
        • Alliance Clinical Research of Tampa /ID# 264594
      • Wellington, Florida, United States, 33449
        • TruDerm Research /ID# 278217
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Centricity Research Columbus Dermatology /ID# 266530
      • Dawsonville, Georgia, United States, 30534
        • Cleaver Medical Group Dermatology /ID# 263845
    • Idaho
      • Boise, Idaho, United States, 83706
        • Treasure Valley Medical Research /ID# 263671
    • Illinois
      • Chicago, Illinois, United States, 60610
        • DeNova Research /ID# 264593
      • Chicago, Illinois, United States, 60611-2927
        • Northwestern University Feinberg School of Medicine /ID# 265007
      • Rolling Meadows, Illinois, United States, 60008
        • Arlington Dermatology /ID# 263410
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Dawes Fretzin /ID# 264601
    • Kansas
      • Leawood, Kansas, United States, 66211
        • Dermatology Partners of Leawood /ID# 263533
    • Kentucky
      • Bowling Green, Kentucky, United States, 42104
        • Equity Medical, LLC /ID# 268590
      • Louisville, Kentucky, United States, 40241
        • Dermatology Specialists Research (DS Research) - Kentucky /ID# 263343
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University School of Medicine /ID# 263899
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center /ID# 263709
      • Worcester, Massachusetts, United States, 01655
        • UMass Memorial Medical Center - Lake Avenue North /ID# 274149
    • Michigan
      • Canton, Michigan, United States, 48187
        • Hamzavi Dermatology - Canton /ID# 263538
      • Clarkston, Michigan, United States, 48346
        • Michigan Center for Medical Research - Clarkston /ID# 263547
      • Clinton Township, Michigan, United States, 48038
        • Michigan Center for Skin Care Research /ID# 267228
    • Missouri
      • Lee's Summit, Missouri, United States, 64064-2301
        • Dermatology and Skin Center of Lees Summit /ID# 263567
      • Saint Joseph, Missouri, United States, 64506
        • MediSearch Clinical Trials /ID# 263582
    • Nevada
      • Las Vegas, Nevada, United States, 89119-5190
        • Vivida Dermatology- Flamingo /ID# 263716
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Dartmouth Hitchcock Medical Center - Old Etna Road /ID# 263713
      • Portsmouth, New Hampshire, United States, 03801
        • StracSkin /ID# 263387
    • New York
      • New York, New York, United States, 10028
        • Mount Sinai Doctors - Dermatology /ID# 264602
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27104
        • Wake Forest University Health Sciences /ID# 264507
    • Ohio
      • Bexley, Ohio, United States, 43209
        • Dermatology of Greater Columbus /ID# 263497
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center /ID# 263600
      • Columbus, Ohio, United States, 43203
        • The Ohio State University Wexner Medical Center - CarePoint East /ID# 263598
      • Mason, Ohio, United States, 45040
        • Dermatologists of Southwest Ohio - Mason /ID# 263588
      • Mayfield Heights, Ohio, United States, 44124
        • Apex Clinical Research Center /ID# 272787
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • Dermatology Partners - Philadelphia /ID# 264999
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center /ID# 264590
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Clinical Research Center of the Carolinas /ID# 263407
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina /ID# 263890
      • Spartanburg, South Carolina, United States, 29307
        • Advanced Dermatology And Cosmetic Surgery - Spartanburg /ID# 267207
    • Texas
      • Arlington, Texas, United States, 76011
        • Arlington Research Center, Inc /ID# 263895
      • Bellaire, Texas, United States, 77401
        • Bellaire Dermatology Associates /ID# 263850
      • Cypress, Texas, United States, 77429
        • Studies in Dermatology LLC /ID# 263399
      • Dallas, Texas, United States, 75235
        • Reveal Research Institute - Dallas /ID# 267233
      • Houston, Texas, United States, 77004
        • Center for Clinical Studies - Houston - Binz Street /ID# 263378
      • Plano, Texas, United States, 75025
        • Texas Dermatology Research Center /ID# 264488
      • San Antonio, Texas, United States, 78218
        • Texas Dermatology and Laser Specialists /ID# 263778
      • The Woodlands, Texas, United States, 77380
        • The Woodlands Dermatology Associates /ID# 266820
      • Tyler, Texas, United States, 75703
        • Dermatology Associates of Tyler /ID# 265002
    • Utah
      • Murray, Utah, United States, 84107
        • University of Utah - Murray /ID# 263818
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Virginia Clinical Research /ID# 264553
    • Washington
      • Mill Creek, Washington, United States, 98012
        • Frontier Dermatology /ID# 278387
      • Spokane, Washington, United States, 99202
        • Dermatology Specialists of Spokane /ID# 264499

Participation Criteria

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

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Period 1
Participants 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 .
Drug: Placebo
Subcutaneous injection
Drug: Lutikizumab
Subcutaneous injection
Other Names:
  • ABT-981
Experimental: Period 2: Lutikizumab Every Week
Participants randomized to lutikizumab in Period 1 who complete Week 16 of the study will be re-randomized to lutikizumab Dose A through Week 52
Drug: Lutikizumab
Subcutaneous injection
Other Names:
  • ABT-981
Experimental: Period 2: Lutikizumab Every Other Week
Participants 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
Drug: Placebo
Subcutaneous injection
Drug: Lutikizumab
Subcutaneous injection
Other Names:
  • ABT-981
Experimental: Period 2: Placebo to Lutikizumab Group
Participants 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.
Drug: Lutikizumab
Subcutaneous injection
Other Names:
  • ABT-981
Experimental: Period 2: Placebo to Lutikizumab Group Every Week
Participants 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
Drug: Lutikizumab
Subcutaneous injection
Other Names:
  • ABT-981
Experimental: Period 2: Placebo to Lutikizumab Group Every Other Week
The 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
Drug: Placebo
Subcutaneous injection
Drug: Lutikizumab
Subcutaneous injection
Other Names:
  • ABT-981
Experimental: Period 3: Open-label Lutikizumab
Starting at Week 68 in Period 3, all participants will receive Open-label Lutikizumab every other week
Drug: Lutikizumab
Subcutaneous injection
Other Names:
  • ABT-981
Experimental: Sub-Study: Lutikizumab Pre-Filled Pen
Lutikizumab solution for injection in prefilled pen (EOW) for 60 weeks, followed by lutikizumab solution for injection in prefilled syringes (EOW) for 96 weeks.
Drug: Lutikizumab
Subcutaneous injection
Other Names:
  • ABT-981

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75
Time Frame: At Week 16
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.
At Week 16
Number of Participants with Adverse Events (AEs)
Time Frame: Up to Approximately Week 62
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.
Up to Approximately Week 62

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3
Time Frame: At Week 8
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.
At Week 8
Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA)
Time Frame: At Week 16
The HSIA is an 18-item PRO questionnaire developed to assess the impact of HS on the daily lives of subjects in the 7 days prior to the assessment. Items 1 - 16 of the HSIA are scored on a 0 to 10 NRS, where 0 represents no impact and 10 represents extreme impact.
At Week 16
Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA) Worst Drainage Score
Time Frame: At Week 16
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.
At Week 16
Percentage of Participants Achieving HiSCR 90
Time Frame: At Week 16
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.
At Week 16
Change from Baseline in the Patient's Global Assessment of HS-related Skin Pain (NRS)
Time Frame: At Week 8
At Week 8
Change from Baseline in HSSA
Time Frame: At Week 16
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.
At Week 16
Change from Baseline in the Patient's Global Assessment of HS-related Odor (smell), based on the HSSA Question 8
Time Frame: At Week 16
The HSSA (24-hour recall) is a 9-item PRO questionnaire developed to assess the primary symptoms of HS in the 7 consecutive days prior to assessments. Each item of the HSSA is scored on an 11-point (0 to 10) NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.
At Week 16
Percentage of Participants with an Occurrence of HS Flare in Period 1
Time Frame: Baseline to Week 16
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.
Baseline to Week 16
Change from Baseline in Dermatology Life Quality Index (DLQI) among participants ≥ 16 years of age at Baseline
Time Frame: At Week 16
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.
At Week 16
Change from Baseline in number of Draining Fistulas Count among participants with at least 1 draining fistula at Baseline
Time Frame: At Week 16
At Week 16
Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA) Emotional Domain
Time Frame: At Week 16
At Week 16
Change from Baseline in HSIA Mobility Domain
Time Frame: at Week 16
at Week 16

Collaborators and Investigators

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

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

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

Helpful Links

Study record dates

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

Study Major Dates

Study Start (Actual)

June 27, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 17, 2024

First Submitted That Met QC Criteria

June 17, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M20-465
  • 2024-510730-40-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible 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.

IPD Sharing Time Frame

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

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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

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