A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
Intrepid
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
2 other identifiers
interventional
1,400
41 countries
268
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2024
268 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2024
CompletedFirst Posted
Study publicly available on registry
June 21, 2024
CompletedStudy Start
First participant enrolled
June 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
July 16, 2026
July 1, 2026
2.4 years
June 17, 2024
July 14, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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.
At Week 16
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.
Up to Approximately Week 62
Secondary Outcomes (12)
Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3
At Week 8
Change from Baseline in Dermatology Life Quality Index (DLQI) among participants ≥ 16 years of age at Baseline
At Week 16
Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA)
At Week 16
Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA) Worst Drainage Score
At Week 16
Change from Baseline in number of Draining Fistulas Count among participants with at least 1 draining fistula at Baseline
At Week 16
- +7 more secondary outcomes
Study Arms (8)
Period 1
EXPERIMENTALParticipants 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 .
Period 2: Lutikizumab Every Week
EXPERIMENTALParticipants randomized to lutikizumab in Period 1 who complete Week 16 of the study will be re-randomized to lutikizumab Dose A through Week 52
Period 2: Lutikizumab Every Other Week
EXPERIMENTALParticipants 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
Period 2: Placebo to Lutikizumab Group
EXPERIMENTALParticipants 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.
Period 2: Placebo to Lutikizumab Group Every Week
EXPERIMENTALParticipants 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
Period 2: Placebo to Lutikizumab Group Every Other Week
EXPERIMENTALThe 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
Period 3: Open-label Lutikizumab
EXPERIMENTALStarting at Week 68 in Period 3, all participants will receive Open-label Lutikizumab every other week
Sub-Study: Lutikizumab Pre-Filled Pen
EXPERIMENTALLutikizumab solution for injection in prefilled pen (EOW) for 60 weeks, followed by lutikizumab solution for injection in prefilled syringes (EOW) for 96 weeks.
Interventions
Subcutaneous injection
Subcutaneous injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Any evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Confirmed positive anti-HIV antibody (HIV Ab) test.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (279)
Cahaba Dermatology & Skin Health Center /ID# 263795
Birmingham, Alabama, 35244, United States
Medical Dermatology Specialists /ID# 263394
Phoenix, Arizona, 85006, United States
Banner University Medicine Dermatology /ID# 263557
Tucson, Arizona, 85718-1407, United States
Dermatology Trial Associates /ID# 264587
Bryant, Arkansas, 72022, United States
Arkansas Research Trials /ID# 263901
North Little Rock, Arkansas, 72217, United States
Private Practice - Dr. Tooraj Raoof /ID# 263756
Encino, California, 91436, United States
Dermatology Research Associates - Los Angeles /ID# 263765
Los Angeles, California, 90045, United States
Stanford University School of Medicine - Redwood City /ID# 263711
Redwood City, California, 94063, United States
Norcal Clinical Research /ID# 279008
Rocklin, California, 95765, United States
Integrative Skin Science and Research /ID# 264600
Sacramento, California, 95815, United States
Clinical Trials Research Institute /ID# 263743
Thousand Oaks, California, 91320, United States
Yale University School of Medicine /ID# 263695
New Haven, Connecticut, 06510, United States
Clearlyderm Dermatology - West Boca /ID# 265023
Boca Raton, Florida, 33428, United States
Apex Clinical Trials /ID# 263815
Brandon, Florida, 33511, United States
TrueBlue Clinical Research - Brandon /ID# 265041
Brandon, Florida, 33511, United States
Florida Academic Dermatology Center /ID# 263834
Coral Gables, Florida, 33134-5755, United States
Direct Helpers Research Center /ID# 278343
Hialeah, Florida, 33012, United States
Skin Care Research - Hollywood /ID# 263805
Hollywood, Florida, 33021-6748, United States
GSI Clinical Research, LLC /ID# 263827
Margate, Florida, 33063-7011, United States
Sullivan Dermatology /ID# 263511
Miami, Florida, 33162, United States
Vitalia Medical Research /ID# 278321
North Palm Beach, Florida, 33408, United States
Renstar Medical Research - Ocala - Northeast 1st Avenue /ID# 263842
Ocala, Florida, 34470, United States
Skin Care Research - Tampa /ID# 263819
Tampa, Florida, 33607-6438, United States
Advanced Clinical Research Institute - Tampa /ID# 263808
Tampa, Florida, 33607, United States
University of South Florida /ID# 269624
Tampa, Florida, 33612, United States
Alliance Clinical Research of Tampa /ID# 264594
Tampa, Florida, 33615, United States
TruDerm Research /ID# 278217
Wellington, Florida, 33449, United States
Centricity Research Columbus Dermatology /ID# 266530
Columbus, Georgia, 31904, United States
Cleaver Medical Group Dermatology /ID# 263845
Dawsonville, Georgia, 30534, United States
Treasure Valley Medical Research /ID# 263671
Boise, Idaho, 83706, United States
DeNova Research /ID# 264593
Chicago, Illinois, 60610, United States
Northwestern University Feinberg School of Medicine /ID# 265007
Chicago, Illinois, 60611-2927, United States
Arlington Dermatology /ID# 263410
Rolling Meadows, Illinois, 60008, United States
Dawes Fretzin /ID# 264601
Indianapolis, Indiana, 46256, United States
Dermatology Partners of Leawood /ID# 263533
Leawood, Kansas, 66211, United States
Equity Medical, LLC /ID# 268590
Bowling Green, Kentucky, 42104, United States
Dermatology Specialists Research (DS Research) - Kentucky /ID# 263343
Louisville, Kentucky, 40241, United States
Tulane University School of Medicine /ID# 263899
New Orleans, Louisiana, 70112, United States
Beth Israel Deaconess Medical Center /ID# 263709
Boston, Massachusetts, 02215, United States
UMass Memorial Medical Center - Lake Avenue North /ID# 274149
Worcester, Massachusetts, 01655, United States
Hamzavi Dermatology - Canton /ID# 263538
Canton, Michigan, 48187, United States
Michigan Center for Medical Research - Clarkston /ID# 263547
Clarkston, Michigan, 48346, United States
Michigan Center for Skin Care Research /ID# 267228
Clinton Township, Michigan, 48038, United States
Dermatology and Skin Center of Lees Summit /ID# 263567
Lee's Summit, Missouri, 64064-2301, United States
MediSearch Clinical Trials /ID# 263582
Saint Joseph, Missouri, 64506, United States
Vivida Dermatology- Flamingo /ID# 263716
Las Vegas, Nevada, 89119-5190, United States
Dartmouth Hitchcock Medical Center - Old Etna Road /ID# 263713
Lebanon, New Hampshire, 03766, United States
StracSkin /ID# 263387
Portsmouth, New Hampshire, 03801, United States
Mount Sinai Doctors - Dermatology /ID# 264602
New York, New York, 10028, United States
Wake Forest University Health Sciences /ID# 264507
Winston-Salem, North Carolina, 27104, United States
Dermatology of Greater Columbus /ID# 263497
Bexley, Ohio, 43209, United States
University Hospitals Cleveland Medical Center /ID# 263600
Cleveland, Ohio, 44106, United States
The Ohio State University Wexner Medical Center - CarePoint East /ID# 263598
Columbus, Ohio, 43203, United States
Dermatologists of Southwest Ohio - Mason /ID# 263588
Mason, Ohio, 45040, United States
Apex Clinical Research Center /ID# 272787
Mayfield Heights, Ohio, 44124, United States
Dermatology Partners - Philadelphia /ID# 264999
Philadelphia, Pennsylvania, 19114, United States
University of Pittsburgh Medical Center /ID# 264590
Pittsburgh, Pennsylvania, 15213, United States
Clinical Research Center of the Carolinas /ID# 263407
Charleston, South Carolina, 29407, United States
Medical University of South Carolina /ID# 263890
Charleston, South Carolina, 29425, United States
Advanced Dermatology And Cosmetic Surgery - Spartanburg /ID# 267207
Spartanburg, South Carolina, 29307, United States
Arlington Research Center, Inc /ID# 263895
Arlington, Texas, 76011, United States
Bellaire Dermatology Associates /ID# 263850
Bellaire, Texas, 77401, United States
Studies in Dermatology LLC /ID# 263399
Cypress, Texas, 77429, United States
Reveal Research Institute - Dallas /ID# 267233
Dallas, Texas, 75235, United States
Center for Clinical Studies - Houston - Binz Street /ID# 263378
Houston, Texas, 77004, United States
Texas Dermatology Research Center /ID# 264488
Plano, Texas, 75025, United States
Texas Dermatology and Laser Specialists /ID# 263778
San Antonio, Texas, 78218, United States
The Woodlands Dermatology Associates /ID# 266820
The Woodlands, Texas, 77380, United States
Dermatology Associates of Tyler /ID# 265002
Tyler, Texas, 75703, United States
University of Utah - Murray /ID# 263818
Murray, Utah, 84107, United States
Virginia Clinical Research /ID# 264553
Norfolk, Virginia, 23507, United States
Frontier Dermatology /ID# 278387
Mill Creek, Washington, 98012, United States
Dermatology Specialists of Spokane /ID# 264499
Spokane, Washington, 99202, United States
Consultorios Reumatologicos Pampa /ID# 265911
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1428, Argentina
Instituto De Investigaciones Clínicas Córdoba /ID# 264297
Córdoba, Córdoba Province, 5000, Argentina
Instituto de Especialidades de la Salud Rosario - Clinica del Torax /ID# 266132
Rosario, Santa Fe Province, 2000, Argentina
Buenos Aires Skin /ID# 264299
Buenos Aires, 1055, Argentina
Paratus Clinical Research Woden /ID# 263125
Phillip, Australian Capital Territory, 2606, Australia
Momentum Clinical Research /ID# 263192
Darlinghurst, New South Wales, 2010, Australia
Premier Dermatology - Kogarah /ID# 263124
Kogarah, New South Wales, 2217, Australia
Veracity Clinical Research /ID# 263126
Woolloongabba, Queensland, 4102, Australia
Sinclair Dermatology - Melbourne /ID# 263121
East Melbourne, Victoria, 3002, Australia
Medizinische Universitaet Graz /ID# 263306
Graz, Styria, 8010, Austria
Medizinische Universitaet Wien /ID# 264043
Vienna, 1090, Austria
Universite Libre de Bruxelles - Hopital Erasme /ID# 263097
Anderlecht, Brussels Capital, 1070, Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 263096
Brussels, Brussels Capital, 1200, Belgium
Universitair Ziekenhuis Brussel /ID# 263101
Jette, Brussels Capital, 1090, Belgium
Grand Hopital de Charleroi - Les Viviers /ID# 263100
Charleroi, Hainaut, 6280, Belgium
UZ Gent /ID# 263099
Ghent, Oost-Vlaanderen, 9000, Belgium
Universitair Ziekenhuis Leuven /ID# 263098
Leuven, Vlaams-Brabant, 3000, Belgium
CHU de Liege /ID# 263095
Liège, 4000, Belgium
Clinical Center University of Sarajevo - Bolnicka /ID# 265908
Sarajevo, Federation of Bosnia and Herzegovina, 71000, Bosnia and Herzegovina
University Clinical Center Tuzla /ID# 265906
Tuzla, Federation of Bosnia and Herzegovina, 75000, Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 265905
Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 265909
Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina
Acibadem City Clinic Tokuda Hospital /ID# 263300
Sofiya, Sofia, 1407, Bulgaria
Ambulatory for Specialized Medical Care-IPSMC-skin and venereal diseases /ID# 262891
Sofiya, Sofia, 1407, Bulgaria
Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 262893
Sofiya, Sofia, 1463, Bulgaria
Medical Center Hera /ID# 263010
Sofiya, Sofia, 1510, Bulgaria
Medical Center Cordis /ID# 262894
Pleven, 5800, Bulgaria
UMHAT Professor Stoyan Kirkovich /ID# 262892
Stara Zagora, 6000, Bulgaria
Beacon Dermatology /ID# 264262
Calgary, Alberta, T3A 2N1, Canada
Rejuvenation Dermatology - Edmonton Downtown /ID# 265963
Edmonton, Alberta, T5J 3S9, Canada
Stratica Dermatology /ID# 265856
Edmonton, Alberta, T5K 1X3, Canada
Interior Dermatology Centre - Probity - PPDS /ID# 266202
Kelowna, British Columbia, V1W 4V5, Canada
Brunswick Dermatology Center /ID# 264260
Fredericton, New Brunswick, R3M 3Z4, Canada
Karma Clinical Trials /ID# 265962
St. John's, Newfoundland and Labrador, A1A 4Y3, Canada
Skin Health /ID# 267735
Cobourg, Ontario, K9A 0Z4, Canada
Leader Research /ID# 266114
Hamilton, Ontario, L8L 3C3, Canada
DermEffects /ID# 265262
London, Ontario, N6H 5L5, Canada
Derm Care Clinic /ID# 265261
Mississauga, Ontario, L4W 0C2, Canada
York Dermatology Clinic and Research Centre /ID# 265265
Richmond Hill, Ontario, L4C 9M7, Canada
FACET Dermatology /ID# 265267
Toronto, Ontario, M4C 1L1, Canada
Private Practice - Dr. Kim Papp Clinical Research /ID# 265266
Waterloo, Ontario, N2J 1C4, Canada
Private Practice - Dr. Angelique Gagne-Henley /ID# 264263
Saint-Jérôme, Quebec, J7Z 7E2, Canada
SkinSense Dermatology /ID# 265964
Saskatoon, Saskatchewan, S7K 0H6, Canada
Diex Recherche Quebec Inc. /ID# 265263
Québec, G1V 4T3, Canada
Centre de Recherche Saint-Louis /ID# 265855
Québec, G1W 4R4, Canada
Centro Internacional de Estudios Clinicos - CIEC /ID# 266129
Santiago, Region Metropolitana Santiago, 8420383, Chile
Clinica Dermacross /ID# 266127
Vitacura, Region Metropolitana Santiago, 7640881, Chile
Fundacion Innovacion Cardiovascular /ID# 264844
Independencia, Santiago Metropolitan, 8380465, Chile
Centro de Inmunologia y Genetica CIGE SAS /ID# 263793
Medellín, Antioquia, 050012, Colombia
Centro Integral de Reumatología del Caribe SAS - Circaribe SAS /ID# 265089
Barranquilla, Atlántico, 80002, Colombia
Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 265093
Bogotá, Cundinamarca, 110221, Colombia
Healthy Medical Center S.A.S /ID# 265091
Zipaquirá, Cundinamarca, 250252, Colombia
Klinicki Bolnicki Centar Zagreb /ID# 263989
Grad Zagreb, City of Zagreb, 10000, Croatia
Klinicki Bolnicki Centar Sestre Milosrdnice /ID# 265069
Zagreb, City of Zagreb, 10000, Croatia
Klinicki bolnicki centar Osijek /ID# 265916
Osijek, County of Osijek-Baranja, 31000, Croatia
Specialty Hospital Medico /ID# 263922
Rijeka, Primorje-Gorski Kotar County, 51000, Croatia
Fakultni nemocnice Ostrava /ID# 264041
Ostrava, Ostrava-mesto, 708 52, Czechia
Karlovarska Krajska Nemocnice - Karlovy Vary /ID# 265354
Karlovy Vary, 360 01, Czechia
Fakultni nemocnice Kralovske Vinohrady /ID# 264040
Prague, 100 34, Czechia
Herlev and Gentofte Hospital /ID# 265839
Hellerup, Capital Region, 2900, Denmark
Aarhus Universitetshospital - Skejby /ID# 265657
Aarhus, Central Jutland, 8200, Denmark
Roskilde Sygehus /ID# 274895
Roskilde, Region Sjælland, 4000, Denmark
Hopital Edouard Herriot /ID# 263456
Lyon, Auvergne-Rhône-Alpes, 69003, France
Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 263459
St-Priest-en-Jarez, Pays de la Loire Region, 42270, France
Cabinet medical - Le bateau Blanc /ID# 263465
Martigues, Provence-Alpes-Côte d'Azur Region, 13500, France
Centre Hospitalier Universitaire de Rouen (CHU)- Hopital Charles Nicolle /ID# 263995
Rouen, Seine-Maritime, 76031, France
Groupe Hospitalier Paris Saint-Joseph /ID# 263996
Paris, 75014, France
Polyclinique Courlancy /ID# 263313
Reims, 51100, France
Universitaetsklinikum Freiburg /ID# 263659
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Universitaetsklinikum Tuebingen /ID# 271718
Tübingen, Baden-Wurttemberg, 72076, Germany
Universitaetsklinikum Erlangen /ID# 263075
Erlangen, Bavaria, 91054, Germany
Beldio Research GmbH /ID# 263074
Memmingen, Bavaria, 87700, Germany
Rosenpark Research /ID# 269202
Darmstadt, Hesse, 64283, Germany
Fachklinik - Bad Bentheim /ID# 263067
Bad Bentheim, Lower Saxony, 48455, Germany
Universitaetsmedizin Rostock /ID# 278301
Rostock, Mecklenburg-Vorpommern, 18057, Germany
Katholisches Klinikum Bochum /ID# 262976
Bochum, North Rhine-Westphalia, 44805, Germany
Universitaetsklinikum Muenster /ID# 263068
Münster, North Rhine-Westphalia, 48149, Germany
Hautarztpraxis Mortazawi /ID# 271673
Remscheid, North Rhine-Westphalia, 42897, Germany
Hautarztpraxis Dr. Kirschner /ID# 263656
Mainz, Rhineland-Palatinate, 55116, Germany
Hautmedizin Saar Science /ID# 278634
Merzig, Saarland, 66663, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 263076
Berlin, 10117, Germany
General Hospital Andreas Syggros /ID# 263417
Athens, Attica, 16121, Greece
University General Hospital Attikon /ID# 263413
Chaïdári, Attica, 12462, Greece
Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 263416
Thessaloniki, 54643, Greece
Papageorgiou General Hospital /ID# 263415
Thessaloniki, 56429, Greece
Dermos S.A. /ID# 265857
Guatemala City, 01015, Guatemala
Prosalud /Id# 266586
Guatemala City, Zona 1, Guatemala
Pecsi Tudomanyegyetem /ID# 264120
Pécs, Baranya, 7632, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 263424
Kaposvár, Somogy County, 7400, Hungary
Semmelweis Egyetem /ID# 263451
Budapest, 1085, Hungary
Debreceni Egyetem /ID# 263423
Debrecen, 4032, Hungary
Our Lady of Lourdes Hospital - Drogheda /ID# 265893
Drogheda, Louth, A92 VW28, Ireland
South Infirmary Victoria University Hospital /ID# 265872
Cork, T12 X23H, Ireland
University College Dublin /ID# 265875
Dublin, D07 A8NN, Ireland
Mater Misericordiae University Hospital /ID# 265914
Dublin, D07 R2WY, Ireland
Rabin Medical Center /ID# 262992
Petah Tikva, Central District, 4941492, Israel
HaEmek Medical Center /ID# 267297
Afula, Haifa District, 1834111, Israel
Galilee Medical Center /ID# 262995
Nahariya, Northern District, 2210001, Israel
The Chaim Sheba Medical Center /ID# 262993
Ramat Gan, Tel Aviv, 5265601, Israel
Tel Aviv Sourasky Medical Center /ID# 266581
Tel Aviv, Tel Aviv, 6423906, Israel
Rambam Health Care Campus- Haifa /ID# 262994
Haifa, 3109601, Israel
Hadassah Medical Center-Hebrew University /ID# 262884
Jerusalem, 91120, Israel
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale S.Anna /ID# 263474
Cona, Ferrara, 44124, Italy
AZIENDA USL TOSCANA CENTRO - Ospedale Piero Palagi /ID# 263454
Florence, Firenze, 50122, Italy
IRCCS Istituto Clinico Humanitas /ID# 263503
Rozzano, Lombardy, 20089, Italy
Azienda Ospedaliera Universitaria Federico II - Naples /ID# 263539
Naples, Napoli, 80131, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 263473
Rome, Roma, 00168, Italy
AOU Policlinico G. Rodolico - San Marco /ID# 263469
Catania, 95123, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 263471
Milan, 20122, Italy
Nagoya City University Hospital /ID# 263874
Nagoya, Aichi-ken, 467-8602, Japan
Fujita Health University Hospital /ID# 265440
Toyoake, Aichi-ken, 470-1192, Japan
Takagi Dermatological Clinic /ID# 264810
Obihiro-Shi, Hokkaido, 080-0013, Japan
Iwate Medical University Hospital /ID# 273799
Shiwa-gun, Iwate, 028-3695, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 264291
Kyoto, Kyoto, 602-8566, Japan
Niigata University Medical and Dental Hospital /ID# 276568
Niigata, Niigata, 951-8520, Japan
University of the Ryukyus Hospital /ID# 264605
Ginowan-shi, Okinawa, 901-2725, Japan
Osaka Metropolitan University Hospital /ID# 265682
Osaka, Osaka, 545-8586, Japan
Kindai University Hospital /ID# 264322
Sakai-shi, Osaka, 590-0197, Japan
Dokkyo Medical University Saitama Medical Center /ID# 265400
Koshigaya, Saitama, 343-0845, Japan
Fukuoka University Hospital /ID# 263991
Fukuoka, 814-0180, Japan
Nihon University Itabashi Hospital /ID# 264661
Tokyo, 173-8610, Japan
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 277709
Kaunas, 50161, Lithuania
Vilnius University Hospital Santaros Klinikos /ID# 277707
Vilnius, 08661, Lithuania
Grupo Clinico CATEI S C /ID# 265276
Guadalajara, Jalisco, 44638, Mexico
Cryptex Investigacion Clinica /ID# 265271
Mexico City, Mexico City, 06100, Mexico
Eukarya PharmaSite /ID# 265307
Monterrey, Nuevo León, 64718, Mexico
Sociedad de Metabolismo y Corazon S.C. /ID# 265915
Veracruz, 91900, Mexico
Erasmus Medisch Centrum /ID# 263377
Rotterdam, South Holland, 3015 CE, Netherlands
Greenlane Clinical Centre /ID# 263191
Epsom, Auckland, 1051, New Zealand
Clinical Trials New Zealand /ID# 265432
Hamilton, Waikato Region, 3204, New Zealand
Stavanger Universitetssykehus /ID# 265997
Stavanger, Rogaland, 4068, Norway
Universitetssykehuset I Nord-Norge /ID# 265992
Tromsø, Troms, 9019, Norway
Oslo University Hospital - Rikshospitalet /ID# 265996
Oslo, 0372, Norway
Oftalmika sp. z o.o. /ID# 263087
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-631, Poland
Specjalistyczny gabinet dermatologiczny Aplikacyjno-Badawczy Marek Brzewski, Paw /ID# 277221
Krakow, Lesser Poland Voivodeship, 30-002, Poland
Centrum Nowoczesnych Terapii Dobry Lekarz sp.z.o.o. /ID# 263146
Krakow, Lesser Poland Voivodeship, 31-011, Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji /ID# 277307
Warsaw, Masovian Voivodeship, 02-507, Poland
Klinika Ambroziak Dermatologia /ID# 263173
Warsaw, Masovian Voivodeship, 02-953, Poland
Centrum Medyczne Angelius Provita /ID# 277204
Katowice, Silesian Voivodeship, 40-615, Poland
DERMED Centrum Medyczne Sp. z o.o /ID# 263147
Lodz, Łódź Voivodeship, 90-265, Poland
Santa Sp. z o..o. Santa Familia PTG Lodz /ID# 263181
Lodz, Łódź Voivodeship, 90-302, Poland
Unidade Local de Saude do Alto Ave, EPE /ID# 265158
Guimarães, Braga District, 4835-044, Portugal
CUF Descobertas Hospital /ID# 263188
Lisbon, Lisbon District, 1998-018, Portugal
Unidade Local de Saude de Sao Jose, EPE /ID# 265155
Lisbon, 1150-199, Portugal
Unidade Local de Saude de Santo Antonio /ID# 265479
Porto, 4099-003, Portugal
Private Practice - Dr. Alma Cruz /ID# 263204
Carolina, 00985, Puerto Rico
Clinical Research Puerto Rico /ID# 263450
San Juan, 00909-1711, Puerto Rico
Spitalul Clinic Colentina /ID# 263303
Bucharest, Bucharest, 020125, Romania
Private Practice - Dr. Orasan Remus /ID# 263305
Cluj-Napoca, Cluj, 400006, Romania
Centrul Medical Euromed /ID# 263304
Bucharest, 020762, Romania
King Abdulaziz Medical City /ID# 266121
Jeddah, Mecca Region, 22384, Saudi Arabia
King Saud University Med City /ID# 266120
Riyadh, 12372, Saudi Arabia
Military Medical Academy /ID# 263257
Belgrade, Beograd, 11000, Serbia
University Clinical Center Serbia /ID# 263256
Belgrade, Beograd, 11000, Serbia
University Clinical Center Kragujevac /ID# 264211
Kragujevac, Sumadijski Okrug, 34000, Serbia
University Clinical Center Vojvodina /ID# 263260
Novi Sad, 21000, Serbia
National University Hospital /ID# 264673
Singapore, 119074, Singapore
National Skin Centre /ID# 264680
Singapore, 308205, Singapore
Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 263921
Bratislava, Bratislava Region, 811 09, Slovakia
Detska Fakultna Nemocnica Kosice /ID# 263907
Košice, Košice Region, 040 11, Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky /ID# 265944
Nové Zámky, Nitra Region, 940 34, Slovakia
Fakultna nemocnica Trnava /ID# 263905
Trnava, 917 02, Slovakia
University Medical Centre Ljubljana /ID# 265720
Ljubljana, 1000, Slovenia
University Medical Centre Maribor /ID# 265827
Maribor, 2000, Slovenia
Global Clinical Trials /ID# 262839
Pretoria, Gauteng, 0157, South Africa
Life Chatsmed Garden Hospital /ID# 270237
Chatsworth, KwaZulu-Natal, 4092, South Africa
Ahmed Al-Kadi Private Hospital /ID# 262837
Durban, KwaZulu-Natal, 4091, South Africa
Dr Ahmed Ismail Manjra /ID# 262838
Westville, KwaZulu-Natal, 3629, South Africa
Pusan National University Hospital /ID# 271496
Busan, Busan Gwang Yeogsi, 49241, South Korea
SoonChunHyang University Hospital Cheonan /ID# 271320
Cheonan-si, Chungcheongnam-do, 31151, South Korea
Korea University Ansan Hospital /ID# 264227
Ansan-si, Gyeonggido, 15355, South Korea
CHA Bundang Medical Center /ID# 264225
Seongnam, Gyeonggido, 13496, South Korea
Yonsei University Health System Severance Hospital /ID# 271353
Seoul, Seoul Teugbyeolsi, 03722, South Korea
SoonChunHyang University Seoul Hospital /ID# 264224
Seoul, Seoul Teugbyeolsi, 04401, South Korea
Asan Medical Center /ID# 264228
Seoul, Seoul Teugbyeolsi, 05505, South Korea
Hallym University Kangnam Sacred Heart Hospital /ID# 264226
Seoul, Seoul Teugbyeolsi, 07441, South Korea
The Catholic University Of Korea, Eunpyeong St. Mary'S Hospital /ID# 271348
Seoul, 03312, South Korea
Hospital Universitari Parc Tauli /ID# 262942
Sabadell, Barcelona, 08208, Spain
Hospital Universitario Marques de Valdecilla /ID# 263039
Santander, Cantabria, 39008, Spain
Hospital de Manises /ID# 262938
Manises, Valencia, 46940, Spain
Hospital General Universitario Gregorio Maranon /ID# 262940
Madrid, 28007, Spain
Hospital Universitario Virgen de la Victoria /ID# 262941
Málaga, 29010, Spain
Consorci Hospital General Universitario de Valencia /ID# 262944
Valencia, 46014, Spain
Karolinska University Hospital Solna /ID# 264530
Solna, Stockholm County, 171 64, Sweden
Universitetssjukhuset Orebro /ID# 265064
Örebro, Örebro County, 701 85, Sweden
University Hospital Basel /ID# 264245
Basel Town, Canton of Basel-City, 4031, Switzerland
Dermatology & Skin Care Clinic /ID# 264030
Buochs, Canton of Nidwalden, 6374, Switzerland
Kantonsspital St.Gallen /ID# 264238
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
University Hospital Zurich /ID# 266142
Zurich, Canton of Zurich, 8091, Switzerland
Kaohsiung Chang Gung Memorial Hospital /ID# 264619
Kaohsiung City, 833, Taiwan
Taichung Veterans General Hospital /ID# 270741
Taichung, 407, Taiwan
National Taiwan University Hospital /ID# 264618
Taipei, 100, Taiwan
Mackay Memorial Hospital /ID# 263661
Taipei, 104, Taiwan
Taipei Veterans General Hospital /ID# 265879
Taipei, 112, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 264620
Taoyuan City, 333, Taiwan
Pamukkale University Medical Faculty Hospital /ID# 264734
Chonai, Denizli, 20330, Turkey (Türkiye)
Erciyes Üniversitesi Tip Fakültesi /ID# 263050
Melikgazi, Kayseri, 38170, Turkey (Türkiye)
Gaziantep Universitesi /ID# 263048
Gaziantep, 27310, Turkey (Türkiye)
Royal Cornwall Hospital /ID# 277507
Truro, Cornwall, TR1 3LQ, United Kingdom
Queen Margaret Hospital /ID# 264198
Dunfermline, Fife, KY12 0SU, United Kingdom
Gloucestershire Royal Hospital /ID# 265848
Gloucester, Gloucestershire, GL1 3NN, United Kingdom
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 264121
London, Greater London, E1 2ES, United Kingdom
Harrogate District Hospital /ID# 265632
Harrogate, North Yorkshire, HG2 7SX, United Kingdom
Southlands Hospital /ID# 276976
Shoreham-by-Sea, West Sussex, BN43 6TQ, United Kingdom
Bristol Royal Infirmary /ID# 263937
Bristol, BS2 8HW, United Kingdom
Royal Victoria Infirmary /ID# 273368
Newcastle upon Tyne, NE1 4LP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2024
First Posted
June 21, 2024
Study Start
June 27, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
July 16, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- 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/
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.