Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
Sponsor: AbbVie
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.
Official title: A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab in Adult and Adolescent Subjects With Moderate to Severe Hidradenitis Suppurativa
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1400
Start Date
2024-06-27
Completion Date
2026-12
Last Updated
2026-09-02
Healthy Volunteers
No
Conditions
Interventions
Lutikizumab
Subcutaneous injection
Placebo
Subcutaneous injection
Locations (279)
Cahaba Dermatology & Skin Health Center /ID# 263795
Birmingham, Alabama, United States
Medical Dermatology Specialists /ID# 263394
Phoenix, Arizona, United States
Banner University Medicine Dermatology /ID# 263557
Tucson, Arizona, United States
Dermatology Trial Associates /ID# 264587
Bryant, Arkansas, United States
Arkansas Research Trials /ID# 263901
North Little Rock, Arkansas, United States
Private Practice - Dr. Tooraj Raoof /ID# 263756
Encino, California, United States
Dermatology Research Associates - Los Angeles /ID# 263765
Los Angeles, California, United States
Stanford University School of Medicine - Redwood City /ID# 263711
Redwood City, California, United States
Norcal Clinical Research /ID# 279008
Rocklin, California, United States
Integrative Skin Science and Research /ID# 264600
Sacramento, California, United States
Clinical Trials Research Institute /ID# 263743
Thousand Oaks, California, United States
Yale University School of Medicine /ID# 263695
New Haven, Connecticut, United States
Clearlyderm Dermatology - West Boca /ID# 265023
Boca Raton, Florida, United States
Apex Clinical Trials /ID# 263815
Brandon, Florida, United States
TrueBlue Clinical Research - Brandon /ID# 265041
Brandon, Florida, United States
Florida Academic Dermatology Center /ID# 263834
Coral Gables, Florida, United States
Direct Helpers Research Center /ID# 278343
Hialeah, Florida, United States
Skin Care Research - Hollywood /ID# 263805
Hollywood, Florida, United States
Gsi Clinical Research /ID# 263827
Margate, Florida, United States
Sullivan Dermatology /ID# 263511
Miami, Florida, United States
Vitalia Medical Research /ID# 278321
North Palm Beach, Florida, United States
Renstar Medical Research - Ocala - Northeast 1st Avenue /ID# 263842
Ocala, Florida, United States
Skin Care Research - Tampa /ID# 263819
Tampa, Florida, United States
Advanced Clinical Research Institute - Tampa /ID# 263808
Tampa, Florida, United States
University of South Florida /ID# 269624
Tampa, Florida, United States
Alliance Clinical Research of Tampa /ID# 264594
Tampa, Florida, United States
TruDerm Research /ID# 278217
Wellington, Florida, United States
Centricity Research Columbus Dermatology /ID# 266530
Columbus, Georgia, United States
Cleaver Medical Group Dermatology /ID# 263845
Dawsonville, Georgia, United States
Treasure Valley Medical Research /ID# 263671
Boise, Idaho, United States
DeNova Research /ID# 264593
Chicago, Illinois, United States
Northwestern University Feinberg School of Medicine /ID# 265007
Chicago, Illinois, United States
Arlington Dermatology /ID# 263410
Rolling Meadows, Illinois, United States
Dawes Fretzin /ID# 264601
Indianapolis, Indiana, United States
Dermatology Partners of Leawood /ID# 263533
Leawood, Kansas, United States
Equity Medical, LLC /ID# 268590
Bowling Green, Kentucky, United States
Dermatology Specialists Research (DS Research) - Kentucky /ID# 263343
Louisville, Kentucky, United States
Tulane University School of Medicine /ID# 263899
New Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center /ID# 263709
Boston, Massachusetts, United States
UMass Memorial Medical Center - Lake Avenue North /ID# 274149
Worcester, Massachusetts, United States
Hamzavi Dermatology - Canton /ID# 263538
Canton, Michigan, United States
Michigan Center for Medical Research - Clarkston /ID# 263547
Clarkston, Michigan, United States
Michigan Center for Skin Care Research /ID# 267228
Clinton Township, Michigan, United States
Dermatology and Skin Center of Lees Summit /ID# 263567
Lee's Summit, Missouri, United States
MediSearch Clinical Trials /ID# 263582
Saint Joseph, Missouri, United States
Vivida Dermatology- Flamingo /ID# 263716
Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center - Old Etna Road /ID# 263713
Lebanon, New Hampshire, United States
StracSkin /ID# 263387
Portsmouth, New Hampshire, United States
Mount Sinai Doctors - Dermatology /ID# 264602
New York, New York, United States
Wake Forest University Health Sciences /ID# 264507
Winston-Salem, North Carolina, United States
Dermatology of Greater Columbus /ID# 263497
Bexley, Ohio, United States
University Hospitals Cleveland Medical Center /ID# 263600
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center - CarePoint East /ID# 263598
Columbus, Ohio, United States
Dermatologists of Southwest Ohio - Mason /ID# 263588
Mason, Ohio, United States
Apex Clinical Research Center /ID# 272787
Mayfield Heights, Ohio, United States
Dermatology Partners - Philadelphia /ID# 264999
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center /ID# 264590
Pittsburgh, Pennsylvania, United States
Clinical Research Center of the Carolinas /ID# 263407
Charleston, South Carolina, United States
Medical University of South Carolina /ID# 263890
Charleston, South Carolina, United States
Advanced Dermatology And Cosmetic Surgery - Spartanburg /ID# 267207
Spartanburg, South Carolina, United States
Arlington Research Center, Inc /ID# 263895
Arlington, Texas, United States
Bellaire Dermatology Associates /ID# 263850
Bellaire, Texas, United States
Studies in Dermatology /ID# 263399
Cypress, Texas, United States
Reveal Research Institute - Dallas /ID# 267233
Dallas, Texas, United States
Center for Clinical Studies - Houston - Binz Street /ID# 263378
Houston, Texas, United States
Texas Dermatology Research Center /ID# 264488
Plano, Texas, United States
Texas Dermatology and Laser Specialists /ID# 263778
San Antonio, Texas, United States
The Woodlands Dermatology Associates /ID# 266820
The Woodlands, Texas, United States
Dermatology Associates of Tyler /ID# 265002
Tyler, Texas, United States
University of Utah - Murray /ID# 263818
Murray, Utah, United States
Virginia Clinical Research /ID# 264553
Norfolk, Virginia, United States
Frontier Dermatology /ID# 278387
Mill Creek, Washington, United States
Dermatology Specialists of Spokane /ID# 264499
Spokane, Washington, United States
Consultorios Reumatologicos Pampa /ID# 265911
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Instituto de Especialidades de la Salud Rosario - Clinica del Torax /ID# 266132
Rosario, Santa Fe Province, Argentina
Buenos Aires Skin /ID# 264299
Buenos Aires, Argentina
Instituto De Investigaciones Clinicas Cordoba /ID# 264297
Córdoba, Argentina
Paratus Clinical Research Woden /ID# 263125
Phillip, Australian Capital Territory, Australia
Momentum Clinical Research /ID# 263192
Darlinghurst, New South Wales, Australia
Premier Dermatology - Kogarah /ID# 263124
Kogarah, New South Wales, Australia
Veracity Clinical Research /ID# 263126
Woolloongabba, Queensland, Australia
Sinclair Dermatology - Melbourne /ID# 263121
East Melbourne, Victoria, Australia
Medizinische Universitaet Graz /ID# 263306
Graz, Styria, Austria
Medizinische Universitaet Wien /ID# 264043
Vienna, Austria
Universite Libre de Bruxelles - Hopital Erasme /ID# 263097
Anderlecht, Brussels Capital, Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 263096
Brussels, Brussels Capital, Belgium
Universitair Ziekenhuis Brussel /ID# 263101
Jette, Brussels Capital, Belgium
Grand Hopital de Charleroi - Les Viviers /ID# 263100
Charleroi, Hainaut, Belgium
UZ Gent /ID# 263099
Ghent, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 263098
Leuven, Vlaams-Brabant, Belgium
CHU de Liege /ID# 263095
Liège, Belgium
Clinical Center University of Sarajevo - Bolnicka /ID# 265908
Sarajevo, Federation of Bosnia and Herzegovina, Bosnia and Herzegovina
University Clinical Center Tuzla /ID# 265906
Tuzla, Federation of Bosnia and Herzegovina, Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 265905
Banja Luka, Republika Srpska, Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 265909
Banja Luka, Republika Srpska, Bosnia and Herzegovina
Acibadem City Clinic Tokuda Hospital /ID# 263300
Sofiya, Sofia, Bulgaria
Ambulatory for Specialized Medical Care-IPSMC-skin and venereal diseases /ID# 262891
Sofiya, Sofia, Bulgaria
Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 262893
Sofiya, Sofia, Bulgaria
Medical Center Hera /ID# 263010
Sofiya, Sofia, Bulgaria
Medical Center Cordis /ID# 262894
Pleven, Bulgaria