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

Status: Recruiting
Location: See all (257) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Cahaba Dermatology & Skin Health Center /ID# 263795
RECRUITING
Birmingham
Arkansas
Dermatology Trial Associates /ID# 264587
RECRUITING
Bryant
Arkansas Research Trials /ID# 263901
RECRUITING
North Little Rock
Arizona
Medical Dermatology Specialists /ID# 263394
RECRUITING
Phoenix
Banner University Medicine Dermatology /ID# 263557
RECRUITING
Tucson
California
Private Practice - Dr. Tooraj Raoof /ID# 263756
RECRUITING
Encino
Dermatology Research Associates - Los Angeles /ID# 263765
RECRUITING
Los Angeles
Stanford University School of Medicine - Redwood City /ID# 263711
RECRUITING
Redwood City
Integrative Skin Science and Research /ID# 264600
RECRUITING
Sacramento
Clinical Trials Research Institute /ID# 263743
RECRUITING
Thousand Oaks
Florida
Clearlyderm Dermatology - West Boca /ID# 265023
COMPLETED
Boca Raton
Apex Clinical Trials /ID# 263815
RECRUITING
Brandon
TrueBlue Clinical Research /ID# 265041
RECRUITING
Brandon
Florida Academic Dermatology Center /ID# 263834
RECRUITING
Coral Gables
Skin Care Research - Hollywood /ID# 263805
RECRUITING
Hollywood
GSI Clinical Research, LLC /ID# 263827
RECRUITING
Margate
Sullivan Dermatology /ID# 263511
RECRUITING
Miami
Renstar Medical Research - Ocala - Northeast 1st Avenue /ID# 263842
RECRUITING
Ocala
Advanced Clinical Research Institute /ID# 263808
RECRUITING
Tampa
Alliance Clinical Research of Tampa /ID# 264594
RECRUITING
Tampa
Skin Care Research - Tampa /ID# 263819
RECRUITING
Tampa
University of South Florida /ID# 269624
RECRUITING
Tampa
TruDerm Research /ID# 278217
RECRUITING
Wellington
Georgia
Centricity Research Columbus Dermatology /ID# 266530
RECRUITING
Columbus
Cleaver Medical Group Dermatology /ID# 263845
RECRUITING
Dawsonville
Idaho
Treasure Valley Medical Research /ID# 263671
RECRUITING
Boise
Illinois
Northwestern University Feinberg School of Medicine /ID# 265007
RECRUITING
Chicago
Arlington Dermatology /ID# 263410
RECRUITING
Rolling Meadows
Indiana
Dawes Fretzin, LLC /ID# 264601
RECRUITING
Indianapolis
Kansas
Dermatology Partners of Leawood /ID# 263533
RECRUITING
Leawood
Kentucky
Equity Medical, LLC /ID# 268590
RECRUITING
Bowling Green
Dermatology Specialists Research (DS Research) - Kentucky /ID# 263343
RECRUITING
Louisville
Louisiana
Tulane University School of Medicine /ID# 263899
RECRUITING
New Orleans
Massachusetts
Beth Israel Deaconess Medical Center /ID# 263709
RECRUITING
Boston
UMass Memorial Medical Center /ID# 274149
RECRUITING
Worcester
Michigan
Hamzavi Dermatology - Canton /ID# 263538
RECRUITING
Canton
Michigan Center for Medical Research /ID# 263547
RECRUITING
Clarkston
Missouri
Dermatology and Skin Center of Lees Summit /ID# 263567
RECRUITING
Lee's Summit
MediSearch Clinical Trials /ID# 263582
RECRUITING
Saint Joseph
North Carolina
Wake Forest University Baptist Medical Center (WFUBMC) /ID# 264507
RECRUITING
Winston-salem
New Hampshire
Dartmouth Hitchcock Medical Center - Old Etna Road /ID# 263713
RECRUITING
Lebanon
StracSkin, PLLC /ID# 263387
RECRUITING
Portsmouth
Nevada
Vivida Dermatology- Flamingo /ID# 263716
RECRUITING
Las Vegas
New York
Mount Sinai Doctors - Dermatology /ID# 264602
RECRUITING
New York
Ohio
Dermatology of Greater Columbus /ID# 263497
RECRUITING
Bexley
University Hospitals Cleveland Medical Center /ID# 263600
RECRUITING
Cleveland
Ohio State Officenter Gahanna /ID# 263598
RECRUITING
Gahanna
Dermatologists of Southwest Ohio - Mason /ID# 263588
RECRUITING
Mason
Apex Clinical Research Center /ID# 272787
RECRUITING
Mayfield Heights
Pennsylvania
Dermatology Partners /ID# 264999
RECRUITING
Philadelphia
University of Pittsburgh Medical Center /ID# 264590
RECRUITING
Pittsburgh
South Carolina
Clinical Research Center of the Carolinas /ID# 263407
RECRUITING
Charleston
Medical University of South Carolina /ID# 263890
RECRUITING
Charleston
ADCS - Spartanburg /ID# 267207
RECRUITING
Spartanburg
Texas
Arlington Research Center, Inc /ID# 263895
RECRUITING
Arlington
Bellaire Dermatology Associates /ID# 263850
RECRUITING
Bellaire
Studies in Dermatology LLC /ID# 263399
RECRUITING
Cypress
Reveal Research Institute - Dallas /ID# 267233
RECRUITING
Dallas
Center for Clinical Studies - Houston - Binz Street /ID# 263378
RECRUITING
Houston
Texas Dermatology Research Center /ID# 264488
RECRUITING
Plano
Texas Dermatology and Laser Specialists /ID# 263778
RECRUITING
San Antonio
Dermatology Associates of Tyler /ID# 265002
RECRUITING
Tyler
Utah
University of Utah /ID# 263818
RECRUITING
Murray
Virginia
Virginia Clinical Research /ID# 264553
RECRUITING
Norfolk
Washington
Dermatology Specialists of Spokane /ID# 264499
RECRUITING
Spokane
Other Locations
Argentina
Buenos Aires Skin /ID# 264299
RECRUITING
Buenos Aires
Consultorios Reumatologicos Pampa /ID# 265911
RECRUITING
Ciudad Autonoma De Buenos Aire
Instituto De Investigaciones Clínicas Córdoba /ID# 264297
RECRUITING
Córdoba
Instituto de Especialidades de la Salud Rosario - Clínica del Tórax /ID# 266132
RECRUITING
Rosario
Australia
Momentum Clinical Research /ID# 263192
RECRUITING
Darlinghurst
Sinclair Dermatology - Melbourne /ID# 263121
RECRUITING
East Melbourne
Premier Dermatology /ID# 263124
RECRUITING
Kogarah
Paratus Clinical Research Woden /ID# 263125
RECRUITING
Phillip
Veracity Clinical Research /ID# 263126
RECRUITING
Woolloongabba
Austria
Medizinische Universitaet Graz /ID# 263306
RECRUITING
Graz
Medizinische Universitaet Wien /ID# 264043
RECRUITING
Vienna
Belgium
Universite Libre de Bruxelles - Hopital Erasme /ID# 263097
RECRUITING
Anderlecht
Cliniques Universitaires UCL Saint-Luc /ID# 263096
RECRUITING
Brussels
Grand Hôpital de Charleroi - Les Viviers /ID# 263100
RECRUITING
Charleroi
UZ Gent /ID# 263099
RECRUITING
Ghent
Universitair Ziekenhuis Brussel /ID# 263101
RECRUITING
Jette
Universitair Ziekenhuis Leuven /ID# 263098
RECRUITING
Leuven
CHU de Liege /ID# 263095
RECRUITING
Liège
Bosnia and Herzegovina
Klinicki centar Banja Luka /ID# 265905
RECRUITING
Banja Luka
Klinicki centar Banja Luka /ID# 265909
RECRUITING
Banja Luka
Clinical Center University of Sarajevo - Bolnička /ID# 265908
RECRUITING
Sarajevo
University Clinical Center Tuzla /ID# 265906
RECRUITING
Tuzla
Bulgaria
Medical Center Cordis /ID# 262894
RECRUITING
Pleven
Acibadem City Clinic Tokuda Hospital /ID# 263300
RECRUITING
Sofiya
Ambulatory for Specialized Medical Care-IPSMC-skin and venereal diseases /ID# 262891
RECRUITING
Sofiya
Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 262893
RECRUITING
Sofiya
Medical Center Hera EOOD /ID# 263010
RECRUITING
Sofiya
UMHAT Professor Stoyan Kirkovich /ID# 262892
RECRUITING
Stara Zagora
Canada
Beacon Dermatology Inc /ID# 264262
RECRUITING
Calgary
Skin Health /ID# 267735
RECRUITING
Cobourg
Rejuvenation Dermatology - Edmonton Downtown /ID# 265963
RECRUITING
Edmonton
Stratica Dermatology /ID# 265856
RECRUITING
Edmonton
Brunswick Dermatology Center /ID# 264260
RECRUITING
Fredericton
Leader Research /ID# 266114
RECRUITING
Hamilton
Interior Dermatology Centre - Probity - PPDS /ID# 266202
RECRUITING
Kelowna
DermEffects /ID# 265262
RECRUITING
London
Derm Care Clinic /ID# 265261
RECRUITING
Mississauga
Centre de Recherche Saint-Louis /ID# 265855
RECRUITING
Québec
Diex Recherche Quebec Inc. /ID# 265263
RECRUITING
Québec
York Dermatology Clinic & Research Centre /ID# 265265
RECRUITING
Richmond Hill
Private Practice - Dr. Angelique Gagne-Henley /ID# 264263
RECRUITING
Saint-jérôme
SkinSense Dermatology /ID# 265964
RECRUITING
Saskatoon
Karma Clinical Trials /ID# 265962
RECRUITING
St. John's
FACET Dermatology /ID# 265267
RECRUITING
Toronto
Private Practice - Dr. Kim Papp Clinical Research /ID# 265266
RECRUITING
Waterloo
Chile
Fundacion Innovacion Cardiovascular /ID# 264844
RECRUITING
Independencia
Centro Internacional de Estudios Clinicos - CIEC /ID# 266129
RECRUITING
Santiago
Clinica Dermacross /ID# 266127
RECRUITING
Vitacura
Croatia
Klinicki Bolnicki Centar Zagreb /ID# 263989
RECRUITING
Grad Zagreb
Klinicki bolnicki centar Osijek /ID# 265916
RECRUITING
Osijek
Specialty Hospital Medico /ID# 263922
RECRUITING
Rijeka
Klinicki Bolnicki Centar Sestre Milosrdnice /ID# 265069
RECRUITING
Zagreb
Denmark
Aarhus Universitetshospital - Skejby /ID# 265657
RECRUITING
Aarhus
Herlev and Gentofte Hospital /ID# 265839
RECRUITING
Hellerup
France
Hopital Edouard Herriot /ID# 263456
RECRUITING
Lyon
Cabinet medical - Le bateau Blanc /ID# 263465
RECRUITING
Martigues
Groupe Hospitalier Paris Saint-Joseph /ID# 263996
RECRUITING
Paris
Polyclinique Courlancy /ID# 263313
RECRUITING
Reims
Centre Hospitalier Universitaire de Rouen (CHU)- Hopital Charles Nicolle /ID# 263995
RECRUITING
Rouen
Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 263459
RECRUITING
St-priest-en-jarez
Germany
Fachklinik Bad Bentheim /ID# 263067
RECRUITING
Bad Bentheim
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 263076
RECRUITING
Berlin
Katholisches Klinikum Bochum /ID# 262976
RECRUITING
Bochum
Rosenpark Research /ID# 269202
RECRUITING
Darmstadt
Universitaetsklinikum Erlangen /ID# 263075
RECRUITING
Erlangen
Universitaetsklinikum Freiburg /ID# 263659
RECRUITING
Freiburg Im Breisgau
Hautarztpraxis Dr. Kirschner /ID# 263656
RECRUITING
Mainz
Beldio Research GmbH /ID# 263074
RECRUITING
Memmingen
HMS GmbH Zimmer /ID# 278634
RECRUITING
Merzig
Universitaetsklinikum Muenster /ID# 263068
RECRUITING
Münster
Hautarztpraxis Mortazawi /ID# 271673
RECRUITING
Remscheid
Universitaetsklinikum Tuebingen /ID# 271718
RECRUITING
Tübingen
Greece
General Hospital Andreas Syggros /ID# 263417
RECRUITING
Athens
University General Hospital Attikon /ID# 263413
RECRUITING
Athens
Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 263416
RECRUITING
Thessaloniki
Papageorgiou General Hospital /ID# 263415
RECRUITING
Thessaloniki
Guatemala
Dermos S.A. /ID# 265857
RECRUITING
Guatemala City
Prosalud /Id# 266586
RECRUITING
Guatemala City
Hungary
Semmelweis Egyetem /ID# 263451
RECRUITING
Budapest
Debreceni Egyetem-Klinikai Kozpont /ID# 263423
RECRUITING
Debrecen
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 263424
RECRUITING
Kaposvár
Pécsi Tudományegyetem /ID# 264120
RECRUITING
Pécs
Ireland
South Infirmary Victoria University Hospital /ID# 265872
RECRUITING
Cork
Our Lady of Lourdes Hospital - Drogheda /ID# 265893
RECRUITING
Drogheda
Mater Misericordiae University Hospital /ID# 265914
RECRUITING
Dublin
University College Dublin /ID# 265875
RECRUITING
Dublin
Israel
HaEmek Medical Center /ID# 267297
RECRUITING
Afula
Rambam Health Care Campus /ID# 262994
RECRUITING
Haifa
Hadassah Medical Center-Hebrew University /ID# 262884
RECRUITING
Jerusalem
Galilee Medical Center /ID# 262995
RECRUITING
Nahariya
Rabin Medical Center /ID# 262992
RECRUITING
Petah Tikva
The Chaim Sheba Medical Center /ID# 262993
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center /ID# 266581
RECRUITING
Tel Aviv
Italy
AOU Policlinico G. Rodolico - San Marco /ID# 263469
RECRUITING
Catania
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale S.Anna /ID# 263474
RECRUITING
Cona
AZIENDA USL TOSCANA CENTRO - Ospedale Piero Palagi /ID# 263454
RECRUITING
Florence
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 263471
RECRUITING
Milan
Azienda Ospedaliera Universitaria Federico II /ID# 263539
RECRUITING
Naples
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 263473
RECRUITING
Rome
IRCCS Istituto Clinico Humanitas /ID# 263503
RECRUITING
Rozzano
Japan
Fukuoka University Hospital /ID# 263991
RECRUITING
Fukuoka
University of the Ryukyus Hospital /ID# 264605
RECRUITING
Ginowan-shi
Dokkyo Medical University Saitama Medical Center /ID# 265400
RECRUITING
Koshigaya
University Hospital Kyoto Prefectural University of Medicine /ID# 264291
RECRUITING
Kyoto
Iwate Medical University Uchimaru Medical Center /ID# 273799
RECRUITING
Morioka
Nagoya City University Hospital /ID# 263874
RECRUITING
Nagoya
Niigata University Medical & Dental Hospital /ID# 276568
RECRUITING
Niigata
Takagi Dermatological Clinic /ID# 264810
COMPLETED
Obihiro-shi
Osaka Metropolitan University Hospital /ID# 265682
RECRUITING
Osaka
Kindai University Hospital /ID# 264322
RECRUITING
Sakai
Nihon University Itabashi Hospital /ID# 264661
RECRUITING
Tokyo
Fujita Health University Hospital /ID# 265440
RECRUITING
Toyoake
Mexico
Grupo Clinico CATEI S C /ID# 265276
RECRUITING
Guadalajara
Cryptex Investigación Clínica /ID# 265271
RECRUITING
Mexico City
Eukarya PharmaSite /ID# 265307
RECRUITING
Monterrey
Sociedad de Metabolismo y Corazon S.C. /ID# 265915
RECRUITING
Veracruz
Netherlands
Erasmus Medisch Centrum /ID# 263377
RECRUITING
Rotterdam
New Zealand
Greenlane Clinical Centre /ID# 263191
RECRUITING
Epsom
Clinical Trials New Zealand /ID# 265432
RECRUITING
Hamilton
Norway
Oslo University Hospital - Rikshospitalet /ID# 265996
RECRUITING
Oslo
Stavanger Universitetssykehus /ID# 265997
RECRUITING
Stavanger
Universitetssykehuset I Nord-Norge /ID# 265992
RECRUITING
Tromsø
Poland
Oftalmika sp. z o.o. /ID# 263087
RECRUITING
Bydgoszcz
Centrum Medyczne Angelius Provita /ID# 277204
RECRUITING
Katowice
Centrum Nowoczesnych Terapii 'Dobry Lekarz' sp.z.o.o. /ID# 263146
RECRUITING
Krakow
Specjalistyczny gabinet dermatologiczny Aplikacyjno-Badawczy Marek Brzewski, Paw /ID# 277221
RECRUITING
Krakow
DERMED Centrum Medyczne Sp. z o.o /ID# 263147
RECRUITING
Lodz
Santa Sp. z o..o. Santa Familia PTG Lodz /ID# 263181
RECRUITING
Lodz
Klinika Ambroziak Dermatologia /ID# 263173
RECRUITING
Warsaw
Panstwowy Instytut Medyczny Mswia /Id# 277307
RECRUITING
Warsaw
Portugal
Unidade Local de Saude do Alto Ave, EPE /ID# 265158
RECRUITING
Guimarães
CUF Descobertas Hospital /ID# 263188
RECRUITING
Lisbon
Unidade Local de Saude de Sao Jose, EPE /ID# 265155
RECRUITING
Lisbon
Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 265479
RECRUITING
Porto
Puerto Rico
Private Practice - Dr. Alma Cruz /ID# 263204
RECRUITING
Carolina
Clinical Research Puerto Rico /ID# 263450
RECRUITING
San Juan
Republic of Korea
Korea University Ansan Hospital /ID# 264227
RECRUITING
Ansan-si
Pusan National University Hospital /ID# 271496
RECRUITING
Busan
SoonChunHyang University Hospital Cheonan /ID# 271320
RECRUITING
Cheonan-si
CHA Bundang Medical Center /ID# 264225
RECRUITING
Seongnam
Asan Medical Center /ID# 264228
RECRUITING
Seoul
Hallym University Kangnam Sacred Heart Hospital /ID# 264226
RECRUITING
Seoul
SoonChunHyang University Seoul Hospital /ID# 264224
RECRUITING
Seoul
The Catholic University Of Korea, Eunpyeong St. Mary'S Hospital /ID# 271348
RECRUITING
Seoul
Yonsei University Health System Severance Hospital /ID# 271353
RECRUITING
Seoul
Romania
Centrul Medical Euromed /ID# 263304
RECRUITING
Bucharest
Spitalul Clinic Colentina /ID# 263303
RECRUITING
Bucharest
Private Practice - Dr. Orasan Remus /ID# 263305
RECRUITING
Cluj-napoca
Saudi Arabia
King Abdulaziz Medical City /ID# 266121
RECRUITING
Jeddah
King Saud University Med City /ID# 266120
RECRUITING
Riyadh
Serbia
Military Medical Academy /ID# 263257
RECRUITING
Belgrade
University Clinical Center Serbia /ID# 263256
RECRUITING
Belgrade
University Clinical Center Kragujevac /ID# 264211
RECRUITING
Kragujevac
University Clinical Center Vojvodina /ID# 263260
RECRUITING
Novi Sad
Singapore
National Skin Centre /ID# 264680
RECRUITING
Singapore
National University Hospital /ID# 264673
RECRUITING
Singapore
Slovakia
Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 263921
RECRUITING
Bratislava
Univerzitna nemocnica L. Pasteura Kosice /ID# 263907
RECRUITING
Košice
Fakultna nemocnica s poliklinikou Nove Zamky /ID# 265944
RECRUITING
Nové Zámky
Fakultna nemocnica Trnava /ID# 263905
RECRUITING
Trnava
Slovenia
University Medical Centre Ljubljana /ID# 265720
RECRUITING
Ljubljana
University Medical Centre Maribor /ID# 265827
RECRUITING
Maribor
South Africa
Life Chatsmed Garden Hospital /ID# 270237
RECRUITING
Chatsworth
Ahmed Al-Kadi Private Hospital /ID# 262837
RECRUITING
Durban
Global Clinical Trials /ID# 262839
RECRUITING
Pretoria
Dr Ahmed Ismail Manjra /ID# 262838
RECRUITING
Westville
Spain
Hospital General Universitario Gregorio Maranon /ID# 262940
RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria /ID# 262941
RECRUITING
Málaga
Hospital de Manises /ID# 262938
RECRUITING
Manises
Hospital Universitari Parc Tauli /ID# 262942
RECRUITING
Sabadell
Hospital Universitario Marques de Valdecilla /ID# 263039
RECRUITING
Santander
Consorci Hospital General Universitario de Valencia /ID# 262944
RECRUITING
Valencia
Sweden
Universitetssjukhuset Örebro /ID# 265064
RECRUITING
Örebro
Karolinska University Hospital Solna /ID# 264530
RECRUITING
Solna
Switzerland
University Hospital Basel /ID# 264245
RECRUITING
Basel Town
Dermatology & Skin Care Clinic /ID# 264030
RECRUITING
Buochs
Kantonsspital St.Gallen /ID# 264238
RECRUITING
Sankt Gallen
University Hospital Zurich /ID# 266142
RECRUITING
Zurich
Taiwan
Kaohsiung Chang Gung Memorial Hospital /ID# 264619
RECRUITING
Kaohsiung City
Taichung Veterans General Hospital /ID# 270741
RECRUITING
Taichung
Mackay Memorial Hospital /ID# 263661
RECRUITING
Taipei
Taipei Veterans General Hospital /ID# 265879
RECRUITING
Taipei
National Taiwan University Hospital /ID# 264618
RECRUITING
Taipei City
Linkou Chang Gung Memorial Hospital /ID# 264620
RECRUITING
Taoyuan
United Kingdom
Bristol Royal Infirmary /ID# 263937
RECRUITING
Bristol
Queen Margaret Hospital /ID# 264198
RECRUITING
Dunfermline
Gloucestershire Royal Hospital /ID# 265848
RECRUITING
Gloucester
Harrogate District Hospital /ID# 265632
RECRUITING
Harrogate
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 264121
RECRUITING
London
Royal Victoria Infirmary /ID# 273368
RECRUITING
Newcastle Upon Tyne
Southlands Hospital /ID# 276976
RECRUITING
Shoreham-by-sea
Royal Cornwall Hospital /ID# 277507
RECRUITING
Truro
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2024-06-27
Estimated Completion Date: 2026-12
Participants
Target number of participants: 1280
Treatments
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 .
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
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
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.
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
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
Experimental: Period 3: Open-label Lutikizumab
Starting at Week 68 in Period 3, all participants will receive Open-label Lutikizumab every other week
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.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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