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Recruiting Phase 3 NCT06468228

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

Phase 3 – large-scale trial before approval
Conditions: Hidradenitis Suppurativa

Sponsor: AbbVie

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 39
Argentina (1)
Consultorios Reumatologicos Pampa /ID# 265911
Ciudad Autonoma de Buenos Aire , Buenos Aires F.D.
Site Coordinator
Australia (1)
Paratus Clinical Research Woden /ID# 263125
Phillip , Australian Capital Territory
Belgium (1)
Universite Libre de Bruxelles - Hopital Erasme /ID# 263097
Anderlecht , Brussels Capital
Bosnia and Herzegovina (1)
Clinical Center University of Sarajevo - Bolnicka /ID# 265908
Sarajevo , Federation of Bosnia and Herzegovina
Bulgaria (1)
Acibadem City Clinic Tokuda Hospital /ID# 263300
Sofiya , Sofia
Canada (1)
Beacon Dermatology Inc /ID# 264262
Calgary , Alberta
Chile (1)
Centro Internacional de Estudios Clinicos - CIEC /ID# 266129
Santiago , Region Metropolitana Santiago
Colombia (1)
Centro de Inmunología y Genética CIGE SAS /ID# 263793
Medellín , Antioquia
Croatia (1)
Klinicki Bolnicki Centar Zagreb /ID# 263989
Grad Zagreb , City of Zagreb
Czech Republic (1)
Fakultni nemocnice Ostrava /ID# 264041
Ostrava , Ostrava-mesto
Denmark (1)
Herlev and Gentofte Hospital /ID# 265839
Hellerup , Capital Region
France (1)
Hopital Edouard Herriot /ID# 263456
Lyon , Auvergne-Rhône-Alpes
Greece (1)
University General Hospital Attikon /ID# 263413
Athens , Attica
Guatemala (1)
Dermos S.A. /ID# 265857
Guatemala City
Hungary (1)
Pécsi Tudományegyetem /ID# 264120
Pécs , Baranya
Ireland (1)
Our Lady of Lourdes Hospital - Drogheda /ID# 265893
Drogheda , Louth
Israel (1)
Rabin Medical Center /ID# 262992
Petah Tikva , Central District
Italy (1)
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale S.Anna /ID# 263474
Cona , Ferrara
Japan (1)
Nagoya City University Hospital /ID# 263874
Nagoya , Aichi-ken
Lithuania (1)
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 277709
Kaunas
Mexico (1)
Grupo Clinico CATEI S C /ID# 265276
Guadalajara , Jalisco
Site Coordinator
Netherlands (1)
Erasmus Medisch Centrum /ID# 263377
Rotterdam , South Holland
New Zealand (1)
Greenlane Clinical Centre /ID# 263191
Epsom , Auckland
Norway (1)
Stavanger Universitetssykehus /ID# 265997
Stavanger , Rogaland
Poland (1)
Oftalmika sp. z o.o. /ID# 263087
Bydgoszcz , Kuyavian-Pomeranian Voivodeship
Puerto Rico (1)
Private Practice - Dr. Alma Cruz /ID# 263204
Carolina
Romania (1)
Spitalul Clinic Colentina /ID# 263303
Bucharest , Bucharest
Saudi Arabia (1)
King Abdulaziz Medical City /ID# 266121
Jeddah , Mecca Region
Serbia (1)
Military Medical Academy /ID# 263257
Belgrade , Beograd
Singapore (1)
National University Hospital /ID# 264673
Singapore
Site Coordinator
Slovakia (1)
Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 263921
Bratislava , Bratislava Region
South Africa (1)
Global Clinical Trials /ID# 262839
Pretoria , Gauteng
South Korea (1)
Pusan National University Hospital /ID# 271496
Busan , Busan Gwang Yeogsi
Spain (1)
Hospital Universitari Parc Tauli /ID# 262942
Sabadell , Barcelona
Sweden (1)
Karolinska University Hospital Solna /ID# 264530
Solna , Stockholm County
Taiwan (1)
Kaohsiung Chang Gung Memorial Hospital /ID# 264619
Kaohsiung City , Kaohsiung
Turkey (1)
Pamukkale University Medical Faculty Hospital /ID# 264734
Chonai , Denizli
United Kingdom (1)
Royal Cornwall Hospital /ID# 277507
Truro , Cornwall
United States (1)
Cahaba Dermatology & Skin Health Center /ID# 263795
Birmingham , Alabama
Site Coordinator
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
12 Years
Healthy volunteers
No
Start date
27.06.2024
Completion date
01.12.2026
Registry ID
NCT06468228
Source
anzctr
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