Исследование JNJ-77242113 для лечения участников с бляшечным псориазом от умеренной до тяжелой степени (ICONIC-ADVANCE 2)
27 августа 2026 г. обновлено: Janssen Research & Development, LLC
Многоцентровое, рандомизированное, двойное слепое, плацебо-контролируемое и активное исследование деукравацитиниба под контролем компаратора фазы 3 для оценки эффективности и безопасности JNJ-77242113 для лечения участников с бляшечным псориазом от умеренной до тяжелой степени
Цель исследования — оценить, насколько эффективен JNJ-77242113 у участников с бляшечным псориазом от умеренной до тяжелой степени по сравнению с плацебо и деукравацитинибом.
Обзор исследования
Статус
Активный, не рекрутирующий
Условия
Тип исследования
Интервенционный
Регистрация (Действительный)
731
Фаза
- Фаза 3
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Benowa, Австралия, 4217
- The Skin Centre
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Clayton, Австралия, 3168
- Monash Medical Centre
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Kogarah, Австралия, 2217
- Premier Specialists
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Melbourne, Австралия, 3004
- The Alfred Hospital
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Mitcham, Австралия, 3132
- ISHI dermatology
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Parkville, Австралия, 3050
- Royal Melbourne Hospital
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Botucatu, Бразилия, 18618-686
- UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
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Brasília, Бразилия, 72145-450
- Chronos Clinica Medica Ltda
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Ribeirão Preto, Бразилия, 14051140
- Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
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São José do Rio Preto, Бразилия, 15090-000
- Funfarme Sjrp
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São Paulo, Бразилия, 05403 900
- Hospital Das Clinicas Da Faculdade De Medicina Da USP
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São Paulo, Бразилия, 09060-870
- Cepes - Fmabc
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Budapest, Венгрия, 1152
- Uno Medical Trials Ltd.
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Gyula, Венгрия, 5700
- Synexus Magyarorszag Kft
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Gyöngyös, Венгрия, 3200
- Bugat Pal Korhaz
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Kecskemét, Венгрия, 6000
- Bacs Kiskun Varmegyei Oktatokorhaz
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Zalaegerszeg, Венгрия, H-8900
- Synexus Magyarorszag Kft 1
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Augsburg, Германия, 86150
- Hautarztpraxis Dr. Mihaescu
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Bad Bentheim, Германия, 48455
- Fachklinik Bad Bentheim
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Berlin, Германия, 13627
- CRS Clinical Research Services Berlin GMBH
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Bochum, Германия, 44793
- Niesmann & Othlinghaus GbR
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Darmstadt, Германия, 64283
- Klinikum Darmstadt GmbH - Hautklinik
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Dresden, Германия, 01307
- Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
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Dülmen, Германия, 48249
- Hautzentrum Dulmen
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Düsseldorf, Германия, 40212
- Privatpraxis Dr. Hilton & Partner
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Friedrichshafen, Германия, 88045
- Derma-Study-Center Friedrichshafen GmbH
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Hamburg, Германия, 20095
- Eurofins bioskin GmbH
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Heidelberg, Германия, 69120
- Universitaetsklinikum Heidelberg
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Mahlow, Германия, 15831
- Hautarztpraxis
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Mainz, Германия, 55131
- Universitatsmedizin der Johannes Gutenberg Universitat Mainz
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Merzig, Германия, 66663
- Hautmedizin Saar Science Hms GmbH
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Münster, Германия, 48149
- Universitaetsklinikum Muenster
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Oldenburg, Германия, 26133
- Klinikum Oldenburg
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Witten, Германия, 58453
- Hautarztpraxis 1
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Wuppertal, Германия, 42287
- CentroDerm GmbH
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Alcorcón, Испания, 28922
- Hosp. Univ. Fundacion Alcorcon
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Badalona, Испания, 08916
- Hosp. Univ. Germans Trias I Pujol
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Barcelona, Испания, 08036
- Hosp Clinic de Barcelona
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Manises, Испания, 46940
- Hosp. de Manises
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Salamanca, Испания, 37007
- Hosp Clinico Univ de Salamanca
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Santiago de Compostela, Испания, 15702
- Clinica Gaias
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Santiago de Compostela, Испания, 15706
- Hosp. Clinico Univ. de Santiago
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Seville, Испания, 41009
- Hosp. Virgen Macarena
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Seville, Испания, 41014
- Hosp. Ntra. Sra. de Valme
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Villajoyosa, Испания, 03570
- Hosp. de La Marina Baixa
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Zaragoza, Испания, 50009
- Hosp. Clinico Univ. Lozano Blesa
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British Columbia
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Surrey, British Columbia, Канада, V3R 6A7
- Dr. Chih ho Hong Medical
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Manitoba
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Winnipeg, Manitoba, Канада, R3M 3Z4
- Wiseman Dermatology Research Inc.
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Ontario
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London, Ontario, Канада, N6A 5R9
- Lovegrove Dermatology
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Markham, Ontario, Канада, L3P 1X2
- Lynderm Research Inc.
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Mississauga, Ontario, Канада, L4Y 4C5
- DermEdge Research
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Peterborough, Ontario, Канада, K9J 5K2
- SKiN Centre for Dermatology
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Toronto, Ontario, Канада, M3H 5Y8
- Toronto Research Centre
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Toronto, Ontario, Канада, M2N 3A6
- North York Research Inc
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Windsor, Ontario, Канада, N8T 1E6
- XLR8 Medical Research
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Quebec
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Montreal, Quebec, Канада, H2X 2V1
- Innovaderm Research Inc.
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Québec, Quebec, Канада, G1V 4X7
- Centre de Recherche Dermatologique du Quebec metropolitain
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Bialystok, Польша, 15 797
- Renew Clinic
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Katowice, Польша, 40 568
- CaRe Clinic
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Katowice, Польша, 40 611
- Centrum Medyczne Angelius Provita
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Kielce, Польша, 25-316
- Prywatny Gabinet Dermatologiczny Elzbieta Klujszo
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Krakow, Польша, 30-002
- SGD s.c.
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Krakow, Польша, 30-303
- Krakowskie Centrum Badan Klinicznych
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Krakow, Польша, 30-348
- Jagiellonskie Centrum Innowacji
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Krakow, Польша, 31 559
- Diamond Clinic
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Olsztyn, Польша, 10-117
- Etyka Osrodek Badan Klinicznych
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Warsaw, Польша, 02-962
- Royalderm Agnieszka Nawrocka
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Warsaw, Польша, 02 661
- Carpe Diem Centrum Medycyny Estetycznej
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Warsaw, Польша, 02 672
- Synexus Polska Sp z o o Oddzial w Warszawie
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Wroclaw, Польша, 51 685
- WroMedica I Bielicka A Strzalkowska s c
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Cluj-Napoca, Румыния, 400105
- Cabinet Medical Dermato-Venerologie
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Craiova, Румыния, 200541
- Centrul Medical Vitaplus
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Craiova, Румыния, 200642
- Spitalul Clinic Județean de Urgență
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Iași, Румыния, 700381
- Sc Iasiprest Srl
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Oradea, Румыния, 410167
- Spitalul Clinic Judetean De Urgenta Bihor
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Timișoara, Румыния, 300757
- New Derm Clinic
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Târgu Mureş, Румыния, 540342
- Spitalul Clinic Judetean Mures
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Arizona
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Phoenix, Arizona, Соединенные Штаты, 85032
- Alliance Dermatology and MOHS Center P C
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California
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Encinitas, California, Соединенные Штаты, 92024
- California Dermatology & Clinical Research Institute
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Encino, California, Соединенные Штаты, 91436
- T Joseph Raoof Md Inc
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Fresno, California, Соединенные Штаты, 93701
- Ucsf Fresno
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Los Angeles, California, Соединенные Штаты, 90056
- Wallace Medical Group, Inc
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Los Angeles, California, Соединенные Штаты, 90024
- University of California Los Angeles - Division of Dermatology
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Oceanside, California, Соединенные Штаты, 92056
- Dermatologist Medical Group of North County, Inc.
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Florida
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Miami, Florida, Соединенные Штаты, 33155
- Bioclinical Research Alliance Inc.
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Miami, Florida, Соединенные Штаты, 33133
- Miami Dermatology And Laser Institute
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Tampa, Florida, Соединенные Штаты, 33613
- Forcare Clinical Research Inc
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Georgia
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Douglasville, Georgia, Соединенные Штаты, 30135
- Southeast Dermatology Specialists
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Illinois
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Rolling Meadows, Illinois, Соединенные Штаты, 60008
- Arlington Dermatology
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Kentucky
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Louisville, Kentucky, Соединенные Штаты, 40217
- Skin Sciences, PLLC
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Owensboro, Kentucky, Соединенные Штаты, 42301
- Qualmedica Research
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Maryland
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Rockville, Maryland, Соединенные Штаты, 20850
- DermAssociates, PC
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Massachusetts
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Brighton, Massachusetts, Соединенные Штаты, 02135
- Metro Boston Clinical Partners
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Methuen, Massachusetts, Соединенные Штаты, 01844
- ActivMed Practices and Research
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Michigan
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Ann Arbor, Michigan, Соединенные Штаты, 48109
- University of Michigan
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Bay City, Michigan, Соединенные Штаты, 48706
- Great Lakes Research Group
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Caledonia, Michigan, Соединенные Штаты, 49316
- The Derm Institute of West Michigan
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Canton, Michigan, Соединенные Штаты, 48187
- Hamzavi Dermatology
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Troy, Michigan, Соединенные Штаты, 48084
- Somerset Skin Centre
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Missouri
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Kirksville, Missouri, Соединенные Штаты, 63501
- Cleaver Dermatology
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Ohio
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Bexley, Ohio, Соединенные Штаты, 43209
- Bexley Dermatology Research
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Oklahoma
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Tulsa, Oklahoma, Соединенные Штаты, 74137
- Essential Medical Research
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Oregon
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Portland, Oregon, Соединенные Штаты, 97210-2996
- Oregon Dermatology & Research Center
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Pennsylvania
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Philadelphia, Pennsylvania, Соединенные Штаты, 19103
- Paddington Testing Co, Inc.
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South Carolina
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Charleston, South Carolina, Соединенные Штаты, 29407
- Clinical Research Center of the Carolinas LLC
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Greenville, South Carolina, Соединенные Штаты, 29615
- Palmetto Clinical Trial Services, LLC
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Texas
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Arlington, Texas, Соединенные Штаты, 76011
- Arlington Research Center, inc.
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Dallas, Texas, Соединенные Штаты, 75390
- UT Southwestern Medical Center
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San Antonio, Texas, Соединенные Штаты, 78229
- Dermatology Clinical Research Center of San Antonio
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Webster, Texas, Соединенные Штаты, 77598
- Center for Clinical Studies
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Utah
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Bountiful, Utah, Соединенные Штаты, 84010
- Cope Family Medicine - Ogden Clinic
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Springville, Utah, Соединенные Штаты, 84663
- Springville Dermatology CCT Research
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West Valley City, Utah, Соединенные Штаты, 84120
- Kalo Clinical Research
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Virginia
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Norfolk, Virginia, Соединенные Штаты, 23502
- Virginia Dermatology Skin Cancer Center Pllc
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Kaohsiung City, Тайвань, 81362
- Kaohsiung Veterans General Hospital
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Kaohsiung City, Тайвань, 80756
- Kaohsiung Medical University Chung Ho Memorial Hospital
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Taichung, Тайвань, 40705
- Taichung Veterans General Hospital
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Taichung, Тайвань, 40201
- Chung Shan Medical University Hospital
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Tainan, Тайвань, 710
- National Cheng Kung University Hospital
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Taipei, Тайвань, 110
- Taipei Medical University
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Taipei, Тайвань, 116
- Taipei Municipal Wanfang Hospital
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Ansan-si, Южная Корея, 15355
- Korea University Ansan Hospital
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Anyang-si, Южная Корея, 14068
- Hallym University Sacred Heart Hospital
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Bucheon-si, Южная Корея, 14647
- The Catholic University of Korea Bucheon St Mary s Hospital
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Gwangju, Южная Корея, 61453
- Chosun University Hospital
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Seongnam, Южная Корея, 13496
- CHA Bundang Medical Center, CHA University
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Seoul, Южная Корея, 05505
- Asan Medical Center
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Seoul, Южная Корея, 8308
- Korea University Guro Hospital
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
Критерии включения:
- Диагностика бляшечного псориаза с псориатическим артритом (ПсА) или без него в течение как минимум 26 недель до первого применения исследуемого вмешательства.
- Общая площадь поверхности тела (ОПТ) превышает или равна (>=) 10 процентам (%) на момент скрининга и исходного уровня.
- Общая площадь и индекс тяжести псориаза (PASI) >=12 при скрининге и исходном уровне
- Общая оценка исследователя (IGA) >=3 на момент скрининга и на исходном уровне
- Кандидат на фототерапию или системное лечение бляшечного псориаза.
Критерий исключения:
- Небляшечная форма псориаза (например, эритродермическая, каплевидная или пустулезная)
- Текущий псориаз, вызванный лекарственными средствами (например, новое начало псориаза или обострение псориаза из-за приема бета-блокаторов, блокаторов кальциевых каналов или лития)
- Текущий диагноз или признаки или симптомы тяжелых, прогрессирующих или неконтролируемых нарушений почек, печени, сердца, сосудов, легких, желудочно-кишечного тракта, эндокринной, неврологической, гематологической, ревматологической, психиатрической или метаболической патологии.
- Известная аллергия, гиперчувствительность или непереносимость JNJ-77242113 или его вспомогательных веществ.
- Крупная хирургическая процедура (например, требующая общей анестезии) в течение 8 недель до скрининга, или не полностью восстановился после хирургической процедуры, или хирургическая процедура запланирована на то время, когда участник, как ожидается, будет участвовать в исследовании.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: JNJ-77242113
Участники будут получать JNJ-77242113 с 0 по 156 неделю и деукравацитиниб, соответствующий плацебо, с 0 по 24 неделю.
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JNJ-77242113 будет вводиться перорально.
Деукравацитиниб, соответствующий плацебо, будет вводиться перорально.
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Плацебо Компаратор: Плацебо
Участники получат соответствующее плацебо для JNJ-77242113 с 0 по 16 неделю, соответствующее плацебо для деукравацитиниба с 0 по 24 неделю и JNJ-77242113 с 16 по 156 неделю.
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JNJ-77242113 будет вводиться перорально.
Соответствующее плацебо JNJ-77242113 будет вводиться перорально.
Деукравацитиниб, соответствующий плацебо, будет вводиться перорально.
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Активный компаратор: Деукравацитиниб
Участники будут получать деукравацитиниб с 0 по 24 неделю и соответствующее плацебо для JNJ-77242113 с 0 по 24 неделю и JNJ-77242113 с 24 по 156 неделю.
|
JNJ-77242113 будет вводиться перорально.
Соответствующее плацебо JNJ-77242113 будет вводиться перорально.
Деукравацитиниб назначают перорально.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2-Grade Improvement From Baseline at Week 16
Временное ограничение: Week 16
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IGA assesses participant's plaque psoriasis.
Lesions were graded for induration, erythema and scaling, each using 5 point scale.
Induration: 0 =no evidence of plaque elevation, 1=minimal plaque elevation,= 0.25 millimeters (mm); 2=mild plaque elevation,= 0.5 mm; 3=moderate plaque elevation,= 0.75 mm; 4=severe plaque elevation, greater than (>) 1 mm; Erythema: 0=no evidence of erythema, hyperpigmentation may be present, 1=faint erythema, 2=light red coloration, 3=moderate red coloration, 4=bright red coloration; Scaling: 0=no evidence of scaling, 1=minimal; 2=mild; fine scale dominates, 3=moderate; coarse scale predominates, 4=severe; thick, scale predominates.
Final IGA score of psoriasis was based upon average of induration, erythema and scaling scores assessed on 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Higher score=more severe disease.
Baseline=closest measurement taken prior to or at the time of first study drug administration date.
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Week 16
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Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Временное ограничение: Week 16
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Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Week 16 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
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Week 16
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Изменение общего балла PASI от исходного уровня на 16-й неделе
Временное ограничение: Исходный уровень (неделя 0), неделя 16
|
Изменение от исходного уровня по общему баллу PASI на 16-й неделе было зарегистрировано.
PASI представлял собой систему, используемую для оценки и классификации тяжести псориатических поражений и их реакции на терапию.
В системе PASI тело было разделено на 4 области: голова, туловище, верхние конечности и нижние конечности.
Каждая из этих областей оценивалась и оценивалась отдельно по эритеме, инфильтрации и шелушению, каждый из которых оценивался по шкале от 0 до 4 (0 = отсутствует, 1 = легкая, 2 = умеренная, 3 = тяжелая и 4 = очень тяжелая) и степени поражения от 0 (указывает на отсутствие поражения) до 6 (90% - 100% поражения).
PASI давал числовой общий балл, который мог варьироваться от 0 (нет псориаза) до 72 (максимальный псориаз).
Более высокий балл указывал на большую тяжесть псориаза.
Исходный уровень был определен как ближайшее измерение, проведенное до или во время даты первого введения исследуемого препарата.
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Исходный уровень (неделя 0), неделя 16
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Percentage of Participants Who Achieved PASI 100 Response at Week 16
Временное ограничение: Week 16
|
Percentage of participants who achieved PASI-100 score (100% improvement from baseline in PASI) at Week 16 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
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Week 16
|
|
Change From Baseline in Body Surface Area (BSA) at Week 16
Временное ограничение: Baseline (Week 0), Week 16
|
A BSA was commonly used measure of severity of skin disease.
It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis).
BSA was assessed using hand print method where the surface area of the participant's hand including the palm and all 5 digits was used as a guide to estimate 1% BSA.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Baseline (Week 0), Week 16
|
|
Percent Change From Baseline in PASI Total Score at Week 16
Временное ограничение: Baseline (Week 0), Week 16
|
Percent change from baseline in PASI total score at Week 16 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Baseline (Week 0), Week 16
|
|
Percentage of Participants Who Achieved IGA Score of 0 at Week 16
Временное ограничение: Week 16
|
The IGA assesses participant's plaque psoriasis.
Lesions were graded for induration, erythema and scaling, each using a 5 point scale.
Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates.
Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
A higher score indicated more severe disease.
|
Week 16
|
|
Percentage of Participants Who Achieved PASI 75 Response at Weeks 4 and 16
Временное ограничение: Weeks 4 and 16
|
Percentage of participants who achieved PASI-75 score (>=75% improvement from baseline in PASI) at Weeks 4 and 16 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Weeks 4 and 16
|
|
Percentage of Participants Who Achieved PASI 90 Response at Week 8
Временное ограничение: Week 8
|
Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Week 8 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 8
|
|
Percentage of Participants Who Achieved Scalp Specific (ss)-IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline Ss-IGA Score >=2
Временное ограничение: Week 16
|
The ss-IGA instrument was used to evaluate the disease severity of scalp psoriasis.
The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness which was scored as: absence of disease = 0, very mild disease = 1, mild disease = 2, moderate disease = 3, and severe disease = 4.
A higher score indicated more severe disease.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 16
|
|
Percentage of Participants Who Achieved Psoriasis Symptom and Signs Diary (PSSD) Symptom Score of 0 at Weeks 8 and 16 Among Participants With a Baseline PSSD Symptom Score >0
Временное ограничение: Weeks 8 and 16
|
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit.
24-hour recall version was used.
PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity.
Each individual item score over seven days was averaged into a weekly item score.
Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items).
Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe).
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Weeks 8 and 16
|
|
Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in PSSD Itch Score at Weeks 4 and 16 Among Participants With a Baseline PSSD Itch Score >=4
Временное ограничение: Weeks 4 and 16
|
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit.
24-hour recall version was used.
PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity.
PSSD itch item score over seven days was averaged into a weekly itch score, ranging from 0 to 10 with higher scores indicating severe disease.
Baseline=closest measurement taken prior to or at time of first study drug administration date.
|
Weeks 4 and 16
|
|
Percentage of Participants Who Achieved an IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Weeks 16 and 24
Временное ограничение: Weeks 16 and 24
|
IGA assesses participant's plaque psoriasis.
Lesions were graded for induration, erythema and scaling, each using 5 point scale.
Induration: 0=no evidence of plaque elevation, 1=minimal plaque elevation,=0.25mm;
2=mild plaque elevation,=0.5
mm; 3=moderate plaque elevation,=0.75
mm; 4=severe plaque elevation,>1 mm; Erythema: 0=no evidence of erythema, hyperpigmentation may be present, 1=faint erythema, 2=light red coloration, 3=moderate red coloration, 4=bright red coloration; Scaling: 0=no evidence of scaling, 1=minimal; occasional fine scale over less than 5% of lesion, 2=mild; fine scale dominates, 3=moderate; coarse scale predominates, 4=severe; thick, scale predominates.
Final IGA score of psoriasis was based upon average of induration, erythema and scaling scores assessed on 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Higher score=more severe disease.Baseline=closest measurement taken prior to or at time of first study drug administration date.
|
Weeks 16 and 24
|
|
Percentage of Participants Who Achieved an IGA Score of 0 at Weeks 16 and 24
Временное ограничение: Weeks 16 and 24
|
The IGA assesses participant's plaque psoriasis.
Lesions were graded for induration, erythema and scaling, each using a 5 point scale.
Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates.
Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
A higher score indicated more severe disease.
|
Weeks 16 and 24
|
|
Percentage of Participants Who Achieved PASI 75 Response at Weeks 16 and 24
Временное ограничение: Weeks 16 and 24
|
Percentage of participants who achieved PASI-75 score (>=75% improvement from baseline in PASI) at Weeks 16 and 24 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Weeks 16 and 24
|
|
Percentage of Participants Who Achieved PASI 90 Response at Weeks 16 and 24
Временное ограничение: Weeks 16 and 24
|
Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Weeks 16 and 24 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Weeks 16 and 24
|
|
Percentage of Participants Who Achieved PASI 100 Response at Weeks 16 and 24
Временное ограничение: Weeks 16 and 24
|
Percentage of participants who achieved PASI-100 score (100% improvement from baseline in PASI) at Weeks 16 and 24 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Weeks 16 and 24
|
|
Percentage of Participants Who Achieved PSSD Symptom Score of 0 at Week 16 Among Participants With a Baseline PSSD Symptom Score >0
Временное ограничение: Week 16
|
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit.
24-hour recall version was used.
PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity.
Each individual item score over seven days was averaged into a weekly item score.
Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items).
Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe).
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 16
|
|
Percentage of Participants Who Achieved Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 and a >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline sPGA-G Score >=2
Временное ограничение: Week 16
|
The sPGA-G was a 6-point scale to assess the severity of genital psoriasis at a given time point.
The sPGA-G evaluates erythema, plaque elevation, and scale of genital psoriatic lesions.
The severity of genital psoriasis was assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5).
Higher score indicates more severity.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 16
|
|
Percentage of Participants Who Achieved Physician's Global Assessment of Hands and Feet (Hf-PGA) Score of 0 or 1 and a >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline Hf-PGA Score >=2
Временное ограничение: Week 16
|
The hf-PGA assesses the severity of hand and foot psoriasis using a 5-point scale to score the plaques on the hands and feet.
hf-PFA was categorized from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Higher score indicates more severity.
Meeting the hf-PGA 0 or 1 criteria defined as having an hf-PGA score of clear (0) or almost clear (1) and a >=2-grade improvement from baseline.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 16
|
|
Percent Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 16 Among Participants With a Baseline mNAPSI Score >0
Временное ограничение: Baseline (Week 0), Week 16
|
Percent change from baseline in mNAPSI score at week 16 was reported.
The mNAPSI was an index used for assessing and grading the severity of nail psoriasis.
Each of the participant's ten fingernails were evaluated on 7 features.
The first three features were each scored from 0 to 3 in severity and were 1=onycholysis and oil-drop dyschromia, 2=pitting, and 3=nail plate crumbling.
Next four features was each scored 0 (absent) or 1 (present), and are (1) leukonychia, (2) splinter hemorrhages (3) nail bed hyperkeratosis, and (4) red spots in lunula.
Each fingernail was rated for the presence and severity of seven features to give a total fingernail score of 0-13 (0= no involvement, 13 = greatest involvement).
Total mNAPSI score is the sum of the 10 fingernail scores (range 0-130; 0= no involvement, 130= greatest involvement).
Higher the score the more severe the nail bed psoriasis.
Baseline=closest measurement taken prior to or at the time of the first study drug administration date.
|
Baseline (Week 0), Week 16
|
|
Percentage of Participants Who Achieved Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16 Among Participants With a Baseline f-PGA Score >=2
Временное ограничение: Week 16
|
Percentage of participants who achieved f-PGA score of 0 or 1 at Week 16 was reported.
f-PGA 0 or 1 criteria was defined as an f-PGA score of clear (0) or minimal (1).
The f-PGA is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease.
A global score of between 0 indicating clear, and 4 indicating severe.
The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe.
Baseline = closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 16
|
|
Change From Baseline in PSSD Symptom Score at Week 16
Временное ограничение: Baseline (Week 0), Week 16
|
Change from baseline in PSSD symptoms scores at Week 16 was reported.
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit.
24-hour recall version was used.
PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity.
Each individual item score over seven days was averaged into a weekly item score.
Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items).
Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe).
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Baseline (Week 0), Week 16
|
|
Change From Baseline in PSSD Sign Score at Week 16
Временное ограничение: Baseline (Week 0), Week 16
|
Change from baseline in PSSD sign scores at Week 16 was reported.
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit.
24-hour recall version was used.
PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity.
Each individual item score over seven days was averaged into a weekly item score.
Sign score was derived by averaging the 6 weekly sign item scores when at least 3 items are available (>=50% of 6 items).
Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe).
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Baseline (Week 0), Week 16
|
|
Percentage of Participants Who Achieved PSSD Sign Score of 0 at Week 16 Among Participants With a Baseline Sign Score >0
Временное ограничение: Week 16
|
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit.
24-hour recall version was used.
PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity.
Each individual item score over seven days was averaged into a weekly item score.
Sign score was derived by averaging the 6 weekly sign item scores when at least 3 items are available (>=50% of 6 items).
Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe).
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 16
|
|
Percentage of Participants Who Achieved Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 Score of 0 or 1 at Week 16 Among Participants With a Baseline GenPS-SFQ Item 2 Score >=2 and With a Baseline sPGA-G Score >=3
Временное ограничение: Week 16
|
The GenPs-SFQ was a 2-item participant-reported instrument used to assess the impact of genital psoriasis on the frequency of sexual activity in the last 7 days.
Item 1 assesses overall frequency of sexual activity in the last 7 days (none/zero, once, or 2 or more times), and item 2 assesses how frequently genital psoriasis symptoms have limited the frequency of sexual activity in the last 7 days (0 = never, 1 = rarely, 2 = sometimes, 3 = often, or 4 = always).
Lower scores of item 2 indicated less limitation of sexual activity due to genital psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 16
|
|
Percentage of Participants Who Achieved Dermatological Life Quality Index (DLQI) Score of 0 or 1 at Week 16 Among Participants With a Baseline DLQI Score >1
Временное ограничение: Week 16
|
The DLQI was a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL.
It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment.
Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL).
The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 16
|
|
Change From Baseline in Total DLQI Score at Week 16
Временное ограничение: Baseline (Week 0), Week 16
|
The DLQI was a dermatology specific HRQoL instrument designed to assess the impact of the disease on a participant's HRQoL.
It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment.
Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL).
The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Baseline (Week 0), Week 16
|
|
Change From Baseline in Domain Scores of the Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16
Временное ограничение: Baseline (Week 0), Week 16
|
PROMIS-29, 29-item generic HRQoL survey, assesses each 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; ability to participate in social roles and activities) with 4 questions and pain intensity.
Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often and 5=always).
Pain intensity was rated on 11-point scale (0=no pain; 10=worst imaginable pain).
Higher score= worst pain.
Each domain included 4 items, plus a single pain intensity item totaling 29 items.
Raw score of each PROMIS domain was converted into a standardized score with mean of 50; standard deviation (SD) of 10 (T-Score).
Higher PROMIS T-score=more of concept being measured that is higher scores in anxiety, depression, fatigue, pain interference, sleep disturbance= worse symptoms, higher scores in physical function, social roles= better functioning.
Baseline: closest measurement taken prior to or at time of first study drug administration date.
|
Baseline (Week 0), Week 16
|
|
Percentage of Participants Who Achieved DLQI Score of 0 or 1 at Weeks 16 and 24 Among Participants With a Baseline DLQI Score >1
Временное ограничение: Weeks 16 and 24
|
The DLQI was a dermatology specific HRQoL instrument designed to assess the impact of the disease on a participant's HRQoL.
It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment.
Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL).
The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Weeks 16 and 24
|
|
Percentage of Participants Who Achieved PSSD Symptoms Score of 0 at Week 24 Among Participants With a Baseline PSSD Symptom Score >0
Временное ограничение: Week 24
|
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit.
24-hour recall version was used.
PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity.
Each individual item score over seven days was averaged into a weekly item score.
Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items).
Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe).
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 24
|
|
Percentage of Participants Who Achieved PASI 75 After Week 24, Among PASI 75 Nonresponders to Deucravacitinib at Week 24
Временное ограничение: From Week 24 up to Week 160
|
From Week 24 up to Week 160
|
|
|
Percentage of Participants Achieving PASI 90 After Week 24, Among PASI 90 Nonresponders to Deucravacitinib at Week 24
Временное ограничение: From Week 24 up to Week 160
|
From Week 24 up to Week 160
|
|
|
Percentage of Participants Achieving IGA Score of 0 or 1 After Week 24, Among Participants in the Deucravacitinib Group With IGA Score >=2 at Week 24
Временное ограничение: From Week 24 up to Week 160
|
From Week 24 up to Week 160
|
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Временное ограничение: From Week 0 to Week 160
|
From Week 0 to Week 160
|
|
|
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Временное ограничение: From Week 0 to Week 160
|
From Week 0 to Week 160
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Директор по исследованиям: Janssen Research & Development, LLC Clinicaltrial, Janssen Research & Development, LLC
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
9 марта 2024 г.
Первичное завершение (Действительный)
15 ноября 2024 г.
Завершение исследования (Оцененный)
20 сентября 2027 г.
Даты регистрации исследования
Первый отправленный
15 января 2024 г.
Впервые представлено, что соответствует критериям контроля качества
15 января 2024 г.
Первый опубликованный (Действительный)
24 января 2024 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
31 августа 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
27 августа 2026 г.
Последняя проверка
1 августа 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 77242113PSO3004 (Другой идентификатор: Janssen Research & Development, LLC)
- 2023 (Грант/контракт NIH США: GRAMMY Museum Foundation)
- 2023-507039-39-00 (Идентификатор реестра: EUCT number)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
Политика обмена данными фармацевтических компаний Janssen, входящая в состав Johnson & Johnson, доступна по адресу www.janssen.com/clinical-trials/transparency.
Как отмечено на этом сайте, запросы на доступ к данным исследования можно подать через сайт Йельского проекта открытого доступа к данным (YODA) по адресу yoda.yale.edu.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Да
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .