Um estudo de JNJ-77242113 para o tratamento de participantes com psoríase em placas moderada a grave (ICONIC-ADVANCE 2)
27 de agosto de 2026 atualizado por: Janssen Research & Development, LLC
Um estudo multicêntrico de fase 3, randomizado, duplo-cego, controlado por placebo e controlado por comparador ativo de deucravacitinibe para avaliar a eficácia e segurança de JNJ-77242113 para o tratamento de participantes com psoríase em placas moderada a grave
O objetivo do estudo é avaliar a eficácia do JNJ-77242113 em participantes com psoríase em placas moderada a grave em comparação com placebo e deucravacitinibe.
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Tipo de estudo
Intervencional
Inscrição (Real)
731
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Augsburg, Alemanha, 86150
- Hautarztpraxis Dr. Mihaescu
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Bad Bentheim, Alemanha, 48455
- Fachklinik Bad Bentheim
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Berlin, Alemanha, 13627
- CRS Clinical Research Services Berlin GMBH
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Bochum, Alemanha, 44793
- Niesmann & Othlinghaus GbR
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Darmstadt, Alemanha, 64283
- Klinikum Darmstadt GmbH - Hautklinik
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Dresden, Alemanha, 01307
- Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
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Dülmen, Alemanha, 48249
- Hautzentrum Dulmen
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Düsseldorf, Alemanha, 40212
- Privatpraxis Dr. Hilton & Partner
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Friedrichshafen, Alemanha, 88045
- Derma-Study-Center Friedrichshafen GmbH
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Hamburg, Alemanha, 20095
- Eurofins bioskin GmbH
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Heidelberg, Alemanha, 69120
- Universitaetsklinikum Heidelberg
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Mahlow, Alemanha, 15831
- Hautarztpraxis
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Mainz, Alemanha, 55131
- Universitatsmedizin der Johannes Gutenberg Universitat Mainz
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Merzig, Alemanha, 66663
- Hautmedizin Saar Science Hms GmbH
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Münster, Alemanha, 48149
- Universitaetsklinikum Muenster
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Oldenburg, Alemanha, 26133
- Klinikum Oldenburg
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Witten, Alemanha, 58453
- Hautarztpraxis 1
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Wuppertal, Alemanha, 42287
- CentroDerm GmbH
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Benowa, Austrália, 4217
- The Skin Centre
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Clayton, Austrália, 3168
- Monash Medical Centre
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Kogarah, Austrália, 2217
- Premier Specialists
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Melbourne, Austrália, 3004
- The Alfred Hospital
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Mitcham, Austrália, 3132
- ISHI dermatology
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Parkville, Austrália, 3050
- Royal Melbourne Hospital
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Botucatu, Brasil, 18618-686
- UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
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Brasília, Brasil, 72145-450
- Chronos Clinica Medica Ltda
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Ribeirão Preto, Brasil, 14051140
- Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
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São José do Rio Preto, Brasil, 15090-000
- Funfarme Sjrp
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São Paulo, Brasil, 05403 900
- Hospital Das Clinicas Da Faculdade De Medicina Da USP
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São Paulo, Brasil, 09060-870
- Cepes - Fmabc
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British Columbia
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Surrey, British Columbia, Canadá, V3R 6A7
- Dr. Chih ho Hong Medical
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Manitoba
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Winnipeg, Manitoba, Canadá, R3M 3Z4
- Wiseman Dermatology Research Inc.
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Ontario
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London, Ontario, Canadá, N6A 5R9
- Lovegrove Dermatology
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Markham, Ontario, Canadá, L3P 1X2
- Lynderm Research Inc.
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Mississauga, Ontario, Canadá, L4Y 4C5
- DermEdge Research
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Peterborough, Ontario, Canadá, K9J 5K2
- SKiN Centre for Dermatology
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Toronto, Ontario, Canadá, M3H 5Y8
- Toronto Research Centre
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Toronto, Ontario, Canadá, M2N 3A6
- North York Research Inc
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Windsor, Ontario, Canadá, N8T 1E6
- XLR8 Medical Research
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Quebec
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Montreal, Quebec, Canadá, H2X 2V1
- Innovaderm Research Inc.
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Québec, Quebec, Canadá, G1V 4X7
- Centre de Recherche Dermatologique du Quebec metropolitain
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Ansan-si, Coréia do Sul, 15355
- Korea University Ansan Hospital
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Anyang-si, Coréia do Sul, 14068
- Hallym University Sacred Heart Hospital
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Bucheon-si, Coréia do Sul, 14647
- The Catholic University of Korea Bucheon St Mary s Hospital
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Gwangju, Coréia do Sul, 61453
- Chosun University Hospital
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Seongnam, Coréia do Sul, 13496
- CHA Bundang Medical Center, CHA University
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Seoul, Coréia do Sul, 05505
- Asan Medical Center
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Seoul, Coréia do Sul, 8308
- Korea University Guro Hospital
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Alcorcón, Espanha, 28922
- Hosp. Univ. Fundacion Alcorcon
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Badalona, Espanha, 08916
- Hosp. Univ. Germans Trias I Pujol
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Barcelona, Espanha, 08036
- Hosp Clinic de Barcelona
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Manises, Espanha, 46940
- Hosp. de Manises
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Salamanca, Espanha, 37007
- Hosp Clinico Univ de Salamanca
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Santiago de Compostela, Espanha, 15702
- Clinica Gaias
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Santiago de Compostela, Espanha, 15706
- Hosp. Clinico Univ. de Santiago
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Seville, Espanha, 41009
- Hosp. Virgen Macarena
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Seville, Espanha, 41014
- Hosp. Ntra. Sra. de Valme
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Villajoyosa, Espanha, 03570
- Hosp. de La Marina Baixa
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Zaragoza, Espanha, 50009
- Hosp. Clinico Univ. Lozano Blesa
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Arizona
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Phoenix, Arizona, Estados Unidos, 85032
- Alliance Dermatology and MOHS Center P C
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California
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Encinitas, California, Estados Unidos, 92024
- California Dermatology & Clinical Research Institute
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Encino, California, Estados Unidos, 91436
- T Joseph Raoof Md Inc
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Fresno, California, Estados Unidos, 93701
- Ucsf Fresno
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Los Angeles, California, Estados Unidos, 90056
- Wallace Medical Group, Inc
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Los Angeles, California, Estados Unidos, 90024
- University of California Los Angeles - Division of Dermatology
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Oceanside, California, Estados Unidos, 92056
- Dermatologist Medical Group of North County, Inc.
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Florida
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Miami, Florida, Estados Unidos, 33155
- Bioclinical Research Alliance Inc.
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Miami, Florida, Estados Unidos, 33133
- Miami Dermatology And Laser Institute
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Tampa, Florida, Estados Unidos, 33613
- Forcare Clinical Research Inc
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Georgia
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Douglasville, Georgia, Estados Unidos, 30135
- Southeast Dermatology Specialists
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Illinois
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Rolling Meadows, Illinois, Estados Unidos, 60008
- Arlington Dermatology
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40217
- Skin Sciences, PLLC
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Owensboro, Kentucky, Estados Unidos, 42301
- Qualmedica Research
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Maryland
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Rockville, Maryland, Estados Unidos, 20850
- DermAssociates, PC
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Massachusetts
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Brighton, Massachusetts, Estados Unidos, 02135
- Metro Boston Clinical Partners
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Methuen, Massachusetts, Estados Unidos, 01844
- ActivMed Practices and Research
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan
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Bay City, Michigan, Estados Unidos, 48706
- Great Lakes Research Group
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Caledonia, Michigan, Estados Unidos, 49316
- The Derm Institute of West Michigan
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Canton, Michigan, Estados Unidos, 48187
- Hamzavi Dermatology
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Troy, Michigan, Estados Unidos, 48084
- Somerset Skin Centre
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Missouri
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Kirksville, Missouri, Estados Unidos, 63501
- Cleaver Dermatology
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Ohio
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Bexley, Ohio, Estados Unidos, 43209
- Bexley Dermatology Research
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74137
- Essential Medical Research
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Oregon
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Portland, Oregon, Estados Unidos, 97210-2996
- Oregon Dermatology & Research Center
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19103
- Paddington Testing Co, Inc.
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29407
- Clinical Research Center of the Carolinas LLC
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Greenville, South Carolina, Estados Unidos, 29615
- Palmetto Clinical Trial Services, LLC
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Texas
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Arlington, Texas, Estados Unidos, 76011
- Arlington Research Center, inc.
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Dallas, Texas, Estados Unidos, 75390
- UT Southwestern Medical Center
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San Antonio, Texas, Estados Unidos, 78229
- Dermatology Clinical Research Center of San Antonio
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Webster, Texas, Estados Unidos, 77598
- Center for Clinical Studies
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Utah
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Bountiful, Utah, Estados Unidos, 84010
- Cope Family Medicine - Ogden Clinic
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Springville, Utah, Estados Unidos, 84663
- Springville Dermatology CCT Research
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West Valley City, Utah, Estados Unidos, 84120
- Kalo Clinical Research
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Virginia
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Norfolk, Virginia, Estados Unidos, 23502
- Virginia Dermatology Skin Cancer Center Pllc
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Budapest, Hungria, 1152
- Uno Medical Trials Ltd.
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Gyula, Hungria, 5700
- Synexus Magyarorszag Kft
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Gyöngyös, Hungria, 3200
- Bugat Pal Korhaz
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Kecskemét, Hungria, 6000
- Bacs Kiskun Varmegyei Oktatokorhaz
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Zalaegerszeg, Hungria, H-8900
- Synexus Magyarorszag Kft 1
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Bialystok, Polônia, 15 797
- Renew Clinic
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Katowice, Polônia, 40 568
- CaRe Clinic
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Katowice, Polônia, 40 611
- Centrum Medyczne Angelius Provita
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Kielce, Polônia, 25-316
- Prywatny Gabinet Dermatologiczny Elzbieta Klujszo
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Krakow, Polônia, 30-002
- SGD s.c.
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Krakow, Polônia, 30-303
- Krakowskie Centrum Badan Klinicznych
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Krakow, Polônia, 30-348
- Jagiellonskie Centrum Innowacji
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Krakow, Polônia, 31 559
- Diamond Clinic
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Olsztyn, Polônia, 10-117
- Etyka Osrodek Badan Klinicznych
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Warsaw, Polônia, 02-962
- Royalderm Agnieszka Nawrocka
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Warsaw, Polônia, 02 661
- Carpe Diem Centrum Medycyny Estetycznej
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Warsaw, Polônia, 02 672
- Synexus Polska Sp z o o Oddzial w Warszawie
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Wroclaw, Polônia, 51 685
- WroMedica I Bielicka A Strzalkowska s c
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Cluj-Napoca, Romênia, 400105
- Cabinet Medical Dermato-Venerologie
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Craiova, Romênia, 200541
- Centrul Medical Vitaplus
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Craiova, Romênia, 200642
- Spitalul Clinic Județean de Urgență
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Iași, Romênia, 700381
- Sc Iasiprest Srl
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Oradea, Romênia, 410167
- Spitalul Clinic Judetean De Urgenta Bihor
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Timișoara, Romênia, 300757
- New Derm Clinic
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Târgu Mureş, Romênia, 540342
- Spitalul Clinic Judetean Mures
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Kaohsiung City, Taiwan, 81362
- Kaohsiung Veterans General Hospital
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Kaohsiung City, Taiwan, 80756
- Kaohsiung Medical University Chung Ho Memorial Hospital
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Taichung, Taiwan, 40705
- Taichung Veterans General Hospital
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Taichung, Taiwan, 40201
- Chung Shan Medical University Hospital
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Tainan, Taiwan, 710
- National Cheng Kung University Hospital
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Taipei, Taiwan, 110
- Taipei Medical University
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Taipei, Taiwan, 116
- Taipei Municipal Wanfang Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Critério de inclusão:
- Diagnóstico de psoríase em placas, com ou sem artrite psoriática (APs), durante pelo menos 26 semanas antes da primeira administração da intervenção do estudo
- Área de superfície corporal total (BSA) maior ou igual a (>=)10 por cento (%) na triagem e linha de base
- Área total de psoríase e índice de gravidade (PASI) >=12 na triagem e no início do estudo
- Avaliação global total do investigador (IGA) >=3 na triagem e linha de base
- Candidato a fototerapia ou tratamento sistêmico para psoríase em placas
Critério de exclusão:
- Forma de psoríase sem placas (por exemplo, eritrodérmica, gutata ou pustulosa)
- Psoríase atual induzida por medicamentos (por exemplo, um novo início de psoríase ou uma exacerbação da psoríase por betabloqueadores, bloqueadores dos canais de cálcio ou lítio)
- Um diagnóstico atual ou sinais ou sintomas de distúrbios renais, hepáticos, cardíacos, vasculares, pulmonares, gastrointestinais, endócrinos, neurológicos, hematológicos, reumatológicos, psiquiátricos ou metabólicos graves, progressivos ou não controlados
- Alergias, hipersensibilidade ou intolerância conhecidas a JNJ-77242113 ou seus excipientes
- Procedimento cirúrgico importante (por exemplo, que requer anestesia geral) dentro de 8 semanas antes da triagem, ou não terá se recuperado totalmente do procedimento cirúrgico, ou terá um procedimento cirúrgico planejado durante o período em que o participante deverá participar do estudo
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: JNJ-77242113
Os participantes receberão JNJ-77242113 da Semana 0 até a Semana 156 e deucravacitinibe correspondente ao placebo da Semana 0 até a Semana 24.
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JNJ-77242113 será administrado por via oral.
O placebo correspondente ao deucravacitinibe será administrado por via oral.
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Comparador de Placebo: Placebo
Os participantes receberão placebo correspondente para JNJ-77242113 da semana 0 até a semana 16, placebo correspondente para deucravacitinibe da semana 0 até a semana 24 e JNJ-77242113 da semana 16 até a semana 156.
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JNJ-77242113 será administrado por via oral.
JNJ-77242113 placebo correspondente será administrado por via oral.
O placebo correspondente ao deucravacitinibe será administrado por via oral.
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Comparador Ativo: Deucravacitinibe
Os participantes receberão deucravacitinibe da Semana 0 até a Semana 24 e placebo correspondente para JNJ-77242113 da Semana 0 até a Semana 24 e JNJ-77242113 da Semana 24 até a Semana 156.
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JNJ-77242113 será administrado por via oral.
JNJ-77242113 placebo correspondente será administrado por via oral.
O deucravacitinibe será administrado por via oral.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Alteração em Relação ao Valor Basal no Ponto Total do PASI na Semana 16
Prazo: Baseline (Semana 0), Semana 16
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Foi relatada a alteração em relação ao valor basal no score total do PASI na Semana 16.
O PASI era um sistema utilizado para avaliar e classificar a gravidade das lesões psoriáticas e a sua resposta à terapêutica.
No sistema PASI, o corpo era dividido em 4 regiões: cabeça, tronco, membros superiores e membros inferiores.
Cada uma destas áreas era avaliada e pontuada separadamente para eritema, induração e descamação, que eram classificados numa escala de 0 a 4 (0 = nenhum, 1 = ligeiro, 2 = moderado, 3 = grave e 4 = muito grave) e a extensão do envolvimento de 0 (indicava ausência de envolvimento) a 6 (90% - 100% de envolvimento).
O PASI produzia um score total numérico que podia variar de 0 (sem psoríase) a 72 (psoríase máxima).
Um score mais elevado indicava uma maior gravidade da psoríase.
O valor basal foi definido como a medição mais próxima realizada antes ou na data da primeira administração do fármaco do estudo.
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Baseline (Semana 0), Semana 16
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Percentage of Participants Who Achieved PASI 100 Response at Week 16
Prazo: Week 16
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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
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Change From Baseline in Body Surface Area (BSA) at Week 16
Prazo: Baseline (Week 0), Week 16
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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.
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Baseline (Week 0), Week 16
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Percent Change From Baseline in PASI Total Score at Week 16
Prazo: Baseline (Week 0), Week 16
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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.
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Baseline (Week 0), Week 16
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Percentage of Participants Who Achieved IGA Score of 0 at Week 16
Prazo: Week 16
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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.
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Week 16
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Percentage of Participants Who Achieved PASI 75 Response at Weeks 4 and 16
Prazo: Weeks 4 and 16
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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.
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Weeks 4 and 16
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Percentage of Participants Who Achieved PASI 90 Response at Week 8
Prazo: Week 8
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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.
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Week 8
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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
Prazo: Week 16
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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.
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Week 16
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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
Prazo: Weeks 8 and 16
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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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: From Week 24 up to Week 160
|
From Week 24 up to Week 160
|
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Prazo: From Week 0 to Week 160
|
From Week 0 to Week 160
|
|
|
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Prazo: From Week 0 to Week 160
|
From Week 0 to Week 160
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Janssen Research & Development, LLC Clinicaltrial, Janssen Research & Development, LLC
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
9 de março de 2024
Conclusão Primária (Real)
15 de novembro de 2024
Conclusão do estudo (Estimado)
20 de setembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
15 de janeiro de 2024
Enviado pela primeira vez que atendeu aos critérios de CQ
15 de janeiro de 2024
Primeira postagem (Real)
24 de janeiro de 2024
Atualizações de registro de estudo
Última Atualização Postada (Real)
31 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 77242113PSO3004 (Outro identificador: Janssen Research & Development, LLC)
- 2023 (Concessão/Contrato do NIH dos EUA: GRAMMY Museum Foundation)
- 2023-507039-39-00 (Identificador de registro: EUCT number)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
A política de partilha de dados das Janssen Pharmaceutical Companies da Johnson & Johnson está disponível em www.janssen.com/clinical-trials/transparency.
Conforme observado neste site, as solicitações de acesso aos dados do estudo podem ser enviadas através do site do Projeto Yale Open Data Access (YODA) em yoda.yale.edu
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .