Une étude de JNJ-77242113 pour le traitement des participants atteints de psoriasis en plaques modéré à sévère (ICONIC-ADVANCE 2)
27 août 2026 mis à jour par: Janssen Research & Development, LLC
Une étude de phase 3 multicentrique, randomisée, en double aveugle, contrôlée par placebo et contrôlée par un comparateur actif deucravacitinib pour évaluer l'efficacité et l'innocuité du JNJ-77242113 pour le traitement des participants atteints de psoriasis en plaques modéré à sévère
Le but de l'étude est d'évaluer l'efficacité du JNJ-77242113 chez les participants atteints de psoriasis en plaques modéré à sévère par rapport au placebo et au deucravacitinib.
Aperçu de l'étude
Statut
Actif, ne recrute pas
Les conditions
Type d'étude
Interventionnel
Inscription (Réel)
731
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Augsburg, Allemagne, 86150
- Hautarztpraxis Dr. Mihaescu
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Bad Bentheim, Allemagne, 48455
- Fachklinik Bad Bentheim
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Berlin, Allemagne, 13627
- CRS Clinical Research Services Berlin GMBH
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Bochum, Allemagne, 44793
- Niesmann & Othlinghaus GbR
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Darmstadt, Allemagne, 64283
- Klinikum Darmstadt GmbH - Hautklinik
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Dresden, Allemagne, 01307
- Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
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Dülmen, Allemagne, 48249
- Hautzentrum Dulmen
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Düsseldorf, Allemagne, 40212
- Privatpraxis Dr. Hilton & Partner
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Friedrichshafen, Allemagne, 88045
- Derma-Study-Center Friedrichshafen GmbH
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Hamburg, Allemagne, 20095
- Eurofins bioskin GmbH
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Heidelberg, Allemagne, 69120
- Universitaetsklinikum Heidelberg
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Mahlow, Allemagne, 15831
- Hautarztpraxis
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Mainz, Allemagne, 55131
- Universitatsmedizin der Johannes Gutenberg Universitat Mainz
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Merzig, Allemagne, 66663
- Hautmedizin Saar Science Hms GmbH
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Münster, Allemagne, 48149
- Universitaetsklinikum Muenster
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Oldenburg, Allemagne, 26133
- Klinikum Oldenburg
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Witten, Allemagne, 58453
- Hautarztpraxis 1
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Wuppertal, Allemagne, 42287
- CentroDerm GmbH
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Benowa, Australie, 4217
- The Skin Centre
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Clayton, Australie, 3168
- Monash Medical Centre
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Kogarah, Australie, 2217
- Premier Specialists
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Melbourne, Australie, 3004
- The Alfred Hospital
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Mitcham, Australie, 3132
- ISHI dermatology
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Parkville, Australie, 3050
- Royal Melbourne Hospital
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Botucatu, Brésil, 18618-686
- UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
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Brasília, Brésil, 72145-450
- Chronos Clinica Medica Ltda
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Ribeirão Preto, Brésil, 14051140
- Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
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São José do Rio Preto, Brésil, 15090-000
- Funfarme Sjrp
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São Paulo, Brésil, 05403 900
- Hospital das Clínicas da Faculdade de Medicina da USP
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São Paulo, Brésil, 09060-870
- Cepes - Fmabc
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British Columbia
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Surrey, British Columbia, Canada, V3R 6A7
- Dr. Chih ho Hong Medical
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Manitoba
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Winnipeg, Manitoba, Canada, R3M 3Z4
- Wiseman Dermatology Research Inc.
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Ontario
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London, Ontario, Canada, N6A 5R9
- Lovegrove Dermatology
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Markham, Ontario, Canada, L3P 1X2
- Lynderm Research Inc.
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Mississauga, Ontario, Canada, L4Y 4C5
- DermEdge Research
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Peterborough, Ontario, Canada, K9J 5K2
- Skin Centre for Dermatology
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Toronto, Ontario, Canada, M3H 5Y8
- Toronto Research Centre
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Toronto, Ontario, Canada, M2N 3A6
- North York Research Inc
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Windsor, Ontario, Canada, N8T 1E6
- XLR8 Medical Research
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Quebec
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Montreal, Quebec, Canada, H2X 2V1
- Innovaderm Research Inc.
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Québec, Quebec, Canada, G1V 4X7
- Centre De Recherche Dermatologique Du Quebec Metropolitain
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Ansan-si, Corée du Sud, 15355
- Korea University Ansan Hospital
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Anyang-si, Corée du Sud, 14068
- Hallym University Sacred Heart Hospital
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Bucheon-si, Corée du Sud, 14647
- The Catholic University of Korea Bucheon St Mary s Hospital
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Gwangju, Corée du Sud, 61453
- Chosun University Hospital
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Seongnam, Corée du Sud, 13496
- CHA Bundang Medical Center, CHA University
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Seoul, Corée du Sud, 05505
- Asan Medical Center
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Seoul, Corée du Sud, 8308
- Korea University Guro Hospital
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Alcorcón, Espagne, 28922
- Hosp. Univ. Fundacion Alcorcon
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Badalona, Espagne, 08916
- Hosp. Univ. Germans Trias I Pujol
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Barcelona, Espagne, 08036
- Hosp Clinic de Barcelona
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Manises, Espagne, 46940
- Hosp. de Manises
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Salamanca, Espagne, 37007
- Hosp Clinico Univ de Salamanca
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Santiago de Compostela, Espagne, 15702
- Clinica Gaias
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Santiago de Compostela, Espagne, 15706
- Hosp. Clinico Univ. de Santiago
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Seville, Espagne, 41009
- Hosp. Virgen Macarena
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Seville, Espagne, 41014
- Hosp. Ntra. Sra. de Valme
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Villajoyosa, Espagne, 03570
- Hosp. de La Marina Baixa
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Zaragoza, Espagne, 50009
- Hosp. Clinico Univ. Lozano Blesa
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Budapest, Hongrie, 1152
- Uno Medical Trials Ltd.
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Gyula, Hongrie, 5700
- Synexus Magyarorszag Kft
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Gyöngyös, Hongrie, 3200
- Bugat Pal Korhaz
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Kecskemét, Hongrie, 6000
- Bacs Kiskun Varmegyei Oktatokorhaz
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Zalaegerszeg, Hongrie, H-8900
- Synexus Magyarorszag Kft 1
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Bialystok, Pologne, 15 797
- Renew Clinic
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Katowice, Pologne, 40 568
- CaRe Clinic
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Katowice, Pologne, 40 611
- Centrum Medyczne Angelius Provita
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Kielce, Pologne, 25-316
- Prywatny Gabinet Dermatologiczny Elzbieta Klujszo
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Krakow, Pologne, 30-002
- SGD s.c.
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Krakow, Pologne, 30-303
- Krakowskie Centrum Badan Klinicznych
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Krakow, Pologne, 30-348
- Jagiellonskie Centrum Innowacji
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Krakow, Pologne, 31 559
- Diamond Clinic
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Olsztyn, Pologne, 10-117
- Etyka Osrodek Badan Klinicznych
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Warsaw, Pologne, 02-962
- Royalderm Agnieszka Nawrocka
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Warsaw, Pologne, 02 661
- Carpe Diem Centrum Medycyny Estetycznej
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Warsaw, Pologne, 02 672
- Synexus Polska Sp z o o Oddzial w Warszawie
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Wroclaw, Pologne, 51 685
- WroMedica I Bielicka A Strzalkowska s c
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Cluj-Napoca, Roumanie, 400105
- Cabinet Medical Dermato-Venerologie
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Craiova, Roumanie, 200541
- Centrul Medical Vitaplus
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Craiova, Roumanie, 200642
- Spitalul Clinic Județean de Urgență
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Iași, Roumanie, 700381
- Sc Iasiprest Srl
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Oradea, Roumanie, 410167
- Spitalul Clinic Judetean de Urgenta Bihor
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Timișoara, Roumanie, 300757
- New Derm Clinic
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Târgu Mureş, Roumanie, 540342
- Spitalul Clinic Judetean Mures
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Kaohsiung City, Taïwan, 81362
- Kaohsiung Veterans General Hospital
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Kaohsiung City, Taïwan, 80756
- Kaohsiung Medical University Chung Ho Memorial Hospital
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Taichung, Taïwan, 40705
- Taichung Veterans General Hospital
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Taichung, Taïwan, 40201
- Chung Shan Medical University Hospital
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Tainan, Taïwan, 710
- National Cheng Kung University Hospital
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Taipei, Taïwan, 110
- Taipei Medical University
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Taipei, Taïwan, 116
- Taipei Municipal Wanfang Hospital
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Arizona
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Phoenix, Arizona, États-Unis, 85032
- Alliance Dermatology and MOHS Center P C
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California
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Encinitas, California, États-Unis, 92024
- California Dermatology & Clinical Research Institute
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Encino, California, États-Unis, 91436
- T Joseph Raoof Md Inc
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Fresno, California, États-Unis, 93701
- Ucsf Fresno
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Los Angeles, California, États-Unis, 90056
- Wallace Medical Group, Inc
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Los Angeles, California, États-Unis, 90024
- University of California Los Angeles - Division of Dermatology
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Oceanside, California, États-Unis, 92056
- Dermatologist Medical Group of North County, Inc.
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Florida
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Miami, Florida, États-Unis, 33155
- Bioclinical Research Alliance Inc.
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Miami, Florida, États-Unis, 33133
- Miami Dermatology And Laser Institute
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Tampa, Florida, États-Unis, 33613
- Forcare Clinical Research Inc
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Georgia
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Douglasville, Georgia, États-Unis, 30135
- Southeast Dermatology Specialists
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Illinois
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Rolling Meadows, Illinois, États-Unis, 60008
- Arlington Dermatology
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Kentucky
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Louisville, Kentucky, États-Unis, 40217
- Skin Sciences, PLLC
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Owensboro, Kentucky, États-Unis, 42301
- Qualmedica Research
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Maryland
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Rockville, Maryland, États-Unis, 20850
- DermAssociates, PC
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Massachusetts
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Brighton, Massachusetts, États-Unis, 02135
- Metro Boston Clinical Partners
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Methuen, Massachusetts, États-Unis, 01844
- ActivMed Practices and Research
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- University of Michigan
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Bay City, Michigan, États-Unis, 48706
- Great Lakes Research Group
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Caledonia, Michigan, États-Unis, 49316
- The Derm Institute of West Michigan
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Canton, Michigan, États-Unis, 48187
- Hamzavi Dermatology
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Troy, Michigan, États-Unis, 48084
- Somerset Skin Centre
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Missouri
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Kirksville, Missouri, États-Unis, 63501
- Cleaver Dermatology
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Ohio
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Bexley, Ohio, États-Unis, 43209
- Bexley Dermatology Research
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Oklahoma
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Tulsa, Oklahoma, États-Unis, 74137
- Essential Medical Research
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Oregon
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Portland, Oregon, États-Unis, 97210-2996
- Oregon Dermatology & Research Center
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19103
- Paddington Testing Co, Inc.
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South Carolina
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Charleston, South Carolina, États-Unis, 29407
- Clinical Research Center of the Carolinas LLC
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Greenville, South Carolina, États-Unis, 29615
- Palmetto Clinical Trial Services, LLC
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Texas
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Arlington, Texas, États-Unis, 76011
- Arlington Research Center, inc.
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Dallas, Texas, États-Unis, 75390
- UT Southwestern Medical Center
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San Antonio, Texas, États-Unis, 78229
- Dermatology Clinical Research Center of San Antonio
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Webster, Texas, États-Unis, 77598
- Center for Clinical Studies
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Utah
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Bountiful, Utah, États-Unis, 84010
- Cope Family Medicine - Ogden Clinic
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Springville, Utah, États-Unis, 84663
- Springville Dermatology CCT Research
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West Valley City, Utah, États-Unis, 84120
- Kalo Clinical Research
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Virginia
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Norfolk, Virginia, États-Unis, 23502
- Virginia Dermatology Skin Cancer Center Pllc
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Critère d'intégration:
- Diagnostic du psoriasis en plaques, avec ou sans rhumatisme psoriasique (RP), au moins 26 semaines avant la première administration de l'intervention de l'étude
- Surface corporelle totale (BSA) supérieure ou égale à (>=) 10 pour cent (%) au moment du dépistage et de référence
- Surface totale et indice de gravité du psoriasis (PASI) > = 12 au moment du dépistage et de l'inclusion
- Évaluation globale totale de l'investigateur (IGA) > = 3 au moment de la sélection et de l'inclusion
- Candidat à la photothérapie ou au traitement systémique du psoriasis en plaques
Critère d'exclusion:
- Forme de psoriasis sans plaques (par exemple, érythrodermique, en gouttes ou pustuleux)
- Psoriasis actuel d'origine médicamenteuse (par exemple, une nouvelle apparition de psoriasis ou une exacerbation du psoriasis due aux bêtabloquants, aux inhibiteurs calciques ou au lithium)
- Un diagnostic actuel ou des signes ou symptômes de troubles rénaux, hépatiques, cardiaques, vasculaires, pulmonaires, gastro-intestinaux, endocriniens, neurologiques, hématologiques, rhumatologiques, psychiatriques ou métaboliques graves, progressifs ou incontrôlés.
- Allergies, hypersensibilité ou intolérance connues au JNJ-77242113 ou à ses excipients
- Intervention chirurgicale majeure (par exemple, nécessitant une anesthésie générale) dans les 8 semaines précédant le dépistage, ou ne se sera pas complètement rétabli de l'intervention chirurgicale, ou une intervention chirurgicale est prévue pendant la période pendant laquelle le participant est censé participer à l'étude.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: JNJ-77242113
Les participants recevront le JNJ-77242113 de la semaine 0 à la semaine 156 et le placebo correspondant au deucravacitinib de la semaine 0 à la semaine 24.
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JNJ-77242113 sera administré par voie orale.
Le placebo correspondant au deucravacitinib sera administré par voie orale.
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Comparateur placebo: Placebo
Les participants recevront un placebo correspondant au JNJ-77242113 de la semaine 0 à la semaine 16, un placebo correspondant au deucravacitinib de la semaine 0 à la semaine 24 et au JNJ-77242113 de la semaine 16 à la semaine 156.
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JNJ-77242113 sera administré par voie orale.
Le placebo correspondant au JNJ-77242113 sera administré par voie orale.
Le placebo correspondant au deucravacitinib sera administré par voie orale.
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Comparateur actif: Deucravacitinib
Les participants recevront du deucravacitinib de la semaine 0 à la semaine 24 et un placebo correspondant pour le JNJ-77242113 de la semaine 0 à la semaine 24 et le JNJ-77242113 de la semaine 24 à la semaine 156.
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JNJ-77242113 sera administré par voie orale.
Le placebo correspondant au JNJ-77242113 sera administré par voie orale.
Le deucravacitinib sera administré par voie orale.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changement par rapport à la valeur initiale du score PASI total à la semaine 16
Délai: Baseline (Semaine 0), Semaine 16
|
Le changement par rapport à la valeur de référence du score total PASI à la semaine 16 a été rapporté.
Le PASI était un système utilisé pour évaluer et classer la gravité des lésions psoriasiques et leur réponse au traitement.
Dans le système PASI, le corps était divisé en 4 régions : la tête, le tronc, les membres supérieurs et les membres inférieurs.
Chacune de ces zones était évaluée et notée séparément pour l'érythème, l'induration et la desquamation, qui étaient chacune notées sur une échelle de 0 à 4 (0 = aucune, 1 = légère, 2 = modérée, 3 = sévère et 4 = très sévère) et l'étendue de l'atteinte de 0 (indiquait aucune atteinte) à 6 (90 % - 100 % d'atteinte).
Le PASI produisait un score total numérique qui pouvait aller de 0 (pas de psoriasis) à 72 (psoriasis maximum).
Un score plus élevé indiquait une plus grande sévérité du psoriasis.
La valeur de référence était définie comme la mesure la plus proche prise avant ou à la date de la première administration du médicament de l'étude.
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Baseline (Semaine 0), Semaine 16
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Percentage of Participants Who Achieved PASI 100 Response at Week 16
Délai: 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
Délai: 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
Délai: 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
|
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Percentage of Participants Who Achieved IGA Score of 0 at Week 16
Délai: 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
Délai: 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.
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Weeks 4 and 16
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Percentage of Participants Who Achieved PASI 90 Response at Week 8
Délai: 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.
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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
Délai: 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
|
|
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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: From Week 24 up to Week 160
|
From Week 24 up to Week 160
|
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Délai: From Week 0 to Week 160
|
From Week 0 to Week 160
|
|
|
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Délai: From Week 0 to Week 160
|
From Week 0 to Week 160
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Janssen Research & Development, LLC Clinicaltrial, Janssen Research & Development, LLC
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
9 mars 2024
Achèvement primaire (Réel)
15 novembre 2024
Achèvement de l'étude (Estimé)
20 septembre 2027
Dates d'inscription aux études
Première soumission
15 janvier 2024
Première soumission répondant aux critères de contrôle qualité
15 janvier 2024
Première publication (Réel)
24 janvier 2024
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
31 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
27 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 77242113PSO3004 (Autre identifiant: Janssen Research & Development, LLC)
- 2023 (Subvention/contrat des NIH des États-Unis: GRAMMY Museum Foundation)
- 2023-507039-39-00 (Identificateur de registre: EUCT number)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
La politique de partage de données des sociétés pharmaceutiques Janssen de Johnson & Johnson est disponible sur www.janssen.com/clinical-trials/transparency.
Comme indiqué sur ce site, les demandes d'accès aux données de l'étude peuvent être soumises via le site du projet Yale Open Data Access (YODA) à l'adresse yoda.yale.edu.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .