En studie av JNJ-77242113 för behandling av deltagare med måttlig till svår plackpsoriasis (ICONIC-ADVANCE 2)
27 augusti 2026 uppdaterad av: Janssen Research & Development, LLC
En fas 3 multicenter, randomiserad, dubbelblind, placebokontrollerad och Deucravacitinib Active Comparator-kontrollerad studie för att utvärdera effektiviteten och säkerheten av JNJ-77242113 för behandling av deltagare med måttlig till svår plackpsoriasis
Syftet med studien är att utvärdera hur effektivt JNJ-77242113 är hos deltagare med måttlig till svår plackpsoriasis jämfört med placebo och deucravacitinib.
Studieöversikt
Status
Aktiv, inte rekryterande
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
731
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Benowa, Australien, 4217
- The Skin Centre
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Clayton, Australien, 3168
- Monash Medical Centre
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Kogarah, Australien, 2217
- Premier Specialists
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Melbourne, Australien, 3004
- The Alfred Hospital
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Mitcham, Australien, 3132
- ISHI dermatology
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Parkville, Australien, 3050
- Royal Melbourne Hospital
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Botucatu, Brasilien, 18618-686
- UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
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Brasília, Brasilien, 72145-450
- Chronos Clinica Medica Ltda
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Ribeirão Preto, Brasilien, 14051140
- Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
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São José do Rio Preto, Brasilien, 15090-000
- Funfarme Sjrp
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São Paulo, Brasilien, 05403 900
- Hospital Das Clinicas Da Faculdade De Medicina Da USP
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São Paulo, Brasilien, 09060-870
- Cepes - Fmabc
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Arizona
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Phoenix, Arizona, Förenta staterna, 85032
- Alliance Dermatology and MOHS Center P C
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California
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Encinitas, California, Förenta staterna, 92024
- California Dermatology & Clinical Research Institute
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Encino, California, Förenta staterna, 91436
- T Joseph Raoof Md Inc
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Fresno, California, Förenta staterna, 93701
- Ucsf Fresno
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Los Angeles, California, Förenta staterna, 90056
- Wallace Medical Group, Inc
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Los Angeles, California, Förenta staterna, 90024
- University of California Los Angeles - Division of Dermatology
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Oceanside, California, Förenta staterna, 92056
- Dermatologist Medical Group of North County, Inc.
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Florida
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Miami, Florida, Förenta staterna, 33155
- Bioclinical Research Alliance Inc.
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Miami, Florida, Förenta staterna, 33133
- Miami Dermatology And Laser Institute
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Tampa, Florida, Förenta staterna, 33613
- Forcare Clinical Research Inc
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Georgia
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Douglasville, Georgia, Förenta staterna, 30135
- Southeast Dermatology Specialists
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Illinois
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Rolling Meadows, Illinois, Förenta staterna, 60008
- Arlington Dermatology
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Kentucky
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Louisville, Kentucky, Förenta staterna, 40217
- Skin Sciences, PLLC
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Owensboro, Kentucky, Förenta staterna, 42301
- Qualmedica Research
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Maryland
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Rockville, Maryland, Förenta staterna, 20850
- DermAssociates, PC
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Massachusetts
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Brighton, Massachusetts, Förenta staterna, 02135
- Metro Boston Clinical Partners
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Methuen, Massachusetts, Förenta staterna, 01844
- ActivMed Practices and Research
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48109
- University of Michigan
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Bay City, Michigan, Förenta staterna, 48706
- Great Lakes Research Group
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Caledonia, Michigan, Förenta staterna, 49316
- The Derm Institute of West Michigan
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Canton, Michigan, Förenta staterna, 48187
- Hamzavi Dermatology
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Troy, Michigan, Förenta staterna, 48084
- Somerset Skin Centre
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Missouri
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Kirksville, Missouri, Förenta staterna, 63501
- Cleaver Dermatology
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Ohio
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Bexley, Ohio, Förenta staterna, 43209
- Bexley Dermatology Research
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Oklahoma
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Tulsa, Oklahoma, Förenta staterna, 74137
- Essential Medical Research
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Oregon
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Portland, Oregon, Förenta staterna, 97210-2996
- Oregon Dermatology & Research Center
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19103
- Paddington Testing Co, Inc.
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South Carolina
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Charleston, South Carolina, Förenta staterna, 29407
- Clinical Research Center of the Carolinas LLC
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Greenville, South Carolina, Förenta staterna, 29615
- Palmetto Clinical Trial Services, LLC
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Texas
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Arlington, Texas, Förenta staterna, 76011
- Arlington Research Center, inc.
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Dallas, Texas, Förenta staterna, 75390
- UT Southwestern Medical Center
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San Antonio, Texas, Förenta staterna, 78229
- Dermatology Clinical Research Center of San Antonio
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Webster, Texas, Förenta staterna, 77598
- Center for Clinical Studies
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Utah
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Bountiful, Utah, Förenta staterna, 84010
- Cope Family Medicine - Ogden Clinic
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Springville, Utah, Förenta staterna, 84663
- Springville Dermatology CCT Research
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West Valley City, Utah, Förenta staterna, 84120
- Kalo Clinical Research
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Virginia
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Norfolk, Virginia, Förenta staterna, 23502
- Virginia Dermatology Skin Cancer Center Pllc
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British Columbia
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Surrey, British Columbia, Kanada, V3R 6A7
- Dr. Chih ho Hong Medical
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Manitoba
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Winnipeg, Manitoba, Kanada, R3M 3Z4
- Wiseman Dermatology Research Inc.
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Ontario
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London, Ontario, Kanada, N6A 5R9
- Lovegrove Dermatology
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Markham, Ontario, Kanada, L3P 1X2
- Lynderm Research Inc.
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Mississauga, Ontario, Kanada, L4Y 4C5
- DermEdge Research
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Peterborough, Ontario, Kanada, K9J 5K2
- SKiN Centre for Dermatology
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Toronto, Ontario, Kanada, M3H 5Y8
- Toronto Research Centre
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Toronto, Ontario, Kanada, M2N 3A6
- North York Research Inc
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Windsor, Ontario, Kanada, N8T 1E6
- XLR8 Medical Research
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Quebec
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Montreal, Quebec, Kanada, H2X 2V1
- Innovaderm Research Inc.
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Québec, Quebec, Kanada, G1V 4X7
- Centre de Recherche Dermatologique du Quebec metropolitain
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Bialystok, Polen, 15 797
- Renew Clinic
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Katowice, Polen, 40 568
- CaRe Clinic
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Katowice, Polen, 40 611
- Centrum Medyczne Angelius Provita
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Kielce, Polen, 25-316
- Prywatny Gabinet Dermatologiczny Elzbieta Klujszo
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Krakow, Polen, 30-002
- SGD s.c.
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Krakow, Polen, 30-303
- Krakowskie Centrum Badan Klinicznych
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Krakow, Polen, 30-348
- Jagiellonskie Centrum Innowacji
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Krakow, Polen, 31 559
- Diamond Clinic
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Olsztyn, Polen, 10-117
- Etyka Osrodek Badan Klinicznych
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Warsaw, Polen, 02-962
- Royalderm Agnieszka Nawrocka
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Warsaw, Polen, 02 661
- Carpe Diem Centrum Medycyny Estetycznej
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Warsaw, Polen, 02 672
- Synexus Polska Sp z o o Oddzial w Warszawie
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Wroclaw, Polen, 51 685
- WroMedica I Bielicka A Strzalkowska s c
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Cluj-Napoca, Rumänien, 400105
- Cabinet Medical Dermato-Venerologie
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Craiova, Rumänien, 200541
- Centrul Medical Vitaplus
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Craiova, Rumänien, 200642
- Spitalul Clinic Județean de Urgență
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Iași, Rumänien, 700381
- Sc Iasiprest Srl
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Oradea, Rumänien, 410167
- Spitalul Clinic Judetean De Urgenta Bihor
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Timișoara, Rumänien, 300757
- New Derm Clinic
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Târgu Mureş, Rumänien, 540342
- Spitalul Clinic Judetean Mures
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Alcorcón, Spanien, 28922
- Hosp. Univ. Fundacion Alcorcon
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Badalona, Spanien, 08916
- Hosp. Univ. Germans Trias I Pujol
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Barcelona, Spanien, 08036
- Hosp Clinic de Barcelona
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Manises, Spanien, 46940
- Hosp. de Manises
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Salamanca, Spanien, 37007
- Hosp Clinico Univ de Salamanca
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Santiago de Compostela, Spanien, 15702
- Clinica Gaias
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Santiago de Compostela, Spanien, 15706
- Hosp. Clinico Univ. de Santiago
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Seville, Spanien, 41009
- Hosp. Virgen Macarena
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Seville, Spanien, 41014
- Hosp. Ntra. Sra. de Valme
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Villajoyosa, Spanien, 03570
- Hosp. de La Marina Baixa
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Zaragoza, Spanien, 50009
- Hosp. Clinico Univ. Lozano Blesa
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Ansan-si, Sydkorea, 15355
- Korea University Ansan Hospital
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Anyang-si, Sydkorea, 14068
- Hallym University Sacred Heart Hospital
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Bucheon-si, Sydkorea, 14647
- The Catholic University of Korea Bucheon St Mary s Hospital
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Gwangju, Sydkorea, 61453
- Chosun University Hospital
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Seongnam, Sydkorea, 13496
- CHA Bundang Medical Center, CHA University
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Seoul, Sydkorea, 05505
- Asan Medical Center
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Seoul, Sydkorea, 8308
- Korea University Guro Hospital
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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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Augsburg, Tyskland, 86150
- Hautarztpraxis Dr. Mihaescu
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Bad Bentheim, Tyskland, 48455
- Fachklinik Bad Bentheim
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Berlin, Tyskland, 13627
- CRS Clinical Research Services Berlin GMBH
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Bochum, Tyskland, 44793
- Niesmann & Othlinghaus GbR
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Darmstadt, Tyskland, 64283
- Klinikum Darmstadt GmbH - Hautklinik
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Dresden, Tyskland, 01307
- Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
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Dülmen, Tyskland, 48249
- Hautzentrum Dulmen
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Düsseldorf, Tyskland, 40212
- Privatpraxis Dr. Hilton & Partner
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Friedrichshafen, Tyskland, 88045
- Derma-Study-Center Friedrichshafen GmbH
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Hamburg, Tyskland, 20095
- Eurofins bioskin GmbH
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Heidelberg, Tyskland, 69120
- Universitaetsklinikum Heidelberg
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Mahlow, Tyskland, 15831
- Hautarztpraxis
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Mainz, Tyskland, 55131
- Universitatsmedizin der Johannes Gutenberg Universitat Mainz
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Merzig, Tyskland, 66663
- Hautmedizin Saar Science Hms GmbH
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Münster, Tyskland, 48149
- Universitaetsklinikum Muenster
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Oldenburg, Tyskland, 26133
- Klinikum Oldenburg
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Witten, Tyskland, 58453
- Hautarztpraxis 1
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Wuppertal, Tyskland, 42287
- CentroDerm GmbH
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Budapest, Ungern, 1152
- Uno Medical Trials Ltd.
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Gyula, Ungern, 5700
- Synexus Magyarorszag Kft
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Gyöngyös, Ungern, 3200
- Bugat Pal Korhaz
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Kecskemét, Ungern, 6000
- Bacs Kiskun Varmegyei Oktatokorhaz
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Zalaegerszeg, Ungern, H-8900
- Synexus Magyarorszag Kft 1
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inklusionskriterier:
- Diagnos av plackpsoriasis, med eller utan psoriasisartrit (PsA), i minst 26 veckor före den första administreringen av studieintervention
- Total kroppsyta (BSA) större än eller lika med (>=)10 procent (%) vid screening och baslinje
- Total psoriasis area och severity index (PASI) >=12 vid screening och baslinje
- Total utredare global bedömning (IGA) >=3 vid screening och baslinje
- Kandidat för fototerapi eller systemisk behandling för plackpsoriasis
Exklusions kriterier:
- Icke-plackform av psoriasis (till exempel erytrodermisk, guttat eller pustulös)
- Aktuell läkemedelsinducerad psoriasis (till exempel en ny debut av psoriasis eller en exacerbation av psoriasis från betablockerare, kalciumkanalblockerare eller litium)
- En aktuell diagnos eller tecken eller symtom på allvarliga, progressiva eller okontrollerade njur-, lever-, hjärt-, vaskulära, pulmonella, gastrointestinala, endokrina, neurologiska, hematologiska, reumatologiska, psykiatriska eller metabola störningar
- Kända allergier, överkänslighet eller intolerans mot JNJ-77242113 eller dess hjälpämnen
- Större kirurgiska ingrepp, (till exempel som kräver generell anestesi) inom 8 veckor före screening, eller kommer inte att ha återhämtat sig helt från kirurgiskt ingrepp, eller har ett kirurgiskt ingrepp planerat under den tid som deltagaren förväntas delta i studien
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: JNJ-77242113
Deltagarna kommer att få JNJ-77242113 från vecka 0 till vecka 156 och deucravacitinib matchande placebo från vecka 0 till vecka 24.
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JNJ-77242113 kommer att administreras oralt.
Deucravacitinib matchande placebo kommer att administreras oralt.
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Placebo-jämförare: Placebo
Deltagarna kommer att få matchande placebo för JNJ-77242113 från vecka 0 till vecka 16, matchande placebo för deucravacitinib från vecka 0 till vecka 24 och JNJ-77242113 från vecka 16 till och med vecka 156.
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JNJ-77242113 kommer att administreras oralt.
JNJ-77242113 matchande placebo kommer att administreras oralt.
Deucravacitinib matchande placebo kommer att administreras oralt.
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Aktiv komparator: Deucravacitinib
Deltagarna kommer att få deucravacitinib från vecka 0 till vecka 24 och matchande placebo för JNJ-77242113 från vecka 0 till vecka 24 och JNJ-77242113 från vecka 24 till och med vecka 156.
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JNJ-77242113 kommer att administreras oralt.
JNJ-77242113 matchande placebo kommer att administreras oralt.
Deucravacitinib kommer att administreras oralt.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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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
Tidsram: 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
Tidsram: Week 16
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Förändring från baslinjen i totalt PASI-poäng vid vecka 16
Tidsram: Baslinje (Vecka 0), Vecka 16
|
Förändringen från baseline i PASI-totalscore vid vecka 16 rapporterades.
PASI var ett system som användes för att bedöma och gradera svårighetsgraden av psoriatiska lesioner och deras svar på behandling.
I PASI-systemet delades kroppen in i 4 regioner: huvudet, bålen, övre extremiteter och nedre extremiteter.
Var och en av dessa områden bedömdes och poängsattes separat för erytem, induration och fjällning, som var och en graderades på en skala från 0 till 4 (0=inget, 1=lätt, 2=måttlig, 3=svår och 4=mycket svår) och omfattning av engagemang från 0 (indikerade inget engagemang) till 6 (90% - 100% engagemang).
PASI producerade ett numeriskt totalscore som kunde variera från 0 (ingen psoriasis) till 72 (maximal psoriasis).
Högre poäng indikerade större svårighetsgrad av psoriasis.
Baseline definierades som den närmsta mätningen som togs före eller vid tidpunkten för det första studieläkemedelsadministrationsdatumet.
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Baslinje (Vecka 0), Vecka 16
|
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Percentage of Participants Who Achieved PASI 100 Response at Week 16
Tidsram: Week 16
|
Percentage of participants who achieved PASI-100 score (100% improvement from baseline in PASI) at Week 16 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 16
|
|
Change From Baseline in Body Surface Area (BSA) at Week 16
Tidsram: Baseline (Week 0), Week 16
|
A BSA was commonly used measure of severity of skin disease.
It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis).
BSA was assessed using hand print method where the surface area of the participant's hand including the palm and all 5 digits was used as a guide to estimate 1% BSA.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Baseline (Week 0), Week 16
|
|
Percent Change From Baseline in PASI Total Score at Week 16
Tidsram: Baseline (Week 0), Week 16
|
Percent change from baseline in PASI total score at Week 16 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Baseline (Week 0), Week 16
|
|
Percentage of Participants Who Achieved IGA Score of 0 at Week 16
Tidsram: Week 16
|
The IGA assesses participant's plaque psoriasis.
Lesions were graded for induration, erythema and scaling, each using a 5 point scale.
Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates.
Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
A higher score indicated more severe disease.
|
Week 16
|
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Percentage of Participants Who Achieved PASI 75 Response at Weeks 4 and 16
Tidsram: Weeks 4 and 16
|
Percentage of participants who achieved PASI-75 score (>=75% improvement from baseline in PASI) at Weeks 4 and 16 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Weeks 4 and 16
|
|
Percentage of Participants Who Achieved PASI 90 Response at Week 8
Tidsram: Week 8
|
Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Week 8 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 8
|
|
Percentage of Participants Who Achieved Scalp Specific (ss)-IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline Ss-IGA Score >=2
Tidsram: Week 16
|
The ss-IGA instrument was used to evaluate the disease severity of scalp psoriasis.
The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness which was scored as: absence of disease = 0, very mild disease = 1, mild disease = 2, moderate disease = 3, and severe disease = 4.
A higher score indicated more severe disease.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 16
|
|
Percentage of Participants Who Achieved Psoriasis Symptom and Signs Diary (PSSD) Symptom Score of 0 at Weeks 8 and 16 Among Participants With a Baseline PSSD Symptom Score >0
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: From Week 24 up to Week 160
|
From Week 24 up to Week 160
|
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Tidsram: From Week 0 to Week 160
|
From Week 0 to Week 160
|
|
|
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Tidsram: From Week 0 to Week 160
|
From Week 0 to Week 160
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studierektor: Janssen Research & Development, LLC Clinicaltrial, Janssen Research & Development, LLC
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
9 mars 2024
Primärt slutförande (Faktisk)
15 november 2024
Avslutad studie (Beräknad)
20 september 2027
Studieregistreringsdatum
Först inskickad
15 januari 2024
Först inskickad som uppfyllde QC-kriterierna
15 januari 2024
Första postat (Faktisk)
24 januari 2024
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
31 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 77242113PSO3004 (Annan identifierare: Janssen Research & Development, LLC)
- 2023 (U.S.S. NIH-anslag/kontrakt: GRAMMY Museum Foundation)
- 2023-507039-39-00 (Registeridentifierare: EUCT number)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Datadelningspolicyn för Janssen Pharmaceutical Companies of Johnson & Johnson finns på www.janssen.com/clinical-trials/transparency.
Som nämnts på den här webbplatsen kan förfrågningar om åtkomst till studiedata skickas via Yale Open Data Access (YODA) projektwebbplats på yoda.yale.edu
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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