Uno studio su JNJ-77242113 per il trattamento di partecipanti con psoriasi a placche da moderata a grave
2 luglio 2026 aggiornato da: Janssen Research & Development, LLC
Uno studio di fase 3 multicentrico, randomizzato, in doppio cieco, controllato con placebo e controllato con comparatore attivo con deucravacitinib per valutare l'efficacia e la sicurezza di JNJ-77242113 per il trattamento dei partecipanti con psoriasi a placche da moderata a grave
Lo scopo dello studio è vedere quanto sia efficace JNJ-77242113 nei partecipanti con psoriasi a placche da moderata a grave rispetto al placebo e deucravacitinib.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Tipo di studio
Interventistico
Iscrizione (Effettivo)
774
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Buenos Aires, Argentina, B1643CRO
- Instituto Medico De Alta Complejidad (IMAC)
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Buenos Aires, Argentina, C1406AGA
- ARCIS Salud SRL Aprillus asistencia e investigacion
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CABA, Argentina, C1425BEA
- Instituto de Neumonologia Y Dermatologia
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Caba, Argentina, C1199ABD
- Hospital Italiano de Buenos Aires
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Caba, Argentina, C1122AAF
- Halitus Instituto Medico S.A. - Dermatologia y Estetica
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La Plata, Argentina, B1900AXI
- Hospital Italiano de La Plata
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Rosario, Argentina, S2000PBJ
- Instituto Caici Srl.
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San Miguel de Tucumán, Argentina, T4000AXL
- Centro de Investigaciones Médicas Tucuman
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Campbelltown, Australia, 5074
- North Eastern Health Specialists
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Canberra, Australia, 2606
- Paratus Clinical Research Woden
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East Melbourne, Australia, 3002
- Sinclair Dermatology
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Melbourne, Australia, 3053
- Skin Health Institute Inc.
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Woolloongabba, Australia, 4102
- Veracity Clinical Research
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Santo André, Brasile, 09060-870
- Fundacao do ABC Centro Universitario FMABC
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British Columbia
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Surrey, British Columbia, Canada, V3V 0C6
- Enverus Medical
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
- Karma Clinical Trials Inc.
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Ontario
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Ajax, Ontario, Canada, L1S7K8
- CCA Medical Research Corporation
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Barrie, Ontario, Canada, L4M 7G1
- SimcoDerm Medical and Surgical Dermatology Centre
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Hamilton, Ontario, Canada, L8N 1Y2
- Dermatrials Research
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Richmond Hill, Ontario, Canada, L4B1L1
- York Dermatology Clinic and Research Centre
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Waterloo, Ontario, Canada, N2J 1C4
- Alliance Clinical Trials
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Windsor, Ontario, Canada, N8T 1E6
- XLR8 Medical Research
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Busan, Corea del Sud, 49241
- Pusan National University Hospital
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Seongnam-si, Corea del Sud, 13620
- Seoul National University Bundang Hospital
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Seoul, Corea del Sud, 03080
- Seoul National University Hospital
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Seoul, Corea del Sud, 06591
- The Catholic University of Korea Seoul St Marys Hospital
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Seoul, Corea del Sud, 05030
- Konkuk University Medical Center
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Seoul, Corea del Sud, 04763
- Hanyang University Medical Center
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Seoul, Corea del Sud, 130 050
- Kyung Hee University Hospital
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Berlin, Germania, 10789
- ISA - Interdisciplinary Study Association GmbH
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Bramsche, Germania, 49565
- Hautarztpraxis 3
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Dresden, Germania, 01069
- Klinische Forschung Dresden GmbH
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Dresden, Germania, 01097
- Praxis fuer Dermatologie und Venerologie
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Düsseldorf, Germania, 40225
- Universitaetsklinikum Duesseldorf
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Hamburg, Germania, 22391
- MensingDerma Research GmbH
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Hamburg, Germania, 20246
- Universitaetsklinikum Hamburg Eppendorf
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Kiel, Germania, 24105
- Universitaetsklinikum Schleswig Holstein Campus Kiel
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Langenau, Germania, 89129
- Studienzentrum Dr Schwarz Germany
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Leipzig, Germania, 04103
- Universitätsklinikum Leipzig AöR
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Lübeck, Germania, 23562
- Universitatsklinikum Schleswig Holstein Campus Lubeck
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Mannheim, Germania, 68167
- Universitaetsklinikum Mannheim
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München, Germania, 80802
- Klinik und Poliklinik fur Dermatologie und Allergologie am Biederstein
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Potsdam, Germania, 14467
- Hautarztpraxis 1
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Rostock, Germania, 18057
- Universitaetsmedizin Rostock
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Fukuoka, Giappone, 814-0180
- Fukuoka University Hospital
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Fukutsu, Giappone, 811-3217
- Hino Dermatology Clinic
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Gifu, Giappone, 501-1112
- Gifu University Hospital
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Ginowan, Giappone, 901 2725
- University of the Ryukyus Hospital
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Gunma, Giappone, 371 8511
- Gunma University Hospital
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Hokkaido, Giappone, 060-0033
- JR Sapporo Hospital
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Hokkaido, Giappone, 078 8510
- Asahikawa Medical University Hospital
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Isehara, Giappone, 259-1193
- Tokai University Hospital
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Itabashi Ku, Giappone, 173 8606
- Teikyo University Hospital
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Kawasaki, Giappone, 216 8511
- St Marianna University Hospital
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Kitakyushu-shi, Giappone, 807-8556
- Hospital of the University of Occupational and Environmental Health
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Nagoya, Giappone, 467 8602
- Nagoya City University Hospital
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Nishiku, Giappone, 593-8324
- Kume Clinic
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Obihiro Shi, Giappone, 080 0013
- Takagi Dermatological Clinic
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Osaka, Giappone, 550 0006
- Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
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Sakai, Giappone, 590 0197
- Kindai University Hospital
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Sapporo, Giappone, 060 0063
- Sapporo Skin Clinic
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Sendai, Giappone, 980 8574
- Tohoku University Hospital
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Suita, Giappone, 565 0871
- The University of Osaka Hospital
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Tachikawa, Giappone, 190 0023
- Jitaikai Tachikawa dermatology clinic
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Takaoka Shi, Giappone, 933-0871
- Shirasaki dermatology clinic
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Tokyo, Giappone, 160-0023
- Tokyo Medical University Hospital
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Tsu, Giappone, 514 8507
- Mie University Hospital
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Bialystok, Polonia, 15-351
- Osteo-Medic s.c A. Racewicz, J Supronik
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Bialystok, Polonia, 15-375
- Specderm Poznanska sp j
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Elblag, Polonia, 82 300
- Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
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Krakow, Polonia, 31-411
- Centrum Medyczne Promed
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Krakow, Polonia, 30 438
- Centrum Medyczne dr Rajzer Sp z o o
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Krakow, Polonia, 30-002
- Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
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Lodz, Polonia, 90-338
- Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
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Lodz, Polonia, 90-265
- Dermed Centrum Medyczne Sp z o o
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Osielsko, Polonia, 86031
- Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C
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Poznan, Polonia, 61 731
- Clinical Research Center sp z o o MEDIC R s k
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Poznan, Polonia, 60 529
- SOLUMED Centrum Medyczne
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Warsaw, Polonia, 02 953
- Klinika Ambroziak Dermatologia
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Warsaw, Polonia, 01 817
- Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna
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Wroclaw, Polonia, 51 503
- DERMMEDICA Sp.z o.o.
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Wroclaw, Polonia, 52 416
- Centrum Medyczne Oporow
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Wroclaw, Polonia, 51 685
- Wro Medica
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London, Regno Unito, SE1 9RT
- Guys and St Thomas NHS Foundation Trust
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Reading, Regno Unito, RG1 5AN
- Royal Berkshire Hospital
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Salford, Regno Unito, M6 8HD
- Salford Royal Hospital
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Southampton, Regno Unito, SO16 6YD
- University Hospital Southampton NHS Foundation Trust
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Alicante, Spagna, 03010
- Hosp. Gral. Univ. Dr. Balmis
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Barakaldo, Spagna, 48902
- Hosp. Univ. de Cruces
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Barcelona, Spagna, 08041
- Hosp. de La Santa Creu I Sant Pau
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Granada, Spagna, 18016
- Hosp. Univ. San Cecilio
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L'Hospitalet de Llobregat, Spagna, 08907
- Hosp. Univ. de Bellvitge
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Madrid, Spagna, 28041
- Hosp. Univ. 12 de Octubre
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Madrid, Spagna, 28007
- Hosp. Gral. Univ. Gregorio Maranon
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Madrid, Spagna, 28031
- Hosp. Univ. Infanta Leonor
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Madrid, Spagna, 28006
- Hosp. Univ. de La Princesa
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Madrid, Spagna, 28046
- Hosp. Univ. de La Paz
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Madrid, Spagna, 28002
- Grupo Dermatologico Y Estetico Pedro Jaen
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Valencia, Spagna, 46026
- Hosp. Univ. I Politecni La Fe
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Arizona
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Phoenix, Arizona, Stati Uniti, 85006
- Medical Dermatology Specialists
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Scottsdale, Arizona, Stati Uniti, 85260
- Center for Dermatology and Plastic Surgery
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Arkansas
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Fort Smith, Arkansas, Stati Uniti, 72916
- Johnson Dermatology
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California
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Fountain Valley, California, Stati Uniti, 92708
- First OC Dermatology
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Fremont, California, Stati Uniti, 94538
- Center for Dermatology Clinical Research
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Sacramento, California, Stati Uniti, 95815
- Integrative Skin Science and Research
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Santa Ana, California, Stati Uniti, 92701
- Southern California Dermatology
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Santa Monica, California, Stati Uniti, 90403
- Clinical Science Institute
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Florida
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Miami, Florida, Stati Uniti, 33126
- Driven Research LLC
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North Miami Beach, Florida, Stati Uniti, 33162
- Ziaderm Research LLC
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Ocala, Florida, Stati Uniti, 34470
- Renstar Medical Research
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Tampa, Florida, Stati Uniti, 33613
- Forcare Clinical Research Inc
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Georgia
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Alpharetta, Georgia, Stati Uniti, 30022
- Hamilton Research LLC
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Macon, Georgia, Stati Uniti, 31217
- Skin Care Physicians of Georgia
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Illinois
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Chicago, Illinois, Stati Uniti, 60602
- DeNova Research
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Rolling Meadows, Illinois, Stati Uniti, 60008
- Arlington Dermatology
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Skokie, Illinois, Stati Uniti, 60077
- Endeavor Health
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West Dundee, Illinois, Stati Uniti, 60118
- Dundee Dermatology
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Indiana
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Indianapolis, Indiana, Stati Uniti, 46250
- Dawes Fretzin Clinical Research Group LLC
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Plainfield, Indiana, Stati Uniti, 46168
- Indiana Clinical Trial Center
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Kentucky
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Louisville, Kentucky, Stati Uniti, 40241
- Dermatology Specialists
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Louisiana
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Lake Charles, Louisiana, Stati Uniti, 70605
- Dermatology and Advanced Aesthetics
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02111
- Tufts Medical Center
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48103
- David Fivenson MD, Dermatology
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Clarkston, Michigan, Stati Uniti, 48346
- Michigan Center of Medical Research
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Detroit, Michigan, Stati Uniti, 48202
- Henry Ford Medical Center
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Fort Gratiot, Michigan, Stati Uniti, 48059
- Hamzavi Dermatology
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Missouri
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Saint Joseph, Missouri, Stati Uniti, 64506
- MediSearch Clinical Trials
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68144
- Skin Specialists
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89119
- Fife Dermatology
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New Hampshire
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Portsmouth, New Hampshire, Stati Uniti, 03801
- Stracskin
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New Jersey
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East Windsor, New Jersey, Stati Uniti, 08520
- Schweiger Dermatology Group
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Hackensack, New Jersey, Stati Uniti, 07601
- Schweiger Dermatology Group 1
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New York
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Stony Brook, New York, Stati Uniti, 11790
- Derm Research Center of New York, Inc.
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North Carolina
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Wilmington, North Carolina, Stati Uniti, 28405
- Wilmington Dermatology Center
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Ohio
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Athens, Ohio, Stati Uniti, 45701
- Oakview Dermatology
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Boardman, Ohio, Stati Uniti, 44512
- Optima Research
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73170
- Central Sooner Research
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Oregon
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Portland, Oregon, Stati Uniti, 97201
- Oregon Medical Research Center
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South Dakota
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Rapid City, South Dakota, Stati Uniti, 57702
- Health Concepts
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Texas
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Dallas, Texas, Stati Uniti, 75231
- Modern Research Associates
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Houston, Texas, Stati Uniti, 77004
- Center for Clinical Studies 1
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Houston, Texas, Stati Uniti, 77056
- Austin Institute for Clinical Research 1
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Pflugerville, Texas, Stati Uniti, 78660
- Austin Institute for Clinical Research
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San Antonio, Texas, Stati Uniti, 78218
- Texas Dermatology and Laser Specialists
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San Antonio, Texas, Stati Uniti, 78213
- Progressive Clinical Research
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Webster, Texas, Stati Uniti, 77598
- Center for Clinical Studies
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Virginia
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Richmond, Virginia, Stati Uniti, 23294
- National Clinical Research
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Washington
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Mill Creek, Washington, Stati Uniti, 98012
- Frontier Derm Partners CRO, LLC
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Spokane, Washington, Stati Uniti, 99202
- Premier Clinical Research
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Hsinchu, Taiwan, 30059
- National Taiwan University Hospital Hsin Chu Branch
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Kaohsiung City, Taiwan, 833
- Chang Kung Memorial Hospital
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New Taipei City, Taiwan, 235
- Taipei Medical University Shuang Ho Hospital
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Taipei, Taiwan, 112
- Taipei Veterans General Hospital
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Taipei, Taiwan, 10048
- National Taiwan University Hospital
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Taipei, Taiwan, 10449
- Taipei Mackay Memorial Hospital
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Taoyuan, Taiwan, 33382
- Linkou Chang Gung Memorial Hospital
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Borgyogyaszati Klinika, Ungheria, 7632
- Pecsi Tudomanyegyetem
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Budapest, Ungheria, 1036
- Obudai Egeszsegugyi Centrum Kft
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Debrecen, Ungheria, 4032
- Debreceni Egyetem Klinikai Kozpont
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Debrecen, Ungheria, 4031
- Derma-B Kft
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Kaposvár, Ungheria, 7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
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Szeged, Ungheria, 6720
- SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati és Allergologiai Klinika
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Szolnok, Ungheria, 5000
- Allergo-Derm Bakos Kft.
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Veszprém, Ungheria, 8200
- Medmare Egeszsegugyi Es Szolgaltato Bt.
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Criterio di inclusione:
- Diagnosi di psoriasi a placche, con o senza artrite psoriasica (PsA), per almeno 26 settimane prima della prima somministrazione dell'intervento in studio
- Superficie corporea totale (BSA) maggiore o uguale a (>=) 10% (%) allo screening e al basale
- Area totale della psoriasi e indice di gravità (PASI) >=12 allo screening e al basale
- Valutazione globale totale dello sperimentatore (IGA) >=3 allo screening e al basale
- Candidato alla fototerapia o al trattamento sistemico per la psoriasi a placche
Criteri di esclusione:
- Forma di psoriasi non a placche (ad esempio eritrodermica, guttata o pustolosa)
- Psoriasi attuale indotta da farmaci (ad esempio, una nuova insorgenza di psoriasi o una esacerbazione della psoriasi da beta-bloccanti, bloccanti dei canali del calcio o litio)
- Una diagnosi attuale o segni o sintomi di disturbi renali, epatici, cardiaci, vascolari, polmonari, gastrointestinali, endocrini, neurologici, ematologici, reumatologici, psichiatrici o metabolici gravi, progressivi o non controllati
- Allergie note, ipersensibilità o intolleranza a JNJ-77242113 o ai suoi eccipienti
- Intervento chirurgico maggiore (ad esempio, che richiede anestesia generale) entro 8 settimane prima dello screening, o non si sarà completamente ripreso dall'intervento chirurgico, o è stata pianificata una procedura chirurgica durante il periodo in cui è prevista la partecipazione del partecipante allo studio
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: JNJ-77242113
I partecipanti riceveranno JNJ-77242113 dalla settimana 0 alla settimana 156 e deucravacitinib corrispondente al placebo dalla settimana 0 alla settimana 24.
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JNJ-77242113 verrà somministrato per via orale.
Deucravacitinib corrispondente al placebo sarà somministrato per via orale.
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Comparatore placebo: Placebo
I partecipanti riceveranno il placebo corrispondente per JNJ-77242113 dalla settimana 0 alla settimana 16, il placebo corrispondente per deucravacitinib dalla settimana 0 alla settimana 24 e JNJ-77242113 dalla settimana 16 alla settimana 156.
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JNJ-77242113 verrà somministrato per via orale.
Il placebo corrispondente al JNJ-77242113 verrà somministrato per via orale.
Deucravacitinib corrispondente al placebo sarà somministrato per via orale.
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Comparatore attivo: Deucravacitinib
I partecipanti riceveranno deucravacitinib dalla settimana 0 alla settimana 24 e placebo corrispondente per JNJ-77242113 dalla settimana 0 alla settimana 24 e JNJ-77242113 dalla settimana 24 alla settimana 156.
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JNJ-77242113 verrà somministrato per via orale.
Il placebo corrispondente al JNJ-77242113 verrà somministrato per via orale.
Deucravacitinib verrà somministrato per via orale.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Greater Than or Equal to (>=) 2-Grade Improvement From Baseline at Week 16
Lasso di tempo: Week 16
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IGA assesses participant's plaque psoriasis.
Lesions were graded for induration, erythema, 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,>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 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.
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Week 16
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Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline in Body Surface Area (BSA) at Week 16
Lasso di tempo: 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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Percentage of Participants Who Achieved IGA Score of 0 at Week 16
Lasso di tempo: 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 Psoriasis Symptom and Signs Diary (PSSD) Symptom Score of 0 at Weeks 8 and 16 Among Participants With a Baseline PSSD Symptom Score >0
Lasso di tempo: Weeks 8 and 16
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PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit.
24-hour recall version was used.
PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity.
Each individual item score over seven days was averaged into a weekly item score.
Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items).
Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe).
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
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Weeks 8 and 16
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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
Lasso di tempo: 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
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Percentage of Participants Who Achieved an IGA Score of 0 at Weeks 16 and 24
Lasso di tempo: 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 PSSD Sign Score of 0 at Week 16 Among Participants With a Baseline Sign Score >0
Lasso di tempo: 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.
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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
Lasso di tempo: 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.
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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
Lasso di tempo: 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
|
|
Percentage of Participants Who Achieved DLQI Score of 0 or 1 at Weeks 16 and 24 Among Participants With a Baseline DLQI Score >1
Lasso di tempo: 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 PASI 75 at Weeks 4 and 16
Lasso di tempo: 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 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 4 and 16
|
|
Percentage of Participants Who Achieved PASI 90 at Week 8
Lasso di tempo: 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 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 8
|
|
Percentage of Participants Who Achieved PASI 100 at Week 16
Lasso di tempo: 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
|
|
Percentage of Participants Who Achieved a 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
Lasso di tempo: 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 an IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Weeks 16 and 24
Lasso di tempo: Weeks 16 and 24
|
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 <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 PASI 75 at Weeks 16 and 24
Lasso di tempo: 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 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 PASI 90 at Weeks 16 and 24
Lasso di tempo: 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 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 PASI 100 at Weeks 16 and 24
Lasso di tempo: 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 Symptom Score >0
Lasso di tempo: 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
|
|
Change From Baseline in PASI Total Score at Week 16
Lasso di tempo: Baseline (Week 0), Week 16
|
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 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.
|
Baseline (Week 0), Week 16
|
|
Percent Change From Baseline in PASI Total Score at Week 16
Lasso di tempo: 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 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.
|
Baseline (Week 0), 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 at Week 16 Among Participants With a Baseline sPGA-G Score >=2
Lasso di tempo: 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 at Week 16 Among Participants With a Baseline Hf-PGA Score >=2
Lasso di tempo: 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
Lasso di tempo: 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 Baseline f-PGA Score >=2
Lasso di tempo: 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.
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 PSSD Symptom Score at Week 16
Lasso di tempo: Baseline (Week 0), Week 16
|
Change from baseline in PSSD symptoms score 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
Lasso di tempo: Baseline (Week 0), Week 16
|
Change from baseline in PSSD sign score 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
|
|
Change From Baseline in Total DLQI Score at Week 16
Lasso di tempo: Baseline (Week 0), Week 16
|
Change from baseline in total DLQI score at Week 16 was reported.
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.
|
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
Lasso di tempo: 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 i.e. 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/at the time of first study drug administration date.
|
Baseline (Week 0), Week 16
|
|
Percentage of Participants Who Achieved PSSD Symptom Score of 0 at Week 24 Among Participants With Baseline Symptom Score >0
Lasso di tempo: 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
Lasso di tempo: Week 24 up to Week 160
|
Week 24 up to Week 160
|
|
|
Percentage of Participants Who Achieved PASI 90 After Week 24, Among PASI 90 Nonresponders to Deucravacitinib at Week 24
Lasso di tempo: Week 24 up to Week 160
|
Week 24 up to Week 160
|
|
|
Percentage of Participants Who Achieved IGA Score of 0 or 1 After Week 24, Among Participants in the Deucravacitinib Group With IGA Score >=2 at Week 24
Lasso di tempo: Week 24 up to Week 160
|
Week 24 up to Week 160
|
|
|
Number of Participants With Adverse Events (AEs)
Lasso di tempo: From Week 0 to Week 160
|
From Week 0 to Week 160
|
|
|
Number of Participants With Serious Adverse Events (SAEs)
Lasso di tempo: From Week 0 to Week 160
|
From Week 0 to Week 160
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Direttore dello studio: Janssen Research & Development, LLC Clinicaltrial, Janssen Research & Development, LLC
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 febbraio 2024
Completamento primario (Effettivo)
17 settembre 2024
Completamento dello studio (Stimato)
1 giugno 2027
Date di iscrizione allo studio
Primo inviato
14 novembre 2023
Primo inviato che soddisfa i criteri di controllo qualità
16 novembre 2023
Primo Inserito (Effettivo)
22 novembre 2023
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
7 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
2 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 77242113PSO3002 (Altro identificatore: Janssen Research & Development, LLC)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
La politica di condivisione dei dati delle società farmaceutiche Janssen di Johnson & Johnson è disponibile all'indirizzo www.janssen.com/clinical-trials/transparency.
Come indicato su questo sito, le richieste di accesso ai dati dello studio possono essere inviate tramite il sito del progetto Yale Open Data Access (YODA) all'indirizzo yoda.yale.edu
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .