Une étude de JNJ-77242113 pour le traitement des participants atteints de psoriasis en plaques modéré à sévère
2 juillet 2026 mis à jour par: Janssen Research & Development, LLC
Une étude de phase 3 multicentrique, randomisée, en double aveugle, contrôlée par placebo et contrôlée par un comparateur actif deucravacitinib pour évaluer l'efficacité et l'innocuité du JNJ-77242113 pour le traitement des participants atteints de psoriasis en plaques modéré à sévère
Le but de l'étude est de voir l'efficacité du JNJ-77242113 chez les participants atteints de psoriasis en plaques modéré à sévère par rapport au placebo et au deucravacitinib.
Aperçu de l'étude
Statut
Actif, ne recrute pas
Les conditions
Type d'étude
Interventionnel
Inscription (Réel)
774
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Berlin, Allemagne, 10789
- ISA - Interdisciplinary Study Association GmbH
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Bramsche, Allemagne, 49565
- Hautarztpraxis 3
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Dresden, Allemagne, 01069
- Klinische Forschung Dresden GmbH
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Dresden, Allemagne, 01097
- Praxis fuer Dermatologie und Venerologie
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Düsseldorf, Allemagne, 40225
- Universitaetsklinikum Duesseldorf
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Hamburg, Allemagne, 22391
- MensingDerma Research GmbH
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Hamburg, Allemagne, 20246
- Universitaetsklinikum Hamburg Eppendorf
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Kiel, Allemagne, 24105
- Universitaetsklinikum Schleswig Holstein Campus Kiel
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Langenau, Allemagne, 89129
- Studienzentrum Dr Schwarz Germany
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Leipzig, Allemagne, 04103
- Universitätsklinikum Leipzig AöR
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Lübeck, Allemagne, 23562
- Universitatsklinikum Schleswig Holstein Campus Lubeck
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Mannheim, Allemagne, 68167
- Universitaetsklinikum Mannheim
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München, Allemagne, 80802
- Klinik und Poliklinik fur Dermatologie und Allergologie am Biederstein
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Potsdam, Allemagne, 14467
- Hautarztpraxis 1
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Rostock, Allemagne, 18057
- Universitaetsmedizin Rostock
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Buenos Aires, Argentine, B1643CRO
- Instituto Medico De Alta Complejidad (IMAC)
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Buenos Aires, Argentine, C1406AGA
- ARCIS Salud SRL Aprillus asistencia e investigacion
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CABA, Argentine, C1425BEA
- Instituto de Neumonología Y Dermatología
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Caba, Argentine, C1199ABD
- Hospital Italiano de Buenos Aires
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Caba, Argentine, C1122AAF
- Halitus Instituto Medico S.A. - Dermatologia y Estetica
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La Plata, Argentine, B1900AXI
- Hospital Italiano de La Plata
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Rosario, Argentine, S2000PBJ
- Instituto Caici Srl.
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San Miguel de Tucumán, Argentine, T4000AXL
- Centro de Investigaciones Médicas Tucuman
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Campbelltown, Australie, 5074
- North Eastern Health Specialists
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Canberra, Australie, 2606
- Paratus Clinical Research Woden
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East Melbourne, Australie, 3002
- Sinclair Dermatology
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Melbourne, Australie, 3053
- Skin Health Institute Inc.
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Woolloongabba, Australie, 4102
- Veracity Clinical Research
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Santo André, Brésil, 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, Corée du Sud, 49241
- Pusan National University Hospital
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Seongnam-si, Corée du Sud, 13620
- Seoul National University Bundang Hospital
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Seoul, Corée du Sud, 03080
- Seoul National University Hospital
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Seoul, Corée du Sud, 06591
- The Catholic University of Korea Seoul St Marys Hospital
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Seoul, Corée du Sud, 05030
- Konkuk University Medical Center
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Seoul, Corée du Sud, 04763
- Hanyang University Medical Center
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Seoul, Corée du Sud, 130 050
- Kyung Hee University Hospital
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Alicante, Espagne, 03010
- Hosp. Gral. Univ. Dr. Balmis
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Barakaldo, Espagne, 48902
- Hosp. Univ. de Cruces
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Barcelona, Espagne, 08041
- Hosp. de La Santa Creu I Sant Pau
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Granada, Espagne, 18016
- Hosp. Univ. San Cecilio
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L'Hospitalet de Llobregat, Espagne, 08907
- Hosp. Univ. de Bellvitge
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Madrid, Espagne, 28041
- Hosp. Univ. 12 de Octubre
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Madrid, Espagne, 28007
- Hosp. Gral. Univ. Gregorio Maranon
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Madrid, Espagne, 28031
- Hosp. Univ. Infanta Leonor
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Madrid, Espagne, 28006
- Hosp. Univ. de La Princesa
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Madrid, Espagne, 28046
- Hosp. Univ. de La Paz
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Madrid, Espagne, 28002
- Grupo Dermatologico Y Estetico Pedro Jaen
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Valencia, Espagne, 46026
- Hosp. Univ. I Politecni La Fe
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Borgyogyaszati Klinika, Hongrie, 7632
- Pecsi Tudomanyegyetem
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Budapest, Hongrie, 1036
- Obudai Egeszsegugyi Centrum Kft
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Debrecen, Hongrie, 4032
- Debreceni Egyetem Klinikai Kozpont
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Debrecen, Hongrie, 4031
- Derma-B Kft
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Kaposvár, Hongrie, 7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
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Szeged, Hongrie, 6720
- SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati és Allergologiai Klinika
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Szolnok, Hongrie, 5000
- Allergo-Derm Bakos Kft.
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Veszprém, Hongrie, 8200
- Medmare Egeszsegugyi Es Szolgaltato Bt.
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Fukuoka, Japon, 814-0180
- Fukuoka University Hospital
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Fukutsu, Japon, 811-3217
- Hino Dermatology Clinic
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Gifu, Japon, 501-1112
- Gifu University Hospital
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Ginowan, Japon, 901 2725
- University of the Ryukyus hospital
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Gunma, Japon, 371 8511
- Gunma University Hospital
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Hokkaido, Japon, 060-0033
- JR Sapporo Hospital
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Hokkaido, Japon, 078 8510
- Asahikawa Medical University Hospital
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Isehara, Japon, 259-1193
- Tokai University Hospital
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Itabashi Ku, Japon, 173 8606
- Teikyo University Hospital
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Kawasaki, Japon, 216 8511
- St Marianna University Hospital
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Kitakyushu-shi, Japon, 807-8556
- Hospital of the University of Occupational and Environmental Health
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Nagoya, Japon, 467 8602
- Nagoya City University Hospital
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Nishiku, Japon, 593-8324
- Kume Clinic
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Obihiro Shi, Japon, 080 0013
- Takagi Dermatological Clinic
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Osaka, Japon, 550 0006
- Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
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Sakai, Japon, 590 0197
- Kindai University Hospital
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Sapporo, Japon, 060 0063
- Sapporo Skin Clinic
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Sendai, Japon, 980 8574
- Tohoku University Hospital
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Suita, Japon, 565 0871
- The University of Osaka Hospital
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Tachikawa, Japon, 190 0023
- Jitaikai Tachikawa dermatology clinic
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Takaoka Shi, Japon, 933-0871
- Shirasaki dermatology clinic
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Tokyo, Japon, 160-0023
- Tokyo Medical University Hospital
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Tsu, Japon, 514 8507
- Mie University Hospital
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Bialystok, Pologne, 15-351
- Osteo-Medic s.c A. Racewicz, J Supronik
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Bialystok, Pologne, 15-375
- Specderm Poznanska sp j
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Elblag, Pologne, 82 300
- Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
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Krakow, Pologne, 31-411
- Centrum Medyczne PROMED
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Krakow, Pologne, 30 438
- Centrum Medyczne dr Rajzer Sp z o o
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Krakow, Pologne, 30-002
- Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
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Lodz, Pologne, 90-338
- Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
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Lodz, Pologne, 90-265
- Dermed Centrum Medyczne Sp z o o
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Osielsko, Pologne, 86031
- Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C
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Poznan, Pologne, 61 731
- Clinical Research Center sp z o o MEDIC R s k
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Poznan, Pologne, 60 529
- SOLUMED Centrum Medyczne
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Warsaw, Pologne, 02 953
- Klinika Ambroziak Dermatologia
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Warsaw, Pologne, 01 817
- Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna
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Wroclaw, Pologne, 51 503
- DERMMEDICA Sp.z o.o.
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Wroclaw, Pologne, 52 416
- Centrum Medyczne Oporow
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Wroclaw, Pologne, 51 685
- Wro Medica
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London, Royaume-Uni, SE1 9RT
- Guys and St Thomas NHS Foundation Trust
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Reading, Royaume-Uni, RG1 5AN
- Royal Berkshire Hospital
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Salford, Royaume-Uni, M6 8HD
- Salford Royal Hospital
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Southampton, Royaume-Uni, SO16 6YD
- University Hospital Southampton NHS Foundation Trust
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Hsinchu, Taïwan, 30059
- National Taiwan University Hospital Hsin Chu Branch
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Kaohsiung City, Taïwan, 833
- Chang Kung Memorial Hospital
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New Taipei City, Taïwan, 235
- Taipei Medical University Shuang Ho Hospital
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Taipei, Taïwan, 112
- Taipei Veterans General Hospital
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Taipei, Taïwan, 10048
- National Taiwan University Hospital
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Taipei, Taïwan, 10449
- Taipei Mackay Memorial Hospital
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Taoyuan, Taïwan, 33382
- Linkou Chang Gung Memorial Hospital
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Arizona
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Phoenix, Arizona, États-Unis, 85006
- Medical Dermatology Specialists
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Scottsdale, Arizona, États-Unis, 85260
- Center for Dermatology and Plastic Surgery
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Arkansas
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Fort Smith, Arkansas, États-Unis, 72916
- Johnson Dermatology
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California
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Fountain Valley, California, États-Unis, 92708
- First OC Dermatology
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Fremont, California, États-Unis, 94538
- Center for Dermatology Clinical Research
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Sacramento, California, États-Unis, 95815
- Integrative Skin Science and Research
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Santa Ana, California, États-Unis, 92701
- Southern California Dermatology
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Santa Monica, California, États-Unis, 90403
- Clinical Science Institute
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Florida
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Miami, Florida, États-Unis, 33126
- Driven Research LLC
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North Miami Beach, Florida, États-Unis, 33162
- Ziaderm Research LLC
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Ocala, Florida, États-Unis, 34470
- Renstar Medical Research
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Tampa, Florida, États-Unis, 33613
- Forcare Clinical Research Inc
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Georgia
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Alpharetta, Georgia, États-Unis, 30022
- Hamilton Research LLC
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Macon, Georgia, États-Unis, 31217
- Skin Care Physicians Of Georgia
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Illinois
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Chicago, Illinois, États-Unis, 60602
- DeNova Research
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Rolling Meadows, Illinois, États-Unis, 60008
- Arlington Dermatology
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Skokie, Illinois, États-Unis, 60077
- Endeavor Health
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West Dundee, Illinois, États-Unis, 60118
- Dundee Dermatology
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Indiana
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Indianapolis, Indiana, États-Unis, 46250
- Dawes Fretzin Clinical Research Group LLC
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Plainfield, Indiana, États-Unis, 46168
- Indiana Clinical Trial Center
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Kentucky
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Louisville, Kentucky, États-Unis, 40241
- Dermatology Specialists
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Louisiana
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Lake Charles, Louisiana, États-Unis, 70605
- Dermatology and Advanced Aesthetics
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Massachusetts
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Boston, Massachusetts, États-Unis, 02111
- Tufts Medical Center
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Michigan
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Ann Arbor, Michigan, États-Unis, 48103
- David Fivenson MD, Dermatology
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Clarkston, Michigan, États-Unis, 48346
- Michigan Center of Medical Research
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Detroit, Michigan, États-Unis, 48202
- Henry Ford Medical Center
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Fort Gratiot, Michigan, États-Unis, 48059
- Hamzavi Dermatology
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Missouri
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Saint Joseph, Missouri, États-Unis, 64506
- MediSearch Clinical Trials
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Nebraska
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Omaha, Nebraska, États-Unis, 68144
- Skin Specialists
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Nevada
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Las Vegas, Nevada, États-Unis, 89119
- Fife Dermatology
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New Hampshire
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Portsmouth, New Hampshire, États-Unis, 03801
- StracSkin
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New Jersey
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East Windsor, New Jersey, États-Unis, 08520
- Schweiger Dermatology Group
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Hackensack, New Jersey, États-Unis, 07601
- Schweiger Dermatology Group 1
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New York
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Stony Brook, New York, États-Unis, 11790
- Derm Research Center of New York, Inc.
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North Carolina
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Wilmington, North Carolina, États-Unis, 28405
- Wilmington Dermatology Center
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Ohio
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Athens, Ohio, États-Unis, 45701
- Oakview Dermatology
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Boardman, Ohio, États-Unis, 44512
- Optima Research
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73170
- Central Sooner Research
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Oregon
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Portland, Oregon, États-Unis, 97201
- Oregon Medical Research Center
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South Dakota
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Rapid City, South Dakota, États-Unis, 57702
- Health Concepts
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Texas
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Dallas, Texas, États-Unis, 75231
- Modern Research Associates
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Houston, Texas, États-Unis, 77004
- Center for Clinical Studies 1
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Houston, Texas, États-Unis, 77056
- Austin Institute for Clinical Research 1
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Pflugerville, Texas, États-Unis, 78660
- Austin Institute for Clinical Research
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San Antonio, Texas, États-Unis, 78218
- Texas Dermatology and Laser Specialists
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San Antonio, Texas, États-Unis, 78213
- Progressive Clinical Research
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Webster, Texas, États-Unis, 77598
- Center for Clinical Studies
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Virginia
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Richmond, Virginia, États-Unis, 23294
- National Clinical Research
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Washington
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Mill Creek, Washington, États-Unis, 98012
- Frontier Derm Partners CRO, LLC
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Spokane, Washington, États-Unis, 99202
- Premier Clinical Research
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Critère d'intégration:
- Diagnostic du psoriasis en plaques, avec ou sans rhumatisme psoriasique (RP), au moins 26 semaines avant la première administration de l'intervention de l'étude
- Surface corporelle totale (BSA) supérieure ou égale à (>=) 10 pour cent (%) au moment du dépistage et de référence
- Surface totale et indice de gravité du psoriasis (PASI) > = 12 au moment du dépistage et de l'inclusion
- Évaluation globale totale de l'investigateur (IGA) > = 3 au moment de la sélection et de l'inclusion
- Candidat à la photothérapie ou au traitement systémique du psoriasis en plaques
Critère d'exclusion:
- Forme de psoriasis sans plaques (par exemple, érythrodermique, en gouttes ou pustuleux)
- Psoriasis actuel d'origine médicamenteuse (par exemple, une nouvelle apparition de psoriasis ou une exacerbation du psoriasis due aux bêtabloquants, aux inhibiteurs calciques ou au lithium)
- Un diagnostic actuel ou des signes ou symptômes de troubles rénaux, hépatiques, cardiaques, vasculaires, pulmonaires, gastro-intestinaux, endocriniens, neurologiques, hématologiques, rhumatologiques, psychiatriques ou métaboliques graves, progressifs ou incontrôlés.
- Allergies, hypersensibilité ou intolérance connues au JNJ-77242113 ou à ses excipients
- Intervention chirurgicale majeure (par exemple, nécessitant une anesthésie générale) dans les 8 semaines précédant le dépistage, ou ne se sera pas complètement rétabli de l'intervention chirurgicale, ou une intervention chirurgicale est prévue pendant la période pendant laquelle le participant est censé participer à l'étude.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: JNJ-77242113
Les participants recevront le JNJ-77242113 de la semaine 0 à la semaine 156 et le placebo correspondant au deucravacitinib de la semaine 0 à la semaine 24.
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JNJ-77242113 sera administré par voie orale.
Le placebo correspondant au deucravacitinib sera administré par voie orale.
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Comparateur placebo: Placebo
Les participants recevront un placebo correspondant au JNJ-77242113 de la semaine 0 à la semaine 16, un placebo correspondant au deucravacitinib de la semaine 0 à la semaine 24 et au JNJ-77242113 de la semaine 16 à la semaine 156.
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JNJ-77242113 sera administré par voie orale.
Le placebo correspondant au JNJ-77242113 sera administré par voie orale.
Le placebo correspondant au deucravacitinib sera administré par voie orale.
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Comparateur actif: Deucravacitinib
Les participants recevront du deucravacitinib de la semaine 0 à la semaine 24 et un placebo correspondant pour le JNJ-77242113 de la semaine 0 à la semaine 24 et le JNJ-77242113 de la semaine 24 à la semaine 156.
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JNJ-77242113 sera administré par voie orale.
Le placebo correspondant au JNJ-77242113 sera administré par voie orale.
Le deucravacitinib sera administré par voie orale.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Greater Than or Equal to (>=) 2-Grade Improvement From Baseline at Week 16
Délai: Week 16
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IGA assesses participant's plaque psoriasis.
Lesions were graded for induration, erythema, 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change From Baseline in Body Surface Area (BSA) at Week 16
Délai: 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.
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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
Délai: Week 16
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The IGA assesses participant's plaque psoriasis.
Lesions were graded for induration, erythema and scaling, each using a 5 point scale.
Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates.
Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
A higher score indicated more severe disease.
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Week 16
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Percentage of Participants Who Achieved Psoriasis Symptom and Signs Diary (PSSD) Symptom Score of 0 at Weeks 8 and 16 Among Participants With a Baseline PSSD Symptom Score >0
Délai: Weeks 8 and 16
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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
Délai: Weeks 4 and 16
|
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit.
24-hour recall version was used.
PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity.
PSSD itch item score over seven days was averaged into a weekly itch score, ranging from 0 to 10 with higher scores indicating severe disease.
Baseline=closest measurement taken prior to or at time of first study drug administration date.
|
Weeks 4 and 16
|
|
Percentage of Participants Who Achieved an IGA Score of 0 at Weeks 16 and 24
Délai: Weeks 16 and 24
|
The IGA assesses participant's plaque psoriasis.
Lesions were graded for induration, erythema and scaling, each using a 5 point scale.
Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates.
Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
A higher score indicated more severe disease.
|
Weeks 16 and 24
|
|
Percentage of Participants Who Achieved PSSD Sign Score of 0 at Week 16 Among Participants With a Baseline Sign Score >0
Délai: Week 16
|
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit.
24-hour recall version was used.
PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity.
Each individual item score over seven days was averaged into a weekly item score.
Sign score was derived by averaging the 6 weekly sign item scores when at least 3 items are available (>=50% of 6 items).
Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe).
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 16
|
|
Percentage of Participants Who Achieved Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 Score of 0 or 1 at Week 16 Among Participants With a Baseline GenPS-SFQ Item 2 Score >=2 and With a Baseline sPGA-G Score >=3
Délai: Week 16
|
The GenPs-SFQ was a 2-item participant-reported instrument used to assess the impact of genital psoriasis on the frequency of sexual activity in the last 7 days.
Item 1 assesses overall frequency of sexual activity in the last 7 days (none/zero, once, or 2 or more times), and item 2 assesses how frequently genital psoriasis symptoms have limited the frequency of sexual activity in the last 7 days (0 = never, 1 = rarely, 2 = sometimes, 3 = often, or 4 = always).
Lower scores of item 2 indicated less limitation of sexual activity due to genital psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 16
|
|
Percentage of Participants Who Achieved Dermatological Life Quality Index (DLQI) Score of 0 or 1 at Week 16 Among Participants With a Baseline DLQI Score >1
Délai: Week 16
|
The DLQI was a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL.
It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment.
Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL).
The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 16
|
|
Percentage of Participants Who Achieved DLQI Score of 0 or 1 at Weeks 16 and 24 Among Participants With a Baseline DLQI Score >1
Délai: Weeks 16 and 24
|
The DLQI was a dermatology specific HRQoL instrument designed to assess the impact of the disease on a participant's HRQoL.
It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment.
Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL).
The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Weeks 16 and 24
|
|
Percentage of Participants Who Achieved PASI 75 at Weeks 4 and 16
Délai: Weeks 4 and 16
|
Percentage of participants who achieved PASI-75 score (>=75% improvement from baseline in PASI) at Weeks 4 and 16 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas 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
Délai: Week 8
|
Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Week 8 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas 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
Délai: 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
Délai: 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
Délai: 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
Délai: Weeks 16 and 24
|
Percentage of participants who achieved PASI-75 score (>=75% improvement from baseline in PASI) at Weeks 16 and 24 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas 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
Délai: Weeks 16 and 24
|
Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Weeks 16 and 24 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas 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
Délai: Weeks 16 and 24
|
Percentage of participants who achieved PASI-100 score (100% improvement from baseline in PASI) at Weeks 16 and 24 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Weeks 16 and 24
|
|
Percentage of Participants Who Achieved PSSD Symptom Score of 0 at Week 16 Among Participants With a Baseline Symptom Score >0
Délai: Week 16
|
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit.
24-hour recall version was used.
PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity.
Each individual item score over seven days was averaged into a weekly item score.
Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items).
Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe).
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date
|
Week 16
|
|
Change From Baseline in PASI Total Score at Week 16
Délai: 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
Délai: Baseline (Week 0), Week 16
|
Percent change from baseline in PASI total score at Week 16 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas 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
Délai: Week 16
|
The sPGA-G was a 6-point scale to assess the severity of genital psoriasis at a given time point.
The sPGA-G evaluates erythema, plaque elevation, and scale of genital psoriatic lesions.
The severity of genital psoriasis was assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5).
Higher score indicates more severity.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 16
|
|
Percentage of Participants Who Achieved Physician's Global Assessment of Hands and Feet (Hf-PGA) Score of 0 or 1 and a >=2-grade Improvement at Week 16 Among Participants With a Baseline Hf-PGA Score >=2
Délai: Week 16
|
The hf-PGA assesses the severity of hand and foot psoriasis using a 5-point scale to score the plaques on the hands and feet.
hf-PFA was categorized from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Higher score indicates more severity.
Meeting the hf-PGA 0 or 1 criteria defined as having an hf-PGA score of clear (0) or almost clear (1) and a >=2-grade improvement from baseline.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 16
|
|
Percent Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 16 Among Participants With a Baseline mNAPSI Score >0
Délai: Baseline (Week 0), Week 16
|
Percent change from baseline in mNAPSI score at week 16 was reported.
The mNAPSI was an index used for assessing and grading the severity of nail psoriasis.
Each of the participant's ten fingernails were evaluated on 7 features.
The first three features were each scored from 0 to 3 in severity and were 1 = onycholysis and oil-drop dyschromia, 2 = pitting, and 3 = nail plate crumbling.
Next four features was each scored 0 absent or 1 present, and are (1) leukonychia, (2) splinter hemorrhages (3) nail bed hyperkeratosis, and (4) red spots in lunula.
Each fingernail was rated for the presence and severity of seven features to give a total fingernail score of 0-13 (0= no involvement, 13 = greatest involvement).
Total mNAPSI score is the sum of the 10 fingernail scores (range 0-130; 0= no involvement, 130= greatest involvement).
Higher the score the more severe the nail bed psoriasis.
Baseline = closest measurement taken prior to or at the time of the first study drug administration date.
|
Baseline (Week 0), Week 16
|
|
Percentage of Participants Who Achieved Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16 Among Participants With Baseline f-PGA Score >=2
Délai: Week 16
|
Percentage of participants who achieved f-PGA score of 0 or 1 at Week 16 was reported.
f-PGA 0 or 1 criteria was defined as an f-PGA score of clear (0) or minimal (1).
The f-PGA is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease.
A global score of between 0 indicating clear, and 4 indicating severe.
The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe.
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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline (Week 0), Week 16
|
PROMIS-29, 29-item generic HRQoL survey, assesses each 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; ability to participate in social roles and activities) with 4 questions and pain intensity.
Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often and 5=always).
Pain intensity was rated on 11-point scale (0=no pain; 10=worst imaginable pain).
Higher score= worst pain.
Each domain included 4 items, plus a single pain intensity item totaling 29 items.
Raw score of each PROMIS domain was converted into a standardized score with mean of 50; standard deviation (SD) of 10 (T-Score).
Higher PROMIS T-score=more of concept being measured 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
Délai: Week 24
|
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit.
24-hour recall version was used.
PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity.
Each individual item score over seven days was averaged into a weekly item score.
Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items).
Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe).
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date
|
Week 24
|
|
Percentage of Participants Who Achieved PASI 75 After Week 24, Among PASI 75 Nonresponders to Deucravacitinib at Week 24
Délai: 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
Délai: 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
Délai: Week 24 up to Week 160
|
Week 24 up to Week 160
|
|
|
Number of Participants With Adverse Events (AEs)
Délai: From Week 0 to Week 160
|
From Week 0 to Week 160
|
|
|
Number of Participants With Serious Adverse Events (SAEs)
Délai: From Week 0 to Week 160
|
From Week 0 to Week 160
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Janssen Research & Development, LLC Clinicaltrial, Janssen Research & Development, LLC
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 février 2024
Achèvement primaire (Réel)
17 septembre 2024
Achèvement de l'étude (Estimé)
1 juin 2027
Dates d'inscription aux études
Première soumission
14 novembre 2023
Première soumission répondant aux critères de contrôle qualité
16 novembre 2023
Première publication (Réel)
22 novembre 2023
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 77242113PSO3002 (Autre identifiant: Janssen Research & Development, LLC)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
La politique de partage de données des sociétés pharmaceutiques Janssen de Johnson & Johnson est disponible sur www.janssen.com/clinical-trials/transparency.
Comme indiqué sur ce site, les demandes d'accès aux données de l'étude peuvent être soumises via le site du projet Yale Open Data Access (YODA) à l'adresse yoda.yale.edu.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .