Uno studio su JNJ-77242113 in partecipanti adolescenti e adulti con psoriasi a placche da moderata a grave (ICONIC-LEAD)
4 giugno 2026 aggiornato da: Janssen Research & Development, LLC
Uno studio di fase 3 multicentrico, randomizzato, in doppio cieco, controllato con placebo per valutare l'efficacia e la sicurezza di JNJ-77242113 per il trattamento dei partecipanti con psoriasi a placche da moderata a grave con ritiro e ritrattamento randomizzati
Lo scopo di questo studio è vedere quanto sia efficace JNJ-77242113 nei partecipanti con psoriasi a placche da moderata a grave.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
684
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, C1417EYG
- Centro Privado de Medicina Familiar
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Buenos Aires, Argentina, C1406AGA
- ARCIS Salud SRL Aprillus asistencia e investigacion
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Buenos Aires, Argentina, C1426
- Derma Internacional S A
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CABA, Argentina, C1425DKG
- Psoriahue
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Mar del Plata, Argentina, B7600FYK
- Centro de Investigaciones Medicas Mar Del Plata
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Rosario, Argentina, S2000DBS
- Instituto De Especialidades De La Salud SRL
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San Fernando, Argentina, B1646
- MR Medicina Reumatologica
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East Melbourne, Australia, 3002
- Dr Rodney Sinclair Pty Ltd
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Melbourne, Australia, 3004
- The Alfred Hospital
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Miranda, Australia, 2228
- Kingsway Dermatology & Aesthetics
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Mitcham, Australia, 3132
- ISHI dermatology
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Parkville, Australia, 3050
- Royal Melbourne Hospital
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Woolloongabba, Australia, 4102
- Veracity Clinical Research
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Alberta
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Calgary, Alberta, Canada, T2J 7E1
- Dermatology Research Institute Inc
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Edmonton, Alberta, Canada, T5J 3S9
- Rejuvenation Dermatology Clinic Edmonton Downtown
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British Columbia
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Surrey, British Columbia, Canada, V3R 6A7
- Dr. Chih ho Hong Medical
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Ontario
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London, Ontario, Canada, N6H 5L5
- Dr Wei Jing Loo Medicine Professional Corporation
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London, Ontario, Canada, N5X 2P1
- Mediprobe Research Inc.
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Newmarket, Ontario, Canada, L3Y 5G8
- Ryan Clinical Research Inc
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Toronto, Ontario, Canada, M3H 5Y8
- Toronto Research Centre
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Toronto, Ontario, Canada, M3B 0A7
- Canadian Dermatology Center
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Toronto, Ontario, Canada, M4C 1L1
- Facet Dermatology
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Windsor, Ontario, Canada, N8T 1E6
- XLR8 Medical Research
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Quebec
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Montreal, Quebec, Canada, H2X 2V1
- Innovaderm Research Inc.
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Beijing, Cina, 100191
- Peking University Third Hospital
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Beijing, Cina, 100050
- Beijing Friendship Hospital Capital Medical University
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Beijing, Cina, 100013
- China Japan Friendship Hospital
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Bengbu, Cina, 233099
- The Affiliated Hospital of Bengbu Medical College
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Chengde, Cina, 067030
- Hosp. of Chengde Medical University
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Chengdu, Cina, 610017
- Chengdu Second People's Hospital
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Jiaxing, Cina, 314001
- The First Hospital of Jiaxing
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Jinan, Cina, 250012
- Qilu Hospital of Shandong University
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Nanchang, Cina, 330000
- Dermatology Hospital of Jiangxi Province
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Nanyang, Cina, 473004
- Nanyang First People's Hospital
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Shanghai, Cina, 200443
- Shanghai Skin Disease Hospital
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Shenyang, Cina, 110016
- Northeast International Hospital
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Wuhan, Cina, 430022
- Union Hospital Tongji Medical College of Huazhong University of Science and Technology
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Xi'an, Cina, 710004
- The Second Affiliated Hospital of Xi'an Jiaotong University
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Zhenjiang, Cina, 212001
- Affiliated Hospital of Jiangsu University
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Ansan-si, Corea del Sud, 15355
- Korea University Ansan Hospital
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Gwangju, Corea del Sud, 61453
- Chosun university hospital
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Gyeonggi-do, Corea del Sud, 13496
- CHA Bundang Medical Center, CHA University
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Gyeonggi-do, Corea del Sud, 14068
- Hallym University Sacred Heart Hospital
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Seoul, Corea del Sud, 05505
- Asan Medical Center
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Antony, Francia, 92160
- Hôpital Privé d'Antony
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Argenteuil, Francia, 95107
- Centre Hospitalier Victor Dupouy
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Bad Bentheim, Germania, 48455
- Fachklinik Bad Bentheim
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Berlin, Germania, 10117
- Charite - Campus Mitte
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Bonn, Germania, 53127
- Universitätsklinikum Bonn
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Dresden, Germania, 01069
- Klinische Forschung Dresden GmbH
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Dülmen, Germania, 48249
- Hautzentrum Dulmen
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Düsseldorf, Germania, 40212
- Privatpraxis Dr. Hilton & Partner
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Frankfurt am Main, Germania, 60590
- Universitaetsklinikum Frankfurt
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Freiburg im Breisgau, Germania, 79104
- Universitaetsklinikum Freiburg
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Friedrichshafen, Germania, 88045
- Derma-Study-Center Friedrichshafen GmbH
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Heidelberg, Germania, 69120
- UniversitaetsKlinikum Heidelberg
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Mahlow, Germania, 15831
- Hautarztpraxis
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Münster, Germania, 48149
- Universitaetsklinikum Muenster
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Oldenburg, Germania, 26133
- Klinikum Oldenburg
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Remscheid, Germania, 42897
- Hautarztpraxis Mortazawi
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Tübingen, Germania, 72076
- Universitaetsklinik Tuebingen
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Witten, Germania, 58453
- Hautarztpraxis 2
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Wuppertal, Germania, 42287
- CentroDerm GmbH
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Itabashi Ku, Giappone, 173 8606
- Teikyo University Hospital
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Kitakyushu-shi, Giappone, 807-8556
- Hospital of the University of Occupational and Environmental Health
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Mito, Giappone, 310 0015
- Mito Kyodo General Hospital
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Nagoya, Giappone, 467 8602
- Nagoya City University Hospital
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Osaka Sayama Shi, Giappone, 589 8511
- Kindai University Hospital
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Sendai, Giappone, 980 8574
- Tohoku University Hospital
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Shinjuku, Giappone, 160 0023
- Tokyo Medical University Hospital
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Tsu, Giappone, 514 8507
- Mie University Hospital
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Palermo, Italia, 90127
- Azienda Di Rilievo Nazionale E Di Alta Specializzazione
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Parma, Italia, 43126
- Azienda Ospedaliero Universitaria di Parma
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Roma, Italia, 00133
- Policlinico Tor Vergata
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Rozzano, Italia, 20089
- Istituto Clinico Humanitas
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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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Harrow, Regno Unito, HA1 3UJ
- London North West University Healthcare NHS Trust
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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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Alcorcón, Spagna, 28922
- Hosp. Univ. Fundacion Alcorcon
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Alicante, Spagna, 03010
- Hosp. Gral. Univ. Dr. Balmis
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Barcelona, Spagna, 08041
- Hosp. de La Santa Creu I Sant Pau
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Barcelona, Spagna, 08036
- Hosp Clinic de Barcelona
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Bilbao, Spagna, 48013
- Hosp. Univ. de Basurto
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Madrid, Spagna, 28007
- Hosp. Gral. Univ. Gregorio Maranon
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Madrid, Spagna, 28002
- Grupo Dermatologico Y Estetico Pedro Jaen
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Palma de Mallorca, Spagna, 07120
- Hosp. Univ. Son Espases
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Santiago de Compostela, Spagna, 15706
- Hosp. Clinico Univ. de Santiago
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Seville, Spagna, 41009
- Hosp. Virgen Macarena
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Valencia, Spagna, 46940
- Hosp. de Manises
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Arizona
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Phoenix, Arizona, Stati Uniti, 85006
- Medical Dermatology Specialists
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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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San Diego, California, Stati Uniti, 92123
- Rady Childrens Hospital San Diego
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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, 33155
- Bioclinical Research Alliance Inc.
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North Miami Beach, Florida, Stati Uniti, 33162
- Ziaderm Research LLC
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Tampa, Florida, Stati Uniti, 33613
- Forcare Clinical Research Inc
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Georgia
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Macon, Georgia, Stati Uniti, 31217
- Skin Care Physicians of Georgia
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Illinois
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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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Owensboro, Kentucky, Stati Uniti, 42301
- Qualmedica Research
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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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Beverly, Massachusetts, Stati Uniti, 01915
- Allcutis Research 1
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Michigan
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Clarkston, Michigan, Stati Uniti, 48346
- Michigan Center of Medical Research
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Minnesota
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New Brighton, Minnesota, Stati Uniti, 55112
- Minnesota Clinical Study Center
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68144
- Skin Specialists
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New Hampshire
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Portsmouth, New Hampshire, Stati Uniti, 03801
- Allcutis Research
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New Jersey
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East Windsor, New Jersey, Stati Uniti, 08520
- Schweiger Dermatology Group
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New York
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New York, New York, Stati Uniti, 10029
- Icahn School of Medicine at Mt. Sinai
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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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Fairborn, Ohio, Stati Uniti, 45324
- Dermatologists of Central States LLC
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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, 97210
- Oregon Dermatology and Research Center
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Portland, Oregon, Stati Uniti, 97201
- Oregon Medical Research Center
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Pennsylvania
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Exton, Pennsylvania, Stati Uniti, 19341
- The Pennsylvania Centre for Dermatology, LLC
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Pittsburgh, Pennsylvania, Stati Uniti, 15213
- University of Pittsburgh Medical Center
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29425
- Medical University of South Carolina
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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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Arlington, Texas, Stati Uniti, 76011
- Arlington Research Center, Inc.
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Bellaire, Texas, Stati Uniti, 77401
- The University of Texas Health Science Center at Houston
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Houston, Texas, Stati Uniti, 77004
- Center for Clinical Studies 1
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San Antonio, Texas, Stati Uniti, 78218
- Texas Dermatology and Laser Specialists
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Webster, Texas, Stati Uniti, 77598
- Center For Clinical Studies
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Utah
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Springville, Utah, Stati Uniti, 84663
- Springville Dermatology CCT Research
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Virginia
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Norfolk, Virginia, Stati Uniti, 23502
- Virginia Dermatology Skin Cancer Center Pllc
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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, 83301
- Kaohsiung Chang Gung Memorial Hospital
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Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
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Taipei, Taiwan, 10449
- Mackay Memorial Hospital
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Taipei, Taiwan, 10048
- National Taiwan University Hospital
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Taoyuan, Taiwan, 33382
- Linkou Chang Gung Memorial Hospital
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Ankara, Turchia (Türkiye), 06560
- Gazi University Medical Faculty
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Ankara, Turchia (Türkiye), 06230
- Hacettepe University Medical Faculty
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Kayseri, Turchia (Türkiye), 38039
- Erciyes University Medical Faculty
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Samsun, Turchia (Türkiye), 55270
- Ondokuz Mayis University
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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
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Criterio di inclusione:
- Diagnosi di psoriasi a placche, con o senza artrite psoriasica, 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
- Una partecipante di sesso femminile in età fertile deve avere un test di gravidanza su siero altamente sensibile negativo per beta-gonadotropina corionica umana (beta-hCG) allo screening e un test di gravidanza sulle urine negativo alla settimana 0 prima della somministrazione dell'intervento dello studio
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
- Procedure chirurgiche maggiori (ad esempio, che richiedono anestesia generale) entro 8 settimane prima dello screening, o non si saranno completamente ripresi da una procedura chirurgica o hanno pianificato 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 adolescenti e adulti riceveranno JNJ-77242113 dalla settimana 0 alla settimana 156.
Alla settimana 24, i partecipanti adulti con indice di area e gravità della psoriasi (PASI) 75 o punteggio IGA (investigator global assessement) pari a 0 o 1 hanno risposto (ovvero, coloro che raggiungono un punteggio IGA pari a 0 o 1 e hanno >=2- miglioramento del grado rispetto al basale) saranno randomizzati nuovamente per continuare con JNJ-77242113 o con placebo (e verranno ritrattati con JNJ-77242113 in caso di perdita >= 50% del miglioramento PASI della settimana 24).
I partecipanti adulti identificati come non-responder con punteggio PASI 75 e IGA 0 o 1 continueranno a ricevere JNJ-77242113 fino alla settimana 52.
Dalla settimana 52 alla settimana 156, tutti i partecipanti adulti riceveranno JNJ-77242113.
Gli adolescenti non parteciperanno alla ri-randomizzazione indipendentemente dal loro punteggio PASI o IGA alla settimana 24.
Gli adolescenti continueranno a ricevere JNJ-77242113 dalla settimana 0 alla settimana 156.
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JNJ-77242113 verrà somministrato per via orale.
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Sperimentale: Placebo
I partecipanti adolescenti e adulti riceveranno il placebo corrispondente JNJ-77242113 dalla settimana 0 alla settimana 16.
I partecipanti passeranno a ricevere JNJ-77242113 dalla settimana 16 alla settimana 156.
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Il placebo verrà somministrato per via orale
JNJ-77242113 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 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 and scaling, each using 5 point scale.Induration: 0=no evidence of plaque elevation,1=minimal plaque elevation,=0.25 millimeters(mm);2=mild plaque elevation,=0.5mm;3=moderate
plaque elevation,=0.75
mm; 4=severe plaque elevation, greater than(>)1 mm; Erythema:0=no evidence of erythema, hyperpigmentation may be present,1=faint erythema,2=light red coloration,3=moderate red coloration,4=bright red coloration; Scaling:0=no evidence of scaling, 1=minimal; 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 a 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 Response at Week 16
Lasso di tempo: Week 16
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Percentage of participants who achieved PASI 90 (at least 90% improvement from baseline in PASI score) response at Week 16 were reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
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Week 16
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Variazione dal Basale del Punteggio Totale PASI alla Settimana 16
Lasso di tempo: Baseline (Settimana 0), Settimana 16
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La variazione rispetto al basale del punteggio totale PASI alla Settimana 16 è stata riportata.
Il PASI era un sistema utilizzato per valutare e classificare la gravità delle lesioni psoriasiche e la loro risposta alla terapia.
Nel sistema PASI, il corpo era suddiviso in 4 regioni: testa, tronco, arti superiori e arti inferiori.
Ciascuna di queste aree era valutata e punteggiata separatamente per eritema, indurimento e desquamazione, ciascuna classificata su una scala da 0 a 4 (0=nessuno, 1=lieve, 2=moderato, 3=grave e 4=moltograve) e per estensione del coinvolgimento da 0 (indicava nessun coinvolgimento) a 6 (90% - 100% di coinvolgimento).
Il PASI produceva un punteggio totale numerico che poteva variare da 0 (nessuna psoriasi) a 72 (psoriasi massima).
Un punteggio più alto indicava una maggiore gravità della psoriasi.
Il basale era definito come la misurazione più vicina effettuata prima o al momento della data di somministrazione del primo farmaco dello studio.
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Baseline (Settimana 0), Settimana 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 millimeter (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates.
Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
A higher score indicated more severe disease.
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Week 16
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Percentage of Participants Who Achieved PASI 75 Response at Week 4
Lasso di tempo: Week 4
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Percentage of participants who achieved PASI 75 (at least >=75% improvement from baseline in PASI) response at Week 4 were reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
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Week 4
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Percentage of Participants Who Achieved PASI 90 Response at Week 8
Lasso di tempo: Week 8
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Percentage of participants who achieved PASI 90 (at least >=90% improvement from baseline in PASI) response at Week 8 were reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
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Week 8
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Percentage of Participants Who Achieved PASI 75 Response at Week 16
Lasso di tempo: Week 16
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Percentage of participants who achieved PASI 75 (>=75% improvement from baseline in PASI) response at Week 16 were reported..
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
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Week 16
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Percentage of Participants Who Achieved PASI 100 Response at Week 16
Lasso di tempo: Week 16
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Percentage of participants who achieved PASI 100 (100% improvement from baseline in PASI) response at Week 16 were reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
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Week 16
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Percentage of Participants Who Achieved Scalp Specific (ss)-IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline Ss-IGA Score >=2
Lasso di tempo: Week 16
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The ss-IGA instrument is 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 are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease.
Higher score indicated severe disease.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
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Week 16
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Percentage of Participants Who Achieved Psoriasis Symptom and Signs Diary (PSSD) Symptom Score of 0 at Week 8 Among Participants With a Baseline PSSD Symptom Score >0
Lasso di tempo: Week 8
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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 first 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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Week 8
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Percentage of Participants Who Achieved Psoriasis Symptom and Signs Diary (PSSD) Symptom Score of 0 at Week 16 Among Participants With a Baseline PSSD Symptom Score >0
Lasso di tempo: Week 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 first 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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Week 16
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Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in PSSD Itch Score at Week 4 Among Participants With a Baseline PSSD Itch Score >=4
Lasso di tempo: Week 4
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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 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.
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Week 4
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Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in PSSD Itch Score at Week 16 Among Participants With a Baseline PSSD Itch Score >=4
Lasso di tempo: Week 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 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.
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Week 16
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Percentage of Participants Who Achieved PASI 75 Response at Week 52 Among Participants Randomized at Week 24 and Were PASI 75 Responders at Week 24
Lasso di tempo: Week 52
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Percentage of participants who achieved PASI-75 score (>=75% improvement from baseline in PASI) at Week 52 among participants randomized at Week 24 and were PASI 75 responders at Week 24 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
Baseline=closest measurement taken prior to or at time of first study drug administration date.
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Week 52
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Percentage of Participants Who Achieved PASI 90 Response at Week 52 Among Participants Randomized at Week 24 and Were PASI 90 Responders at Week 24
Lasso di tempo: Week 52
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Percentage of participants who achieved PASI 90 (at least >=90% improvement from baseline in PASI) response at Week 52 among participants randomized at Week 24 and were PASI 90 responders at Week 24 were reported.
PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
Baseline=closest measurement taken prior to or at time of first study drug administration date.
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Week 52
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Time to Loss of PASI 75 Among Participants Randomized at Week 24 and Were PASI 75 Responders at Week 24
Lasso di tempo: Week 24 up to Week 52
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Time to loss of PASI 75 response was defined as time from re-randomization at Week 24 to visit of loss of PASI 75 response.
Loss of PASI 75 response was defined as less than (<)75% improvement in PASI from Week 24 up to Week 52 in an adult participant who had achieved >=75% improvement in PASI from baseline at Week 24.
PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy.
In PASI system, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
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Week 24 up to Week 52
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Time to Loss of PASI 90 Among Participants Randomized at Week 24 and Were PASI 90 Responders at Week 24
Lasso di tempo: Week 24 up to Week 52
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The time to loss of PASI 90 response was defined as the time from re-randomization at Week 24 to the visit of loss of PASI 90 response.
Loss of PASI 90 response is defined as <90% improvement in PASI from Week 24 up to Week 52 in an adult participant who had achieved >=90% improvement in PASI from baseline at Week 24.
PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy.
In PASI system, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
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Week 24 up to Week 52
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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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Percent Change From Baseline in PASI Total Score at Week 16
Lasso di tempo: Baseline (Week 0), Week 16
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Percent change from baseline in PASI total score at Week 16 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
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Baseline (Week 0), Week 16
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Percentage of Participants Who Achieved Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 and a >=2-Grade Improvement in Genital Psoriasis From Baseline at Week 16 Among Participants With a Baseline sPGA-G Score >=2
Lasso di tempo: Week 16
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Percentage of participants achieving a sPGA-G Score of 0 or 1 and at least a 2-grade improvement in genital psoriasis from baseline at Week 16 among participants with a baseline sPGA-G score >=2 was reported.
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.
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Week 16
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Percentage of Participants Achieving a Physician's Global Assessment of Hands and Feet (Hf-PGA) Score of 0 or 1 and at Least a 2-grade Improvement at Week 16 Among Participants With a Baseline Hf-PGA Score >=2
Lasso di tempo: Week 16
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Percentage of participants achieving a hf-PGA score of 0 or 1 and at least a 2-grade improvement at Week 16 among participants with a baseline hf-PGA score >=2 was reported.
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.
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Week 16
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Percent Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 16 Among Participants With Baseline mNAPSI Score >0
Lasso di tempo: Baseline (Week 0), Week 16
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The mNAPSI was an index used for assessing and grading the severity of nail psoriasis.
Each of the participant's ten fingernails are evaluated on 7 features.
The first three features are each scored from 0 to 3 in severity and were 1 = onycholysis and oil-drop dyschromia, 2 = pitting, and 3 = nail plate crumbling.
The 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 the lunula.
Each fingernail is rated for the presence and severity of seven features to give a total fingernail score of 0-13 (0= no involvement, 13 = greatest involvement).
The total mNAPSI score is the sum of the 10 fingernail scores (range 0-130; 0= no involvement, 130= greatest involvement).
The higher the score the more severe the nail bed psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
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Baseline (Week 0), Week 16
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Percentage of Participants Who Achieved Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16 Among Participants With a Baseline f-PGA Score >=2
Lasso di tempo: Week 16
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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.
Higher score indicated more severe disease.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
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Week 16
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Change From Baseline in PSSD Symptom Score at Week 16
Lasso di tempo: Baseline (Week 0), Week 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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Baseline (Week 0), Week 16
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Change From Baseline in PSSD Sign Score at Week 16
Lasso di tempo: Baseline (Week 0), Week 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.
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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Baseline (Week 0), Week 16
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Percentage of Participants Achieving PSSD Sign Score of 0 at Week 16 Among Participants With Baseline PSSD Sign Score >0
Lasso di tempo: Week 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.
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
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Percentage of Participants Achieving Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 Score of 0 or 1 at Week 16 Among Participants With Baseline GenPS-SFQ Item 2 Score >=2 and a Baseline sPGA-G Score >=3
Lasso di tempo: Week 16
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Percentage of participants achieving GenPs-SFQ Item 2 score of 0 or 1 at Week 16 among participants with baseline GenPS-SFQ Item 2 score >=2 and a baseline sPGA-G score >=3 was reported.
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
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Percentage of Participants Achieving Dermatology 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
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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.
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Week 16
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Change From Baseline in Total DLQI Score at Week 16
Lasso di tempo: Baseline (Week 0), Week 16
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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.
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Baseline (Week 0), Week 16
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Adult Participants: 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
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PROMIS-29, 29-item generic HRQoL survey, assesses each 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; ability to participate in social roles and activities) with 4 questions and pain intensity.
Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often and 5=always).
Pain intensity was rated on 11-point scale (0=no pain; 10=worst imaginable pain).
Higher score= worst pain.
Each domain included 4 items, plus a single pain intensity item totaling 29 items.
Raw score of each PROMIS domain was converted into a standardized score with mean of 50; standard deviation (SD) of 10 (T-Score).
Higher PROMIS T score=more of concept being measured that is, higher scores in anxiety, depression, fatigue, pain interference, sleep disturbance= worse symptoms, higher scores in physical function, social roles=better functioning.
Baseline: closest measurement taken prior to/at the time of first study drug administration date.
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Baseline (Week 0), Week 16
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Adolescent Participants: Percentage of Participants Achieving Children's Dermatology Life Quality Index (CDLQI) Score of 0 or 1 at Week 16 Among Participants With a Baseline CDLQI Score >1
Lasso di tempo: Week 16
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The CDLQI was an adapted version of the DLQI for the pediatric population and was utilized in the adolescent population in this study.
The CDLQI is a 10-item instrument that has 4 item response options and a recall period of 1 week.
Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life.
CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much).
Higher scores indicated more impact on quality of life of children.
The instrument is designed for use in children, is self-explanatory and can be simply handed to the participant who asked to fill it in with the help of the child's parent or caregiver.
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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Adolescent Participants: Change From Baseline in CDLQI at Week 16
Lasso di tempo: Baseline (Week 0), Week 16
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The CDLQI was an adapted version of the DLQI for the pediatric population and was utilized in the adolescent population in this study.
The CDLQI is a 10-item instrument that has 4 item response options and a recall period of 1 week.
Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life.
CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much).
Higher scores indicated more impact on quality of life of children.
The instrument is designed for use in children, is self-explanatory and can be simply handed to the participant who asked to fill it in with the help of the child's parent or caregiver.
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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Adolescent Participants: Change From Baseline in Domain Scores of the PROMIS-25 Pediatric Score at Week 16
Lasso di tempo: Baseline (Week 0), Week 16
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The PROMIS-25 was utilized in the adolescent population and is a 25-item generic HRQoL survey.
Six PROMIS domains (physical function mobility, anxiety, depressive symptoms, fatigue, peer relationships, pain interference) are each assessed with 4 questions.
Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often, 5=always).
Higher score=worst pain.
Raw scores for each domain were converted to T-scores using standardized score with a mean of 50 and a standard deviation (SD) of 10 with an observed range 20 to 80.
For anxiety, depressive symptoms, fatigue, and pain interference, a negative change indicates an improvement while for physical function mobility and peer relationships, a positive change indicates an improvement.
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 an IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Week 52
Lasso di tempo: Week 52
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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, =0.25mm; 2=mild plaque elevation, =0.5 mm; 3=moderate plaque elevation, =0.75mm;4=severe plaque elevation, >1 mm; Erythema: 0=no evidence of erythema, hyperpigmentation may be present, 1=faint erythema, 2=light red coloration, 3=moderate red coloration, 4=bright red coloration; Scaling: 0=no evidence of scaling, 1=minimal; occasional fine scale over less than 5% of lesion, 2=mild; fine scale dominates,3 =moderate; coarse scale predominates, 4 =severe; thick, scale predominates.Final IGA score of psoriasis was based upon average of induration,erythema and scaling scores assessed on a 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 52
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Percentage of Participants Achieving IGA Score of 0 at Week 52 Among Participants Who Were IGA 0 Responders at Week 24
Lasso di tempo: Week 52
|
The IGA assesses participant's plaque psoriasis.
Lesions were graded for induration, erythema and scaling, each using a 5 point scale.
Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates.
Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
A higher score indicated more severe disease.
|
Week 52
|
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Percentage of Participants Achieving PASI 100 Response at Week 52 Among PASI 100 Responders at Week 24
Lasso di tempo: Week 52
|
Percentage of participants achieving PASI 100 (100% improvement from baseline in PASI) response at Week 52 among PASI 100 responders at Week 24 were reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
|
Week 52
|
|
Time to Loss of IGA Response of 0 or 1
Lasso di tempo: Week 24 up to Week 52
|
The IGA assesses participant's plaque psoriasis.
Lesions were graded for induration, erythema and scaling, each using a 5 point scale.
Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates.
Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
A higher score indicated more severe disease.
|
Week 24 up to Week 52
|
|
Adolescent Participants: Percentage of Participants With IGA Score of 0 or 1 and a >=2-grade Improvement From Baseline at Week 52
Lasso di tempo: Week 52
|
IGA assesses participant's plaque psoriasis.
Lesions were graded for induration,erythema and scaling,each using 5 point scale.
Induration: 0=no evidence of plaque elevation, 1=minimal plaque elevation,=0.25mm;
2=mild plaque elevation,=0.5
mm; 3=moderate plaque elevation,= 0.75 mm; 4=severe plaque elevation, >1mm; Erythema: 0=no evidence of erythema, hyperpigmentation may be present, 1=faint erythema, 2=light red coloration, 3=moderate red coloration, 4=bright red coloration; Scaling:0=no evidence of scaling, 1=minimal; occasional fine scale over less than 5% of lesion, 2=mild; fine scale dominates, 3=moderate; coarse scale predominates, 4=severe; thick, scale predominates.
Final IGA score of psoriasis was based upon 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).
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 52
|
|
Adolescent Participants: Percentage of Participants Who Achieved PASI 75 Response at Week 52
Lasso di tempo: Week 52
|
Percentage of participants who achieved PASI 75 (>=75% improvement in PASI from baseline) response at Week 52 were reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
Baseline:closest measurement taken prior to or at time of first study drug administration date.
|
Week 52
|
|
Adolescent Participants: Percentage of Participants Who Achieved PASI 90 Response at Week 52
Lasso di tempo: Week 52
|
Percentage of participants who achieved PASI 90 (at least >=90% improvement in PASI from baseline) response at Week 52 were reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
Baseline: closest measurement taken prior to or at time of first study drug administration date.
|
Week 52
|
|
Number of Participants With Treatment-emergent Adverse Events (AEs)
Lasso di tempo: From Week 0 up to Week 160
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From Week 0 up to Week 160
|
|
|
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
Lasso di tempo: From Week 0 up to Week 160
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From Week 0 up to Week 160
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Direttore dello studio: Janssen Research & Development, LLC Clinical Trial, 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)
12 ottobre 2023
Completamento primario (Effettivo)
29 luglio 2024
Completamento dello studio (Stimato)
6 aprile 2027
Date di iscrizione allo studio
Primo inviato
18 ottobre 2023
Primo inviato che soddisfa i criteri di controllo qualità
18 ottobre 2023
Primo Inserito (Effettivo)
23 ottobre 2023
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
8 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
4 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 77242113PSO3001 (Altro identificatore: Janssen Research & Development, LLC)
- 2023-505120-59-00 (Identificatore di registro: EUCT number)
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 .