Um estudo de JNJ-77242113 para o tratamento de participantes com psoríase em placas moderada a grave
2 de julho de 2026 atualizado por: Janssen Research & Development, LLC
Um estudo multicêntrico de fase 3, randomizado, duplo-cego, controlado por placebo e controlado por comparador ativo de deucravacitinibe para avaliar a eficácia e segurança de JNJ-77242113 para o tratamento de participantes com psoríase em placas moderada a grave
O objetivo do estudo é verificar a eficácia do JNJ-77242113 em participantes com psoríase em placas moderada a grave em comparação com placebo e deucravacitinibe.
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Tipo de estudo
Intervencional
Inscrição (Real)
774
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
-
Berlin, Alemanha, 10789
- ISA - Interdisciplinary Study Association GmbH
-
Bramsche, Alemanha, 49565
- Hautarztpraxis 3
-
Dresden, Alemanha, 01069
- Klinische Forschung Dresden GmbH
-
Dresden, Alemanha, 01097
- Praxis fuer Dermatologie und Venerologie
-
Düsseldorf, Alemanha, 40225
- Universitaetsklinikum Duesseldorf
-
Hamburg, Alemanha, 22391
- MensingDerma Research GmbH
-
Hamburg, Alemanha, 20246
- Universitaetsklinikum Hamburg Eppendorf
-
Kiel, Alemanha, 24105
- Universitaetsklinikum Schleswig Holstein Campus Kiel
-
Langenau, Alemanha, 89129
- Studienzentrum Dr Schwarz Germany
-
Leipzig, Alemanha, 04103
- Universitätsklinikum Leipzig AöR
-
Lübeck, Alemanha, 23562
- Universitatsklinikum Schleswig Holstein Campus Lubeck
-
Mannheim, Alemanha, 68167
- Universitaetsklinikum Mannheim
-
München, Alemanha, 80802
- Klinik und Poliklinik fur Dermatologie und Allergologie am Biederstein
-
Potsdam, Alemanha, 14467
- Hautarztpraxis 1
-
Rostock, Alemanha, 18057
- Universitaetsmedizin Rostock
-
-
-
-
-
Buenos Aires, Argentina, B1643CRO
- Instituto Medico De Alta Complejidad (IMAC)
-
Buenos Aires, Argentina, C1406AGA
- ARCIS Salud SRL Aprillus asistencia e investigacion
-
CABA, Argentina, C1425BEA
- Instituto de Neumonología Y Dermatología
-
Caba, Argentina, C1199ABD
- Hospital Italiano de Buenos Aires
-
Caba, Argentina, C1122AAF
- Halitus Instituto Medico S.A. - Dermatologia y Estetica
-
La Plata, Argentina, B1900AXI
- Hospital Italiano de La Plata
-
Rosario, Argentina, S2000PBJ
- Instituto Caici Srl.
-
San Miguel de Tucumán, Argentina, T4000AXL
- Centro de Investigaciones Médicas Tucuman
-
-
-
-
-
Campbelltown, Austrália, 5074
- North Eastern Health Specialists
-
Canberra, Austrália, 2606
- Paratus Clinical Research Woden
-
East Melbourne, Austrália, 3002
- Sinclair Dermatology
-
Melbourne, Austrália, 3053
- Skin Health Institute Inc.
-
Woolloongabba, Austrália, 4102
- Veracity Clinical Research
-
-
-
-
-
Santo André, Brasil, 09060-870
- Fundacao do ABC Centro Universitario FMABC
-
-
-
-
British Columbia
-
Surrey, British Columbia, Canadá, V3V 0C6
- Enverus Medical
-
-
Newfoundland and Labrador
-
St. John's, Newfoundland and Labrador, Canadá, A1A 4Y3
- Karma Clinical Trials Inc.
-
-
Ontario
-
Ajax, Ontario, Canadá, L1S7K8
- CCA Medical Research Corporation
-
Barrie, Ontario, Canadá, L4M 7G1
- SimcoDerm Medical and Surgical Dermatology Centre
-
Hamilton, Ontario, Canadá, L8N 1Y2
- Dermatrials Research
-
Richmond Hill, Ontario, Canadá, L4B1L1
- York Dermatology Clinic and Research Centre
-
Waterloo, Ontario, Canadá, N2J 1C4
- Alliance Clinical Trials
-
Windsor, Ontario, Canadá, N8T 1E6
- XLR8 Medical Research
-
-
-
-
-
Busan, Coréia do Sul, 49241
- Pusan National University Hospital
-
Seongnam-si, Coréia do Sul, 13620
- Seoul National University Bundang Hospital
-
Seoul, Coréia do Sul, 03080
- Seoul National University Hospital
-
Seoul, Coréia do Sul, 06591
- The Catholic University of Korea Seoul St Marys Hospital
-
Seoul, Coréia do Sul, 05030
- Konkuk University Medical Center
-
Seoul, Coréia do Sul, 04763
- Hanyang University Medical Center
-
Seoul, Coréia do Sul, 130 050
- Kyung Hee University Hospital
-
-
-
-
-
Alicante, Espanha, 03010
- Hosp. Gral. Univ. Dr. Balmis
-
Barakaldo, Espanha, 48902
- Hosp. Univ. de Cruces
-
Barcelona, Espanha, 08041
- Hosp. de La Santa Creu I Sant Pau
-
Granada, Espanha, 18016
- Hosp. Univ. San Cecilio
-
L'Hospitalet de Llobregat, Espanha, 08907
- Hosp. Univ. de Bellvitge
-
Madrid, Espanha, 28041
- Hosp. Univ. 12 de Octubre
-
Madrid, Espanha, 28007
- Hosp. Gral. Univ. Gregorio Maranon
-
Madrid, Espanha, 28031
- Hosp. Univ. Infanta Leonor
-
Madrid, Espanha, 28006
- Hosp. Univ. de La Princesa
-
Madrid, Espanha, 28046
- Hosp. Univ. de La Paz
-
Madrid, Espanha, 28002
- Grupo Dermatologico Y Estetico Pedro Jaen
-
Valencia, Espanha, 46026
- Hosp. Univ. I Politecni La Fe
-
-
-
-
Arizona
-
Phoenix, Arizona, Estados Unidos, 85006
- Medical Dermatology Specialists
-
Scottsdale, Arizona, Estados Unidos, 85260
- Center for Dermatology and Plastic Surgery
-
-
Arkansas
-
Fort Smith, Arkansas, Estados Unidos, 72916
- Johnson Dermatology
-
-
California
-
Fountain Valley, California, Estados Unidos, 92708
- First OC Dermatology
-
Fremont, California, Estados Unidos, 94538
- Center for Dermatology Clinical Research
-
Sacramento, California, Estados Unidos, 95815
- Integrative Skin Science and Research
-
Santa Ana, California, Estados Unidos, 92701
- Southern California Dermatology
-
Santa Monica, California, Estados Unidos, 90403
- Clinical Science Institute
-
-
Florida
-
Miami, Florida, Estados Unidos, 33126
- Driven Research LLC
-
North Miami Beach, Florida, Estados Unidos, 33162
- Ziaderm Research LLC
-
Ocala, Florida, Estados Unidos, 34470
- Renstar Medical Research
-
Tampa, Florida, Estados Unidos, 33613
- Forcare Clinical Research Inc
-
-
Georgia
-
Alpharetta, Georgia, Estados Unidos, 30022
- Hamilton Research LLC
-
Macon, Georgia, Estados Unidos, 31217
- Skin Care Physicians Of Georgia
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60602
- DeNova Research
-
Rolling Meadows, Illinois, Estados Unidos, 60008
- Arlington Dermatology
-
Skokie, Illinois, Estados Unidos, 60077
- Endeavor Health
-
West Dundee, Illinois, Estados Unidos, 60118
- Dundee Dermatology
-
-
Indiana
-
Indianapolis, Indiana, Estados Unidos, 46250
- Dawes Fretzin Clinical Research Group LLC
-
Plainfield, Indiana, Estados Unidos, 46168
- Indiana Clinical Trial Center
-
-
Kentucky
-
Louisville, Kentucky, Estados Unidos, 40241
- Dermatology Specialists
-
-
Louisiana
-
Lake Charles, Louisiana, Estados Unidos, 70605
- Dermatology and Advanced Aesthetics
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02111
- Tufts Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, Estados Unidos, 48103
- David Fivenson MD, Dermatology
-
Clarkston, Michigan, Estados Unidos, 48346
- Michigan Center of Medical Research
-
Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Medical Center
-
Fort Gratiot, Michigan, Estados Unidos, 48059
- Hamzavi Dermatology
-
-
Missouri
-
Saint Joseph, Missouri, Estados Unidos, 64506
- MediSearch Clinical Trials
-
-
Nebraska
-
Omaha, Nebraska, Estados Unidos, 68144
- Skin Specialists
-
-
Nevada
-
Las Vegas, Nevada, Estados Unidos, 89119
- Fife Dermatology
-
-
New Hampshire
-
Portsmouth, New Hampshire, Estados Unidos, 03801
- StracSkin
-
-
New Jersey
-
East Windsor, New Jersey, Estados Unidos, 08520
- Schweiger Dermatology Group
-
Hackensack, New Jersey, Estados Unidos, 07601
- Schweiger Dermatology Group 1
-
-
New York
-
Stony Brook, New York, Estados Unidos, 11790
- Derm Research Center of New York, Inc.
-
-
North Carolina
-
Wilmington, North Carolina, Estados Unidos, 28405
- Wilmington Dermatology Center
-
-
Ohio
-
Athens, Ohio, Estados Unidos, 45701
- Oakview Dermatology
-
Boardman, Ohio, Estados Unidos, 44512
- Optima Research
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Estados Unidos, 73170
- Central Sooner Research
-
-
Oregon
-
Portland, Oregon, Estados Unidos, 97201
- Oregon Medical Research Center
-
-
South Dakota
-
Rapid City, South Dakota, Estados Unidos, 57702
- Health Concepts
-
-
Texas
-
Dallas, Texas, Estados Unidos, 75231
- Modern Research Associates
-
Houston, Texas, Estados Unidos, 77004
- Center for Clinical Studies 1
-
Houston, Texas, Estados Unidos, 77056
- Austin Institute for Clinical Research 1
-
Pflugerville, Texas, Estados Unidos, 78660
- Austin Institute for Clinical Research
-
San Antonio, Texas, Estados Unidos, 78218
- Texas Dermatology and Laser Specialists
-
San Antonio, Texas, Estados Unidos, 78213
- Progressive Clinical Research
-
Webster, Texas, Estados Unidos, 77598
- Center for Clinical Studies
-
-
Virginia
-
Richmond, Virginia, Estados Unidos, 23294
- National Clinical Research
-
-
Washington
-
Mill Creek, Washington, Estados Unidos, 98012
- Frontier Derm Partners CRO, LLC
-
Spokane, Washington, Estados Unidos, 99202
- Premier Clinical Research
-
-
-
-
-
Borgyogyaszati Klinika, Hungria, 7632
- Pecsi Tudomanyegyetem
-
Budapest, Hungria, 1036
- Obudai Egeszsegugyi Centrum Kft
-
Debrecen, Hungria, 4032
- Debreceni Egyetem Klinikai Kozpont
-
Debrecen, Hungria, 4031
- Derma-B Kft
-
Kaposvár, Hungria, 7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
-
Szeged, Hungria, 6720
- SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati és Allergologiai Klinika
-
Szolnok, Hungria, 5000
- Allergo-Derm Bakos Kft.
-
Veszprém, Hungria, 8200
- Medmare Egeszsegugyi Es Szolgaltato Bt.
-
-
-
-
-
Fukuoka, Japão, 814-0180
- Fukuoka University Hospital
-
Fukutsu, Japão, 811-3217
- Hino Dermatology Clinic
-
Gifu, Japão, 501-1112
- Gifu University Hospital
-
Ginowan, Japão, 901 2725
- University of the Ryukyus hospital
-
Gunma, Japão, 371 8511
- Gunma University Hospital
-
Hokkaido, Japão, 060-0033
- JR Sapporo Hospital
-
Hokkaido, Japão, 078 8510
- Asahikawa Medical University Hospital
-
Isehara, Japão, 259-1193
- Tokai University Hospital
-
Itabashi Ku, Japão, 173 8606
- Teikyo University Hospital
-
Kawasaki, Japão, 216 8511
- St Marianna University Hospital
-
Kitakyushu-shi, Japão, 807-8556
- Hospital of the University of Occupational and Environmental Health
-
Nagoya, Japão, 467 8602
- Nagoya City University Hospital
-
Nishiku, Japão, 593-8324
- Kume Clinic
-
Obihiro Shi, Japão, 080 0013
- Takagi Dermatological Clinic
-
Osaka, Japão, 550 0006
- Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
-
Sakai, Japão, 590 0197
- Kindai University Hospital
-
Sapporo, Japão, 060 0063
- Sapporo Skin Clinic
-
Sendai, Japão, 980 8574
- Tohoku University Hospital
-
Suita, Japão, 565 0871
- The University of Osaka Hospital
-
Tachikawa, Japão, 190 0023
- Jitaikai Tachikawa dermatology clinic
-
Takaoka Shi, Japão, 933-0871
- Shirasaki dermatology clinic
-
Tokyo, Japão, 160-0023
- Tokyo Medical University Hospital
-
Tsu, Japão, 514 8507
- Mie University Hospital
-
-
-
-
-
Bialystok, Polônia, 15-351
- Osteo-Medic s.c A. Racewicz, J Supronik
-
Bialystok, Polônia, 15-375
- Specderm Poznanska sp j
-
Elblag, Polônia, 82 300
- Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
-
Krakow, Polônia, 31-411
- Centrum Medyczne PROMED
-
Krakow, Polônia, 30 438
- Centrum Medyczne dr Rajzer Sp z o o
-
Krakow, Polônia, 30-002
- Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
-
Lodz, Polônia, 90-338
- Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
-
Lodz, Polônia, 90-265
- Dermed Centrum Medyczne Sp z o o
-
Osielsko, Polônia, 86031
- Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C
-
Poznan, Polônia, 61 731
- Clinical Research Center sp z o o MEDIC R s k
-
Poznan, Polônia, 60 529
- SOLUMED Centrum Medyczne
-
Warsaw, Polônia, 02 953
- Klinika Ambroziak Dermatologia
-
Warsaw, Polônia, 01 817
- Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna
-
Wroclaw, Polônia, 51 503
- DERMMEDICA Sp.z o.o.
-
Wroclaw, Polônia, 52 416
- Centrum Medyczne Oporow
-
Wroclaw, Polônia, 51 685
- Wro Medica
-
-
-
-
-
London, Reino Unido, SE1 9RT
- Guys and St Thomas NHS Foundation Trust
-
Reading, Reino Unido, RG1 5AN
- Royal Berkshire Hospital
-
Salford, Reino Unido, M6 8HD
- Salford Royal Hospital
-
Southampton, Reino Unido, SO16 6YD
- University Hospital Southampton NHS Foundation Trust
-
-
-
-
-
Hsinchu, Taiwan, 30059
- National Taiwan University Hospital Hsin Chu Branch
-
Kaohsiung City, Taiwan, 833
- Chang Kung Memorial Hospital
-
New Taipei City, Taiwan, 235
- Taipei Medical University Shuang Ho Hospital
-
Taipei, Taiwan, 112
- Taipei Veterans General Hospital
-
Taipei, Taiwan, 10048
- National Taiwan University Hospital
-
Taipei, Taiwan, 10449
- Taipei Mackay Memorial Hospital
-
Taoyuan, Taiwan, 33382
- Linkou Chang Gung Memorial Hospital
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Critério de inclusão:
- Diagnóstico de psoríase em placas, com ou sem artrite psoriática (APs), durante pelo menos 26 semanas antes da primeira administração da intervenção do estudo
- Área de superfície corporal total (BSA) maior ou igual a (>=)10 por cento (%) na triagem e linha de base
- Área total de psoríase e índice de gravidade (PASI) >=12 na triagem e no início do estudo
- Avaliação global total do investigador (IGA) >=3 na triagem e linha de base
- Candidato a fototerapia ou tratamento sistêmico para psoríase em placas
Critério de exclusão:
- Forma de psoríase sem placas (por exemplo, eritrodérmica, gutata ou pustulosa)
- Psoríase atual induzida por medicamentos (por exemplo, um novo início de psoríase ou uma exacerbação da psoríase por betabloqueadores, bloqueadores dos canais de cálcio ou lítio)
- Um diagnóstico atual ou sinais ou sintomas de distúrbios renais, hepáticos, cardíacos, vasculares, pulmonares, gastrointestinais, endócrinos, neurológicos, hematológicos, reumatológicos, psiquiátricos ou metabólicos graves, progressivos ou não controlados
- Alergias, hipersensibilidade ou intolerância conhecidas a JNJ-77242113 ou seus excipientes
- Procedimento cirúrgico importante (por exemplo, que requer anestesia geral) dentro de 8 semanas antes da triagem, ou não terá se recuperado totalmente do procedimento cirúrgico, ou terá um procedimento cirúrgico planejado durante o período em que o participante deverá participar do estudo
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: JNJ-77242113
Os participantes receberão JNJ-77242113 da Semana 0 até a Semana 156 e deucravacitinibe correspondente ao placebo da Semana 0 até a Semana 24.
|
JNJ-77242113 será administrado por via oral.
O placebo correspondente ao deucravacitinibe será administrado por via oral.
|
|
Comparador de Placebo: Placebo
Os participantes receberão placebo correspondente para JNJ-77242113 da semana 0 até a semana 16, placebo correspondente para deucravacitinibe da semana 0 até a semana 24 e JNJ-77242113 da semana 16 até a semana 156.
|
JNJ-77242113 será administrado por via oral.
JNJ-77242113 placebo correspondente será administrado por via oral.
O placebo correspondente ao deucravacitinibe será administrado por via oral.
|
|
Comparador Ativo: Deucravacitinibe
Os participantes receberão deucravacitinibe da Semana 0 até a Semana 24 e placebo correspondente para JNJ-77242113 da Semana 0 até a Semana 24 e JNJ-77242113 da Semana 24 até a Semana 156.
|
JNJ-77242113 será administrado por via oral.
JNJ-77242113 placebo correspondente será administrado por via oral.
O deucravacitinibe será administrado por via oral.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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
Prazo: Week 16
|
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.
|
Week 16
|
|
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16
Prazo: 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.
|
Week 16
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change From Baseline in Body Surface Area (BSA) at Week 16
Prazo: Baseline (Week 0), Week 16
|
A BSA was commonly used measure of severity of skin disease.
It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis).
BSA was assessed using hand print method where the surface area of the participant's hand including the palm and all 5 digits was used as a guide to estimate 1% BSA.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Baseline (Week 0), Week 16
|
|
Percentage of Participants Who Achieved IGA Score of 0 at Week 16
Prazo: Week 16
|
The IGA assesses participant's plaque psoriasis.
Lesions were graded for induration, erythema and scaling, each using a 5 point scale.
Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates.
Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
A higher score indicated more severe disease.
|
Week 16
|
|
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
Prazo: Weeks 8 and 16
|
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit.
24-hour recall version was used.
PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity.
Each individual item score over seven days was averaged into a weekly item score.
Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items).
Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe).
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Weeks 8 and 16
|
|
Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in PSSD Itch Score at Weeks 4 and 16 Among Participants With a Baseline PSSD Itch Score >=4
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Week 24 up to Week 160
|
Week 24 up to Week 160
|
|
|
Number of Participants With Adverse Events (AEs)
Prazo: From Week 0 to Week 160
|
From Week 0 to Week 160
|
|
|
Number of Participants With Serious Adverse Events (SAEs)
Prazo: From Week 0 to Week 160
|
From Week 0 to Week 160
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Janssen Research & Development, LLC Clinicaltrial, Janssen Research & Development, LLC
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de fevereiro de 2024
Conclusão Primária (Real)
17 de setembro de 2024
Conclusão do estudo (Estimado)
1 de junho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
14 de novembro de 2023
Enviado pela primeira vez que atendeu aos critérios de CQ
16 de novembro de 2023
Primeira postagem (Real)
22 de novembro de 2023
Atualizações de registro de estudo
Última Atualização Postada (Real)
7 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 77242113PSO3002 (Outro identificador: Janssen Research & Development, LLC)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
A política de partilha de dados das Janssen Pharmaceutical Companies da Johnson & Johnson está disponível em www.janssen.com/clinical-trials/transparency.
Conforme observado neste site, as solicitações de acesso aos dados do estudo podem ser enviadas através do site do Projeto Yale Open Data Access (YODA) em yoda.yale.edu
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .