Un estudio de JNJ-77242113 para el tratamiento de participantes con psoriasis en placas de moderada a grave
2 de julio de 2026 actualizado por: Janssen Research & Development, LLC
Un estudio de fase 3 multicéntrico, aleatorizado, doble ciego, controlado con placebo y controlado con comparador activo de deucravacitinib para evaluar la eficacia y seguridad de JNJ-77242113 para el tratamiento de participantes con psoriasis en placas de moderada a grave
El propósito del estudio es ver qué tan efectivo es JNJ-77242113 en participantes con psoriasis en placas de moderada a grave en comparación con placebo y deucravacitinib.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
774
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Berlin, Alemania, 10789
- ISA - Interdisciplinary Study Association GmbH
-
Bramsche, Alemania, 49565
- Hautarztpraxis 3
-
Dresden, Alemania, 01069
- Klinische Forschung Dresden GmbH
-
Dresden, Alemania, 01097
- Praxis fuer Dermatologie und Venerologie
-
Düsseldorf, Alemania, 40225
- Universitaetsklinikum Duesseldorf
-
Hamburg, Alemania, 22391
- MensingDerma Research GmbH
-
Hamburg, Alemania, 20246
- Universitaetsklinikum Hamburg Eppendorf
-
Kiel, Alemania, 24105
- Universitaetsklinikum Schleswig Holstein Campus Kiel
-
Langenau, Alemania, 89129
- Studienzentrum Dr Schwarz Germany
-
Leipzig, Alemania, 04103
- Universitätsklinikum Leipzig AöR
-
Lübeck, Alemania, 23562
- Universitatsklinikum Schleswig Holstein Campus Lubeck
-
Mannheim, Alemania, 68167
- Universitaetsklinikum Mannheim
-
München, Alemania, 80802
- Klinik und Poliklinik fur Dermatologie und Allergologie am Biederstein
-
Potsdam, Alemania, 14467
- Hautarztpraxis 1
-
Rostock, Alemania, 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, Australia, 5074
- North Eastern Health Specialists
-
Canberra, Australia, 2606
- Paratus Clinical Research Woden
-
East Melbourne, Australia, 3002
- Sinclair Dermatology
-
Melbourne, Australia, 3053
- Skin Health Institute Inc.
-
Woolloongabba, Australia, 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, Corea del Sur, 49241
- Pusan National University Hospital
-
Seongnam-si, Corea del Sur, 13620
- Seoul National University Bundang Hospital
-
Seoul, Corea del Sur, 03080
- Seoul National University Hospital
-
Seoul, Corea del Sur, 06591
- The Catholic University of Korea Seoul St Marys Hospital
-
Seoul, Corea del Sur, 05030
- Konkuk University Medical Center
-
Seoul, Corea del Sur, 04763
- Hanyang University Medical Center
-
Seoul, Corea del Sur, 130 050
- Kyung Hee University Hospital
-
-
-
-
-
Alicante, España, 03010
- Hosp. Gral. Univ. Dr. Balmis
-
Barakaldo, España, 48902
- Hosp. Univ. de Cruces
-
Barcelona, España, 08041
- Hosp. de La Santa Creu I Sant Pau
-
Granada, España, 18016
- Hosp. Univ. San Cecilio
-
L'Hospitalet de Llobregat, España, 08907
- Hosp. Univ. de Bellvitge
-
Madrid, España, 28041
- Hosp. Univ. 12 de Octubre
-
Madrid, España, 28007
- Hosp. Gral. Univ. Gregorio Maranon
-
Madrid, España, 28031
- Hosp. Univ. Infanta Leonor
-
Madrid, España, 28006
- Hosp. Univ. de La Princesa
-
Madrid, España, 28046
- Hosp. Univ. de La Paz
-
Madrid, España, 28002
- Grupo Dermatologico Y Estetico Pedro Jaen
-
Valencia, España, 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, Hungría, 7632
- Pecsi Tudomanyegyetem
-
Budapest, Hungría, 1036
- Obudai Egeszsegugyi Centrum Kft
-
Debrecen, Hungría, 4032
- Debreceni Egyetem Klinikai Kozpont
-
Debrecen, Hungría, 4031
- Derma-B Kft
-
Kaposvár, Hungría, 7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
-
Szeged, Hungría, 6720
- SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati és Allergologiai Klinika
-
Szolnok, Hungría, 5000
- Allergo-Derm Bakos Kft.
-
Veszprém, Hungría, 8200
- Medmare Egeszsegugyi Es Szolgaltato Bt.
-
-
-
-
-
Fukuoka, Japón, 814-0180
- Fukuoka University Hospital
-
Fukutsu, Japón, 811-3217
- Hino Dermatology Clinic
-
Gifu, Japón, 501-1112
- Gifu University Hospital
-
Ginowan, Japón, 901 2725
- University of the Ryukyus hospital
-
Gunma, Japón, 371 8511
- Gunma University Hospital
-
Hokkaido, Japón, 060-0033
- JR Sapporo Hospital
-
Hokkaido, Japón, 078 8510
- Asahikawa Medical University Hospital
-
Isehara, Japón, 259-1193
- Tokai University Hospital
-
Itabashi Ku, Japón, 173 8606
- Teikyo University Hospital
-
Kawasaki, Japón, 216 8511
- St Marianna University Hospital
-
Kitakyushu-shi, Japón, 807-8556
- Hospital of the University of Occupational and Environmental Health
-
Nagoya, Japón, 467 8602
- Nagoya City University Hospital
-
Nishiku, Japón, 593-8324
- Kume Clinic
-
Obihiro Shi, Japón, 080 0013
- Takagi Dermatological Clinic
-
Osaka, Japón, 550 0006
- Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
-
Sakai, Japón, 590 0197
- Kindai University Hospital
-
Sapporo, Japón, 060 0063
- Sapporo Skin Clinic
-
Sendai, Japón, 980 8574
- Tohoku University Hospital
-
Suita, Japón, 565 0871
- The University of Osaka Hospital
-
Tachikawa, Japón, 190 0023
- Jitaikai Tachikawa dermatology clinic
-
Takaoka Shi, Japón, 933-0871
- Shirasaki dermatology clinic
-
Tokyo, Japón, 160-0023
- Tokyo Medical University Hospital
-
Tsu, Japón, 514 8507
- Mie University Hospital
-
-
-
-
-
Bialystok, Polonia, 15-351
- Osteo-Medic s.c A. Racewicz, J Supronik
-
Bialystok, Polonia, 15-375
- Specderm Poznanska sp j
-
Elblag, Polonia, 82 300
- Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
-
Krakow, Polonia, 31-411
- Centrum Medyczne PROMED
-
Krakow, Polonia, 30 438
- Centrum Medyczne dr Rajzer Sp z o o
-
Krakow, Polonia, 30-002
- Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
-
Lodz, Polonia, 90-338
- Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
-
Lodz, Polonia, 90-265
- Dermed Centrum Medyczne Sp z o o
-
Osielsko, Polonia, 86031
- Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C
-
Poznan, Polonia, 61 731
- Clinical Research Center sp z o o MEDIC R s k
-
Poznan, Polonia, 60 529
- SOLUMED Centrum Medyczne
-
Warsaw, Polonia, 02 953
- Klinika Ambroziak Dermatologia
-
Warsaw, Polonia, 01 817
- Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna
-
Wroclaw, Polonia, 51 503
- DERMMEDICA Sp.z o.o.
-
Wroclaw, Polonia, 52 416
- Centrum Medyczne Oporow
-
Wroclaw, Polonia, 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, Taiwán, 30059
- National Taiwan University Hospital Hsin Chu Branch
-
Kaohsiung City, Taiwán, 833
- Chang Kung Memorial Hospital
-
New Taipei City, Taiwán, 235
- Taipei Medical University Shuang Ho Hospital
-
Taipei, Taiwán, 112
- Taipei Veterans General Hospital
-
Taipei, Taiwán, 10048
- National Taiwan University Hospital
-
Taipei, Taiwán, 10449
- Taipei Mackay Memorial Hospital
-
Taoyuan, Taiwán, 33382
- Linkou Chang Gung Memorial Hospital
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Criterios de inclusión:
- Diagnóstico de psoriasis en placas, con o sin artritis psoriásica (PsA), durante al menos 26 semanas antes de la primera administración de la intervención del estudio.
- Área de superficie corporal total (BSA) mayor o igual a (>=)10 por ciento (%) en el momento de la selección y al inicio
- Área total de psoriasis e índice de gravedad (PASI) >=12 en el momento de selección y al inicio del estudio
- Evaluación global total del investigador (IGA) >=3 en la selección y al inicio
- Candidato a fototerapia o tratamiento sistémico para la psoriasis en placas.
Criterio de exclusión:
- Forma de psoriasis sin placas (por ejemplo, eritrodérmica, guttata o pustulosa)
- Psoriasis actual inducida por fármacos (por ejemplo, una nueva aparición de psoriasis o una exacerbación de la psoriasis por betabloqueantes, bloqueadores de los canales de calcio o litio)
- Un diagnóstico actual o signos o síntomas de trastornos renales, hepáticos, cardíacos, vasculares, pulmonares, gastrointestinales, endocrinos, neurológicos, hematológicos, reumatológicos, psiquiátricos o metabólicos graves, progresivos o no controlados.
- Alergias, hipersensibilidad o intolerancia conocidas a JNJ-77242113 o sus excipientes
- Procedimiento quirúrgico mayor (por ejemplo, que requiera anestesia general) dentro de las 8 semanas previas a la selección, o no se habrá recuperado completamente del procedimiento quirúrgico, o tiene un procedimiento quirúrgico planificado durante el tiempo que se espera que el participante participe en el estudio.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: JNJ-77242113
Los participantes recibirán JNJ-77242113 desde la semana 0 hasta la semana 156 y un placebo equivalente a deucravacitinib desde la semana 0 hasta la semana 24.
|
JNJ-77242113 se administrará por vía oral.
Se administrará un placebo equivalente a deucravacitinib por vía oral.
|
|
Comparador de placebos: Placebo
Los participantes recibirán un placebo equivalente para JNJ-77242113 desde la semana 0 hasta la semana 16, un placebo equivalente para deucravacitinib desde la semana 0 hasta la semana 24 y JNJ-77242113 desde la semana 16 hasta la semana 156.
|
JNJ-77242113 se administrará por vía oral.
El placebo equivalente JNJ-77242113 se administrará por vía oral.
Se administrará un placebo equivalente a deucravacitinib por vía oral.
|
|
Comparador activo: Deucravacitinib
Los participantes recibirán deucravacitinib desde la semana 0 hasta la semana 24 y un placebo equivalente para JNJ-77242113 desde la semana 0 hasta la semana 24 y JNJ-77242113 desde la semana 24 hasta la semana 156.
|
JNJ-77242113 se administrará por vía oral.
El placebo equivalente JNJ-77242113 se administrará por vía oral.
Deucravacitinib se administrará por vía oral.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change From Baseline in Body Surface Area (BSA) at Week 16
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Week 24 up to Week 160
|
Week 24 up to Week 160
|
|
|
Number of Participants With Adverse Events (AEs)
Periodo de tiempo: From Week 0 to Week 160
|
From Week 0 to Week 160
|
|
|
Number of Participants With Serious Adverse Events (SAEs)
Periodo de tiempo: From Week 0 to Week 160
|
From Week 0 to Week 160
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Janssen Research & Development, LLC Clinicaltrial, Janssen Research & Development, LLC
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de febrero de 2024
Finalización primaria (Actual)
17 de septiembre de 2024
Finalización del estudio (Estimado)
1 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
14 de noviembre de 2023
Primero enviado que cumplió con los criterios de control de calidad
16 de noviembre de 2023
Publicado por primera vez (Actual)
22 de noviembre de 2023
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
2 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 77242113PSO3002 (Otro identificador: Janssen Research & Development, LLC)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
La política de intercambio de datos de Janssen Pharmaceutical Companies de Johnson & Johnson está disponible en www.janssen.com/clinical-trials/transparency.
Como se indica en este sitio, las solicitudes de acceso a los datos del estudio se pueden enviar a través del sitio del Proyecto Yale Open Data Access (YODA) en yoda.yale.edu.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .