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Un estudio de JNJ-77242113 para el tratamiento de participantes con psoriasis en placas que afecta áreas especiales (cuero cabelludo, genitales y/o palmas de las manos y plantas de los pies) (ICONIC-TOTAL)

27 de agosto de 2026 actualizado por: Janssen Research & Development, LLC

Un estudio de fase 3 multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y seguridad de JNJ-77242113 para el tratamiento de participantes con psoriasis en placas que involucra áreas especiales

El propósito del estudio es ver qué tan efectivo es JNJ-77242113 en participantes con psoriasis en placas que afecta áreas especiales (cuero cabelludo, genitales y/o palmas de las manos y plantas de los pies).

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

311

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

  • Alemania
      • Berlin, Alemania, 10789
        • ISA - Interdisciplinary Study Association GmbH
      • Berlin, Alemania, 13627
        • CRS Clinical Research Services Berlin GMBH
      • Bochum, Alemania, 44793
        • Niesmann & Othlinghaus GbR
      • Darmstadt, Alemania, 64283
        • Rosenpark Research GmbH
      • Dresden, Alemania, 01307
        • Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
      • Frankfurt am Main, Alemania, 60590
        • Universitaetsklinikum Frankfurt
      • Hamburg, Alemania, 20354
        • Dermatologikum Hamburg Gmbh
      • Schwerin, Alemania, 19055
        • Klinische Forschung Schwerin GmbH
      • Witten, Alemania, 58453
        • Hautarztpraxis 2
  • Argentina
      • Buenos Aires, Argentina, C1417EYG
        • Centro Privado de Medicina Familiar
      • Buenos Aires, Argentina, C1061AAS
        • CIPREC
      • CABA, Argentina, C1012AAY
        • CONEXA Investigacion Clinica S.A.
      • Caba, Argentina, C1060ABN
        • CEDIC Centro de Investigación Clínica
  • Canadá
    • Alberta
      • Edmonton, Alberta, Canadá, T6G 1C3
        • Alberta Dermasurgery Centre
    • Ontario
      • Markham, Ontario, Canadá, L3P 1X3
        • Lynderm Research Inc.
      • Peterborough, Ontario, Canadá, K9J 5K2
        • SKiN Centre for Dermatology
      • Richmond Hill, Ontario, Canadá, L4B1L1
        • York Dermatology Clinic and Research Centre
    • Quebec
      • Montreal, Quebec, Canadá, H2X 2V1
        • Innovaderm Research Inc.
      • Québec, Quebec, Canadá, G1V 4X7
        • Centre Dermatologique
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canadá, S7K 2C1
        • Skinsense Medical Research
  • Corea del Sur
      • 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, 08308
        • Korea University Guro Hospital
      • Seoul, Corea del Sur, 05030
        • Konkuk University Medical Center
  • España
      • Badalona, España, 08916
        • Hosp. Univ. Germans Trias I Pujol
      • Barcelona, España, 08003
        • Hosp. Del Mar
      • Esplugues de Llobregat, España, 08950
        • Hosp. Sant Joan de Deu
      • Granada, España, 18016
        • Hosp. Univ. San Cecilio
      • Madrid, España, 28041
        • Hosp. Univ. 12 de Octubre
      • Manises, España, 46940
        • Hosp. de Manises
      • Seville, España, 41009
        • Hosp. Virgen Macarena
      • Valencia, España, 46026
        • Hosp. Univ. I Politecni La Fe
  • Estados Unidos
    • Arizona
      • Scottsdale, Arizona, Estados Unidos, 85260
        • Center for Dermatology and Plastic Surgery
    • Arkansas
      • Fort Smith, Arkansas, Estados Unidos, 72916
        • Johnson Dermatology
    • California
      • Encinitas, California, Estados Unidos, 92024
        • California Dermatology & Clinical Research Institute
    • Florida
      • Tampa, Florida, Estados Unidos, 33613
        • Forcare Clinical Research Inc
    • Georgia
      • Alpharetta, Georgia, Estados Unidos, 30022
        • Hamilton Research LLC
    • Illinois
      • Rolling Meadows, Illinois, Estados Unidos, 60008
        • Arlington Dermatology
      • 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
    • Louisiana
      • Lake Charles, Louisiana, Estados Unidos, 70605
        • Dermatology and Advanced Aesthetics
    • Massachusetts
      • Beverly, Massachusetts, Estados Unidos, 01915
        • Allcutis Research 1
    • Michigan
      • Fort Gratiot, Michigan, Estados Unidos, 48059
        • Hamzavi Dermatology
    • Minnesota
      • New Brighton, Minnesota, Estados Unidos, 55112
        • Minnesota Clinical Study Center
    • Missouri
      • Saint Joseph, Missouri, Estados Unidos, 64506
        • MediSearch Clinical Trials
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68144
        • Skin Specialists
    • New Jersey
      • East Windsor, New Jersey, Estados Unidos, 08520
        • Schweiger Dermatology Group
    • Ohio
      • Boardman, Ohio, Estados Unidos, 44512
        • Optima Research
    • Oregon
      • Portland, Oregon, Estados Unidos, 97210
        • Oregon Dermatology and Research Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19103
        • Paddington Testing Co, Inc.
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • University of Pittsburgh Medical Center
    • Texas
      • Arlington, Texas, Estados Unidos, 76011
        • Arlington Research Center, inc.
      • Houston, Texas, Estados Unidos, 77004
        • Center for Clinical Studies 1
      • Pflugerville, Texas, Estados Unidos, 78660
        • Austin Institute for Clinical Research
      • San Antonio, Texas, Estados Unidos, 78229
        • Dermatology Clinical Research Center of San Antonio
      • San Antonio, Texas, Estados Unidos, 78213
        • Progressive Clinical Research
      • Webster, Texas, Estados Unidos, 77598
        • Center for Clinical Studies
    • Utah
      • Bountiful, Utah, Estados Unidos, 84010
        • Cope Family Medicine - Ogden Clinic
    • Washington
      • Mill Creek, Washington, Estados Unidos, 98012
        • Frontier Derm Partners CRO, LLC
  • Hungría
      • Borgyogyaszati Klinika, Hungría, 7632
        • Pecsi Tudomanyegyetem
      • Budapest, Hungría, 1036
        • Obudai Egeszsegugyi Centrum Kft
      • Debrecen, Hungría, 4031
        • Derma-B Kft
      • 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.
  • Polonia
      • Bialystok, Polonia, 15-351
        • Osteo-Medic s.c A. Racewicz, J Supronik
      • Bialystok, Polonia, 15-375
        • Specderm Poznanska sp j
      • 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, 90-265
        • 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, 52 416
        • Centrum Medyczne Oporow
      • Wroclaw, Polonia, 51 685
        • Wro Medica
  • Reino Unido
      • Harrow, Reino Unido, HA1 3UJ
        • London North West University Healthcare NHS Trust
      • Salford, Reino Unido, M6 8HD
        • Salford Royal Hospital
      • Southampton, Reino Unido, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust
  • Taiwán
      • Hsinchu, Taiwán, 30059
        • National Taiwan University Hospital Hsin Chu Branch
      • Kaohsiung City, Taiwán, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Taipei, Taiwán, 10048
        • National Taiwan University Hospital
      • Taoyuan, Taiwán, 33382
        • Linkou Chang Gung Memorial Hospital
  • Turquía (Türkiye)
      • Konya, Turquía (Türkiye), 42080
        • Necmettin Erbakan University Meram Medical Faculty
      • Samsun, Turquía (Türkiye), 55270
        • Ondokuz Mayis University
      • Trabzon, Turquía (Türkiye), 61080
        • Karadeniz Teknik University Medical Faculty

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

  • Niño
  • 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.
  • Candidato a fototerapia o tratamiento sistémico para la psoriasis en placas.
  • Necesidad de cumplir con los criterios: área de superficie corporal total (BSA) mayor o igual a (>=)1 por ciento (%) en la selección y al inicio, y evaluación global del investigador (IGA) (general) >=2 en la selección y al inicio y al al menos uno de los siguientes: puntuación de evaluación global del investigador específica del cuero cabelludo (ss-IGA) >=3 en la selección y al inicio, y/o evaluación global estática de los genitales por parte del médico (sPGA-G) >=3 en la selección y al inicio, y/ o puntuación de la evaluación global de manos y pies (hf-PGA) realizada por el médico >= 3 en el momento de la selección y al inicio del estudio
  • No respondió a al menos una terapia tópica (por ejemplo, corticosteroides, inhibidores de la calcineurina y/o análogos de la vitamina D) utilizada para el tratamiento de la psoriasis.
  • Confirmación de psoriasis en placas en un área no especial (por ejemplo, áreas que excluyen el cuero cabelludo, genital y palmoplantar) en la selección y al inicio del estudio.

Criterio de exclusión:

  • Forma de psoriasis sin placa (por ejemplo, eritrodérmica, guttata o pustulosa)
  • Dermatosis distintas de la psoriasis en placas (como la dermatitis de contacto) o la pustulosis palmoplantar del área palmoplantar (si hf-PGA >=3 al inicio del estudio)
  • 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

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.
Droga: JNJ-77242113
JNJ-77242113 se administrará por vía oral.
Comparador de placebos: Placebo
Los participantes recibirán placebo desde la semana 0 hasta la semana 16 y posteriormente recibirán JNJ-77242113 desde la semana 16 hasta la semana 156.
Droga: Placebo
El placebo se administrará por vía oral.
Droga: JNJ-77242113
JNJ-77242113 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cambio desde el valor basal en la puntuación total del PASI en la semana 16
Periodo de tiempo: Línea de base (Semana 0), Semana 16
Se informó el cambio desde el valor basal en la puntuación total del PASI en la semana 16. El PASI era un sistema utilizado para evaluar y clasificar la gravedad de las lesiones psoriásicas y su respuesta a la terapia. En el sistema PASI, el cuerpo se dividía en 4 regiones: la cabeza, el tronco, las extremidades superiores y las extremidades inferiores. Cada una de estas áreas se evaluaba y puntuaba por separado para eritema, induración y descamación, que se clasificaban cada una en una escala de 0 a 4 (0=ausente, 1=leve, 2=moderado, 3=grave y 4=muy grave) y la extensión de la afectación de 0 (indicaba ninguna afectación) a 6 (90% - 100% de afectación). El PASI producía una puntuación total numérica que podía oscilar entre 0 (sin psoriasis) y 72 (psoriasis máxima). Una puntuación más alta indicaba una mayor gravedad de la psoriasis. El valor basal se definía como la medición más cercana tomada antes o en la fecha de la primera administración del fármaco del estudio.
Línea de base (Semana 0), Semana 16
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
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 were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), 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
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
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 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
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
Percentage of Participants Who Achieved a Scalp Specific (ss)-IGA Score of 0 or 1 at Week 16 Among Participants With a Baseline Ss-IGA Score >=3
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 Psoriasis Scalp Severity Index (PSSI) 90 at Week 16 Among Participants With a Baseline Ss-IGA Score >=3
Periodo de tiempo: Week 16
PSSI 90 response is defined as a percentage of participants who achieved at least 90% improvement from baseline in the PSSI score. PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity). Higher scores indicating more severe symptoms. Baseline=closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 at Week 16 Among Participants With a Baseline sPGA Score >=3
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 at Week 16 Among Participants With a Baseline Hf-PGA Score >=3
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) among participants. 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 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 Week 16 Among Participants With a Baseline PSSD 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
Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in PSSD Itch Score at Week 16 Among Participants With a Baseline PSSD Itch Score >=4
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 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.
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 sPGA-G Score >=3 and a Baseline GenPs-SFQ Item 2 Score >=2
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). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. Lower scores of item 2 indicated less limitation of sexual activity due to genital psoriasis.
Week 16
Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in Scalp Itch Numeric Rating Scale (NRS) Score at Week 16 Among Participants With a Baseline Ss-IGA Score >=3 and a Baseline Scalp Itch NRS Score >=4
Periodo de tiempo: Week 16
The Scalp Itch NRS is a single item instrument that evaluates the severity of scalp itch in adult and adolescent populations over the past 24 hours. The instrument uses an NRS score ranging from 0 (no scalp itch) to 10 (worst scalp itch imaginable), with higher scores indicative of greater symptom 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 >=4-Point Improvement From Baseline in Genital Psoriasis Symptoms Score (GPSS) Genital Itch NRS Score at Week 16 Among Participants With a Baseline sPGA-G Score >=3 and a Baseline GPSS Genital Itch NRS Score >=4
Periodo de tiempo: Week 16
The GPSS is a participant-administered assessment of 8 symptoms: itch, pain, discomfort, stinging, burning, redness, scaling, and cracking. Each respondent is asked to answer the questions based on the psoriasis symptoms in his or her genital area. The overall severity for each individual genital psoriasis symptom is indicated by selecting the number from an NRS of 0 to 10 that best describes the worst level of each symptom in the genital area in the past 24 hours, ranging from 0 (no severity) to 10 (worst imaginable severity). Higher scores indicate greater itch intensity. 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 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 were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved PASI 75 at Week 16
Periodo de tiempo: Week 16
Percentage of participants who achieved PASI-75 score (>=75% 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 were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved Fingernail Physician's Global Assessment (fPGA) Score of 0 or 1 at Week 16 Among Participants With a 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
Percentage of Participants Who Achieved PSSD Symptoms Score of 0 at Week 8 Among Participants With a Baseline PSSD Symptom Score >0
Periodo de tiempo: Week 8
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 8
Change From Baseline in PSSD Symptoms Score at Week 16
Periodo de tiempo: Baseline (Week 0), Week 16
Change from baseline in PSSD symptoms scores 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
Percentage of Participants Achieving >=4-Point Improvement From Baseline in PSSD Itch Score at Week 4 Among Participants With a Baseline Itch Score >=4
Periodo de tiempo: Week 4
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.
Week 4
Percentage of Participants Who Achieved PSSD Sign Score of 0 at Week 16 Among Participants With a Baseline PSSD 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 Children's Dermatological Life Quality Index (CDLQI) Score of 0 or 1 at Week 16 Among Adolescent Participants With a Baseline CDLQI Score >1
Periodo de tiempo: Week 16
The CDLQI was an adapted version of the DLQI for the pediatric population and was utilized in the adolescent population in this study. The CDLQI is a 10-item instrument that has 4 item response options and a recall period of 1 week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children. The instrument is designed for use in children, is self-explanatory and can be simply handed to the participant who asked to fill it in with the help of the child's parent or caregiver. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Change From Baseline in Domain Scores of the PROMIS-25 Pediatric Score at Week 16
Periodo de tiempo: Baseline (Week 0), Week 16
The PROMIS-25 was utilized in the adolescent population and is a 25-item generic HRQoL survey. Six PROMIS domains (physical function mobility, anxiety, depressive symptoms, fatigue, peer relationships, pain interference) are each assessed with 4 questions. Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often, 5=always). Higher score=worst pain. Raw scores for each domain were converted to T-scores using standardized score with a mean of 50 and a standard deviation (SD) of 10 with an observed range 20 to 80. For anxiety, depressive symptoms, fatigue, and pain interference, a negative change indicates an improvement while for physical function mobility and peer relationships, a positive change indicates an improvement. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Change From Baseline in Palmoplantar Quality of Life Instrument (ppQLI) Hands Score at Week 16 Among Participants With a Baseline Hf-PGA Score >=3
Periodo de tiempo: Baseline (Week 0), Week 16
The ppQLI assesses impact on patient quality of life due to palmoplantar psoriasis over the past month in adult and adolescent populations. Sixteen items evaluate hand functionality, pain, and social impact due to psoriasis. Fourteen items evaluate foot functionality, pain, and physical limitations due to psoriasis. All items use verbal rating scales ranging from 1 to 5. The ppQLI yields a score for hands, ranging from 16 to 80, and a score for feet, ranging from 14 to 70. Higher score indicating 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.
Baseline (Week 0), Week 16
Change From Baseline in ppQLI Feet Score at Week 16 Among Participants With a Baseline Hf-PGA Score >=3
Periodo de tiempo: Baseline (Week 0), Week 16
The ppQLI assesses impact on patient quality of life due to palmoplantar psoriasis over the past month in adult and adolescent populations. Sixteen items evaluate hand functionality, pain, and social impact due to psoriasis. Fourteen items evaluate foot functionality, pain, and physical limitations due to psoriasis. All items use verbal rating scales ranging from 1 to 5. The ppQLI yields a score for hands, ranging from 16 to 80, and a score for feet, ranging from 14 to 70. Higher score indicating 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.
Baseline (Week 0), Week 16
Change From Baseline in Genital Psoriasis Symptoms Score (GPSS) Total Score at Week 16 Among Participants With a Baseline sPGA-G Score >=3
Periodo de tiempo: Baseline (Week 0), Week 16
The GPSS was a participant-administered assessment of 8 symptoms: itch, pain, discomfort, stinging, burning, redness, scaling, and cracking. Each respondent was asked to answer the questions based on the psoriasis symptoms in his or her genital area. The overall severity for each individual genital psoriasis symptom was indicated by selecting the number from an NRS of 0 to 10 that best describes the worst level of each symptom in the genital area in the past 24 hours, ranging from 0 (no severity) to 10 (worst imaginable severity). Results from each symptom assessment were summed to generate a total GPSS score ranging from 0 (no genital psoriasis symptoms) to 80 (worst imaginable genital psoriasis symptoms). A negative change from baseline indicates an improvement in genital psoriasis symptoms. 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

Colaboradores e Investigadores

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Patrocinador

Janssen Research & Development, LLC

Investigadores

  • Director de estudio: Janssen Research &Development, LLC Clinical trial, Janssen Research & Development, LLC

Publicaciones y enlaces útiles

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Publicaciones Generales

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)

12 de octubre de 2023

Finalización primaria (Actual)

19 de junio de 2024

Finalización del estudio (Estimado)

17 de febrero de 2027

Fechas de registro del estudio

Enviado por primera vez

18 de octubre de 2023

Primero enviado que cumplió con los criterios de control de calidad

18 de octubre de 2023

Publicado por primera vez (Actual)

23 de octubre de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

27 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 77242113PSO3003 (Otro identificador: Janssen Research & Development, LLC)

Plan de datos de participantes individuales (IPD)

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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

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