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Estudio de guselkumab versus placebo para el tratamiento de la psoriasis en placas moderada con área de superficie corporal baja (SPECTREM)

10 de abril de 2026 actualizado por: Janssen Research & Development, LLC

Un estudio de fase 3b, multicéntrico, aleatorizado, doble ciego y controlado con placebo que evalúa la seguridad y eficacia de guselkumab frente a placebo para el tratamiento de la psoriasis en placas moderada con área de superficie corporal baja (ASC) con afectación de un sitio especial

El propósito de este estudio es evaluar la eficacia de guselkumab en comparación con un fármaco inactivo en participantes con psoriasis en placas moderada de superficie corporal baja y afectación de sitios especiales.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

338

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

  • Canadá
    • Alberta
      • Calgary, Alberta, Canadá, T3E 0B2
        • Beacon Dermatology
      • Edmonton, Alberta, Canadá, T5J 3S9
        • Rejuvenation Dermatology Clinic Edmonton Downtown
    • British Columbia
      • Surrey, British Columbia, Canadá, V3V 0C6
        • Enverus Medical
      • Surrey, British Columbia, Canadá, V3R 6A7
        • Dr. Chih ho Hong Medical
    • Manitoba
      • Winnipeg, Manitoba, Canadá, R3M 3Z4
        • Wiseman Dermatology Research Inc.
      • Winnipeg, Manitoba, Canadá, R3C 0N2
        • Winnipeg Clinic
    • New Brunswick
      • Fredericton, New Brunswick, Canadá, E3B 1G9
        • Brunswick Dermatology Center
    • 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
      • London, Ontario, Canadá, N6H 5L5
        • Dr Wei Jing Loo Medicine Professional Corporation
      • North York, Ontario, Canadá, M2M 4J5
        • North York Research Inc
      • Ottawa, Ontario, Canadá, K1H 7X3
        • JRB Research Inc
      • Toronto, Ontario, Canadá, M4W 2N2
        • Research Toronto
      • Toronto, Ontario, Canadá, M3H 5Y8
        • Toronto Research Centre
      • Toronto, Ontario, Canadá, M3B 0A7
        • Canadian Dermatology Center
      • Toronto, Ontario, Canadá, M4E 2Y9
        • FACET Dermatology
      • Waterloo, Ontario, Canadá, N2J 1C4
        • K. Papp Clinical Research Inc.
    • Quebec
      • Québec, Quebec, Canadá, G1W 4R4
        • The Centre de recherche Saint-Louis
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35244
        • Cahaba Research Inc
      • Birmingham, Alabama, Estados Unidos, 35203
        • Total Dermatology
    • California
      • Encinitas, California, Estados Unidos, 92024
        • California Dermatology & Clinical Research Institute
      • Fountain Valley, California, Estados Unidos, 92708
        • First OC Dermatology
      • Riverside, California, Estados Unidos, 92505
        • Practice Wang
      • San Diego, California, Estados Unidos, 92123
        • Therapeutics Clinical Research
      • Santa Ana, California, Estados Unidos, 92701
        • Rehlen, Bartlow, Goodman and Baron Dermatology Group
      • Santa Monica, California, Estados Unidos, 90404
        • Clinical Science Institute
    • Connecticut
      • Farmington, Connecticut, Estados Unidos, 06030
        • University of Conn Health Center
    • Florida
      • Brandon, Florida, Estados Unidos, 33511
        • TrueBlue Clinical Research
      • Coral Gables, Florida, Estados Unidos, 33134
        • Florida Academic Dermatology Centers
      • Doral, Florida, Estados Unidos, 33122
        • Revival Research
      • Margate, Florida, Estados Unidos, 33063
        • Glick Research Institute
      • Miami, Florida, Estados Unidos, 33124
        • Miami VA Healthcare System
      • North Miami Beach, Florida, Estados Unidos, 33162
        • Tory P Sullivan M D PA
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 303331
        • Atlanta Biomedical Clinical Research
    • Maryland
      • Columbia, Maryland, Estados Unidos, 21045
        • Kindred Hair and Skin Center
      • Rockville, Maryland, Estados Unidos, 20850
        • DermAssociates, PC
      • Rockville, Maryland, Estados Unidos, 20850
        • Lawrence J Green MD LLC
    • Massachusetts
      • Brighton, Massachusetts, Estados Unidos, 02135
        • Metro Boston Clinical Partners
      • Quincy, Massachusetts, Estados Unidos, 02169
        • DermCare, LLC
    • Michigan
      • West Bloomfield, Michigan, Estados Unidos, 48322
        • Henry Ford Medical Center
    • New York
      • New York, New York, Estados Unidos, 10003
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, Estados Unidos, 10128
        • Markowitz Medical OptiSkin
    • North Carolina
      • Cary, North Carolina, Estados Unidos, 27511
        • Accellacare Research of Cary
      • Charlotte, North Carolina, Estados Unidos, 28277
        • Darst Dermatology
      • Huntersville, North Carolina, Estados Unidos, 28078
        • Piedmont Plastic Surgery and Dermatology
    • Ohio
      • Bexley, Ohio, Estados Unidos, 43209
        • Bexley Dermatology Research
      • Columbus, Ohio, Estados Unidos, 43215
        • Remington Davis Inc
      • Mayfield Heights, Ohio, Estados Unidos, 44124
        • Apex Dermatology Mayfield Heights
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29414
        • Dermatology and Laser Center of Charleston
      • Fountain Inn, South Carolina, Estados Unidos, 29644
        • Palmetto Clinical Trial Services, LLC
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37215
        • Tennessee Clinical Research Center
      • Nashville, Tennessee, Estados Unidos, 37212
        • Nashville Skin: Comprehensive Dermatology Center
    • Texas
      • Arlington, Texas, Estados Unidos, 76011
        • Arlington Center for Dermatology
      • Bellaire, Texas, Estados Unidos, 77401
        • Bellair Dermatology
      • Dallas, Texas, Estados Unidos, 75231
        • Modern Research Associates PLLC
      • Dallas, Texas, Estados Unidos, 75246
        • Menter Dermatology Research Institute
      • Dallas, Texas, Estados Unidos, 75235
        • Bare Dermatology
      • Houston, Texas, Estados Unidos, 77004
        • Center for Clinical Studies
      • Houston, Texas, Estados Unidos, 77056-4132
        • Suzanne Bruce and Associates - The Center for Skin Research
      • San Antonio, Texas, Estados Unidos, 78229
        • Progressive Clinical Research
      • San Antonio, Texas, Estados Unidos, 78218
        • Texas Dermatology and Laser Specialists
      • Sugar Land, Texas, Estados Unidos, 77479
        • Acclaim Dermatology
    • Washington
      • Mill Creek, Washington, Estados Unidos, 98102
        • Frontier Derm Partners CRO, LLC

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:

  • Todos los participantes deben tener un diagnóstico de psoriasis en placas (con o sin artritis psoriásica) durante al menos 6 meses antes de la primera administración de la intervención del estudio.
  • Todos los participantes deben cumplir con los siguientes criterios de gravedad de la enfermedad en la selección y al inicio del estudio: (a) Evaluación global del investigador (IGA) 3 (moderada) psoriasis en placas; (b) Área de superficie corporal (BSA) del 2 al 15 por ciento (%) con al menos 1 placa fuera de los sitios especiales; (c) Afectación de al menos 1 sitio especial con al menos gravedad moderada. Los sitios calificados incluyen cuero cabelludo con IGA específica del cuero cabelludo mayor o igual a (>=) 3, cara con psoriasis facial IGA >=3, intertriginosa con psoriasis intertriginosa IGA >=3, o genital con evaluación global de los genitales por un médico estático (sPGA- G) >=3
  • Todos los participantes deben tener un control inadecuado o ser intolerantes a al menos 1 tratamiento tópico previo (incluidos, entre otros, corticosteroides, retinoides, vitamina D o combinaciones de vitamina D/esteroide y retinoide/esteroide, tacrolimus, pimecrolimus, antralina/ditranol, carbón). preparaciones de alquitrán, tapinarof, roflumilast, etcétera) para el tratamiento de la psoriasis tanto en el cribado
  • Todos los participantes serán candidatos a fototerapia o tratamiento sistémico para la psoriasis.

Criterio de exclusión:

  • Tiene una forma de psoriasis sin placa (por ejemplo, eritrodérmica, guttata o pustulosa) en el momento de la selección o la aleatorización.
  • Tiene 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)
  • Para los participantes con afectación palmoplantar, se deben confirmar y excluir diagnósticos de confusión, incluidos, entre otros, pustulosis palmoplantar, dermatitis eccematosa, dermatitis de contacto/irritante, queratodermia adquirida, etc.
  • Los participantes no serán elegibles si alguna vez han recibido biológicos (o biosimilares) previamente para el tratamiento de la psoriasis, la artritis psoriásica (PsA) o cualquier otra indicación que pueda afectar la evaluación de la psoriasis. Los productos biológicos anteriores (o biosimilares de) pueden incluir, entre otros, inhibidores del factor de necrosis tumoral (TNF) (por ejemplo: adalimumab, etanercept, infliximab o certolizumab o biosimilares), inhibidores de interleucina (IL)-17 (por ejemplo: secukinumab, ixekizumab, brodalumab o bimekizumab) e inhibidores de IL-12/23 (por ejemplo: ustekinumab) o inhibidor de IL-23 (por ejemplo: guselkumab, risankizumab o tildrakizumab)
  • Tiene antecedentes de enfermedades infecciosas crónicas o recurrentes, que incluyen, entre otras, infección renal crónica, infección respiratoria crónica (por ejemplo, bronquiectasias), infección recurrente del tracto urinario (pielonefritis recurrente o cistitis crónica no remitente), infección por hongos (mucocutánea). candidiasis), o úlceras o heridas en la piel abiertas, supurantes o infectadas

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: Grupo 1: Guselkumab
Los participantes recibirán guselkumab mediante inyección subcutánea con placebo según sea necesario para mantener a los ciegos.
Droga: Placebo
El placebo se administrará como inyección subcutánea.
Droga: Guselkumab
Guselkumab se administrará como inyección subcutánea.
Otros nombres:
  • Tremfya
  • CNTO1959
Comparador de placebos: Grupo 2: Placebo
Los participantes recibirán placebo mediante inyección subcutánea y luego recibirán guselkumab mediante inyección subcutánea.
Droga: Placebo
El placebo se administrará como inyección subcutánea.
Droga: Guselkumab
Guselkumab se administrará como inyección subcutánea.
Otros nombres:
  • Tremfya
  • CNTO1959

¿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 Cleared (0) or Minimal (1) 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 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (>) 1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over 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). Higher score indicated more severe disease.
Week 16

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percent Change From Baseline in Body Surface Area (BSA) at Week 16
Periodo de tiempo: Baseline (Week 0), Week 16
Percent change from baseline in BSA at Week 16 was reported. 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 percent (%) 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 Psoriasis Area Severity Index (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. 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 IGA Score of Cleared (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, greater than (>) 1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over 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). Higher score indicated more severe disease.
Week 16
Percentage of Participants Who Achieved PASI 90 Response at Week 16
Periodo de tiempo: Week 16
Percentage of participants who achieved PASI 90 score (greater than or equal to [>=] 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 100 Response 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 Scalp Specific (ss)-IGA Score of Absence of Disease (0) or Very Mild Disease (1) at Week 16 Among Randomized Participants With Ss-IGA Score >=3 at Baseline
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 Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 at Week 16 Among Randomized Participants With sPGA-G Score >=3 at Baseline
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 Intertriginous IGA (i-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Randomized Participants With an i-IGA Score >=3 at Baseline
Periodo de tiempo: Week 16
The IGA used for the full body assessment was adapted with descriptions of disease features that were more consistent with intertriginous psoriasis presentation. The intertriginous areas assessed included the axillary, sub mammary, abdominal fold, inguinal, and intergluteal cleft/peri-anal region (distinct from genital/perineum involvement). The i-IGA was 5-point scale evaluating the severity of plaque psoriasis in the intertriginous area with scores defined as clear (0), minimal (1), mild (2), moderate (3), and severe (4). A higher score indicated greater disease 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 Facial IGA (f-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Randomized Participants With f-IGA Score >=3 at Baseline
Periodo de tiempo: Week 16
The standard IGA used for full body evaluation was adapted for assessment of psoriasis on the face only. The f-IGA used a 5-point scale to assess overall facial disease severity, defined as clear (0), minimal (1), mild (2), moderate (3), and severe (4). A higher score indicated more severe facial 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
Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Total Symptom Score at Week 16
Periodo de tiempo: Baseline (Week 0), Week 16
The PSSD was a patient reported outcome (PRO) questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. 7-day 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. Items were averaged on the weekly symptom score when at least 3 items (>=50 percentage of 5 items) on these scales were answered. The average value was converted into 0-100 scoring, such that symptom score = average value*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in PSSD Itch Score at Week 16 Among Participants With a PSSD Itch Score >=4 at Baseline
Periodo de tiempo: Week 16
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 7-day 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 was defined as the closest measurement taken prior to or at time of first study drug administration date.
Week 16
Percentage of Participants Who Achieved PSSD Individual Symptom Scale Score=0 at Week 16 Among Participants With a PSSD Symptom Score >0 at Baseline
Periodo de tiempo: Week 16
The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. 7-day 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. Items were averaged on the weekly symptom score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value was converted into 0-100 scoring, such that symptom score = average value*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Periodo de tiempo: Group 1: Placebo: From Week 0 to Week 16; Group 1: Placebo followed by Guselkumab 100 mg: From Week 16 to Week 56; Group 2: Guselkumab 100 mg: From Week 0 to Week 56
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAE was defined as any event that occurred after the start of initial study agent administration and those AEs that were presented at baseline but worsened in severity after the start of initial study agent administration.
Group 1: Placebo: From Week 0 to Week 16; Group 1: Placebo followed by Guselkumab 100 mg: From Week 16 to Week 56; Group 2: Guselkumab 100 mg: From Week 0 to Week 56
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
Periodo de tiempo: Group 1: Placebo: From Week 0 to Week 16; Group 1: Placebo followed by Guselkumab 100 mg: From Week 16 to Week 56; Group 2: Guselkumab 100 mg: From Week 0 to Week 56
An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect. TEAE was defined as any event that occurred after the start of initial study agent administration and those AEs that were presented at baseline but worsened in severity after the start of initial study agent administration.
Group 1: Placebo: From Week 0 to Week 16; Group 1: Placebo followed by Guselkumab 100 mg: From Week 16 to Week 56; Group 2: Guselkumab 100 mg: From Week 0 to Week 56

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Janssen Research & Development, LLC

Investigadores

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

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)

24 de agosto de 2023

Finalización primaria (Actual)

14 de abril de 2025

Finalización del estudio (Actual)

14 de abril de 2025

Fechas de registro del estudio

Enviado por primera vez

9 de septiembre de 2023

Primero enviado que cumplió con los criterios de control de calidad

9 de septiembre de 2023

Publicado por primera vez (Actual)

15 de septiembre de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de mayo de 2026

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

10 de abril de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CR109328
  • CNTO1959PSO3017 (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. .

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