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Estudo de guselcumabe versus placebo para o tratamento de psoríase em placas moderada com área de superfície corporal baixa (SPECTREM)

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

Um estudo de fase 3b, multicêntrico, randomizado, duplo-cego e controlado por placebo que avalia a segurança e a eficácia de guselcumabe versus placebo para o tratamento de psoríase em placas moderada de área de superfície corporal baixa (BSA) com envolvimento especial do local

O objetivo deste estudo é avaliar a eficácia deste guselcumabe em comparação com um medicamento inativo em participantes com psoríase em placas moderada de baixa área de superfície corporal e envolvimento de local especial.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

338

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • 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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  • Todos os participantes devem ter um diagnóstico de psoríase em placas (com ou sem artrite psoriática) durante pelo menos 6 meses antes da primeira administração da intervenção do estudo
  • Todos os participantes devem atender aos seguintes critérios de gravidade da doença na triagem e no início do estudo: (a) Avaliação Global do Investigador Geral (IGA) 3 (moderada) psoríase em placas; (b) Área de Superfície Corporal (BSA) 2-15 por cento (%) com pelo menos 1 placa fora de locais especiais; (c) Envolvimento de pelo menos 1 local especial com gravidade pelo menos moderada. Os locais qualificados incluem couro cabeludo com IGA específico do couro cabeludo maior ou igual a (>=) 3, rosto com psoríase facial IGA >=3, intertriginoso com psoríase intertriginosa IGA >=3, ou genital com avaliação global médica estática da genitália (sPGA- G) >=3
  • Todos os participantes sejam inadequadamente controlados ou intolerantes a pelo menos 1 terapia tópica anterior (incluindo, mas não limitado a, corticosteróides, retinóides, vitamina D ou vitamina D/esteróide e combinações de retinóide/esteróide, tacrolimus, pimecrolimus, antralina/ditranol, carvão preparações de alcatrão, tapinarof, roflumilaste, etc.) para o tratamento da psoríase tanto no rastreio
  • Todos os participantes serão candidatos à fototerapia ou tratamento sistêmico para psoríase

Critério de exclusão:

  • Tem uma forma de psoríase sem placas (por exemplo, eritrodérmica, gutata ou pustulosa) na triagem ou randomização
  • Tem psoríase induzida por medicamentos (por exemplo, um novo início de psoríase ou uma exacerbação da psoríase por betabloqueadores, bloqueadores dos canais de cálcio ou lítio)
  • Para participantes com envolvimento palmoplantar, diagnósticos confusos, incluindo, entre outros, pustulose palmoplantar, dermatite eczematosa, dermatite de contato/irritante, ceratodermia adquirida, etc., devem ser confirmados e excluídos
  • Os participantes não serão elegíveis se já tiverem recebido produtos biológicos (ou biossimilares) anteriores para o tratamento da psoríase, artrite psoriática (APs) ou quaisquer outras indicações que possam impactar a avaliação da psoríase. Produtos biológicos anteriores (ou biossimilares de) podem incluir, entre outros, inibidores do fator de necrose tumoral (TNF) (por exemplo: adalimumabe, etanercepte, infliximabe ou certolizumabe ou biossimilares), inibidores de interleucina (IL)-17 (por exemplo: secuquinumabe, ixequizumabe, brodalumabe ou bimequizumabe) e inibidores de IL-12/23 (por exemplo: ustekinumabe) ou inibidor de IL-23 (por exemplo: guselkumabe, risankizumabe ou tildrakizumabe)
  • Tem histórico de doença infecciosa crônica ou recorrente, incluindo, entre outros, infecção renal crônica, infecção torácica crônica (por exemplo, bronquiectasia), infecção recorrente do trato urinário (pielonefrite recorrente ou cistite crônica não remitente), infecção fúngica (mucocutânea). candidíase), ou feridas ou úlceras cutâneas abertas, drenantes ou infectadas

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Grupo 1: Guselcumabe
Os participantes receberão guselcumabe por injeção subcutânea com placebo conforme necessário para manter a cegueira.
Medicamento: Placebo
O placebo será administrado como injeção subcutânea.
Medicamento: Guselcumabe
Guselcumabe será administrado como injeção subcutânea.
Outros nomes:
  • Tremfya
  • CTO1959
Comparador de Placebo: Grupo 2: Placebo
Os participantes receberão placebo por injeção subcutânea e depois receberão guselcumabe por injeção subcutânea.
Medicamento: Placebo
O placebo será administrado como injeção subcutânea.
Medicamento: Guselcumabe
Guselcumabe será administrado como injeção subcutânea.
Outros nomes:
  • Tremfya
  • CTO1959

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
Prazo: Week 16
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percent Change From Baseline in Body Surface Area (BSA) at Week 16
Prazo: 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
Prazo: 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
Prazo: Week 16
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, 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
Prazo: 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
Prazo: Week 16
Percentage of participants who achieved PASI-100 score (100% improvement from baseline in PASI) at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved 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
Prazo: Week 16
The ss-IGA instrument was used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness which was scored as: absence of disease = 0, very mild disease = 1, mild disease = 2, moderate disease = 3, and severe disease = 4. A higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved 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
Prazo: Week 16
The sPGA-G was a 6-point scale to assess the severity of genital psoriasis at a given time point. The sPGA-G evaluates erythema, plaque elevation, and scale of genital psoriatic lesions. The severity of genital psoriasis was assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5). Higher score indicates more severity. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Janssen Research & Development, LLC

Investigadores

  • Diretor de estudo: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

24 de agosto de 2023

Conclusão Primária (Real)

14 de abril de 2025

Conclusão do estudo (Real)

14 de abril de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

9 de setembro de 2023

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de setembro de 2023

Primeira postagem (Real)

15 de setembro de 2023

Atualizações de registro de estudo

Última Atualização Postada (Real)

1 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de abril de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CR109328
  • CNTO1959PSO3017 (Outro identificador: Janssen Research & Development, LLC)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

A política de partilha de dados das Janssen Pharmaceutical Companies da Johnson & Johnson está disponível em www.janssen.com/clinical-trials/transparency. Conforme observado neste site, as solicitações de acesso aos dados do estudo podem ser enviadas através do site do Projeto Yale Open Data Access (YODA) em yoda.yale.edu

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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