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Um estudo de extensão de longo prazo de JNJ-77242113 em participantes com psoríase em placas moderada a grave (FRONTIER 2)

29 de maio de 2026 atualizado por: Janssen Research & Development, LLC

Um estudo multicêntrico de fase 2b, extensão de longo prazo e variação de dose para avaliar a eficácia e a segurança do JNJ-77242113 para o tratamento da psoríase em placas moderada a grave

O objetivo deste estudo é avaliar a resposta clínica a longo prazo do tratamento com JNJ-77242113 em participantes com psoríase em placas moderada a grave.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

A população de pessoas que vivem com psoríase moderada a grave é de aproximadamente 3,5 bilhões, sendo a maioria tratada com terapias tópicas e convencionais. O JNJ-77242113, medicamento experimental, visa as respostas imunes no corpo e na pele que afetam doenças, como a psoríase, e este estudo avalia o JNJ-77242113 como opções de terapias avançadas na psoríase em placas moderada a grave. Este é um estudo de extensão de longo prazo de JNJ-77242113 em participantes elegíveis que concluíram a visita da semana 16 do estudo original 77242113PSO2001. A duração total deste estudo será de até 40 semanas, que incluirá um período de tratamento de 36 semanas e um período de acompanhamento de segurança de 4 semanas após a administração da última intervenção do estudo. A segurança será avaliada por eventos adversos (EAs), avaliações laboratoriais de segurança clínica, eletrocardiogramas (ECGs), sinais vitais e exames físicos.

Tipo de estudo

Intervencional

Inscrição (Real)

227

Estágio

  • Fase 2

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

  • Alemanha
      • Bad Bentheim, Alemanha, 48455
        • Fachklinik Bad Bentheim
      • Berlin, Alemanha, 10789
        • ISA - Interdisciplinary Study Association GmbH
      • Berlin, Alemanha, 13627
        • CRS Clinical Research Services Berlin GMBH
      • Bochum, Alemanha, 44793
        • Niesmann & Othlinghaus GbR
      • Darmstadt, Alemanha, 64283
        • Rosenpark Research GmbH
      • Frankfurt am Main, Alemanha, 60590
        • Universitätsklinikum Frankfurt
      • Friedrichshafen, Alemanha, 88045
        • Derma-Study-Center Friedrichshafen GmbH
      • Hamburg, Alemanha, 22391
        • MensingDerma Research GmbH
      • Heidelberg, Alemanha, 69120
        • Universitaetsklinikum Heidelberg
      • Kiel, Alemanha, 24105
        • Universitatsklinikum Schleswig Holstein Kiel
      • Mahlow, Alemanha, 15831
        • Gemeinschaftspraxis Scholz/Sebastian/Schilling
      • Witten, Alemanha, 58453
        • Hautarztpraxis
  • Canadá
    • Ontario
      • Hamilton, Ontario, Canadá, L8N 1Y2
        • Dermatrials Research
      • Waterloo, Ontario, Canadá, N2J 1C4
        • Alliance Clinical Trials
      • Windsor, Ontario, Canadá, N8T 1E6
        • XLR8 Medical Research
    • Quebec
      • Montreal, Quebec, Canadá, H2H2B5
        • Innovaderm Research Inc.
  • Coréia do Sul
      • Busan, Coréia do Sul, 49241
        • Pusan National University Hospital
      • Gyeonggi-do, Coréia do Sul, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Coréia do Sul, 03080
        • Seoul National University Hospital
      • Seoul, Coréia do Sul, 05030
        • Konkuk University Medical Center
      • Seoul, Coréia do Sul, 102-1703
        • KyungHee University Hospital
  • Espanha
      • Barcelona, Espanha, 08916
        • Hosp. Univ. Germans Trias I Pujol
      • Madrid, Espanha, 28041
        • Hosp. Univ. 12 de Octubre
      • Valencia, Espanha, 46940
        • Hosp. de Manises
      • Valencia, Espanha, 46026
        • Hosp. Univ. I Politecni La Fe
  • Estados Unidos
    • California
      • Sacramento, California, Estados Unidos, 95815
        • Pacific Skin Institute
    • Florida
      • Ocala, Florida, Estados Unidos, 34470
        • Renstar Medical Research
      • Tampa, Florida, Estados Unidos, 33613
        • Forcare Clinical Research Inc
    • Illinois
      • Rolling Meadows, Illinois, Estados Unidos, 60008
        • Arlington Dermatology
    • Indiana
      • Plainfield, Indiana, Estados Unidos, 46168
        • Indiana Clinical Trial Center
    • Michigan
      • Fort Gratiot, Michigan, Estados Unidos, 48059
        • Hamzavi Dermatology
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89119
        • Vivida Dermatology
    • New Jersey
      • East Windsor, New Jersey, Estados Unidos, 08520
        • Windsor Dermatology, PC
    • Oregon
      • Portland, Oregon, Estados Unidos, 97210
        • Oregon Dermatology and Research Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • University of Pittsburgh Department of Dermatology
    • Texas
      • Dallas, Texas, Estados Unidos, 75231
        • Modern Research Associates
      • Houston, Texas, Estados Unidos, 77004
        • Center for Clinical Studies
      • Webster, Texas, Estados Unidos, 77598
        • Center for Clinical Studies
    • Washington
      • Spokane, Washington, Estados Unidos, 99202
        • Premier Clinical Research
  • França
      • Le Mans, França, 72037
        • Centre Hospitalier Le Mans
      • Rouen, França, 76031
        • Hôpital Charles Nicolle
      • Toulon, França, 83800
        • Hia Sainte Anne
  • Japão
      • Obihiro-shi, Japão, 080-0013
        • Takagi Dermatological Clinic
      • Sakai, Japão, 593 8324
        • Kume Clinic
      • Sapporo, Japão, 060-0063
        • Sapporo Skin Clinic
      • Shizuoka, Japão, 420-8527
        • Shizuoka General Hospital
      • Takaoka, Japão, 933-0871
        • Shirasaki dermatology clinic
      • Toyama, Japão, 930 8550
        • Toyama Prefectural Central Hospital
      • Yokohama, Japão, 221 0825
        • Nomura Dermatology Clinic
  • Polônia
      • Bialystok, Polônia, 15-351
        • Nzoz Zdrowie Osteo-Medic
      • Lodz, Polônia, 90-265
        • Dermed Centrum Medyczne Sp z o o
      • Osielsko, Polônia, 86031
        • Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C
      • Warsaw, Polônia, 02-953
        • Klinika Ambroziak Estederm Sp. z o.o
      • Wroclaw, Polônia, 51-685
        • Wro Medica
  • Reino Unido
      • London, Reino Unido, SE1 9RT
        • Guys and St Thomas NHS Foundation Trust
      • Southampton, Reino Unido, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust
  • Taiwan
      • Kaohsiung City, Taiwan, 83342
        • Chang Gung Memorial Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 333
        • Chang-Gung Memorial Hospital, LinKou Branch

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

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  • Deve ter concluído a visita da Semana 16 no Protocolo 77242113PSO2001
  • Na opinião do investigador, pode se beneficiar da inclusão neste estudo de extensão de longo prazo (LTE)
  • Deve concordar em evitar a exposição prolongada ao sol e evitar o uso de cabines de bronzeamento ou outras fontes de luz ultravioleta durante o estudo
  • Deve concordar em descontinuar todas as terapias tópicas que possam afetar a psoríase ou o índice de gravidade da área da psoríase (PASI) ou a avaliação global do investigador (IGA), exceto xampus emolientes não medicinais e ácido salicílico, antes da primeira administração da intervenção do estudo
  • Concordar em não receber um vírus vivo ou vacinação bacteriana viva durante o estudo ou dentro de 4 semanas após a última administração da intervenção do estudo

Critério de exclusão:

  • Foi permanentemente descontinuado da intervenção do estudo no Protocolo 77242113PSO2001 por qualquer motivo
  • Recebeu qualquer terapia biológica ou terapia experimental desde a conclusão do estudo de origem, 77242113PSO2001
  • Recebeu qualquer vírus vivo ou vacinação bacteriana dentro de 12 semanas antes da primeira administração da intervenção do estudo
  • Recebeu a vacina bacilo Calmette-Guerin (BCG) dentro de 12 meses após a primeira administração da intervenção do estudo
  • Atualmente tem antígeno de superfície da hepatite B (HBsAg) ou anticorpo da hepatite C (anti-HCV) positivo, ou tem outra doença hepática clinicamente ativa, ou testes positivos para HBsAg ou anti-HCV

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: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Grupo 1: JNJ-77242113 Dose 1 uma vez ao dia (QD)
Os participantes originalmente randomizados para JNJ-77242113 Dose 1 QD no estudo original 77242113PSO2001 continuarão a receber JNJ-77242113 Dose 1 QD da Semana 0 até a Semana 36 neste estudo.
Medicamento: JNJ-77242113
O comprimido JNJ-77242113 será administrado por via oral.
Experimental: Grupo 2: JNJ-77242113 Dose 2 QD
Os participantes originalmente randomizados para JNJ-77242113 Dose 2 QD no estudo original 77242113PSO2001 continuarão a receber JNJ-77242113 Dose 2 QD da Semana 0 até a Semana 36 neste estudo.
Medicamento: JNJ-77242113
O comprimido JNJ-77242113 será administrado por via oral.
Experimental: Grupo 3: JNJ-77242113 Dose 3 QD
Os participantes originalmente randomizados para JNJ-77242113 Dose 3 QD no estudo original 77242113PSO2001 continuarão a receber JNJ-77242113 Dose 3 QD da Semana 0 até a Semana 36 neste estudo.
Medicamento: JNJ-77242113
O comprimido JNJ-77242113 será administrado por via oral.
Experimental: Grupo 4: JNJ-77242113 Dose 1 duas vezes ao dia (BID)
Os participantes originalmente randomizados para JNJ-77242113 Dose 1 BID no estudo original 77242113PSO2001 continuarão a receber JNJ-77242113 Dose 1 BID da Semana 0 até a Semana 36 neste estudo.
Medicamento: JNJ-77242113
O comprimido JNJ-77242113 será administrado por via oral.
Experimental: Grupo 5: JNJ-77242113 Dose 3 BID
Os participantes originalmente randomizados para JNJ-77242113 Dose 3 BID no estudo original 77242113PSO2001 continuarão a receber JNJ-77242113 Dose 3 BID da Semana 0 até a Semana 36 neste estudo.
Medicamento: JNJ-77242113
O comprimido JNJ-77242113 será administrado por via oral.
Experimental: Grupo 6: JNJ-77242113 Dose 3 QD
Os participantes originalmente randomizados para placebo no Estudo originário 77242113PSO2001 receberão JNJ-77242113 Dose 3 QD da Semana 0 até a Semana 36 neste estudo.
Medicamento: JNJ-77242113
O comprimido JNJ-77242113 será administrado por via oral.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 75 Percent (%) Improvement From Baseline in Psoriasis Area Severity Index Score (PASI-75) at LTE Week 36
Prazo: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of participants who achieved >=75% improvement from baseline in PASI score at LTE Week 36 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, 4=very severe) and extent of involvement from 0 (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 more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants Who Achieved at Least 90% Improvement From Baseline in PASI Score (PASI-90) at LTE Week 36
Prazo: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of participants who achieved >=90% improvement from baseline in PASI score at LTE Week 36 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In 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, 4=very severe) and extent of involvement from 0 (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 more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of Participants Who Achieved 100% Improvement From Baseline in PASI Score (PASI-100) at LTE Week 36
Prazo: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of participants who achieved 100% improvement from baseline in PASI score at LTE Week 36 was reported. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: 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 (no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range on a scale of 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Change From Baseline in PASI Total Score at LTE Week 36
Prazo: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Change from baseline in PASI total score at LTE Week 36 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 first study drug administration date in 77242113PSO2001 study.
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at LTE Week 36
Prazo: At LTE Week 36 (52 weeks from originating study baseline)
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). A higher score indicated more severe disease.
At LTE Week 36 (52 weeks from originating study baseline)
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at LTE Week 36
Prazo: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Change from baseline in PSSD symptoms scores at LTE Week 36 was reported. PSSD was a patient-reported outcome (PRO) questionnaire designed to measure severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD: 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 scales for severity. Items were averaged on the daily 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. Baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Change From Baseline in PSSD Signs Score at LTE Week 36
Prazo: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Change from baseline in PSSD sign scores at LTE Week 36 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 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 daily sign score when at least 3 items (>=50 percentage of 6 items) on these scales were answered. The average value was converted into 0-100 scoring, such that sign 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 first study drug administration date in 77242113PSO2001 study.
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of Participants Who Achieved PSSD Symptoms Score Equal (=) 0 at LTE Week 36 Among Participants With a Baseline (Week 0 of the Originating Study) Symptoms Score >=1
Prazo: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. 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 daily symptom score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is 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 first study drug administration date in 77242113PSO2001 study.
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of Participants Achieving PSSD Signs Score=0 at Week 36 Among Participants With a Baseline (Week 0 of the Originating Study) Signs Score >=1
Prazo: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. 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 daily sign score when at least 3 items (>=50 percentage of 6 items) on these scales are answered. The average value is converted into 0-100 scoring, such that sign 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 first study drug administration date in 77242113PSO2001 study.
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Prazo: From LTE Week 0 up to LTE Week 40
An adverse event (AE) was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. A 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 AE that occurred after receiving the treatment in originating study (77242113PSO2001). TEAEs and TESAEs that occurred during this study are reported.
From LTE Week 0 up to LTE Week 40

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

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)

10 de junho de 2022

Conclusão Primária (Real)

29 de setembro de 2023

Conclusão do estudo (Real)

29 de setembro de 2023

Datas de inscrição no estudo

Enviado pela primeira vez

3 de maio de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de maio de 2022

Primeira postagem (Real)

6 de maio de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

1 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CR109155
  • 2021-004320-16 (Número EudraCT)
  • 77242113PSO2002 (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 compartilhamento de dados da Janssen Pharmaceutical Companies of 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 por meio 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

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Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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