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Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis (STATURE)

17 de março de 2015 atualizado por: Novartis Pharmaceuticals

A Randomized, Double-blind, Double Dummy, Multicenter Study to Assess the Safety, Tolerability and Long-term Efficacy of Intravenous (10mg/kg) and Subcutaneous (300mg) Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Who Are Partial Responders to Secukinumab

The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

43

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

  • Alemanha
      • Essen, Alemanha, 45147
        • Novartis Investigative Site
      • Frankfurt, Alemanha, 60590
        • Novartis Investigative Site
      • Hamburg, Alemanha, 22143
        • Novartis Investigative Site
      • Luebeck, Alemanha, 23538
        • Novartis Investigative Site
      • Mainz, Alemanha, 55131
        • Novartis Investigative Site
  • Canadá
    • Ontario
      • Barrie, Ontario, Canadá, L4M 6L2
        • Novartis Investigative Site
      • Waterloo, Ontario, Canadá, N2J 1C4
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canadá, H2K 4L5
        • Novartis Investigative Site
  • Eslováquia
    • Slovak Republic
      • Kosice, Slovak Republic, Eslováquia, 040 15
        • Novartis Investigative Site
  • Estados Unidos
    • Florida
      • Jacksonville, Florida, Estados Unidos, 32216
        • Novartis Investigative Site
      • West Palm Beach, Florida, Estados Unidos, 33409
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02111
        • Novartis Investigative Site
    • Missouri
      • St. Louis, Missouri, Estados Unidos, 63117
        • Novartis Investigative Site
    • North Carolina
      • Greensboro, North Carolina, Estados Unidos, 27401
        • Novartis Investigative Site
    • South Carolina
      • Greer, South Carolina, Estados Unidos, 29651
        • Novartis Investigative Site
  • França
      • Rouen, França, 76031
        • Novartis Investigative Site
      • Toulouse Cedex, França, 31059
        • Novartis Investigative Site
  • Japão
    • Chiba
      • Kisarazu, Chiba, Japão, 292-8535
        • Novartis Investigative Site
    • Tokyo
      • Hachioji-city, Tokyo, Japão, 193-0998
        • Novartis Investigative Site
      • Minato-ku, Tokyo, Japão, 105-8471
        • Novartis Investigative Site
      • Shinjuku-ku, Tokyo, Japão, 160-0023
        • Novartis Investigative Site
  • Áustria
      • Graz, Áustria, A-8036
        • Novartis Investigative Site
      • Vienna, Áustria, A-1220
        • Novartis Investigative Site
      • Wels, Áustria, 4600
        • Novartis Investigative Site
  • Índia
    • Karnataka
      • Mangalore, Karnataka, Índia, 575 004
        • Novartis Investigative Site
    • Maharashtra
      • Nagpur, Maharashtra, Índia, 440 010
        • Novartis Investigative Site
      • Nashik, Maharashtra, Índia, 422 001
        • Novartis Investigative Site

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

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion criteria:

  • Written Informed Consent must be obtained before any assessment is performed,
  • Subject must be able to understand and communicate with the investigator and comply with the requirements of the study.
  • Subjects must have participated in the study CAIN457A2304 and have achieved a partial response after twelve weeks of treatment with no major protocol deviations.

A partial response is defined as having achieved ≥ PASI 50 but < 75 response.

Exclusion criteria

  • Pregnant women or lactating women
  • Forms of psoriasis other than chronic plaque -type
  • Ongoing use of prohibited psoriasis treatments
  • Ongoing use of other non-psoriasis prohibited treatments
  • Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor, except secukinumab in study CAIN457A2304
  • Active ongoing inflammation diseases other than psoriasis that might confound the evaluation of the benefits of secukinumab therapy
  • UV therapy or excessive exposure to sunlight

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: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: AIN457 subcutaneous (s.c.)
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
Medicamento: secukinumab 150mg
secukinumab 150mg (2 injections per dose)
Experimental: AIN457 I.V.
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
Medicamento: secukinumab 10mg/kg i.v. regimen
secukinumab 10mg/kg i.v. regimen

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in Psoriasis Area and Severity Index (PASI) After 12 Weeks of Treatment in Study AIN457A2304) With 75% Improvement From Baseline in PASI
Prazo: Week 8
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Week 8
Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in PASI After 12 Weeks of Treatment in Study AIN457A2304) With Investigator's Global Assessment Model 2011 (IGA Mod 2011) 0 or 1 Response
Prazo: Week 8
The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
Week 8

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Prazo: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
Mean Percent Change From Baseline in PASI Scores
Prazo: Baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.
Baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
Percentage of Participants in Each IGA Mod 2011 Score Category
Prazo: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1
Prazo: Baseline, Week 8, Week 16, Week 24, Week 32,up to Week 40
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A DLQI of 0 or 1 indicates no impairment or little impairment, respectively. A negative mean percentage change from baseline indicates improvement.
Baseline, Week 8, Week 16, Week 24, Week 32,up to Week 40
Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores
Prazo: Baseline, weeks 8, 16, 24, 32 and 40
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Baseline, weeks 8, 16, 24, 32 and 40
Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100)
Prazo: Baseline, weeks 8, 16, 24, 32 and 40
The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.
Baseline, weeks 8, 16, 24, 32 and 40
Number of Participants Who Developed Anti-secukinumab Antibodies
Prazo: Baseline, weeks 12, 24 and 40
The development of anti-secunimubab anti-bodies would decrease a participant's ability to respond to secukinumab treatment.
Baseline, weeks 12, 24 and 40
Relationship Between Response to AIN457 and Failed Response to Previous Biologic Psoriasis Therapy
Prazo: End of study
This outcome measure was not analyzed due to the small sample size of the study (43 participants).
End of study

Colaboradores e Investigadores

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

Patrocinador

Novartis Pharmaceuticals

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

1 de dezembro de 2011

Conclusão Primária (Real)

1 de abril de 2013

Conclusão do estudo (Real)

1 de abril de 2013

Datas de inscrição no estudo

Enviado pela primeira vez

5 de agosto de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de agosto de 2011

Primeira postagem (Estimativa)

9 de agosto de 2011

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

18 de março de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de março de 2015

Última verificação

1 de março de 2015

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CAIN457A2307
  • 2011-002510-36 (Número EudraCT)

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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