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

2015年3月17日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

43

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
药品：secukinumab 150mg
secukinumab 150mg (2 injections per dose)
实验性的：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.
药品：secukinumab 10mg/kg i.v. regimen
secukinumab 10mg/kg i.v. regimen

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
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
大体时间：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
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：End of study
This outcome measure was not analyzed due to the small sample size of the study (43 participants).
End of study

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Novartis Pharmaceuticals

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年12月1日

初级完成 (实际的)

2013年4月1日

研究完成 (实际的)

2013年4月1日

研究注册日期

首次提交

2011年8月5日

首先提交符合 QC 标准的

2011年8月8日

首次发布 (估计)

2011年8月9日

研究记录更新

最后更新发布 (估计)

2015年3月18日

上次提交的符合 QC 标准的更新

2015年3月17日

最后验证

2015年3月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

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

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