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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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

43

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Florida
      • Jacksonville、Florida、アメリカ、32216
        • Novartis Investigative Site
      • West Palm Beach、Florida、アメリカ、33409
        • Novartis Investigative Site
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02111
        • Novartis Investigative Site
    • Missouri
      • St. Louis、Missouri、アメリカ、63117
        • Novartis Investigative Site
    • North Carolina
      • Greensboro、North Carolina、アメリカ、27401
        • Novartis Investigative Site
    • South Carolina
      • Greer、South Carolina、アメリカ、29651
        • Novartis Investigative Site
  • インド
    • Karnataka
      • Mangalore、Karnataka、インド、575 004
        • Novartis Investigative Site
    • Maharashtra
      • Nagpur、Maharashtra、インド、440 010
        • Novartis Investigative Site
      • Nashik、Maharashtra、インド、422 001
        • Novartis Investigative Site
  • オーストリア
      • Graz、オーストリア、A-8036
        • Novartis Investigative Site
      • Vienna、オーストリア、A-1220
        • Novartis Investigative Site
      • Wels、オーストリア、4600
        • Novartis Investigative Site
  • カナダ
    • Ontario
      • Barrie、Ontario、カナダ、L4M 6L2
        • Novartis Investigative Site
      • Waterloo、Ontario、カナダ、N2J 1C4
        • Novartis Investigative Site
    • Quebec
      • Montreal、Quebec、カナダ、H2K 4L5
        • Novartis Investigative Site
  • スロバキア
    • Slovak Republic
      • Kosice、Slovak Republic、スロバキア、040 15
        • Novartis Investigative Site
  • ドイツ
      • Essen、ドイツ、45147
        • Novartis Investigative Site
      • Frankfurt、ドイツ、60590
        • Novartis Investigative Site
      • Hamburg、ドイツ、22143
        • Novartis Investigative Site
      • Luebeck、ドイツ、23538
        • Novartis Investigative Site
      • Mainz、ドイツ、55131
        • Novartis Investigative Site
  • フランス
      • Rouen、フランス、76031
        • Novartis Investigative Site
      • Toulouse Cedex、フランス、31059
        • 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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：secukinumab 150mg
secukinumab 150mg (2 injections per dose)
実験的：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.
薬：secukinumab 10mg/kg i.v. regimen
secukinumab 10mg/kg i.v. regimen

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：End of study
This outcome measure was not analyzed due to the small sample size of the study (43 participants).
End of study

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Novartis Pharmaceuticals

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2011年12月1日

一次修了 (実際)

2013年4月1日

研究の完了 (実際)

2013年4月1日

試験登録日

最初に提出

2011年8月5日

QC基準を満たした最初の提出物

2011年8月8日

最初の投稿 (見積もり)

2011年8月9日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年3月18日

QC基準を満たした最後の更新が送信されました

2015年3月17日

最終確認日

2015年3月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

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

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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