CTRI/2011/12/002201已完成3 期
A Randomized, Double-blind, Multicenter Study of Subcutaneous Secukinumab, Assessing Psoriasis Area and Severity Index (PASI) Response and Maintenance of Response in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis on Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen
Novartis Healthcare Pvt Ltd9 个研究点 分布在 1 个国家目标入组 918 人开始时间: 2011年12月20日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 918
- 试验地点
- 9
- 主要终点
- •Proportion of subjects who maintain Psoriasis Area and Severity Index 75 (PASI 75) response relative to baseline after having achieved PASI 75 response after 12 weeks of treatment with secukinumab
研究概览
简要总结
Brief Summary:
Purpose of the study: This study will assess the safety and efficacy of two different doses and two different dose regimens of subcutaneous secukinumab in patients that have moderate to severe, chronic, plaque-type psoriasis.
FPFV for India:20-Dec-2011
Enrollment Target for India:95
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.
- •Severity of disease meeting all of the following three criteria: PASI score of 12 or greater, Investigators Global Assessment (IGA) score of 3 or greater Total body surface area (BSA) affected of 10 percent or greater.
- •Inadequate control by prior use of topical treatment, phototherapy and or systemic therapy.
排除标准
- •Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
- •Current drug-induced psoriasis.
- •Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
- •Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject.
- •Hematological abnormalities.
- •History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
- •History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
- •Pregnant or nursing (lactating) women.
- •Other protocol-defined inclusion or exclusion criteria may apply.
结局指标
主要结局
•Proportion of subjects who maintain Psoriasis Area and Severity Index 75 (PASI 75) response relative to baseline after having achieved PASI 75 response after 12 weeks of treatment with secukinumab
时间窗: •Proportion of subjects who maintain Psoriasis Area and Severity Index 75 (PASI 75) response relative to baseline after having achieved PASI 75 response after 12 weeks of treatment with secukinumab
次要结局
- •Proportion of subjects who achieve PASI 50/75/90/100 response or Investigators Global Assessment (IGA) 0 or 1 response relative to baseline after 12 weeks and after 52 weeks of treatment with secukinumab(12 and 52 weeks)
研究者
研究点 (9)
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