A Randomized, Double-blind, Placebo Controlled, Multicenter Dose Ranging Study of Subcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13
研究概览
简要总结
The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization
- •At randomization, moderate to severe psoriasis as defined by:
- •PASI score of 12 or greater and,
- •IGA score of 3 or greater and,
- •Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater At screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by topical treatment.
排除标准
- •Forms of psoriasis other than chronic plaque-type
- •Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at randomization
- •Previous exposure to AIN457
- •Ongoing use of prohibited psoriasis treatments / medications and other prohibited medication at randomization. Washout periods detailed in the protocol have to be adhered to
- •Known immunosuppression (e.g., AIDS) at screening and / or randomization
- •History or evidence of active tuberculosis at screening
- •Active systemic infections (other than common cold)
- •History or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years.
- •Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study
- •Any clinically significant abnormal laboratory tests at randomization, that in the judgment of the investigator prevents the patient from participating in the study
- •Inability or unwillingness to undergo repeated venipuntures
- •History or evidence of drug or alcohol abuse
- •Pregnant or nursing (lactating) women
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
AIN457 1x25mg
干预措施: AIN457 (Drug)
AIN457 3x25mg
干预措施: AIN457 (Drug)
AIN457 3x75mg
干预措施: AIN457 (Drug)
AIN457 3x150mg
干预措施: AIN457 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13
时间窗: week 13
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).
次要结局
- To Assess the Time to Relapse(37 weeks)
- Percentage of Participants With Investigator's Global Assessment (IGA) Response(Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37)
- Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)(Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37)