Phase II Single Dose, Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Study to Assess the Efficacy of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
研究概览
简要总结
This is an exploratory, 4 arm, parallel group, placebo-controlled study comparing three doses of AIN457 to placebo. Subjects with a diagnosis of moderate to severe chronic plaque psoriasis will be randomized to receive either AIN457 at one of the three doses studied or 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criterion:
- •Coverage of the body surface area (BSA) of 10% or more with plaques
- •A score of 3 or more on the IGA (Investigator Global Assessment) scale
- •A PASI score of at least 12 at baseline;
排除标准
- •Have forms of psoriasis other than the required "plaque psoriasis"
- •Women of childbearing potential
- •Recent use of investigational drugs or treatment with other biological therapies (wash-out periods required)
- •Previous treatment with this investigational drug
- •Subjects with active or history of clinically significant cardiac, kidney or liver abnormalities
- •Other protocol-defined inclusion/exclusion criteria may have applied.
研究组 & 干预措施
AIN457 0.3 mg/kg
Participants received AIN457 0.3 mg/kg IV on Day 1.
干预措施: AIN457 (Biological)
AIN457 3.0 mg/kg
Participants received AIN457 3.0 mg/kg IV on Day 1.
干预措施: AIN457 (Biological)
Placebo
Participants received placebo to AIN457A IV on day 1.
干预措施: Placebo (Biological)
AIN457 1.0 mg/kg
Participants received AIN457 1.0 mg/kg IV on Day 1.
干预措施: AIN457 (Biological)
结局指标
主要结局
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
时间窗: baseline, week 4
This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.
次要结局
- Investigator Global Assessment (IGA) Scores(baseline, day 1, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32)
- Change From Baseline in PASI(baseline, weeks 12, 14, 16, 20, 24, 28 and 32)