Phase II Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Multiple-loading Dose Regimen Study to Assess the Safety, Efficacy and Duration of Response 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
- 130
- 主要终点
- Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
研究概览
简要总结
Loading dose, four arm, double-blind, parallel group, placebo-controlled study comparing single and multiple doses of AIN457 to placebo in patients with a diagnosis of moderate to severe chronic plaque psoriasis.
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 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 apply
研究组 & 干预措施
Placebo
Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
干预措施: Placebo (Drug)
AIN457 3 mg/kg
Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
干预措施: AIN457 (Drug)
AIN457 3 mg/kg
Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
干预措施: Placebo (Drug)
AIN457 10 mg/kg
Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
干预措施: AIN457 (Drug)
AIN457 10 mg/kg
Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
干预措施: Placebo (Drug)
AIN457 10 mg/kg x3
Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
干预措施: AIN457 (Drug)
结局指标
主要结局
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
时间窗: Baseline, Week 12
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).
Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
时间窗: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56
This outcome measure shows the proportion of participants in each of the AIN457 treatment groups who were relapse free throughout the study up to and including week 56.
次要结局
- Percentage of Participants in Each Investigator Global Assessment (IGA) Category(Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56))
- Percentage of Participants With at Least 50% Improvement From Baseline in PASI(Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, end of study (EOS) (up to week 56))
- Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI(Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56))