A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 198
- 主要终点
- Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
研究概览
简要总结
The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12.
详细描述
The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12. Subjects were randomized ina 1:1:1:1:1 ratio. Subjects randomized to receive AMG 827 received 70, 140, or 210 mg at day 1 and weeks 4 and 8.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has had stable moderate to severe plaque psoriasis for at least 6 months
- •Subject has received at least one previous phototherapy or systemic psoriasis therapy or has been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator.
- •Subject has involved BSA ≥ 10% and PASI ≥ 12 at screening and at baseline.
排除标准
- •Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication-exacerbated psoriasis.
- •Evidence of skin conditions at the time of the screening visit (eg, eczema, guttate psoriasis) that would interfere with evaluations of the effect of IP on psoriasis.
- •Subject has any active CTCAE grade 2 or higher infection
- •Subject has a significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol.
- •Subject has used the following therapies within 14 days of the first dose: UVB therapy or topical psoriasis therapies other than Class I or II topical steroids
- •Subject has used the following therapies within 28 days of the first dose: Class I or II topical steroids, UVA therapy (with or without psoralen), or systemic psoriasis therapies
- •Subject has used the following therapies within 3 months of the first dose: adalimumab, alefacept, etanercept, infliximab, certolizumab, or live vaccines
- •Subject has used an anti-IL12/IL23 inhibitor within 6 months of the first dose
- •Subject has previously used an anti-IL17 biologic therapy, efalizumab, or rituximab
研究组 & 干预措施
140 mg SC
140 mg SC
干预措施: 140 mg SC (Drug)
70 mg SC
70 mg SC
干预措施: 70 mg SC (Drug)
280 mg SC
280 mg SC
干预措施: 280 mg SC (Drug)
210 mg SC
210 mg SC
干预措施: 210 mg SC (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
时间窗: Baseline and 12 weeks
At screening a subject would need to have a PASI score of equal to or greater than 12, so at week 12 they were assessed to see percentage of change from there baseline PASI score.
次要结局
- Change in Percent of Body Surface Area (BSA) Affected by Psoriasis(Baseline and Week 12)