NCT03518047已完成3 期
Risankizumab Versus Placebo in a Randomized, Double Blind, Parallel Group Trial in Moderate to Severe Plaque Psoriasis to Assess Safety and Efficacy After 16 Weeks of Treatment in the Russian Federation (IMMpress)
AbbVie6 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年7月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Proportion of participants with a 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of risankizumab compared to placebo in subjects with moderate to severe chronic plaque psoriasis in the Russian Federation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug.
- •Moderate to severe chronic plaque psoriasis at both Screening and Baseline (Randomization) Visits
- •Candidates for systemic therapy or phototherapy for psoriasis treatment as assessed by the investigator
排除标准
- •Prior therapy with an anti-interleukin (IL)-17 or anti-IL12/23p40 or anti-IL-23p19 inhibitor
- •Concurrent therapy with a biologic and/or other systemic therapy
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo for risankizumab by subcutaneous (SC) injection.
干预措施: placebo for rizankizumab (Drug)
Risankizumab
Experimental
Risankizumab by subcutaneous (SC) injection.
干预措施: risankizumab (Drug)
结局指标
主要结局
Proportion of participants with a 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16
时间窗: Week 16
The PASI score is an established measure of clinical efficacy for psoriasis medications.
次要结局
- Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16(Week 16)
- Proportion of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 16(Week 16)
- Proportion of participants with a 75% reduction from Baseline Psoriasis Area and Severity Index (PASI 75) at Week 16(Week 16)
- Proportion of participants with a 100% reduction from Baseline Psoriasis Area and Severity Index (PASI 100) at Week 16(Week 16)
研究者
研究点 (6)
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