NCT02054481已完成2 期
A 48 Weeks Study of Three Different Dose Regimens of BI 655066 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque Psoriasis (Randomised, Dose-ranging, Active-comparator-controlled (Ustekinumab), Double-blind Within Dose Groups of BI 655066)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 32
- 主要终点
- Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12
研究概览
简要总结
The overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of BI 655066 in adult patients with chronic plaque psoriasis in order to select doses for further clinical trials.
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
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 1
Experimental
BI 655066 s.c.
干预措施: BI 655066 (Drug)
Arm 2
Experimental
BI 655066 s.c.
干预措施: BI 655066 (Drug)
Arm 3
Experimental
BI 655066 s.c.
干预措施: BI 655066 (Drug)
Arm 4
Active Comparator
Ustekinumab s.c.
干预措施: Ustekinumab (Drug)
结局指标
主要结局
Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12
时间窗: Baseline and Week 12
Percentage of participants who achieved ≥90% reduction from baseline in Psoriasis Area and Severity Index score (PASI90) at Week 12. PASI score ranges from 0 (best) to 72 (worst).
次要结局
- Achievement of ≥50% Reduction From Baseline in PASI Score (PASI50) at Week 12(Baseline and Week 12)
- Achievement of 100% Reduction From Baseline in PASI Score (PASI100) at Week 12(Baseline and Week 12)
- Achievement of sPGA Clear or Almost Clear at Week 12(Week 12)
- Time to Loss of PASI50 Response(From first drug administration until end of follow-up period, up to 48 weeks)
- Achievement of PASI90 at Week 24(Week 24)
- Percentage Change in PASI Score From Baseline at Week 12(Baseline and Week 12)
- Achievement of ≥75% Reduction From Baseline in PASI Score (PASI75) at Weeks 12 and 24(Baseline, Week 12 and Week 24)
研究者
研究点 (32)
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