A 48 Weeks, Phase II, Randomized, Double-blind, Placebo-controlled, Proof of Concept and Dose Finding Study of Three Different Dose Regimens of BI 655066 Administered Subcutaneously in Patients With Ankylosing Spondylitis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 159
- 主要终点
- Percentage of Patients Who Achieved Assessment of Spondyloarthritis International Society (ASAS) 40 Improvement Criteria at Week 12.
研究概览
简要总结
The overall purpose of the trial is to assess the clinical efficacy of three different subcutaneous doses of BI 655066 (risankizumab) in adult patients with AS, in order to provide clinical proof of concept and to select dose (s) for confirmatory 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 70 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
Placebo
Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
干预措施: placebo for risankizumab (Drug)
Risankizumab 18 mg
Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
干预措施: risankizumab (Drug)
Risankizumab 90 mg
Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
干预措施: risankizumab (Drug)
Risankizumab 180 mg
Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
干预措施: risankizumab (Drug)
结局指标
主要结局
Percentage of Patients Who Achieved Assessment of Spondyloarthritis International Society (ASAS) 40 Improvement Criteria at Week 12.
时间窗: Week 12
ASAS 40 evaluations are based on the following 4 components (also called domains) that include patient' self-assessments on a numerical rating scale (NRS) from 0 to 10 with higher numbers representing a worse disease status: * Global AS disease activity * Inflammation based on the mean of Bath AS Disease Activity Index (BASDAI) questions addressing the level of morning stiffness and duration * Spinal pain based on the mean of 2 questions * Physical function based on the Bath AS Functional Index (BASFI) The ASAS 40 response is defined as an improvement in 3 of 4 components and no worsening in the remaining component; an improvement is defined as a reduction from baseline of ≥40% and an absolute reduction of ≥2 units in each of the 3 components.
次要结局
- Change From Baseline to Week 12 in Disease Activity Assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS).(Baseline and Week 12)
- Percentage of Patients Who Achieved Partial Remission According to the ASAS Criteria at Week 12(Week 12)
- Percentage of Patients Who Achieved ASAS 5/6 Improvement Criteria at Week 12(Week 12)
- Percentage of Patients Who Achieved ASAS 20 Improvement Criteria at Week 12(Week 12)
- Change From Baseline to Week 12 in Disease Activity Assessed by BASDAI(Baseline and Week 12)
- Percentage of Patients Who Achieved ASAS 40 Improvement Criteria at Week 24(Week 24)