A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF therapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 208
- 试验地点
- 75
- 主要终点
- Part 1: Clinical remission (non-inferiority) at Week 24: CDAI < 150
研究概览
简要总结
Part 1: The objective is to compare the efficacy and safety of risankizumab versus ustekinumab over 48 weeks for the treatment of adult subjects with moderate to severe Crohn's Disease (CD) who have failed anti-TNF therapy.
Part 2: The objective is to evaluate the long-term safety of risankizumab up to 220 weeks in subjects who received risankizumab during Part 1 and have completed the Week 48 visit.
Continuous Treatment Extension (CTE) The objective of the Continuous Treatment Extension (CTE) is to provide Part 2 completers with continuous treatment of risankizumab with the aim to ensure uninterrupted care in accordance with local regulations until commercially available and/or the subject can access treatment locally or transition to a Continued Treatment for Trial Participants (CTTP) Open Label Extension (OLE) study. Additional objectives of the CTE are to continue to investigate and evaluate long-term safety data for risankizumab.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Part 2
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female aged ≥ 18 to ≤ 80 years of age at the Baseline visit. Confirmed diagnosis of Crohns disease (CD) for at least 3 months prior to Baseline.
- •Crohn's disease activity index (CDAI) score 220 – 450 at Baseline. Confirmed diagnosis of moderate to severe Crohns Disease as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic score for CD (SES-CD).
- •Demonstrated intolerance or inadequate response to one or more anti- TNF therapies
- •If female, subject must meet the contraception recommendations
排除标准
- •Subject with a current diagnosis of ulcerative colitis or indeterminate colitis.
- •Subjects with unstable doses of concomitant CD therapy
- •Receipt of CD approved biologic agents prior to baseline (as detailed in protocol), or any investigational biologic or other agent or procedure prior to Baseline (as detailed in protocol)
- •Subject with prior exposure to p19 and/or p40 inhibitors (e.g., risankizumab and ustekinumab).
- •Subject with complications of CD (strictures, short bowel, etc.)
结局指标
主要结局
Part 1: Clinical remission (non-inferiority) at Week 24: CDAI < 150
Part 1: Clinical remission (non-inferiority) at Week 24: CDAI < 150
Part 1: Endoscopic remission (superiority) at Week 48: defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤ 4 and at least a 2-point reduction versus Baseline and no sub score greater than 1 in any individual variable, as scored by a central reviewer
Part 1: Endoscopic remission (superiority) at Week 48: defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤ 4 and at least a 2-point reduction versus Baseline and no sub score greater than 1 in any individual variable, as scored by a central reviewer
Part 2: Evaluation of long-term safety
Part 2: Evaluation of long-term safety
次要结局
- Achievement of clinical remission (CDA < 150) at Week 48: superiority of risankizumab vs. ustekinumab.
- Achievement of endoscopic response at Week 48, superiority of risankizumab vs. ustekinumab
- Achievement of endoscopic response at Week 24, superiority of risankizumab vs. ustekinumab
- Achievement of steroid-free endoscopic remission Week 48, superiority of risankizumab vs. ustekinumab
- Achievement of steroid-free clinical remission at Week 48, superiority of risankizumab vs. ustekinumab.
研究者
Global Clinical Trials Helpdesk
Scientific
Abbvie Deutschland GmbH & Co. KG