A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Risankizumab Subcutaneous Induction Treatment in Subjects with Moderately to Severely Active Crohn’s Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 31
- 试验地点
- 10
- 主要终点
- Achievement of CDAI clinical remission (defined as CDAI < 150) at Week 12
研究概览
简要总结
To assess the efficacy, safety, and tolerability of RZB SC induction treatment in comparison with placebo in subjects with moderately to severely active CD.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Period C
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Male or Female adult individuals, at least 18 years old (subjects must also meet the legal age of majority per local law) at the baseline visit.
- •Confirmed diagnosis of CD for at least 3 months prior to Baseline.
- •Moderately to severely active CD meeting the following disease activity criteria: -CDAI 220 to 450 at Baseline - Endoscopic evidence of mucosal inflammation as documented by a SES-CD of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are confirmed by a blinded central reader.
- •Demonstrated intolerance or inadequate response to conventional and/or advanced therapies (biologics or targeted small molecules approved for CD)
- •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 Crohn's disease therapy
- •Receipt of Crohn's disease approved biologic agent or advanced therapeutic agent, or any investigational drug within the period prior to Baseline as detailed in the protocol
- •Subjects with complications of CD (abscess, ostomy, ileoanal pouch, short bowel syndrome, etc. as detailed in the protocol
- •Prior exposure to p19 inhibitors (e.g.,risankizumab
结局指标
主要结局
Achievement of CDAI clinical remission (defined as CDAI < 150) at Week 12
Achievement of CDAI clinical remission (defined as CDAI < 150) at Week 12
Achievement of endoscopic response (defined as decrease in SES-CD > 50% from baseline or for subjects with isolated ileal disease and a baseline SES-CD of 4, at least a 2-point reduction from baseline, as scored by blinded central reviewer) at Week 12
Achievement of endoscopic response (defined as decrease in SES-CD > 50% from baseline or for subjects with isolated ileal disease and a baseline SES-CD of 4, at least a 2-point reduction from baseline, as scored by blinded central reviewer) at Week 12
次要结局
- Achievement of SF/APS Clinical remission (defined as average daily SF ≤ 2.8 and not worse than Baseline AND average daily AP score ≤ 1 and not worse than Baseline) at Week 12
- Achievement of endoscopic remission (defined as SES-CD ≤ 4 and at least a 2-point reduction versus Baseline and no subscore greater than 1 in any individual variable, as scored by a blinded central reviewer) at Week 12
- Achievement of ulcer-free endoscopy (defined as SES-CD ulcerated surface subscore of 0 in subjects with SESCD ulcerated surface subscore ≥ 1 at Baseline, as scored by a blinded central reviewer) at Week 12
- Change from Baseline in FACIT-Fatigue at Week 12
- Achievement of CR-100 CDAI clinical response (defined as at least a 100-point reduction from Baseline in CDAI) at Week 4
研究者
Global Clinical Trials Contact
Scientific
AbbVie Deutschland GmbH & Co. KG