Phase 2 Study to Investigate the Efficacy, Safety, and Tolerability of Six Weeks Treatment With V565 in Subjects With Active Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 94
- 主要终点
- Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of V565 in participants with active Crohn's Disease (CD).
详细描述
This study will be a multiple-site, double-blind, placebo-controlled, parallel-group study in approximately 126 subjects with a confirmed diagnosis of CD for at least three months and have CD involving the ileum and/or colon. Following a screening period of up to 28 days, subjects will be randomly allocated into one of two treatment arms: either V565 or placebo using a 2:1 active:placebo ratio for a treatment period of 6 weeks.
Subjects will be treated with study drug as an add-on to any permitted stable medications already being taken for CD.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of Crohn's Disease of at least 3 months duration prior to screening
- •Crohn's Disease Activity Index (CDAI) score of ≥220 to ≤450 during screening
- •C-reactive protein (CRP) ≥5 mg/L (or, if CRP is normal, faecal calprotectin (FCP) ≥250 µg/g) at screening
- •Permitted CD medication regimen expected to remain stable during the period of the study
排除标准
- •Previous lack of response or current contra-indication to an anti-tumour necrosis factor α (anti-TNFα) agent
- •Certain complications of Crohn's Disease that would make it hard to assess response to study drug
- •Known history or suspicion of inflammatory bowel disease other than Crohn's disease
- •History of tuberculosis (TB) or latent TB infection that has not been treated
- •Any significant illness or condition which would preclude effective participation in the study
- •GI infection as demonstrated by presence of enteric pathogens
- •Pregnant or lactating women
- •Abdominal surgery in the previous 6 months
- •Unsuitable for inclusion in the study in the opinion of the investigator or sponsor for any reason that may compromise the subject's safety or confound data interpretation
研究组 & 干预措施
V565
V565 three times a day (TID) PO for 6 weeks
干预措施: V565 (Drug)
Placebo
Placebo TID PO for 6 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42.
时间窗: Day 42
Number of responders at Day 42, defined as subjects achieving both CDAI ≥ 70-point reduction from baseline or CDAI score \< 150, and a reduction of ≥ 40% from the baseline value of CRP or FCP. Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.
次要结局
- Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42.(Day 42)