NCT00737932已完成2 期
A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn's Disease.
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
- 180
- 试验地点
- 34
- 主要终点
- Safety, Tolerability, Clinical Effect - proportion of subjects in clinical remission, proportion of subjects who respond to treatment.
研究概览
简要总结
The study aims to evaluate the safety and clinical effect of daily oral treatment of Laquinimod capsules in active moderate to severe Crohn's disease. This study will assess Laquinimod doses of 0.5mg /day to 2 mg/day in sequential dose groups (cohorts). Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for Multiple Sclerosis.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with Crohn's disease for at least 3 months prior to screening.
- •Moderate to severe Crohn's disease patients as determined by the CDAI score
排除标准
- •Subjects who have had recent bowel surgery
- •Subjects with clinically significant GI obstructive symptoms
- •Subjects with a clinically significant or unstable medical or surgical condition
- •Subjects with unstable doses of standard of care medications (5-ASA, antibiotics, oral corticosteroids, immunosuppressants )
- •Women who are pregnant or nursing or who intend to be during the study period.
- •Women of child-bearing potential who do not practice an acceptable method of birth control
研究组 & 干预措施
Laquinimod
Experimental
Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day (sequential cohorts)
干预措施: Laquinimod (Drug)
Placebo
Placebo Comparator
Matching placebo
干预措施: placebo (Other)
结局指标
主要结局
Safety, Tolerability, Clinical Effect - proportion of subjects in clinical remission, proportion of subjects who respond to treatment.
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
研究点 (34)
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