A Multicentre, Double-blind, Randomised, Parallel-group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment
研究概览
简要总结
The purpose of this study is to determine whether treatment with D9421-C for 8 weeks in Japanese patients with mild to moderate active Crohn's disease will improve their symptoms of Crohn's disease and quality of life.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male aged ≥ 18 and ≤ 65 years
- •Diagnosis of Crohn's Disease
排除标准
- •Having ileostomy or pouch and/or colostomy
- •Having previous gastric surgery
- •Having a known or suspected systemic infection
研究组 & 干预措施
1
D9421-C 9 mg
干预措施: D9421-C, 9mg (Drug)
2
D9421-C 15 mg
干预措施: D9421-C, 15mg (Drug)
3
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment
时间窗: Baseline to 8 weeks
Remission is defined by a Crohn's Disease Activity Index (CDAI) score of ≤ 150. That is, if a participant had 150 or less of CDAI score after 8-week treatment, the participant had the remission of Crohn's disease. The number of participants who had remission of Crohn's disease after 8-week treatment was the primary measure of this study.
次要结局
- Number of Participants Who Had Remission of Crohn's Disease After 2-week Treatment(Baseline to 2 weeks)
- Number of Participants Who Had Remission of Crohn's Disease After 4-week Treatment(Baseline to 4 weeks)
- Cumulative Percentage of Participants Who Achieved Remission up to 8 Weeks by Kaplan-Meier Method(At 8 weeks)
- Change in CDAI Score From Baseline to 8 Weeks(Baseline to 8 weeks)