NCT00306215已完成2 期
A Multinational, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With 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
- 发起方
- Amgen
- 入组人数
- 436
- 试验地点
- 112
- 主要终点
- Percentage of subjects achieving a clinical response (defined as a decrease from baseline in Crohn's Disease Activity Index [CDAI] score of at least 70) on Day 57
研究概览
简要总结
The purpose of this study is to determine whether CCX282-B is effective in treating patients with moderate to severe Crohn's Disease.
详细描述
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate to severe Crohn's Disease
- •CDAI 250-450
- •CRP >7.5
- •signed written informed consent
排除标准
- •> 100 cm of small bowel resected
- •ileostomy, colostomy or rectal pouch
- •diagnosis of ulcerative colitis or indeterminate colitis
- •evidence of short bowel syndrome requiring enteral or parenteral supplementation or total parenteral nutrition
- •hepatitis B, C or HIV infection
- •history of infection requiring IV antibiotics
- •serious or GI infection in the previous 12 weeks
研究组 & 干预措施
4
Experimental
Blinded study arm
干预措施: CCX282-B (Drug)
3
Experimental
Blinded study arm
干预措施: CCX282-B (Drug)
1
Experimental
Blinded study arm
干预措施: CCX282-B (Drug)
2
Experimental
Blinded study arm
干预措施: CCX282-B (Drug)
结局指标
主要结局
Percentage of subjects achieving a clinical response (defined as a decrease from baseline in Crohn's Disease Activity Index [CDAI] score of at least 70) on Day 57
时间窗: Day 57
次要结局
- Percentage of subjects achieving clinical remission (defined as a Crohn's Disease Activity Index [CDAI] score less than or equal to 150) on Day 57(Day 57)
研究者
研究点 (112)
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