NCT00540657已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Phase II Study Testing CCX282-B in the Treatment of Celiac 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
- 90
- 试验地点
- 1
- 主要终点
- Evaluation of the effect of CCX282-B compared to placebo on the villous height/crypt depth ratio of small intestinal biopsy specimens taken from subjects with celiac disease, before and after gluten exposure.
研究概览
简要总结
The purpose of this study is to determine whether CCX282-B is effective in mitigating the effects of gluten ingestion in patients with celiac 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female, between 18 and 75 years of age
- •Established diagnosis of celiac disease
- •Subject has been following a strict gluten-free diet for at least 24 months
排除标准
- •History of any infection requiring intravenous antibiotics, a serious local infection, systemic infection, or gastrointestinal infection within 12 weeks of randomization
- •Use of any immunosuppressants, TNF inhibitors, or natalizumab during the 12 weeks prior to study randomization
- •Use of steroids during the 4 weeks prior to study randomization
- •Receipt of an experimental treatment for any disease within 4 weeks prior to randomization
- •Known IgE-mediated atopy or allergy or anaphylactic reactions to gluten
- •The subject suffers from a condition that carries a risk at endoscopy or is on anticoagulant treatment
研究组 & 干预措施
1
Experimental
干预措施: CCX282-B (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluation of the effect of CCX282-B compared to placebo on the villous height/crypt depth ratio of small intestinal biopsy specimens taken from subjects with celiac disease, before and after gluten exposure.
次要结局
- Evaluation of CCX282-B compared to placebo on gluten-induced celiac-type serology before and after gluten exposure
- Evaluation of CCX282-B compared to placebo on small intestinal mucosal inflammation before and after gluten exposure
- Evaluation of CCX282-B compared to placebo on symptom scores before and after gluten exposure
研究者
研究点 (1)
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