NCT01203631已完成2 期
A Randomised, Double-blind, Parallel-group, Placebo Controlled Induction Trial to Assess the Clinical Efficacy and Safety of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active 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
- 78
- 试验地点
- 1
- 主要终点
- Change in disease activity assessed by CDAI (Crohn's disease activity index)
研究概览
简要总结
This trial is conducted in Europe and North America. The aim of the trial is to assess disease activity and safety in subjects with moderately to severely active Crohn's disease (CD) when treated with NNC 0142-0000-0002.
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 with CD for at least 3 months
- •Subjects not treated before, or subjects who have either not responded to treatment, or responded and then lost the response during continued administration of a therapeutic compound
排除标准
- •Any of the following: Symptomatic bowel obstruction, short bowel syndrome, ileostomy or colostomy, surgical bowel resection within 6 months prior to randomisation or clinically relevant un-drained abscess
- •History of dysplasia or malignancy in the colon
- •Any ongoing chronic or active infectious disease or microbial infection requiring systemic oral or intravenous treatment against infection within 1 month prior to randomisation
- •Body mass index (BMI) higher or equal to 38.0 kg/m^2
研究组 & 干预措施
NNC 0142-0000-0002
Experimental
干预措施: NNC 0142-0000-0002 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in disease activity assessed by CDAI (Crohn's disease activity index)
时间窗: From baseline to week 4
次要结局
- Number of adverse events (AEs)(From baseline to weeks 12 and 24)
- Immunogenicity of NNC 142-0002(At week 24)
研究者
研究点 (1)
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