EUCTR2010-020836-21-PL进行中（未招募）不适用
A randomised, double-blind, parallel-group, placebo-controlled, induction trial to assess the clinical efficacy and safety of NNC0142-0000-0002 in subjects with moderately to severely active Crohn’s disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Men and women (not pregnant and not nursing) of =18 and =75 years of age
- •- Subjects with CD for at least 3 months having active disease with a CDAI score of =220 and =450 and evidence of inflammation confirmed by a C-reactive protein (CRP) level =10 mg/L (or =1.0 mg/dL) or endoscopic verification
- •- Biologic-naïve subjects or biologic-experienced for the treatment of CD having discontinued due to lack of efficacy to only one biologic therapy (primary or secondary failure), intolerance to therapy, or other reasons (e.g. drug holiday).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
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) =38.0 kg/m^2
研究者
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