EUCTR2012-002432-93-SK进行中（未招募）不适用
A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 114
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
- •- Moderately to severely active Crohn’s disease, defined as a CDAI of 220-450 (both inclusive) at Visit 2 (Dosing), with evidence of inflammation confirmed by a C-reactive protein (CRP) =10 mg/L or endoscopic verification (according to endoscopy imaging manual) performed at Visit 1 (Screening).
- •- Men and women between =18 and =75 years of age
- •- Biologic-naïve subjects or biologic-experienced for the treatment of Crohn’s disease. Biologic-experienced subjects are eligible if they have not failed more than one marketed biologic therapy for the treatment of Crohn’s disease due to lack of efficacy (primary or secondary efficacy failures).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 102
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •- Body mass index (BMI) =38.0 kg/m^2
- •- Any of the following: symptomatic bowel obstruction, short bowel syndrome, ileostomy or colostomy, surgical bowel resection within 6 months prior to randomisation, total colectomy or subtotal colectomy with less than 20 cm colon remaining, any abscesses not adequately treated
- •- History of dysplasia in the colon
研究者
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