NCT01751152已完成2 期
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
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
- 53
- 试验地点
- 1
- 主要终点
- Change in Crohn's disease activity index (CDAI)
研究概览
简要总结
This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn's disease.
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
- •Moderately to severely active Crohn's disease, defined as a Crohn's disease activity index (CDAI) of 220-450 (both inclusive) at Visit 2 (Day 0, Dosing), with evidence of inflammation confirmed by a C-reactive protein (CRP) above or equal to 10 mg/L or endoscopic verification (according to endoscopy imaging manual) performed at Visit 1 (Day -28 to -7, Screening)
- •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)
排除标准
- •Body mass index (BMI) equal to or above 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
- •Any active or ongoing bacterial infections within 4 weeks prior to randomisation, unless treated and resolved with appropriate therapy
- •Any history of serious recurrent infections requiring hospitalisation
研究组 & 干预措施
NNC0114-0006
Experimental
干预措施: NNC0114-0006 (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change in Crohn's disease activity index (CDAI)
时间窗: Week 0, week 4
次要结局
- Clinical remission, defined as CDAI of less than 150(At week 8)
- Incidence of adverse events (AEs)(Up to weeks 24 or 36)
- Change in the inflammatory bowel disease questionnaire (IBDQ) score(Week 0, week 4)
- Change in CDAI(Week 0, week 12)
- Incidence of anti-NNC0114-0006 antibodies(Up to weeks 24 or 36)
- Changes in the Short Form Health Survey (SF-36v2) physical and mental component scores(Week 0, week 4)
研究者
研究点 (1)
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