A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Proof-of-concept Study to Assess the Efficacy, Safety and Tolerability of Two Single iv Infusions of AIN457 10 mg/kg (Anti IL-17 Monoclonal Antibody) in Patients With Moderate to Severe Active Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Crohns Disease Activity Index (CDAI) Score
研究概览
简要总结
This study will assess the safety and efficacy of AIN457 in patients with moderate to severe 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
- •Male or female; 18-75 years old
- •Diagnosis of Crohn's disease for at least 3 months prior to screening
- •Confirmation of Crohn's disease by endoscopic or imaging examination
- •Moderately active Crohn's disease at baseline, defined as:
- •CDAI ≥220 and ≤450
- •Active disease despite prior treatment with corticosteroids for at least 2 weeks, or immunosuppressants for at least 3 months. Treatment with azathioprine, 6-MP or MTX is allowed but must have been on a stable dose for at least 10 weeks, corticosteroids are allowed but must have been on a stable doses of prednisolone not exceeding 40 mg for two weeks prior to baseline. Immunosuppressants other than those listed above, such as cyclosporine, tacrolimus and mycophenolate, are not allowed and must be stopped (wash-out periods defined in the protocol);
排除标准
- •Body Mass Index >34
- •Positive PPD tuberculin skin test or QuantiFeron test
- •Any subject with evidence of active pulmonary disease or evidence of latent tuberculosis or fungal infection at screening or within past 3 months
- •Symptoms associated with active bowel structuring disease and pre-stenotic dilation on radiographs
- •Fistulizing disease if complicated by sepsis and/or untreated abscess
- •Multiple bowel surgeries and clinically important short bowel syndrome defined as an inability to maintain caloric intake
- •Use of certain medications as specified in the protocol
- •Clinical improvement due to other Crohn's therapy
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
AIN457
AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
干预措施: AIN457 (Drug)
Placebo
Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in Crohns Disease Activity Index (CDAI) Score
时间窗: 6 weeks
The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to \>=600, where remission of Crohn's disease is defined as CDAI \< 150, and severe disease is defined as CDAI \> 450. A negative change in mean score indicates improvement.
次要结局
- Percentage of Participants Achieving Remission and/or Response(6 weeks)
- Percentage of Participants Maintaining Remission(10 weeks)
- Percentage of Participants Achieving Response(6 weeks)
- Mean Change From Baseline in CDAI Score(baseline, 2 weeks, 4 weeks)
- Percentage of Participants Achieving Remission(6 weeks)
- Area Under CDAI Curve(10 weeks)