EUCTR2020-005770-99-PT进行中（未招募）1 期
Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease
试验速览
- 阶段
- 1 期
- 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
- •- Male and female patients, 18 to 75 years when signing informed consent at screening
- •- Established diagnosis of clinical CD prior to screening
- •- Suspicion of symptomatic small bowel stenosis, as defined by inclusion criteria 3 and 4
- •- Presence of abdominal pain after eating or limitation in amount or types of food at screening
- •- 1 or 2 naïve or anastomotic stenoses in the terminal ileum at screening, confirmed by MRE at randomization
- •- Have achieved Symptomatic Stenosis Response before randomization (i.e. 7 day average scores <2 for diary questions on the abdominal pain after eating AND on the limitation in amount or types of food)
- •- Endoscopic activity defined by Colonic Simple Endoscopic Score in CD (SES-CD) =12 after Lead-in Period, at the time of randomization
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- No stenosis in reach of ileocolonoscopy
- •- Systemic corticosteroid treatment of current obstructive symptoms for >1 week prior to screening
- •- Endoscopic balloon dilation (EBD) or surgical treatment of the same small bowel stenosis within the last 6 months prior to screening Visit 1
- •- More than 2 smal intestinal stenoses
- •- Patients who require immediate EBD or surgical intervention as per the investigator´s discretion
- •- Failure of >2 different biological drug classes prior to screening (e.g. TNF inhibitors, Integrin Receptor antagonists and
- •IL-12 / IL-23 antagonists)
- •- Current complications of CD at screening Visit 1 and randomization (Day 1) that would possibly confound the evaluation of benefit from treatment with spesolimab
- •- Current stenosis in the colon
- •- Previous strictureplasty on current stricture
- •- Current ileostomy or colostomy
- •- Any kind of bowel resection or diversion within 6 months of screening Visit 1
- •- Any other intra-abdominal surgery (except for abscess drainage) within 3 months prior to screening Visit
- •- Colorectal cancer (CRC) present and past (<5 years) history
研究者
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