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
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Proportion of Patients With Maintained Symptomatic Stenosis Response at Week 48
研究概览
简要总结
This study is open to adults, between 18 and 75 years of age, who have narrowings in the small bowel (strictures) due to Crohn's disease. Strictures can lead to bowel obstruction (blockage). People whose symptoms got worse because of strictures can join the study. Participants get standard treatment for Crohn's disease and the strictures. The purpose of the study is to test whether the strictures improve further when treated with a medicine called spesolimab added to standard treatment.
Participants are in the study for about 1 year and 4 months. In the first 3 months, participants get standard treatment only. After 3 months, participants whose condition improved are put into 2 groups randomly, which means by chance. One group gets spesolimab added to their standard treatment. The other group gets placebo added to their standard treatment. Both spesolimab and placebo are given as infusions into a vein. Placebo infusions look like spesolimab infusions but do not contain any medicine. For the first 2 months, participants get the infusions every month. Thereafter, participants get the infusions every 2 months.
During the study, participants have about 11 visits to the study site. The doctors regularly check participants' health and take note of any unwanted effects. At 3 of the visits, doctors take images of the bowel using Magnetic Resonance Imaging and with an endoscope. At these visits, the doctors also take a small sample of bowel tissue (biopsy). The participants note their symptoms of Crohn's disease and how the symptoms affect daily life in an electronic diary. At the end of the study, results from the diaries and bowel imaging are compared between the spesolimab group and the placebo group.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •18 to 75 years of legal age
- •Established diagnosis of clinical Crohn's Disease
- •Suspicion of symptomatic small bowel obstruction at screening
- •1 or 2 naïve or anastomotic stenoses in the terminal ileum, with at least one being in reach of ileocolonoscopy as defined by the CrOhN´S disease antifibrotic STRICTure Therapies (CONSTRICT) criteria, confirmed by MRE
- •Have achieved a Symptomatic Stenosis Response after optimized anti-inflammatory therapy
- •Absent, mild or moderate endoscopic activity defined by Simple Endoscopic Score in Crohn's Disease (SES-CD) ≤12 Further criteria apply
排除标准
- •More than 2 small intestinal stenoses
- •No stenosis is in reach of ileocolonoscopy
- •Patients who require immediate endoscopic balloon dilation or surgical intervention as per the investigator´s discretion or who have undergone any of the two within the 6 months prior to the study
- •Failure of >2 different biological drug classes
- •Current complications of Crohn's Disease such as enterocutaneous, internal or rectovaginal fistules, short gut syndrome or abscess,
- •Use of any prohibited concomitant medications as described in the study protocol
- •Active tuberculosis (TB) or history of latent TB that has not been treated Further criteria apply
研究组 & 干预措施
Spesolimab
干预措施: Spesolimab (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Patients With Maintained Symptomatic Stenosis Response at Week 48
时间窗: At Week 48.
Proportion of Patients With Radiographic Stenosis Response at Week 48
时间窗: At Week 48.
次要结局
- Proportion of Patients With Radiographic Stenosis Response at Week 24(At Week 24)
- Proportion of Patients With Maintained Symptomatic Stenosis Response at Week 24(At Week 24.)