Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment With BI 655130 in Patients With Active Ulcerative Colitis (UC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 4
- 主要终点
- The Total Number of Deregulated Genes Comparing Baseline to Post Treatment, Analysed by Gene Expression of Mucosal Biopsies Via RNA Sequencing, Per Time Point up to Week 12
研究概览
简要总结
The primary objective of this trial is to understand the mechanism of action of BI655130 in patients with UC
Secondary objectives are to explore clinical effect, safety and tolerability (including immunogenicity) of BI 655130 treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 - 75 years at screening
- •Diagnosis of UC >= 3 months prior to screening.
- •Moderately to severely active UC as confirmed by Mayo Score ≥6
- •Receiving conventional, non-biologic therapy for UC.
- •Negative colon cancer screening
- •Further inclusion criteria apply
排除标准
- •Prior use of any biological treatment in the past (e.g.integrin inhibitors, IL12/23 or IL23 inhibitors, any investigational biological drugs)
- •Extensive colonic resection
- •Evidence of infection with C. difficile or other intestinal pathogen < 30 days prior to screening
- •Active or latent tuberculosis
- •Further exclusion criteria apply
研究组 & 干预措施
Spesolimab
干预措施: Spesolimab (Drug)
结局指标
主要结局
The Total Number of Deregulated Genes Comparing Baseline to Post Treatment, Analysed by Gene Expression of Mucosal Biopsies Via RNA Sequencing, Per Time Point up to Week 12
时间窗: Measurements done at baseline (day -8 to -6), day 1, day 4, day 15, day 57 and day 85 (week 12).
The total number of deregulated genes comparing baseline to post treatment, analysed by gene expression of mucosal biopsies via RNA sequencing, per time point up to Week 12. A total of 60,675 genes were evaluated, 40,586 genes were included in the differential expression analyses. Based on the raw read count values the DESeq2 method, one of the standard methods to analyse RNAseq data, was used for the gene expression analysis and to identify deregulated genes. A gene was considered deregulated with a FDR (false discovery rate) adjusted p-value \< 0.01 and a fold change ≤ -1.3 or ≥ 1.3.
次要结局
- Percent Change in C-reactive Protein (CRP) From Baseline to Week 12(Measurements done at baseline (day -8 to -6) and week 12 (day 85).)
- Percent Change in Faecal Lactoferrin From Baseline to Week 12(Measurements done at baseline (day -8 to -6) and week 12 (day 85).)
- Number of Participants With Clinical Remission (Defined as Mayo Score ≤2 Points, and All Subscores ≤1 Point) at Week 12(Week 12 (day 85) following start of treatment.)
- Percent Change in Faecal Calprotectin From Baseline to Week 12(Measurements done at baseline (day -8 to -6) and week 12 (day 85).)
- Number of Patients With Drug Related Adverse Events (AEs)(Date of start of infusion of first study drug (Day 1) till the date of end of infusion of last study drug (day 57) + 140 days at 11:59 p.m., up to 197 days.)