Proof-of-concept Study of BI 655130 add-on Treatment in Patients With Mild-to-moderately Active Ulcerative Colitis During TNF Inhibitor Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 16
- 主要终点
- Proportion of Participants With Endoscopic Improvement (MCS mESS ≤1) at Week 12
研究概览
简要总结
The objectives of this trial are safety and efficacy (proof-of-concept) of induction of mucosal healing by BI 655130 add-on therapy in patients with mild or moderate ulcerative colitis and persisting endoscopic activity despite pre-existing TNFi treatment.
This trial will explore safety and efficacy of a dose of BI 655130 that was modelled to achieve the similar exposures as the highest exposures tested and found safe and tolerable in preceding single and multiple dose studies in healthy subjects, as add-on to pre-existing TNFi (Tumor necrosis factor inhibitor) treatment. Secondary and further objectives include assessment of the pharmacokinetic (PK) profile of BI 655130 and early exploration of specific biomarkers with potential usefulness to predict clinical efficacy or safety outcome or help understand BI 655130's mode of action.
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
- 未提供
排除标准
- •Prior use of more than two different TNF inhibitors or vedolizumab
- •Extensive colonic resection
- •Evidence of infection with C. difficile or other intestinal pathogen <28 days prior to screening
- •Active or latent tuberculosis
- •Further exclusion criteria apply
研究组 & 干预措施
Spesolimab
1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment (3 injections of Spesolimab 1200 mg in total during the 12 weeks: at Week 0, 4, and 8 respectively).
干预措施: Spesolimab (Drug)
Placebo
Matching placebo was administered via intravenous infusion over 12 weeks of treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Participants With Endoscopic Improvement (MCS mESS ≤1) at Week 12
时间窗: At Week 12
Proportion of participants with endoscopic improvement (Mayo clinical score (MCS) modified endoscopic sub-score (mESS) ≤1) at Week 12 was reported. The endoscopic improvement (mucosal healing) was defined as the Mayo clinical score (MCS) modified endoscopic sub-score (mESS) ≤ 1 point. The MCS mESS ranged from 0 (normal) to 3 (severe disease). The mESS was assessed by a central reader who was independent from the investigator. The 95% confidence intervals (in the descriptive statistics part) were calculated using the method of Wilson.
次要结局
- Proportion of Participants With Total Clinical Remission (tCR) Based on Total Mayo Clinical Score at Week 12(At Week 12)
- Proportion of Participants With Histological Remission at Week 12(At Week 12)
- Proportion of Participants With Clinical Remission (CR) Based on Mayo Clinical Score at Week 12(At Week 12)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(From first does of study medication until end of the follow-up period, up to 36 weeks.)