NCT03482635已完成2 期
A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI655130 (SPESOLIMAB) Induction Therapy in Patients With Moderate-to-severely Active Ulcerative Colitis Who Have Failed Previous Biologics Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 54
- 主要终点
- Proportion of Patients With Clinical Remission at Week 12
研究概览
简要总结
This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are
- to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II)
- to confirm efficacy and safety of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III)
- To provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020, the target population to be evaluated in study 1368-0020.
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
- •18 - 75 years, at date of signing informed consent, males or females
- •Diagnosis of ulcerative colitis ≥ 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report
- •Moderate to severe activity (total MCS 6 to 12 with a RBS ≥ 1 AND an SFS ≥ 1 AND mESS ≥ 2 within 7-28 days prior to first dose)
- •Endoscopic activity extending proximal to the rectum (≥ 15 cm from anal verge)
- •Well-documented demonstration of inadequate response or loss of response or have had unacceptable side effects with approved doses of TNFɑ antagonists (infliximab, adalimumab, golimumab) and/or vedolizumab in the past (screening of both TNFɑ antagonists-AND-Vedolizumab failure patients will be capped once 48 randomized patients in Part 1 and 117 randomized patients in Part 2 meet this criterion; patients who have already been screened at the time of the cap will continue to be randomized into the study)
- •Further inclusion criteria apply
排除标准
- •Evidence of abdominal abscess at screening
- •Evidence of fulminant colitis or toxic megacolon at screening
- •Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
- •Further exclusion criteria apply
研究组 & 干预措施
Group 1- Placebo Group
Experimental
干预措施: Placebo (Drug)
Group 2- Small Dose Group
Experimental
干预措施: Spesolimab (Drug)
Group 3- Medium Dose Group
Experimental
干预措施: Spesolimab (Drug)
Group 4 - High Dose Group
Experimental
干预措施: Spesolimab (Drug)
结局指标
主要结局
Proportion of Patients With Clinical Remission at Week 12
时间窗: At week 12.
Proportion of patients with clinical remission (defined as modified Mayo Clinical Score (MCS) ≤ 2, with Stool Frequency Score (SFS) = 0 or 1 \[if drop ≥1 from baseline\] and Rectal Bleeding Score (RBS) = 0 and modified Endoscopic Subscore (mESS) ≤ 1) at week 12. Proportion of patients was calculated as n/N, with n=number of patients with clinical remission at week 12 and N=number analyzed. 95% Confidence Intervals (CI) were calculated using the method of Wilson.
次要结局
- Proportion of Patients With Clinical Response at Week 12(At week 12.)
- Proportion of Patients With Combined Endoscopic Improvement and Histologic Remission at Week 12(At week 12.)
- Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline at Week 12(At baseline and at week 12.)
- Proportion of Patients With Endoscopic Improvement at Week 12(At week 12.)
研究者
研究点 (54)
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