Phase IIa, Sequential Cohort, Open-label, Multi-center Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Induction and Subcutaneous Maintenance Treatment With BI 3032950 in Patients With Moderate to Severe Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 86
- 主要终点
- Proportion of patients with clinical remission defined by the modified Mayo Score [mSC] with mSC of 0 to 2, including stool frequency subscore [SFS] of 0 or 1, rectal bleeding subscore [RBS] of 0, and centrally-read endoscopy subscore [ESS] of 0 or 1
研究概览
简要总结
Adults between 18 and 80 years of age with ulcerative colitis can participate in this study. This is a study for people for whom previous treatment was not successful or who stopped previous treatment. The purpose of this study is to find out whether BI 3032950 helps people with ulcerative colitis.
This study has 2 parts. In Part A, participants get BI 3032950 as an infusion into a vein every 4 weeks. After 12 weeks, doctors check whether the signs and symptoms of ulcerative colitis have improved. Before the results of this assessment are available, participants move on to Part B and get BI 3032950 as an injection under the skin. Participants whose results show clinical response after 12 weeks can continue treatment with BI 3032950. They get BI 3032950 injections under the skin every 4 weeks for up to 2 years.
Participants visit their doctors every 4 weeks. During these visits, the doctors check the signs and symptoms of ulcerative colitis. This includes taking blood and stool samples. Doctors also do endoscopies. This is a procedure that uses a tube with a camera to look inside the body.
The doctors also regularly check participants' health and take note of any unwanted effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male participants aged 18 to 80 years (inclusive) at the time of informed consent,
- •Diagnosis of ulcerative colitis (UC) ≥3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report,
- •Inadequate response, loss of response, or intolerance to treatment with biologic/targeted therapy or termination of treatment with biologic/targeted therapy for any other reason,
- •Female participants of childbearing potential must be ready and able to use highly effective methods of birth control and male participants are required to use condoms,
- •Further inclusion criteria apply.
排除标准
- •Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis, or Crohn's disease (CD),
- •Findings suggestive of CD (e.g. fistulae, granulomas on biopsy),
- •Evidence of colonic moderate/severe mucosal dysplasia or colonic adenomas, unless properly removed,
- •Gastrointestinal neoplasia, primary sclerosing cholangitis, or known colonic stricture,
- •Evidence of fulminant colitis or toxic megacolon at screening,
- •Current ileal-pouch anal anastomosis, ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine,
- •Previous surgery or anticipated surgical intervention for UC (trial participants with previous colonic surgery may be allowed based on investigator's judgement after discussion with the sponsor),
- •Any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to first trial drug administration and are not anticipated to require surgery,
- •Further exclusion criteria apply.
研究组 & 干预措施
All participants
All participants will receive an intravenous dose of BI 3032950 in Part A followed by a subcutaneous dose of BI 3032950 in Part B.
干预措施: BI 3032950 intravenous (Part A) (Drug)
All participants
All participants will receive an intravenous dose of BI 3032950 in Part A followed by a subcutaneous dose of BI 3032950 in Part B.
干预措施: BI 3032950 subcutaneous (Part B) (Drug)
结局指标
主要结局
Proportion of patients with clinical remission defined by the modified Mayo Score [mSC] with mSC of 0 to 2, including stool frequency subscore [SFS] of 0 or 1, rectal bleeding subscore [RBS] of 0, and centrally-read endoscopy subscore [ESS] of 0 or 1
时间窗: Up to Week 12
The modified Mayo score (mMS) consists of 3 components 1. Stool frequency subscore (SFS) 2. Rectal bleeding subscore (RBS) 3. Endoscopy subscore (ESS) Each component is graded from 0 = none to 3 = severe. The overall range of the mMS is from 0 to 9 with a higher score indicating a worsening of the symptoms.
次要结局
- Endoscopic remission (defined as centrally-read ESS of 0)(Up to Week 12)
- Clinical response (defined as a decrease from baseline in mMS ≥2 and at least a 30% reduction from baseline, and a decrease in RBS of ≥1 or an absolute RBS of 0 or 1)(Up to Week 12)
- Endoscopic improvement (defined as centrally-read ESS of 0 or 1)(Up to Week 12)
- Modified Mayo Score change from baseline(Up to Week 12)
- Stool frequency subscore of 0 or 1(Up to Week 12)
- Rectal bleeding subscore of 0(Up to Week 12)
- Occurrence of treatment-emergent adverse events (AEs)(Up to Week 12 and up to Week 104)