Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients With Mild-to-Moderate Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 114
- 试验地点
- 49
- 主要终点
- Proportion of participants with endoscopic response on flexible sigmoidoscopy after 8 weeks of treatment with VE202 or placebo.
研究概览
简要总结
A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC).
详细描述
A Phase 2 double-blind, placebo-controlled, randomized study to evaluate the safety, efficacy, and microbiota changes of VE202 in biologic-naïve patients with mild to moderate UC. In Parts 1 and 2 of the study, patients will receive VE202 or placebo for 8 weeks or 2 weeks. In Part 3, patients will be followed for safety for 1 year from the start of treatment.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group A: Part 1 Active and Part 2 Placebo Treatment with Vancomycin pretreatment.
In Part 1 of the study, patients in Group A will receive VE202 for 8 weeks.
In Part 2 of the study, patients in Group A will receive VE202 placebo for 2 weeks.
In Part 3, patients will be followed for safety for 1 year from the start of treatment.
干预措施: VE202 Placebo (Other)
Group A: Part 1 Active and Part 2 Placebo Treatment with Vancomycin pretreatment.
In Part 1 of the study, patients in Group A will receive VE202 for 8 weeks.
In Part 2 of the study, patients in Group A will receive VE202 placebo for 2 weeks.
In Part 3, patients will be followed for safety for 1 year from the start of treatment.
干预措施: VE202 (Biological)
Group A: Part 1 Active and Part 2 Placebo Treatment with Vancomycin pretreatment.
In Part 1 of the study, patients in Group A will receive VE202 for 8 weeks.
In Part 2 of the study, patients in Group A will receive VE202 placebo for 2 weeks.
In Part 3, patients will be followed for safety for 1 year from the start of treatment.
干预措施: Vancomycin Placebo (Other)
Group A: Part 1 Active and Part 2 Placebo Treatment with Vancomycin pretreatment.
In Part 1 of the study, patients in Group A will receive VE202 for 8 weeks.
In Part 2 of the study, patients in Group A will receive VE202 placebo for 2 weeks.
In Part 3, patients will be followed for safety for 1 year from the start of treatment.
干预措施: Vancomycin Oral Capsule (Drug)
Group B: Part 1 Placebo and Part 2 Active Treatment with Vancomycin pretreatment.
In Part 1 of the study, patients in Group B will receive VE202 placebo for 8 weeks.
In Part 2 of the study, patients in Group B will receive VE202 for 2 weeks.
In Part 3, patients will be followed for safety for 1 year from the start of treatment.
干预措施: VE202 Placebo (Other)
Group B: Part 1 Placebo and Part 2 Active Treatment with Vancomycin pretreatment.
In Part 1 of the study, patients in Group B will receive VE202 placebo for 8 weeks.
In Part 2 of the study, patients in Group B will receive VE202 for 2 weeks.
In Part 3, patients will be followed for safety for 1 year from the start of treatment.
干预措施: Vancomycin Placebo (Other)
Group B: Part 1 Placebo and Part 2 Active Treatment with Vancomycin pretreatment.
In Part 1 of the study, patients in Group B will receive VE202 placebo for 8 weeks.
In Part 2 of the study, patients in Group B will receive VE202 for 2 weeks.
In Part 3, patients will be followed for safety for 1 year from the start of treatment.
干预措施: VE202 (Biological)
Group B: Part 1 Placebo and Part 2 Active Treatment with Vancomycin pretreatment.
In Part 1 of the study, patients in Group B will receive VE202 placebo for 8 weeks.
In Part 2 of the study, patients in Group B will receive VE202 for 2 weeks.
In Part 3, patients will be followed for safety for 1 year from the start of treatment.
干预措施: Vancomycin Oral Capsule (Drug)
结局指标
主要结局
Proportion of participants with endoscopic response on flexible sigmoidoscopy after 8 weeks of treatment with VE202 or placebo.
时间窗: 8 Weeks
Endoscopic response is defined as a reduction from baseline of 1 point or more in Mayo endoscopic subscore. The Mayo endoscopic subscore is evaluated on a scale of 0 to 3, with a higher score representing more severe disease.
Percentage of participants with Grade ≥ 3 Treatment-Emergent Adverse Events (TEAEs) that are treatment-related or Serious Adverse Events (SAEs) that are treatment-related in Part 1 and Part 2 of the study.
时间窗: 16 Weeks
The safety of VE202 and placebo in Parts 1 and 2 of the study, which include an 8-week and 2-week course of treatment, respectively, will be evaluated.
次要结局
- Percentage of participants with clinical remission at Week 8 of Part 1 and Week 8 of Part 2.(8 Weeks)
- Percentage of participants with endoscopic remission on flexible sigmoidoscopy at Week 8 of Part 1 and Week 8 of Part 2.(8 Weeks)
- Change in Mayo score compared with baseline at Week 8 of Part 1 and Week 8 of Part 2.(8 Weeks)
- Change in the total percent of relative abundance of VE202 strains in feces at various time points in patients treated with 2- and 8-week courses of VE202.(52 Weeks)
- Change in patient-reported outcome measures using the Inflammatory Bowel Disease Questionnaire (IBDQ) to evaluate the impact of 2- and 8-week courses of VE202 IBD-specific health-related quality of life.(52 Weeks)
- Histologic improvement at Week 8 of Part 1 and Week 8 of Part 2 as measured by Geboes score.(8 Weeks)
- Number of participants with TEAEs, SAEs, and Adverse Events of Special Interest (AESIs) in Parts 1, 2, and 3 of the study.(52 Weeks)
- Change in colonization with VE202 strains detected in feces at various time points in patients treated with 2- and 8-week courses of VE202.(52 Weeks)
- Change in patient-reported outcome measures using the EuroQoL-5D Health Assessment Questionnaire (EQ-5D) scores to evaluate the impact of 2- and 8-week courses of VE202 IBD-specific health-related quality of life.(52 Weeks)
- Percentage of participants with endoscopic response on flexible sigmoidoscopy at Week 8, following treatment with VE202 for 2 weeks.(8 Weeks)
- Percentage of participants with clinical response at Week 8 of Part 1 and Week 8 of Part 2.(8 Weeks)
- Change in fecal calprotectin levels after 2- and 8-week courses of VE202.(52 Weeks)
- Change in taxonomic composition of gut microbiome in patients treated with 2- and 8-week courses of VE202.(52 Weeks)
- Change in fecal metabolite profiles at baseline and post-VE202 or placebo at various time points.(52 Weeks)
- Histologic improvement at Week 8 of Part 1 and Week 8 of Part 2 as measured by the Robarts Histopathology Index (RHI).(8 Weeks)
- Number of participants with hospitalization or surgical procedure related to UC after 2- and 8-week courses of VE202.(52 weeks)