NCT06260267撤回1 期
A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Treatment-emergent adverse events from baseline to week 52
研究概览
简要总结
To explore the safety of FE 999322 (microbiota suspension) and FE 999324 (microbiota capsule) versus placebo in subjects with active mild to moderate ulcerative colitis (UC).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject aged ≥18 at screening
- •Established diagnosis of ulcerative colitis by standard clinical, endoscopic and histological criteria, for more than 3 months at screening
排除标准
- •Active disease or history of Crohn's disease
- •Active disease or history of irritable bowel syndrome (IBS) or any other chronic intestinal disease apart from UC
- •Active gastrointestinal infection.
研究组 & 干预措施
Placebo FE 999322
Placebo Comparator
Placebo suspension
干预措施: Placebo suspension (Drug)
FE 999322
Experimental
Microbiota suspension
干预措施: Microbiota suspension (Drug)
FE 999324
Experimental
Microbiota capsule
干预措施: Microbiota capsule (Drug)
Placebo FE 999324
Placebo Comparator
Placebo capsule
干预措施: Placebo capsule (Drug)
结局指标
主要结局
Treatment-emergent adverse events from baseline to week 52
时间窗: From baseline to week 52
次要结局
未报告次要终点
研究者
研究点 (1)
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