NCT05057273撤回2 期
A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe Disease
NImmune Biopharma0 个研究点开始时间: 2021年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Biomarkers of reponse
研究概览
简要总结
This is a phase 2, randomized, double-blind, multicenter study to assess the therapeutic efficacy, safety, and mechanisms of omilancor (BT-11) in patients with moderate to severe Crohn's Disease (CD).
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, 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
- •Male and female subjects age 18 to 75 years, inclusive.
- •Diagnosis of CD for at least 6 weeks prior to screening
- •Moderate to severely active CD as defined by all of the following:
- •CDAI score of 220-450
- •PRO-2 stool frequency (SF) ≥ 4 and/or abdominal pain (AP) ≥ 2
- •SES-CD ≥ 6 ( ≥4 for isolated ileitis) scored by a blinded central reader
排除标准
- •Participant has ulcerative colitis
- •Participant is at imminent risk of ileo-colectomy
- •Prior enrolment in the current study and had received study treatment.
研究组 & 干预措施
BT-11 880 mg
Experimental
Oral once daily tablet
干预措施: BT-11 (Drug)
Standard of care
Active Comparator
Biologic
干预措施: Active comparator (Drug)
结局指标
主要结局
Biomarkers of reponse
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
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