NCT03861143已完成2 期
A Randomized , Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Ulcerative Colitis
NImmune Biopharma16 个研究点 分布在 5 个国家目标入组 198 人开始时间: 2019年8月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 试验地点
- 16
- 主要终点
- Clinical Remission
研究概览
简要总结
This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter study with an optional open-label extension (OLE) period. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 compared to placebo in subjects with UC. This study includes 3 periods: induction, maintenance, and an optional OLE period.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •. Male and female subjects aged 18 to 75 years, inclusive.
- •. Diagnosis of UC for at least 3 months prior to screening.
- •. UC, as defined by a total Mayo Score of 4 to 10 inclusive at baseline with a MES 2 (confirmed by central reader).
- •. Able to participate fully in all aspects of this clinical trial.
- •. Written informed consent must be obtained and documented.
排除标准
- •. A diagnosis of CD, indeterminate colitis, or presence or history of the fistula with CD.
- •. Modified Truelove and Witts criteria (2: 6 bloody stools per day and one or more of the following: pulse > 90 bpm, temperature > 37.8°C, hemoglobin < 10.5 g/dl, or hs-CRP > 30 mg/I).
- •. Disease activity limited to distal 15 cm (proctitis).
- •. Treatment with an immunosuppressant (azathioprine, 6- mercaptopurine [6-MP]) within 25 days prior to randomization.
- •. Unable to attend study visits or comply with procedures.
- •. Concurrent participation in any other interventional study.
- •. Prior enrollment in the current study and had received study treatment.
研究组 & 干预措施
BT-11 low-dose (440 mg)
Experimental
Oral, once daily tablet
干预措施: BT-11 (440 mg) (Drug)
BT-11 high-dose (880 mg)
Experimental
Oral, once daily tablet
干预措施: BT-11 (880 mg) (Drug)
Placebo
Placebo Comparator
Oral, once daily tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Remission
时间窗: Week 12
Clinical remission rate at Week 12, defined using the 3-component modified Mayo Score as a rectal bleeding subscore of 0, a stool frequency subscore of 0 or 1, and an endoscopic subscore of 0 or 1.
次要结局
未报告次要终点
研究者
研究点 (16)
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