NCT04583358进行中（未招募）2 期
A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects With Moderate to Severe Ulcerative Colitis (LOMBARD)
Applied Molecular Transport59 个研究点 分布在 13 个国家目标入组 105 人开始时间: 2020年8月26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
- 进行中（未招募）
- 发起方
- 入组人数
- 105
- 试验地点
- 59
- 主要终点
- Change in Mayo Score
研究概览
简要总结
Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis.
详细描述
This is a Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study to evaluate the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis.
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 80 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 moderate to severe UC.
- •Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and at the randomization visit.
- •Able to participate fully in all aspects of this clinical trial.
- •Written informed consent must be obtained and documented.
排除标准
- •Known gastrologic, or systemic condition that may compromise severity or diagnosis of disease.
- •History or current evidence of colonic or abdominal abnormalities.
- •Prohibited therapies or procedures before the screening period as specified per protocol.
- •A concurrent clinically significant, serious, unstable, or uncontrolled underlying cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, might confound the study results, pose additional risk to the subject, or interfere with the subject's ability to participate fully in the study.
- •Pregnant or lactating females.
- •Current or recent history of alcohol dependence, illicit drug use, mental or legal incapacitation, or a history of clinically significant psychiatric disorders that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures.
- •Unable to attend study visits or comply with procedures.
- •Previous exposure to AMT-101 or similar and known hypersensitivity to AMT-101 or its excipients.
研究组 & 干预措施
AMT-101
Active Comparator
AMT-101 Tablet
干预措施: AMT-101 (oral) (Drug)
Placebo
Placebo Comparator
Placebo Tablet
干预措施: Placebo (oral) (Other)
结局指标
主要结局
Change in Mayo Score
时间窗: 12 weeks
次要结局
- Endoscopic Remission Rate(12 weeks)
- Mucosal Healing Rate(12 weeks)
- Histologic Remission Rate(12 weeks)
- Clinical Remission Rate(12 weeks)
研究者
研究点 (59)
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