NCT05372939已完成2 期
A Randomized, Placebo-controlled, Double-blind, Parallel-group, Exploratory, Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Combination With Adalimumab in Subjects With Moderate to Severe Ulcerative Colitis
Applied Molecular Transport18 个研究点 分布在 4 个国家目标入组 51 人开始时间: 2021年2月5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
- 51
- 试验地点
- 18
- 主要终点
- Ulcerative Colitis disease activity as assessed by mean change in UC-100 Score from baseline
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 Combination With Adalimumab 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 Combination with Adalimumab 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 75 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.
- •Moderate to severe UC.
- •Eligible for Humira (adalimumab) therapy.
- •Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and at the randomization visit.
- •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 and Humira (adalimumab)
Active Comparator
AMT-101 Tablet
干预措施: AMT-101 (oral) (Drug)
AMT-101 and Humira (adalimumab)
Active Comparator
AMT-101 Tablet
干预措施: Humira (adalimumab) (Combination Product)
Placebo and Humira (adalimumab)
Placebo Comparator
Placebo Tablet
干预措施: Placebo (oral) (Other)
Placebo and Humira (adalimumab)
Placebo Comparator
Placebo Tablet
干预措施: Humira (adalimumab) (Combination Product)
结局指标
主要结局
Ulcerative Colitis disease activity as assessed by mean change in UC-100 Score from baseline
时间窗: 8 weeks
To evaluate the effects of AMT-101 in combination with adalimumab on ulcerative colitis (UC) disease activity
次要结局
- Clinical response rate(8 weeks)
- Mean change in high-sensitivity C-reactive protein (hs-CRP) from baseline(8 weeks)
- Proportion of subjects who achieve a significant reduction in RHI(8 weeks)
- Clinical remission rate(8 weeks)
- Mean change in Robarts Histopathology Index (RHI) from baseline(8 weeks)
- Mean change in total Mayo Clinic Score (MCS) and component scores (Mayo Endoscopic Subscore [MES], partial MCS, rectal bleeding and stool frequency) from baseline(8 weeks)
- Mean change in fecal calprotectin from baseline(8 weeks)
研究者
研究点 (18)
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