A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Phase 2 Induction Study With Long-Term Extension to Evaluate the Clinical Activity and Safety of Oral NX-13 in Participants w/ Moderate to Severe Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 81
- 试验地点
- 35
- 主要终点
- To assess the clinical activity of oral NX-13 vs placebo
研究概览
简要总结
Phase 2 induction study with a long-term extension (LTE) period in participants with moderate to severe ulcerative colitis (UC).
详细描述
This is a randomized, multicenter, double-blind, placebo-controlled, multiple dose exploratory Phase 2 induction study with a long-term extension (LTE) period in participants with moderate to severe 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
- 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
- •Adult subjects aged 18 to 75 years (inclusive)
- •Diagnosis of UC ≥ 90 days before screening confirmed by histologic evidence
- •Active UC defined as a total Mayo Score (MMS) of ≥ 5 (inclusive) at baseline
- •ES ≥ 2 within 14 days prior to randomization
排除标准
- •Severe extensive colitis as evidenced by physician judgment that the participant is likely to require hospitalization for medical care or surgical intervention of any kind for UC (e.g., colectomy) within the 12 weeks after randomization;
- •Current evidence of fulminant colitis, toxic megacolon or recent history (within 6 months prior to screening) of toxic megacolon, or bowel perforation
- •Diagnosis of Crohn's disease (CD) or indeterminate colitis, or the presence or history of a fistula consistent with CD
- •Diagnosis of microscopic colitis, ischemic colitis, or radiation colitis
- •Bacterial or parasitic pathogenic enteric infection;
研究组 & 干预措施
NX-13 250mg
Subjects will take study drug by ingesting three tablets per day, recommended at the same time daily for consistency. Subjects in a NX-13 group will receive either 250 mg or 750 mg of NX-13 in 3 tablets and subjects in the placebo group will receive matching placebo.
干预措施: NX-13 250mg (Drug)
NX-13 750mg
Subjects will take study drug by ingesting three tablets per day, recommended at the same time daily for consistency. Subjects in a NX-13 group will receive either 250 mg or 750 mg of NX-13 in 3 tablets and subjects in the placebo group will receive matching placebo.
干预措施: NX-13 750mg (Drug)
NX-13 Placebo
Subjects will take study drug by ingesting three tablets per day, recommended at the same time daily for consistency. Subjects in a NX-13 group will receive either 250 mg or 750 mg of NX-13 in 3 tablets and subjects in the placebo group will receive matching placebo.
干预措施: NX-13 Placebo (Drug)
结局指标
主要结局
To assess the clinical activity of oral NX-13 vs placebo
时间窗: 365 days
Change from baseline in mean Modified Mayo Score (MMS) vs placebo. Total score Modified Mayo score 0-9, with higher scores representing more severe disease activity.
次要结局
- Safety and Tolerability-AE/SAE - Hematology(365 days)
- Safety and Tolerability-AE/SAE - Chemistry(365 days)
- Safety and Tolerability-AE/SAE - Vital Signs(365 days)