NCT07686081招募中3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ponesimod in Patients With Moderately to Severely Active Ulcerative Colitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Clinical Remission at Week 16
研究概览
简要总结
A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Ponesimod (VSP-128) in patients with moderately to severely active 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 18-75 years
- •Able to provide written informed consent
- •Diagnosis of ulcerative colitis for ≥90 days prior to screening
- •Three-component Mayo score of 5-9 with endoscopy subscore ≥2 and rectal bleeding subscore ≥1
- •History of inadequate response, loss of response, or intolerance to at least one approved UC therapy
排除标准
- •Severe or fulminant UC likely to require hospitalization or surgery
- •Diagnosis of Crohn's disease or other non-UC colitis
- •Prior exposure to S1P receptor modulators
- •Active or chronic infections
- •Clinically significant cardiovascular, hepatic, or other uncontrolled systemic disease
- •History of an allergic reaction or significant sensitivity to constituents of study drug
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Ponesimod (VSP-128)
Experimental
干预措施: Ponesimod (Drug)
结局指标
主要结局
Clinical Remission at Week 16
时间窗: Week 16
Proportion of participants achieving clinical remission at Week 16.
次要结局
- Clinical Response at Week 16(Week 16)
- Endoscopic Improvement at Week 16(Week 16)
- Symptomatic Remission at Week 16(Week 16)
- Change From Baseline in Mayo Score at Week 16(Baseline to Week 16.)
研究者
研究点 (4)
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