NCT06693908进行中（未招募）1 期
A Phase Ic Open-label Study to Evaluate the Pharmacodynamic Effects, Pharmacokinetics, and Safety of Vixarelimab in Patients With Moderate to Severe Active Ulcerative Colitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change From Baseline in Fibroblast Products From Colonic Tissue
研究概览
简要总结
This study aims to evaluate the pharmacodynamic (PD) effects of vixarelimab in the gut of participants with active moderate to severe ulcerative colitis (UC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of UC established at least 3 months
- •Moderately to severely active UC
- •Participants must meet criteria for either advanced therapy failure or conventional therapy failure
排除标准
- •Diagnosis of Crohn's disease or indeterminate colitis
- •Suspicion of ischemic colitis, radiation colitis, microscopic colitis or infectious colitis
- •Prior colectomy
- •Prior treatment with systemic janus kinase (JAK) inhibitors
研究组 & 干预措施
Vixarelimab
Experimental
Participants will receive subcutaneous (SC) injections of vixarelimab during the treatment period.
干预措施: Vixarelimab (Drug)
结局指标
主要结局
Change From Baseline in Fibroblast Products From Colonic Tissue
时间窗: Baseline up to approximately 3 months
次要结局
- Serum Concentration of Vixarelimab(Up to approximately 3 months)
- Number of Participants with Anti-drug Antibodies (ADA) to Vixarelimab(Up to approximately 3 months)
- Number of Participants With Adverse Events (AEs), With Severity Determined According to Division of AIDS (DAIDS) Toxicity Grading Scale(Up to approximately 3 months)
研究者
研究点 (1)
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