2023-506655-19-00已完成2 期
A Phase II, Multicenter Induction Study with an Active Treatment Extension to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Patients with Moderate to Severe Ulcerative Colitis
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 66
- 主要终点
- 1. Clinical remission at Week 12, with clinical remission defined as modified Mayo Score (mMS) of ≤ 2, including stool frequency subscore ≤ 1, rectal bleeding subscore = 0, endoscopy subscore ≤ 1
研究概览
简要总结
To evaluate the efficacy of vixarelimab compared to placebo in the induction of clinical remission at Week 12
研究设计
- 分配方式
- Randomized
- 主要目的
- A Phase Ii, Study With Extension To Evaluate Vixarelimab In Patients With Ulcerative Colitis
- 盲法
- Double (Monitor, Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of UC for at least 3 months
- •Moderately to severely active UC, assessed by Modified Mayo Score (mMS)
- •Inadequate response, loss of response to, or intolerance to conventional or advanced therapies for UC
排除标准
- •Diagnosis of Crohn’s disease or indeterminate colitis
- •Suspicion of ischemic, radiation, microscopic, or infectious colitis
- •Prior colectomy
- •Inadequate response to or loss of response to previous treatment of UC with Janus kinase (JAK) inhibitors.
研究组 & 干预措施
Vixarelimab Placebo
Placebo
干预措施: Vixarelimab Placebo (Drug)
Vixarelimab
Test
干预措施: Vixarelimab (Drug)
结局指标
主要结局
1. Clinical remission at Week 12, with clinical remission defined as modified Mayo Score (mMS) of ≤ 2, including stool frequency subscore ≤ 1, rectal bleeding subscore = 0, endoscopy subscore ≤ 1
1. Clinical remission at Week 12, with clinical remission defined as modified Mayo Score (mMS) of ≤ 2, including stool frequency subscore ≤ 1, rectal bleeding subscore = 0, endoscopy subscore ≤ 1
次要结局
- 1. Clinical response at Week 12, with clinical response defined as decrease from baseline in the mMS of ≥ 2 and ≥ 30% reduction from baseline, with either a decrease in rectal bleeding subscore of ≥ 1 or absolute rectal bleeding subscore of ≤ 1
- 2. Endoscopic improvement at Week 12, with endoscopic improvement defined as a Mayo endoscopy subscore of ≤ 1 (score of 1 modified to exclude friability)
- 3. Endoscopic remission at Week 12, with endoscopic remission defined as a Mayo endoscopy subscore of 0
- 4. Incidence and severity of adverse events, with severity determined according to the DAIDS toxicity grading scale
- 5. Serum concentration of vixarelimab at specified timepoints
- 6. Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study
研究者
US Program Manager Product Development Regulatory
Scientific
Genentech Inc.
研究点 (66)
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