NCT05910528进行中（未招募）2 期
A Phase 2, Multicenter, Double-blind, Two-arm Study of Subcutaneous RO7790121 for the Treatment of Subjects With Moderate to Severe Active Crohn's Disease
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 21
- 试验地点
- 18
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE) and AE Leading to Discontinuation
研究概览
简要总结
This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of Afimkibart (RO7790121, RVT-3101) in adult participants with moderate to severe active Crohn's disease.
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
- •Moderately to severely active CD as defined by CDAI and SES-CD, assessed by central read
- •Elevated very soft or liquid stool frequency and/or abdominal pain
- •Must have no response, insufficient response, loss of response and/or intolerance to at least 1 conventional therapy (e.g. corticosteroids) or advanced therapy
排除标准
- •Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis or active diverticular disease
- •Short gut syndrome
- •Presence of an ostomy or ileoanal pouch
- •Bowel resection or diversion with ~6-months
研究组 & 干预措施
Treatment Sequence A; Drug: Afimkibart (RO7790121) Induction dose A, Maintenance dose and OLE dose
Experimental
干预措施: Afimkibart (Drug)
Treatment Sequence B; Drug: Afimkibart (RO7790121) Induction dose B, Maintenance dose and OLE dose
Experimental
干预措施: Afimkibart (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE) and AE Leading to Discontinuation
时间窗: Until end of study, approximately 5 years
次要结局
- Proportion of Participants Achieving Endoscopic Response(Week 14)
- Proportion of Participants Achieving Clinical Remission by Crohn's Disease Activity Index (CDAI)(Week 14)
- Proportion of Participants Achieving Clinical Remission by Patient Reported Outcome 2 (PRO2)(Week 14)
- Trough Concentration (Ctrough)(Up to Week 64)
研究者
研究点 (18)
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