Parallel-Group Treatment, Double-Blind, 2-Arm to Investigate Comparative Efficacy Safety Immunogenicity Between Intravenous AVT16 and Entyvio® in Male and Female Subjects 18 to 80 Years Inclusive, Moderate to Severe Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 301
- 试验地点
- 99
- 主要终点
- Clinical Response at week 6
研究概览
简要总结
The study has been designed as a randomised, parallel-group, double-blind, 2 arm study of the comparative efficacy, safety and immunogenicity of AVT16 and Entyvio in male and female subjects with moderate to severe active ulcerative colitis.
详细描述
The study will consist of a screening period, a treatment and assessment period and an End of Study visit. Eligibility for the study will be determined during a screening period. Subjects who meet the eligibility criteria will be randomised to either AVT16 or Entyvio.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of giving signed informed consent
- •Male and female subjects from 18 to 80 years of age
- •Diagnosis of Ulcerative Colitis
排除标准
- •Diagnosis of Crohn's colitis
- •Extensive colonic resection
- •Active or latent tuberculosis
研究组 & 干预措施
AVT16
Experimental Arm AVT16 300mg iv is the proposed biosimilar for Entyvio (vedolizumab)
干预措施: AVT16 (Biological)
Entyvio
Entyvio (vedolizumab) 300mg iv is the proposed active comparator for AVT16
干预措施: Vedolizumab (Biological)
结局指标
主要结局
Clinical Response at week 6
时间窗: Week 6
Change in Mayo Score/Disease Activity for Ulcerative Colitis. Scale 0-12, higher score - worse outcome
次要结局
- Clinical Response at week 52(Week 52)