A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of VAY736 in Autoimmune Hepatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 32
- 主要终点
- ALT (Alanine aminotransferase) normalization
研究概览
简要总结
VAY736 dose testing; VAY736 efficacy and safety testing.
详细描述
This is a randomized, placebo-controlled, double-blind dose range study in autoimmune hepatitis. The study population consists of female and male adult autoimmune hepatitis patients with incomplete response or intolerant to standard treatment of care. The diagnosis of autoimmune hepatitis has to fulfill the IAIHG criteria and must be confirmed by liver histology.
Patients will be randomly assigned to different doses of VAY736 or placebo. The primary analysis is planned at 24 weeks. A subsequent study part will then test the efficacy and safety of VAY736 in a parallel group design. For this part of the trial a new group of autoimmune hepatitis patients will be enrolled.
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)
盲法说明
Double blind, placebo-controlled
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
- •AIH diagnosed per International Autoimmune Hepatitis Group
- •Liver biopsy with Ishak modified HAI indicating active AIH
- •Incomplete response to OR intolerance of standard therapy (per AASLD)
排除标准
- •Prior use of any B-cell depleting therapy (e.g., rituximab or other anti-CD20 mAb, anti-CD22 mAb or anti-CD52 mAb) within 1 year prior to Screening or as long as B-cell count <50 cells/µL
- •Required regular use of medications with known hepatotoxicity
- •Decompensated cirrhosis
- •Diagnosis of overlap syndrome with AIH (e.g., AIH+PBC, AIH+PSC).
- •Drug related AIH at screening or a history of drug related AIH.
- •History of drug abuse or unhealthy alcohol use
- •History of malignancy of any organ system
- •Pregnant or nursing (lactating) women
研究组 & 干预措施
Arm 1
VAY736 Dose 1
干预措施: VAY736 (Biological)
Arm 2
VAY736 Dose 2
干预措施: VAY736 (Biological)
Arm 3
VAY736 Dose 3
干预措施: VAY736 (Biological)
Arm 4
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
ALT (Alanine aminotransferase) normalization
时间窗: Week 24
Difference in ALT normalization
次要结局
- ALT normalization by dose(Week 24)