NCT03155932终止2 期
An Open-label, Pilot, Proof of Concept Study to Evaluate the Safety, Tolerability, and Efficacy of Oral Etrasimod (APD334) in Patients With Primary Biliary Cholangitis
Arena Pharmaceuticals9 个研究点 分布在 3 个国家目标入组 2 人开始时间: 2017年12月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 9
- 主要终点
- Change in Serum Alkaline Phosphatase (ALP) Concentration
研究概览
简要总结
The purpose of this open-label, pilot, proof of concept study is to evaluate the safety, tolerability, and efficacy of oral etrasimod (APD334) in participants with primary biliary cholangitis (PBC).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 18 to 80 years (inclusive) at the time of screening, with confirmed Primary Biliary Cholangitis (PBC) diagnosis based upon at least 2 of 3 criteria:
- •Anti-mitochondrial antibodies (AMA) titer >1:40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies (anti-GP210 and/or anti-SP100)
- •Alkaline phosphatase (ALP) >1.5 x upper limit of normal (ULN) for at least 6 months
- •Liver biopsy findings consistent with PBC
- •Use of ursodeoxycholic acid (UDCA) for at least 6 months prior to screening (stable dose for at least 3 months immediately prior to screening)
- •Participants must have ALP >1.5 x ULN but <10 x ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <5 x ULN, and total bilirubin <ULN, at all screening visits
- •AST, ALT, ALP, and total bilirubin must have 2 values at least 4 weeks apart that are within 20% of each other
排除标准
- •Chronic liver disease of a non-PBC etiology. However, PBC participants accompanied with primary Sjögren's syndrome (pSS) are eligible to be enrolled.
- •History or evidence of clinically significant hepatic decompensation
- •Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease)
- •Clinically significant infections within 6 weeks prior to treatment start, or infection with hepatitis C virus anytime in the past
- •Immunosuppressive, immunomodulating, or investigational agents within 30 days prior to treatment start
- •Treatment with obeticholic acid (OCA) within 30 days prior to Day 1
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
APD334
Experimental
APD334 active treatment for 24 weeks.
干预措施: APD334 (Drug)
结局指标
主要结局
Change in Serum Alkaline Phosphatase (ALP) Concentration
时间窗: Baseline, Week 24
Reduction in ALP concentration is a surrogate marker of slower disease progression.
Number of Participants With Adverse Events
时间窗: Up to Week 26
Safety was assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
次要结局
- Change in Serum ALP Concentration(Baseline, Week 12)
- Pharmacokinetic Parameters of Etrasimod, and Its Metabolites(Up to Week 24)
研究者
研究点 (9)
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