NCT02768974Unknown2 期
An Open Label, Proof of Concept Study to Assess the Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis
Protalix7 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 7
- 主要终点
- Adverse events following daily administration of OPRX 106
研究概览
简要总结
This is a proof of concept, randomized, open label, 2-arm study of OPRX-106 in subjects with active mild to moderate ulcerative colitis. Eligible subjects will be enrolled and randomized to receive 2 mg or 8 mg of OPRX-106 administered orally, once daily for 8 weeks.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have had a diagnosis of ulcerative colitis for a minimum of 3 months
- •Have active mild to moderate ulcerative colitis, as defined by a full Mayo score at screening
- •Have adequate cardiac, renal and hepatic functions as determined by the investigator and demonstrated by screening clinical and laboratory evaluations, and physical examination results
- •High level of calprotectin (>100 mg/kg of stool)
排除标准
- •Have a history of colonic or rectal surgery other than hemorrhoidal surgery or appendectomy
- •.Positive for active/ latent mycobacterium tuberculosis (TB) infection
- •.Have a history of infection requiring administration of any IV antibiotic, antiviral or antifungal medication or any oral anti-infective agent
- •Severe ulcerative colitis
- •Ulcerative proctitis, defined as disease limited to less than 15 cm from the anal verge
- •Use >4.8 g 5-ASA or equivalent
- •Use of corticosteroid or 5-ASA enemas, foams, or suppositories
- •Use of anti-inflammatory medications or natural remedies
- •Use oral or parenteral antibiotics
- •Use of chronic non-steroidal anti-inflammatory (NSAID) therapy
- •Use of immune suppressive agents including anti-TNF agents, Azathioprine, 6MP, Methotrexate
- •Use of steroids
- •Have a diagnosis of: Crohn's disease; Indeterminate colitis; Microscopic colitis; Ischemic or infectious colitis; Clostridium difficile colitis, Parasitic disease
研究组 & 干预措施
OPRX-106 2 mg
Experimental
Open label, 1:1 randomization ration (up to 10 subjects)
干预措施: OPRX-106 (Drug)
OPRX-106 8 mg
Experimental
Open label, 1:1 randomization ration (up to 10 subjects)
干预措施: OPRX-106 (Drug)
结局指标
主要结局
Adverse events following daily administration of OPRX 106
时间窗: 70 days
Adverse events from subject reporting or other assessments
次要结局
未报告次要终点
研究者
研究点 (7)
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