NCT01839214已完成2 期
A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects With Mild to Moderate Ulcerative Colitis
Vascular Biogenics Ltd. operating as VBL Therapeutics1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Modified Mayo Score indicating remission
研究概览
简要总结
This study will examine the safety and efficacy in subjects with mild to moderate ulcerative colitis, as measured by Modified Mayo Score, Modified Baron Score, IBDQ, calprotectin and other assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, ≥18 years of age, who has a diagnosis of active UC for at least 6 months prior to screening
- •A rectal/colonic biopsy obtained previously and consistent with a diagnosis of UC
- •Endoscopy (flexible sigmoidoscopy unless surveillance colonoscopy is clinically indicated) confirming diagnosis of UC within 2 weeks prior to randomization
- •Endoscopy (flexible sigmoidoscopy unless surveillance colonoscopy is clinically indicated) confirming diagnosis of UC within 2 weeks prior to randomization
- •Active UC despite previous treatment with at least one 5-ASA compound at a dose of ≥2000 mg/day for at least 4 weeks or documented intolerance to such therapy
排除标准
- •Diagnosis of indeterminate colitis, Crohn's disease, or clinical findings suggestive of Crohn's disease (fistula or granulomas on biopsy) or microscopic colitis (collagenous colitis or lymphocytic colitis)
- •Subject whose symptoms are likely caused by factors other than inflammatory UC, including infection or irritable bowel syndrome (IBS)
- •History of dysplasia on colonic biopsy
- •Subject with ≥ 8 year history of pancolitis or ≥ 15 year history of left sided colitis unless a colonoscopy with surveillance biopsies to screen for colon cancer has been performed within the past year
- •Subject ≥ 50 years of age who has not had a colonoscopy to screen for colorectal polyps and colon cancer within the past 5 years
- •Subject who has had any prior surgical resection of any part of the colon excluding the appendix
- •Previous treatment with any biologic product including investigational biologic products within 1 year prior to baseline visit
- •The subject is taking Systemic corticosteroids, Azathioprine/6-mercaptopurine/methotrexate, immunosuppressants, Oral 5-ASA compounds unless they have been on a stable dose of sufficient duration prior to Baseline. If recently discontinued the subject must have had a wash-out periods of sufficient duration prior to Baseline
- •Rectally administered corticosteroids or 5-ASA, antibiotics for the treatment of UC and probiotics within 14 days of the Baseline Visit and throughout the study
- •The subject has with a stool culture positive for pathogenic ova or parasites, enteric pathogens or Clostridium difficile toxin at the Screening Visit
- •Presence of, or history of cancer, with the exception of skin cancer
研究组 & 干预措施
VB-201 160mg
Experimental
Subjects will received 80mg twice daily for 24 weeks.
干预措施: VB-201 160mg (Drug)
Placebo with crossover to VB-201 160mg
Placebo Comparator
Subjects on placebo will crossover to VB-201 160 at week 12.
干预措施: VB-201 160mg (Drug)
Placebo with crossover to VB-201 160mg
Placebo Comparator
Subjects on placebo will crossover to VB-201 160 at week 12.
干预措施: Placebo (Drug)
结局指标
主要结局
Modified Mayo Score indicating remission
时间窗: Week 12 and Week 24
The proportion of subjects in remission at Weeks 12 and 24 in the VB-201 160mg (80 mg BID) treatment group compared to placebo group.
次要结局
- Modified Mayo Score indicating response(Week 12 and Week 24)
研究者
研究点 (1)
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