An Open Label, Dose Ranging, Exploratory Study to Evaluate the Safety, Tolerability, Compliance, Mechanism of Action and Efficacy of QBECO Site Specific Immunomodulation for the Induction of Clinical Response and Remission in Subjects With Moderate to Severe Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 3
- 主要终点
- Proportion of subjects in clinical remission
研究概览
简要总结
The purpose of this open-label, dose-ranging, exploratory study is to evaluate the safety, tolerability, compliance, mechanism of action and efficacy of QBECO site specific immunomodulation for the induction of clinical response and remission in subjects with moderate to severe ulcerative colitis
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects who have reached age of majority
- •Willing to learn and able to self-administer study drug
- •Diagnosis of UC established at least 6 months before screening visit, by clinical and endoscopic evidence.
- •Currently experiencing moderate to severe active UC defined as a Mayo score of 6-12 (inclusive) at Screening.
- •Endoscopic evidence of active mucosal disease, as assessed by flexible sigmoidoscopy, with an Endoscopic Finding Sub-score of ≥2 at Screening.
- •Rectal Bleeding Sub-score of ≥1 at Screening.
- •Physician's Global Assessment Sub-score of ≥2 at Screening.
- •Male/female subjects who agree to practice effective methods of contraception
排除标准
- •History of colonic or rectal surgery other than hemorrhoid surgery or appendectomy
- •Currently receiving total parenteral nutrition
- •Disease limited to ulcerative proctitis
- •Diagnosed with Crohn's disease, indeterminate colitis, microscopic colitis or, ischemic or infectious colitis
- •Known or suspected hypersensitivity to any component of the product
- •Known human immunodeficiency virus (HIV) infection or other immunosuppressive disorder
- •Concurrently participating in another study or receiving other experimental or investigational therapies within past 3 months
- •Females who are currently pregnant or lactating
- •Any history of malignancy. Exceptions may apply for cervical cancer and some forms of skin cancer
研究组 & 干预措施
QBECO SSI 0.02 mL
0.02 mL administered subcutaneously, every other day for 16 weeks. After completion of the initial 16-week fixed dose treatment period, subjects deemed to be responders will be randomized to one of three maintenance dosing schedules (every second day, weekly, no treatment) for an additional 36 weeks.
干预措施: QBECO SSI (Biological)
QBECO SSI 0.05 mL
0.05 mL administered subcutaneously, every other day for 16 weeks. After completion of the initial 16-week fixed dose treatment period, subjects deemed to be responders will be randomized to one of three maintenance dosing schedules (every second day, weekly, no treatment) for an additional 36 weeks.
干预措施: QBECO SSI (Biological)
QBECO SSI 0.1 mL
0.1 mL administered subcutaneously, every other day for 16 weeks. After completion of the initial 16-week fixed dose treatment period, subjects deemed to be responders will be randomized to one of three maintenance dosing schedules (every second day, weekly, no treatment) for an additional 36 weeks.
干预措施: QBECO SSI (Biological)
结局指标
主要结局
Proportion of subjects in clinical remission
时间窗: Week 52
Mayo score ≤ 2 points, with no individual subscore \>1
Incidence of treatment emergent AEs and clinically significant changes or abnormalities from physical examinations, vital signs and laboratory results (composite)
时间窗: Day 1 to Week 56
次要结局
- Proportion of subjects with a clinical response(Week 52)
- Proportion of subjects in clinical remission(Week 16)