A Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of GED-0507-34-Levo (GED0507) for Treatment of Subjects With Active Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 60
- 主要终点
- Efficacy on Ulcerative Colitis Disease Activity Index
研究概览
简要总结
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 2 doses of GED-0507-34-Levo in subjects with active, mild-to-moderate UC.
详细描述
This is a Phase 2, Proof of Concept, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 2 doses of GED-0507-34-Levo in subjects with active, mild-to-moderate Ulcerative Colitis.
The study will consist of 3 phases:
- Screening Phase - up to 4 weeks
- Double-blind Placebo-controlled Phase - Weeks 0 to 8
- Follow-up Phase - Week 9
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)
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 aged 18 and over at the time of signing the informed consent.
- •Diagnosis of UC with a duration of at least 3 months prior to the Screening Visit.
- •MMS ≥ 4 to ≤ 8 (range: 0 - 9) prior to randomization in the study
- •Subjects are required to have a colonoscopy if one has not been performed within 12 months prior to the Screening Visit.
- •Subjects who have relapsed on maintenance therapy with doses of 5-ASA ≤ 2.4 g/day
排除标准
- •Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis, or diverticular disease-associated colitis.
- •UC restricted to the distal 15 cm or less (eg, ulcerative proctitis).
- •Subjects who have had surgery as a treatment for UC or who, in the opinion of the Investigator, are likely to require surgery for UC during the study.
- •Clinical signs suggestive of fulminant colitis or toxic megacolon.
- •Evidence of pathogenic enteric infection.
- •History of colorectal cancer or colorectal dysplasia.
- •Prior use of any TNF inhibitor (or any biologic agent).
- •Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine, or thalidomide.
- •Use of budesonide-MMx within the last 8 weeks.
- •Use of oral and/or IV corticosteroids within 2 weeks of the Screening Visit.
- •Use of immunosuppressants (azathioprine [AZA], 6-mercaptopurine [6-MP] or methotrexate [MTX]) within 8 weeks of the Screening Visit.
研究组 & 干预措施
80 mg BID
GED-0507-34-Levo 80 mg BID for 8 Weeks
干预措施: GED-0507-34-Levo 80 mg (Drug)
160 mg BID
GED-0507-34-Levo 160 mg BID for 8 Weeks
干预措施: GED-0507-34-Levo 160 mg (Drug)
Placebo
Placebo BID for 8 Weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy on Ulcerative Colitis Disease Activity Index
时间窗: up to 8 Weeks
After 17 months, only 19 patients out of the target 207 patients, were enrolled in the study. Therefore neither descriptive nor comparative analyses were performed on outcome measures and the project in mild to moderate ulcerative colitis has been terminated.
次要结局
未报告次要终点