ECO-RESET: A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Clinical Remission (Count of Participants)
研究概览
简要总结
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER-287 in Adults with Active Mild-to-Moderate Ulcerative Colitis
详细描述
This is a Phase 2B randomized, double-blind, placebo-controlled, multiple dose, multicenter study designed to evaluate the efficacy, safety and microbiome alterations associated with two dose levels of SER-287, after pre-treatment with vancomycin, in adult subjects, age 18-80, with active mild-to-moderate ulcerative colitis (UC).
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Documented diagnosis of UC at least three months prior to screening, and with a minimum disease extent of 15 cm from the anal verge
- •Active mild-to-moderate UC
- •Inadequate response to, loss of response to, or intolerance of, at least one of the following conventional therapies: 5-ASA compounds, corticosteroids, 6-mercaptopurine (6-MP) or azathioprine (AZA), anti-TNFα, anti-integrin or tofacitinib
排除标准
- •Known history of Crohn's disease
- •No previous history of treatment for UC (treatment-naïve)
- •Subjects on steroid medication who are unable to have steroids tapered and be completely off steroids at least two weeks prior to screening
- •Unable to stop steroid enemas or suppositories, or 5-ASA enemas or suppositories, at least two weeks prior to screening
- •Subjects who have received any investigational or approved biologic therapy within eight weeks or five half-lives prior to screening (whichever is longer)
- •Subjects who have received any investigational or approved non-biologic therapy, except for those specifically listed in the Permitted Concomitant Medications, for the treatment of underlying disease, within 30 days or five half-lives prior to screening (whichever is longer)
- •Major gastrointestinal surgery (not including appendectomy or cholecystectomy) within two months before screening, or any history of total colectomy
研究组 & 干预措施
Placebo (after placebo pre-treatment)
Once-daily dosing of Placebo (after placebo pre-treatment)
干预措施: Placebo for Vancomycin Pre-Treatment (Drug)
Placebo (after placebo pre-treatment)
Once-daily dosing of Placebo (after placebo pre-treatment)
干预措施: Placebo for SER-287 (Drug)
SER-287 Induction Dosing (after vancomycin pre-treatment)
Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)
干预措施: Vancomycin Pre-Treatment (Drug)
SER-287 Induction Dosing (after vancomycin pre-treatment)
Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)
干预措施: SER-287 (Drug)
SER-287 Step-Down Induction Dosing (after vancomycin pre-treatment)
Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)
干预措施: Vancomycin Pre-Treatment (Drug)
SER-287 Step-Down Induction Dosing (after vancomycin pre-treatment)
Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)
干预措施: SER-287 (Drug)
结局指标
主要结局
Clinical Remission (Count of Participants)
时间窗: After 10 weeks of induction dosing
Clinical remission for the induction treatment period: * Stool Frequency subscore = 0 or 1, with at least 1-point decrease from baseline * Rectal Bleeding subscore = 0 * Endoscopic subscore = 0 or 1 on modified Mayo Score, with at least 1-point decrease from baseline * No occurrence of UC Flare during the treatment period Clinical remission was measured using 3 components of the modified Mayo Score (stool frequency, rectal bleeding and endoscopic subscore), a measure of UC disease activity. These 3 components are each graded from 0 to 3, and are summed together for a composite score, with a higher overall score indicating more severe disease (0 = no disease; 9 = worst disease). The modified Mayo endoscopic subscore excludes friability from an endoscopic subscore of 1.
次要结局
- Endoscopic Improvement (Count of Participants)(After 10 weeks of induction dosing)