A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Ulcerative Colitis (UC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 305
- 试验地点
- 24
- 主要终点
- Proportion of the subjects with clinical remission (defined as Mayo score ≤ 2 points with no individual subscore > 1 point) of BMS-936557 with that of the placebo
研究概览
简要总结
The purpose of this study is to determine whether BMS-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical therapy for 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
- 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
- •Clinical diagnosis of moderate to severe UC confirmed by endoscopic and histologic evidence
- •Mayo score ≥6 with an endoscopic subscore of ≥2
- •Inadequate response and/or intolerance to one or more conventional therapy (i.e. oral aminosalicylates, immunosuppressants, corticosteroids, and/or TNF antagonist)
排除标准
- •Diagnosis of Crohn's Disease or Indeterminate Colitis
- •Diagnosis of UC that is limited to the rectum
- •Evidence of fulminant colitis, toxic megacolon, or bowel perforation
- •Current need for a colostomy or ileostomy
- •Previous total or subtotal colectomy
研究组 & 干预措施
Cohort 1: Induction
Placebo or Anti-IP-10 Antibody
干预措施: Placebo (Drug)
Cohort 1: Induction
Placebo or Anti-IP-10 Antibody
干预措施: Anti-IP-10 Antibody (Drug)
Cohort 2: Induction
Placebo or Anti-IP-10 Antibody
干预措施: Placebo (Drug)
Cohort 2: Induction
Placebo or Anti-IP-10 Antibody
干预措施: Anti-IP-10 Antibody (Drug)
Cohort 3: Induction
Placebo or Anti-IP-10 Antibody
干预措施: Placebo (Drug)
Cohort 3: Induction
Placebo or Anti-IP-10 Antibody
干预措施: Anti-IP-10 Antibody (Drug)
Maintenance
Placebo or Anti-IP-10 Antibody
干预措施: Placebo (Drug)
Maintenance
Placebo or Anti-IP-10 Antibody
干预措施: Anti-IP-10 Antibody (Drug)
Open Label
干预措施: Anti-IP-10 Antibody (Drug)
结局指标
主要结局
Proportion of the subjects with clinical remission (defined as Mayo score ≤ 2 points with no individual subscore > 1 point) of BMS-936557 with that of the placebo
时间窗: End of Induction [Week 11, Induction Period-78 (IP-78)]
次要结局
- Proportion of subjects with mucosal healing (defined as endoscopy subscore of ≤1 point) of BMS-936557 with that of the placebo(IP-78 (Week 11))
- Mean change from baseline at Inflammatory Bowel Disease Questionnaire (IBDQ) of subjects treated with BMS-936557 and placebo(Baseline (IP-1, Week 1) and IP-78 (Week 11))
- Proportion of the subjects with clinical response of BMS-936557 with that of the placebo(IP-78 (Week 11))
- Proportion of subjects reporting Adverse event (AE), Serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values(IP-78 (Week 11))