A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 12
- 主要终点
- Clinical remission (CDAI score of <150)
研究概览
简要总结
The purpose of this study is to determine whether BMS-936557 is effective for the treatment of moderate to severely active Crohn's Disease in patients who have had insufficient response and/or intolerance to conventional therapy for Crohn's Disease.
详细描述
Anti-IP10: Anti Interferon-inducible ligand 10
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
- •Adults subjects with confirmed Crohn's Disease (CD) for at least 3 months
- •Moderate to severely active CD as defined by Crohn's Disease Activity Index (CDAI) 220 to 450
- •In the past have had insufficient response and or intolerance to ≥ 1 of the conventional therapy (immunosuppressants, corticosteroids and/or approved biologic therapy)
排除标准
- •Ulcerative colitis (UC) or indeterminate colitis
- •Short bowel syndrome
- •Known stricture or noninflammatory stenosis leading to symptoms of obstruction
- •Current stoma or current need for colostomy or ileostomy
研究组 & 干预措施
Cohort 1: Induction
Placebo
干预措施: Placebo (Drug)
Cohort 2: Induction
Anti-IP-10 Antibody
干预措施: BMS-936557 (Anti-IP-10 Antibody) (Drug)
Cohort 3: Induction
Anti-IP-10 Antibody
干预措施: BMS-936557 (Anti-IP-10 Antibody) (Drug)
Cohort 1: Maintenance
Placebo
干预措施: Placebo (Drug)
Cohort 2: Maintenance
Anti-IP-10 Antibody
干预措施: BMS-936557 (Anti-IP-10 Antibody) (Drug)
Cohort 3: Maintenance
Anti-IP-10 Antibody
干预措施: BMS-936557 (Anti-IP-10 Antibody) (Drug)
Cohort 1: Open Label
Anti-IP-10 Antibody
干预措施: BMS-936557 (Anti-IP-10 Antibody) (Drug)
结局指标
主要结局
Clinical remission (CDAI score of <150)
时间窗: Week 11
CDAI: Crohn's Disease Activity Index
次要结局
- Proportion of subjects in clinical remission (defined by an absolute CDAI score < 150)(Week 7 and Week 11)
- Safety of BMS-936557 in the induction period defined by proportion of subjects reporting AE, SAEs, AEs leading to discontinuation, and markedly abnormal laboratory values(Week 11)
- Proportion of subjects in clinical response (defined as CDAI score reduction from Baseline of ≥ 100 points or an absolute CDAI score of < 150)(Week 7 and Week 11)
- Mean change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)(Week 11)