A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-945429 in Subjects With Moderate to Severe Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- CSL Behring
- 入组人数
- 72
- 试验地点
- 56
- 主要终点
- Percent of Participants With Clinical Remission (CDAI<150) as Measured by the Crohn's Disease Activity Index (CDAI)
研究概览
简要总结
The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with moderate to severe Crohn's disease and who have had an insufficient response to conventional therapy or have failed Anti-Tumor Necrosis Factor (anti-TNF) therapy.
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
- •Confirmed Crohn's Disease diagnosis via radiology, endoscopy or histology within prior 12 months. Diagnosed for at least 3 months
- •Active Disease with Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450
- •Failed conventional therapy or steroid dependent
排除标准
- •Diagnosed/clinical findings of Ulcerative Colitis (UC), indeterminate colitis, non colonic/ileal disease
- •Stricture/stenosis, Stoma, proctocolectomy, subtotal colectomy, ileorectal anastomosis
- •History of diverticulitis, or evidence of Gastrointestinal (GI) perforations
研究组 & 干预措施
Induction Cohort: BMS-945429 (Clazakizumab)(600 IV/200 SC mg)
干预措施: Placebo matching with BMS-945429 (Biological)
Induction Cohort: BMS-945429 (Clazakizumab)(300 IV/100 SC mg)
干预措施: Placebo matching with BMS-945429 (Biological)
Induction Cohort: BMS-945429 (Clazakizumab)(150 IV/100 SC mg)
干预措施: Placebo matching with BMS-945429 (Biological)
Induction Cohort: BMS-945429 (Clazakizumab)(400 SC/200 SC mg)
干预措施: Placebo matching with BMS-945429 (Biological)
Maintenance Cohort: Placebo matching with BMS-945429 (Clazakizumab)
干预措施: Placebo matching with BMS-945429 (Biological)
Induction Cohort: Placebo matching with BMS-945429 (Clazakizumab)
干预措施: Placebo matching with BMS-945429 (Biological)
Open Label Cohort: BMS-945429 (Clazakizumab)(200 SC mg)
干预措施: BMS-945429 (Biological)
Maintenance Cohort: BMS-945429 (Clazakizumab)(200 SC mg)
干预措施: BMS-945429 (Biological)
Maintenance Cohort: BMS-945429 (Clazakizumab)(100 SC mg)
干预措施: BMS-945429 (Biological)
Induction Cohort: BMS-945429 (Clazakizumab)(400 SC/200 SC mg)
干预措施: BMS-945429 (Biological)
Induction Cohort: BMS-945429 (Clazakizumab)(150 IV/100 SC mg)
干预措施: BMS-945429 (Biological)
Induction Cohort: BMS-945429 (Clazakizumab)(300 IV/100 SC mg)
干预措施: BMS-945429 (Biological)
Induction Cohort: BMS-945429 (Clazakizumab)(600 IV/200 SC mg)
干预措施: BMS-945429 (Biological)
结局指标
主要结局
Percent of Participants With Clinical Remission (CDAI<150) as Measured by the Crohn's Disease Activity Index (CDAI)
时间窗: At 8 weeks during the Induction Period
CDAI scores range from 0 to 600. A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease. A decrease in greater than 100 points indicates a clinically significant improvement in disease activity
次要结局
- Observed Maximum Concentration (Cmax) of Clazakizumab During the Induction Period(Week 0 and Week 4)
- Change From Baseline at Week 8 and 12 of Inflammatory Bowel Disease Questionnaire (IBDQ) Score(Week 8 and Week 12)
- Number of Participants During the Induction Period With Anti-clazakizumab Antibodies(Up to Week 12)
- Percent of Participants With Clinical Response (>100 Point Decrease in CDAI) During Induction Period as Measured by CDAI(At 8 weeks during the Induction Period)
- Steady-state Trough Concentration (Cmin) of Clazakizumab During the Induction Period(Week 4, Week 8)
- Area Under the Plasma Concentration-time Curve in One Dosing Interval [AUC(TAU)] of Clazakizumab During the Induction Period(Week 0, Week 4, Week 8)