NCT01659138终止2 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Efficacy and Safety of SAR339658 in Patients With Active Moderate to Severe Ulcerative Colitis (UC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 28
- 试验地点
- 41
- 主要终点
- Proportion of Participants with Clinical Response by Mayo Score
研究概览
简要总结
Primary Objective:
To assess the efficacy of SAR339658
Secondary Objective:
To assess the safety of SAR339658
详细描述
The study period per patient will include up to 4 weeks screening, 8 weeks treatment, 6 weeks post treatment safety follow-up, followed by a long term safety follow-up performed in the form of a phone interview at 3, 6, 12, 18 and 24 months from the last administration of the study medication.
After completion of the 8-week treatment phase, patients may be eligible to enter a long term safety study (LTS12593) for active treatment with SAR339658.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SAR339658
Experimental
SAR339658 at Weeks 0, 2, 4, and 6
干预措施: SAR339658 (Drug)
Placebo
Placebo Comparator
Placebo at Weeks 0, 2, 4, and 6
干预措施: Placebo (Other)
结局指标
主要结局
Proportion of Participants with Clinical Response by Mayo Score
时间窗: At Week 8
次要结局
- Proportion of Participants with Clinical Remission by Mayo Score(At Week 8)
- Proportion of Participants with Mucosal Healing(At Week 8)
- Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)(At Weeks 4 and 8)
- Change from Baseline in Quality of Life (QoL) SF-36(At Weeks 4 and 8)
- Change from Baseline in the partial Mayo Score(At Weeks 4 and 6)
- Number of Participants with adverse events(Up to Week 17)
研究者
研究点 (41)
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