NCT04205643已完成3 期
A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Ulcerative Colitis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 548
- 试验地点
- 2
- 主要终点
- Percentage of Patients Achieving Clinical Remission at Week 54
研究概览
简要总结
This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is male or female aged 18 to 75 years, inclusive.
- •Patient has moderately to severely active UC with a modified Mayo score of 5 to 9 points with endoscopic subscore of ≥ 2 points
排除标准
- •Patient who has previously received 2 or more biologic agents and/or JAK inhibitors
- •Patient who has previously received either a TNFα inhibitor or biologic agent within 5 half-lives
结局指标
主要结局
Percentage of Patients Achieving Clinical Remission at Week 54
时间窗: Week 54
Clinical remission defined by modified Mayo score which ranges from 0 to 9, including Stool frequency subscore, Rectal bleeding subscore and Endoscopic subscore but excluding Physician's global assessment subscore from the Total Mayo score. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
次要结局
- Percentage of Patients Achieving Corticosteroid-Free Remission at Week 54(Week 54)
- Percentage Patients Achieving Clinical Response at Week 54(Week 54)
- Percentage of Patients Achieving Endoscopic-Histologic Mucosal Improvement at Week 54(Week 54)
研究者
研究点 (2)
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