A Randomised, Active-Controlled, Double-Blind and Open Label Extensions Study to Evaluate the Efficacy, Long-Term Safety and Tolerability of TP05 3.2g/Day for the Treatment of Active Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 817
- 试验地点
- 1
- 主要终点
- Period 1: Clinical and Endoscopic Remission
研究概览
简要总结
The purpose of this research study was to compare the medication TP05 to the medication Asacol™ for the treatment of ulcerative colitis (UC) and to assess the safety and tolerability of TP05. This study investigated whether TP05 is as good as (non-inferior to) Asacol™(1).
(1)The trademark Asacol™ is registered in over 55 countries as Asacol™ and as Octasa™, Fivasa™, Lixacol™, Asacolon™ in the United Kingdom, France, Spain and Ireland, respectively. The rights to Asacol, including the rights to the trademark, are owned by Tillotts Pharma AG in various countries except for the following: Switzerland, USA, United Kingdom, Canada, Italy, Belgium, the Netherlands and Luxembourg.
详细描述
This is a Phase 3, randomised, double-blind, active-controlled, multi-centre, non-inferiority trial evaluating the safety and efficacy of 3.2 g of TP05/day compared to 3.2 g/day of Asacol™ with an open label extension to assess the long-term safety and tolerability of TP05 administered over a 26 week period. A total of 817 subjects with mildly to moderately active UC were evaluated. Eligible subjects were randomly assigned in a 1:1 ratio to receive 3.2 g/day of TP05 (administered once daily(OD)) or 3.2 g/day of Asacol™. The primary efficacy outcome was assessed at Week 8. All subjects who respond to TP05/Asacol™ (response or remission) continued receiving blinded study treatment for up to 12 weeks. After that, subjects could enroll in an Open Label Extension (OLE) for 26 weeks duration to receive TP05. Subjects failing to respond to study drug at the Week 8 visit could enroll in the OLE at week 8 and received 4.8 g/day of TP05.
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)
盲法说明
Double-blind
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Asacol 400 mg (Tillotts Pharma)
week 1 - week 12 (blinded), switch to TP05 for weeks 13-38 (open label)
干预措施: Asacol 400 mg (Drug)
TP05 (Mesalazine) 1600mg
week 1 - week 12 (blinded), week 13 - week 38 (OpenLabel)
干预措施: TP05 (Drug)
结局指标
主要结局
Period 1: Clinical and Endoscopic Remission
时间窗: Week 8
Mayo Score of \<= 2 points with no individual sub-score \> 1
Period 2: Clinical Response, Open-Label Extended Induction
时间窗: Week 16
A decrease in the PMCS of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.
Period 3: Clinical Remission
时间窗: Week 38
Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)
次要结局
- Period 3: Clinical and Endoscopic Remission(Week 38)
- Period 3: UC-Related Complications(Week 38)
- Period 1: Endoscopic Remission(Week 8)
- Period 1: Endoscopic Response(Week 8)
- Period 1: Clinical Response(Week 12)
- Period 1: Change in Stool Frequency Score(Baseline and Week 8)
- Period 1: Change in Rectal Bleeding Score From Baseline(Baseline and Week 8)
- Period 1: Change in Physician Global Assessment Score From Baseline(Baseline and Week 8)
- Period 3: Endoscopic Response(Week 38)
- Period 3: Rectal Bleeding Sub Score of 0(Week 38)
- Period 1: Clinical Remission(Week 12)
- Period 1: Rectal Bleeding Sub-score of 0(Week 8)
- Period 1: Clinical and Endoscopic Response(Week 8)
- Period 1: Rectal Bleeding Score of 0(Week 12)
- Period 1: Change in Mayo Score From Baseline(Baseline and Week 8)
- Period 1: Clinical Remission at Both Week 8 and 12(Week 8 and week 12)
- Period 1: Clinical Response at Both Week 8 and Week 12(Week 8 and Week 12)
- Period 2: Clinical Remission(Week 16)
- Period 2: Rectal Bleeding Sub-score of 0(Week 16)
- Period 2: Stool Frequency 0(Week 16)
- Period 1: Change in Partial Mayo Score From Baseline(Baseline and Week 8)
- Period 1: Change in Endoscopic Score From Baseline(Baseline and Week 8)
- Period 2: Urgency(Week 16)
- Period 2: UC-Related Complications(Week 16)
- Period 3: Clinical Response(Week 38)
- Period 3: Endoscopic Remission(Week 38)
- Period 3: Clinical and Endoscopic Response(Week 38)
- Period 3: Stool Frequency Sub-score 0(Week 38)
- Period 3: No Urgency(Week 38)