A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 171
- 试验地点
- 202
- 主要终点
- Induction - Proportion of participants with clinical remission.
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of cobitolimod treatment compared to placebo in inducing clinical remission, in participants with moderate to severe active left-sided UC and to evaluate the efficacy of cobitolimod maintenance treatment compared to placebo in inducing or maintaining clinical remission at week 52, in participants with clinical response at week 6 after induction treatment with cobitolimod.
详细描述
This phase III study protocol includes an induction study for 6 weeks and a maintenance study for an additional 45 weeks.
In the induction study there will be an initial phase to explore the best dose, between cobitolimod 250 mg and cobitolimod 500 mg using adaptive design.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cobitolimod 250 mg
Dose of 250 mg cobitolimod
2 treatments during induction study and subsequently every third week
干预措施: Cobitolimod 250 mg (Drug)
Cobitolimod 500 mg
Dose of 500 mg cobitolimod
2 treatments during induction study and subsequently every third week
干预措施: Cobitolimod 500 mg (Drug)
Placebo
Dose of Placebo
2 treatments during induction study and subsequently every third week
干预措施: Placebo (Drug)
结局指标
主要结局
Induction - Proportion of participants with clinical remission.
时间窗: Week 6
Clinical remission defined by the 3-component Mayo score.
Maintenance - Proportion of participants with clinical remission.
时间窗: Week 52
Clinical remission defined by the 3-component Mayo score.
次要结局
- Induction - Proportion of participants with symptomatic remission.(Week 6)
- Induction - Mean stool frequency.(Week 6)
- Induction - Proportion of participants with histologic remission.(Week 6)
- Induction - Proportion of participants with mucosal healing.(Week 6)
- Induction - Mean IBDQ total score.(Week 6)
- Maintenance - Proportion of participants with clinical remission and steroid-free.(Week 52)
- Induction - Proportion of participants with normalisation of stool frequency.(Week 6)
- Induction - Proportion of participants with endoscopic improvement.(Week 6)
- Induction - Proportion of participants with absence of rectal bleeding.(Week 6)
- Induction - Proportion of participants with clinical response.(Week 6)
- Induction - Proportion of participants with histologic improvement.(Week 6)
- Maintenance - Proportion of participants with histologic improvement.(Week 52)
- Maintenance - Proportion of participants with clinical response.(Week 52)
- Maintenance - Proportion of participants with absence of rectal bleeding.(Week 52)
- Maintenance - Mean 3-component and 4-component Mayo scores.(Week 52)
- Induction - Mean ln-transformed faecal calprotectin.(Week 6)
- Induction - Mean 3-component and 4-component Mayo scores.(Week 6)
- Induction - Proportion of participants with an improvement in IBDQ total score.(Week 6)
- Maintenance - Proportion of participants with endoscopic improvement.(Week 52)
- Maintenance - Proportion of participants with clinical remission among those who achieved clinical remission(Week 52)
- Maintenance - Proportion of participants with symptomatic remission.(Week 52)
- Maintenance - Proportion of participants with histologic remission.(Week 52)
- Maintenance - Proportion of participants with mucosal healing.(Week 52)
- Maintenance - Proportion of participants with normalisation of stool frequency.(Week 52)
- Maintenance - Mean stool frequency.(Week 52)
- Maintenance - Mean ln-transformed faecal calprotectin.(Week 52)
- Maintenance - Mean IBDQ total score.(Week 52)
- Maintenance - Proportion of participants with an improvement in IBDQ total score.(Week 52)