A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of CBP-307 in Subjects With Moderate to Severe Ulcerative Colitis (UC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 66
- 主要终点
- Change From Baseline for Adapted Mayo Score: 0.2 mg Versus Placebo
研究概览
简要总结
This study will evaluate the efficacy and safety of CBP-307 in subjects with moderate to severe ulcerative colitis (UC).
详细描述
This is a multicenter, multicountry, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the efficacy and safety of CBP-307 in subjects with moderate to severe ulcerative colitis (UC). CBP-307 capsules are administered orally. This study includes stage 1 and stage 2.
Study Stage 1 After screening, subjects entered the randomized, double-blind, placebo-controlled induction therapy for 12 weeks.
Subjects were screened at 1 to 21 days prior to the baseline visit. The eligible subjects were enrolled and randomized at the baseline visit. As per study protocol (version 5.0 or earlier), subjects received CBP 307 0.1 mg, CBP-307 0.2 mg, and placebo at a ratio of 1:1:1. The subjects enrolled under protocol (version 6.0) were randomized to CBP-307 0.2 mg and placebo at a ratio of 1:1 into the 2 groups (approximately 52 subjects in each group) and stratified according to whether the subject failed a previous tumor necrosis factor (TNF)-α antagonist therapy. Subjects assigned were blinded to their treatment assignment (CBP-307 or placebo) in the 12-week double-blinded placebo-controlled treatment period.
Subjects randomized to CBP-307 group underwent dose titration for 1 week, while those in placebo group underwent simulated titration. Both CBP-307 and placebo were administered through the oral route. For subjects in the CBP-307 0.1 mg QD group, a daily dose of 0.05 mg CBP-307 was given from Day 1 to Day 4; then a daily dose of 0.1 mg CBP-307 was given for 3 days from Day 5 to Day 7; from Day 8, a daily target dose of 0.1 mg was administered. For subjects in the group of CBP-307 0.2 mg QD, a daily dose of 0.05 mg CBP-307 was given from Day 1 to Day 4; then, a dose of 0.1 mg CBP-307 was given daily for 3 days from Day 5 to Day 7; from Day 8, a daily target dose of 0.2 mg was administered.
For the subjects already enrolled as per study protocol version 5.0 or earlier, they continued the treatment in the Stage 1 according to the previous planned schedule.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Double-Blind 0.1mg CBP-307
0.1 mg CBP-307 capsules oral administration.
干预措施: Double-Blind 0.1mg CBP-307 (Drug)
Double-Blind 0.2mg CBP-307
0.2 mg CBP-307 capsules oral administration.
干预措施: Double-Blind 0.2mg CBP-307 (Drug)
Double-Blind Placebo
Placebo capsules oral administration.
干预措施: Double-Blind Placebo (Drug)
Open-Label CBP-307
0.2 mg CBP-307 capsules oral administration.
干预措施: Open-label CBP-307 (Drug)
结局指标
主要结局
Change From Baseline for Adapted Mayo Score: 0.2 mg Versus Placebo
时间窗: The adapted Mayo score was evaluated at screening and Week 12 (or early termination visit) during the study Stage 1 as well as at Week 24 (only for the sub-study 2) and Week 48 (or early termination visit) during the study Stage 2.
Change in adapted Mayo score from baseline at week 12 compared between CBP-307 0.2 mg and placebo in the Full Analysis Set by Multiple Imputation. Adapted Mayo scores were calculated based on data in stool frequency, rectal bleeding, and endoscopic findings. The Mayo scores range from 0 to 9 and consist of 3 subscores, each ranging from 0 to 3. The higher the score is, the more severe the disease is.
次要结局
- Comparison of Clinical Response Rate by Adapted Mayo Score(at Week 12)
- Comparison of Clinical Remission Rate by Adapted Mayo Score(at Week 12)
- Change in Complete Mayo Score From Baseline(at Week 12)
- Comparison of Clinical Response Rate by Complete Mayo Score(at Week 12)
- Comparison of Clinical Remission Rate by Complete Mayo Score(at Week 12)
- Mucosal Healing Rate(at Week 12)
- Incidence, Type and Severity of Treatment Emergent Adverse Event (TEAE)(for 12 consecutive weeks)
- Incidence, Type and Severity of Serious Adverse Event (SAE)(for 12 consecutive weeks)
- Incidence, Type and Severity of Adverse Events (AE)(for 12 consecutive weeks)
- Change From Baseline in Adapted Mayo Score: 0.1 mg Versus Placebo(at Week 12)