Early Phase 2 Clinical Trial of E6011 in Patients With Active Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 46
- 主要终点
- Percentage of Participants With Clinical Response (CR) 100 (CR100) at Week 12
研究概览
简要总结
The primary purpose of this study is to examine the efficacy and safety of E6011 at 12 weeks after administration by means of double-blind placebo-controlled trial.
详细描述
Participants with moderate to severe Crohn's disease will be enrolled in this study.
The study will include screening period, remission-induction period (double-blind), rescue period (open-label), extension period (open-label), post-observation period, and a follow-up period.
At the end of remission-induction period, participants with reduction in Crohn's disease activity index (CDAI) score of 70 points or more when compared to baseline will move on to the open-label extension period, and participants with less than 70 points reduction in CDAI score will move on to the rescue period. At the end of the rescue period, participants with a reduction in the CDAI of 70 points or more will move on to the open-label extension period and with less than 70 points reduction in the CDAI score will be discontinued.
The post-observation period will include in-person assessment after the completion or discontinuation of the extension period, and participants will be contacted by telephone, etc. after the last dose of study drug administration. Participants will be contacted over phone after the last dose of study drug administration for follow up assessments.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has diagnosed on basis of clinical findings, endoscopic findings, etc. with small intestine-type, small and large-intestine type, or large-intestine type Crohn's disease at least 12 weeks before giving consent.
- •With a baseline (at week 0 before the start of investigational medicinal product [IMP] administration) disease severity ranging from moderate to severe. CDAI score between 220 and 450, and a PRO2 score between 14 and
- •With a SES-CD >=7 (or for participants with isolated ileal disease, >=4 in ileum segment) in the screening period, with one or more ulcers (in SES-CD score, ulcer presence subscore >=1 in any segment) assessed by colonoscopy and confirmed by a centralised review.
- •Who received adrenocorticosteroids or immunomodulators in the past, but showed no therapeutic response (insufficient response) or the drugs were not tolerated (intolerance). Alternatively, participants who cannot taper adrenocorticosteroids (dependence). Alternatively, participants who showed no therapeutic response after administering biologic(s) (primary nonresponse), participants who initially showed therapeutic response but it lessened or disappeared afterwards (secondary nonresponse), or participants who did not tolerate the drug (intolerance).
- •If the participants are taking aminosalicylic acid (5-ASA), salazosulfapyridine, or antibiotics for the treatment of Crohn's disease (metronidazole, ciprofloxacin, etc.), the dosage and administration have not changed for at least 4 weeks prior to the start of the IMP administration.
- •If the participants are taking under 30 milligram per day (mg/day) of oral prednisolone (or equivalent adrenocorticosteroid) or 9 mg/day or less of oral budesonide, the dosage and administration have not changed for at least 4 weeks prior to the start of the IMP administration.
- •If the participants are taking azathioprine (AZP), 6-mercaptopurine (6-MP) or methotrexate (MTX), the dosage and administration have not changed for at least 8 weeks prior to the start of the IMP administration.
排除标准
- •Diagnosed with ulcerative colitis or indeterminate colitis.
- •Diagnosed with gastrointestinal epithelial dysplasia.
- •Who have an abscess or are suspected to have one.
- •With an artificial anus, ileo-anal pouch or fistula.
- •With symptomatic or high-grade gastrointestinal stenosis (participants who require expansion by endoscopy or who require have SES-CD score stenosis sub-score of 3, etc.).
- •Who, after undergoing small bowel resection, have been diagnosed with a short bowel syndrome, which makes maintaining caloric intake difficult.
研究组 & 干预措施
E6011
干预措施: E6011 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Clinical Response (CR) 100 (CR100) at Week 12
时间窗: At Week 12
CR100 was defined as clinical response with a reduction of greater than or equal to (\>=) 100 points in CDAI score from baseline. The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. The sub scores of abdominal pain (0-3), general well-being (0-4, higher values mean worse well-being), and number of very soft or liquid stools were then summed. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
次要结局
- Percent Change From Baseline in Steroid Dosage in Participants Concomitantly Using Adrenocorticosteroids up to Week 64(Baseline up to Week 64)
- Percentage of Participants With CR70 and CR100(At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64)
- Percentage of Participants With Below 150 CDAI Points(At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64)
- Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2)(At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64)
- Percentage of Participants With Below 8 Points in PRO2(At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64)
- Percentage of Participants With at Least 50 Percent (%) Improvement in (Endoscopic Response) Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 12(At Week 12)
- Percentage of Participants With Less Than or Equal to (<=) 2 (Endoscopic Remission) SES-CD Score at Week 12(At Week 12)
- Change From Baseline in CDAI Score(Baseline, at Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64)
- Percent Change From Baseline in CDAI Score(Baseline, at Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64)
- Change From Baseline in PRO2(Baseline, at Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64)
- Percent Change From Baseline in PRO2(At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64)
- Change From Baseline in SES-CD Score at Week 12(Baseline, at Week 12)
- Percent Change From Baseline in SES-CD Score at Week 12(Baseline, at Week 12)
- Percentage of Participants Who Achieved Steroid-free Remission up to Week 64(Up to Week 64)
- Percentage of Participants Who Achieved Steroid-free Improvement up to Week 64(Up to Week 64)
- Change From Baseline in Steroid Dosage in Participants Concomitantly Using Adrenocorticosteroids up to Week 64(Baseline up to Week 64)