A Phase 2, Multicenter, Platform Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics with Multiple Therapies in Participants With Active Crohns Disease or Active Ulcerative Colitis
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Mirador Therapeutics, Inc
- 入组人数
- 210
- 试验地点
- 6
- 主要终点
- a. Assess the proportion of participants reporting treatment emergent adverse events, serious adverse events, adverse events leading to discontinuation, and markedly abnormal laboratory values
概览
简要总结
A Phase 2, Multi-Center, Platform Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics with Multiple Therapies in Participants with Active Crohn’s Disease or Active Ulcerative Colitis (ASCEND-IBD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria Crohns Disease a.
- •Diagnosis of Crohn s Disease as confirmed by endoscopy and histopathology b.
- •Moderately to severely active CD as defined by Clinical Disease Activity Index and Simple Endoscopic Score c.
- •Meets drug stabilization requirements Inclusion Criteria Ulcerative Colitis a.
- •Diagnosis of Ulcerative Colitis as confirmed by endoscopy and histopathology b.
- •Moderately to severely active UC as defined by a 3 component MMCS c Meets drug stabilization requirements.
排除标准
- •Exclusion Criteria Crohns Disease a.
- •Diagnosis of indeterminate colitis b.
- •Suspected or diagnosed intra-abdominal or perianal abscess at Screening c.
- •Previous small bowel resection with combined resected length of greater than 100 cm or previous colonic resection of greater than 2 segments d.
- •CD isolated to the stomach duodenum jejunum or perianal region without colonic and or ileal involvement Exclusion Criteria Ulcerative Colitis a.
- •Current evidence or within recent history (within last 6 months) of fulminant colitis, toxic megacolon, or bowel perforation b.
- •Current stoma or impending need for colostomy or ileostomy c.
- •Received IV corticosteroids within 14 days prior to Screening or during the Screening Phase d.
- •Previous total proctocolectomy or subtotal colectomy.
结局指标
主要结局
a. Assess the proportion of participants reporting treatment emergent adverse events, serious adverse events, adverse events leading to discontinuation, and markedly abnormal laboratory values
时间窗: a. Time Frame Up to 13 weeks | b. Time Frame 13 weeks. | c. Time Frame 12 weeks | d. Time Frame 13 weeks | e. Time Frame 12 weeks
b. Assess the Proportion of Participants with Endoscopic Response as assessed by SES CD score.
时间窗: a. Time Frame Up to 13 weeks | b. Time Frame 13 weeks. | c. Time Frame 12 weeks | d. Time Frame 13 weeks | e. Time Frame 12 weeks
c. Assess the Proportion of Participants Endoscopic Improvement as assessed by MES.
时间窗: a. Time Frame Up to 13 weeks | b. Time Frame 13 weeks. | c. Time Frame 12 weeks | d. Time Frame 13 weeks | e. Time Frame 12 weeks
d. Assess the Proportion of Participants with Clinical Remission as assessed by CDAI score.
时间窗: a. Time Frame Up to 13 weeks | b. Time Frame 13 weeks. | c. Time Frame 12 weeks | d. Time Frame 13 weeks | e. Time Frame 12 weeks
e. Assess the Proportion of Participants with Clinical Remission by endoscopy, rectal bleeding and stool frequency
时间窗: a. Time Frame Up to 13 weeks | b. Time Frame 13 weeks. | c. Time Frame 12 weeks | d. Time Frame 13 weeks | e. Time Frame 12 weeks
次要结局
- a. Assess the Proportion of Participants with Clinical Remission as assessed by CDAI score.(b. Assess the Proportion of Participants with Clinical Remission by endoscopy rectal bleeding and stool frequency.)
- j. Characterize the Change in Endoscopy as assessed by SES CD.(k. Characterize the Change in Endoscopy Score as assessed by MES.)
研究者
Dr Radhika Bobba
PSI CRO PHARMA India Private Limited