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)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 65
- 主要终点
- Assess the proportion of participants reporting treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, and markedly abnormal laboratory values
研究概览
简要总结
This is a Phase 2, multicenter, platform study in adult participants with IBD (moderately to severely active Crohn's Disease or Ulcerative Colitis). The primary goal of this study is to assess the safety and efficacy of multiple investigational drugs.
详细描述
The purpose of this platform study is to assess the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) to evaluate multiple oral or parenteral experimental therapies for moderately to severely active Crohn's Disease or Ulcerative Colitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Prospective Observer-Blinded Endpoint
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Crohn's Disease:
- •Diagnosis of Crohn's Disease (CD), as confirmed by endoscopy and histopathology
- •Moderately to severely active CD as defined by Clinical Disease Activity Index (CDAI) and Simple Endoscopic Score (SES-CD)
- •Meets drug stabilization requirements
- •Inclusion Criteria-Ulcerative Colitis:
- •Diagnosis of Ulcerative Colitis (UC), as confirmed by endoscopy and histopathology
- •Moderately to severely active UC as defined by a 3-component MMCS
- •Meets drug stabilization requirements
排除标准
- •Crohn's Disease:
- •Diagnosis of indeterminate colitis
- •Suspected or diagnosed intra-abdominal or perianal abscess at Screening
- •Previous small bowel resection with combined resected length of > 100 cm or previous colonic resection of > 2 segments
- •CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement
- •Exclusion Criteria-Ulcerative Colitis:
- •Current evidence or within recent history (within last 6 months) of fulminant colitis, toxic megacolon, or bowel perforation
- •Current stoma or impending need for colostomy or ileostomy
- •Received IV corticosteroids within 14 days prior to Screening or during the Screening Phase
- •Previous total proctocolectomy or subtotal colectomy
研究组 & 干预措施
Intervention Specific Appendix- Crohn's Disease
Participants will receive MT-501 Tablets
干预措施: MT-501 (Drug)
Intervention Specific Appendix- Ulcerative Colitis
Participants will receive MT-501Tablets
干预措施: MT-501 (Drug)
Intervention Specific Appendix- Crohn's Disease with Standard of Care
Participants will receive multiple intravenous doses of MT-201 with standard of care
干预措施: MT-201 (Drug)
结局指标
主要结局
Assess the proportion of participants reporting treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, and markedly abnormal laboratory values
时间窗: Up to 13 weeks
Assess the Proportion of Participants with Endoscopic Response (CD)
时间窗: 13 weeks
Endoscopic response as assessed by SES-CD score.
Assess the Proportion of Participants Endoscopic Improvement (UC)
时间窗: 12 weeks
Endoscopic improvement as assessed by MES.
Assess the Proportion of Participants with Clinical Remission (CD)
时间窗: 13 weeks
Clinical remission as assessed by CDAI score.
Assess the Proportion of Participants with Clinical Remission (UC)
时间窗: 12 weeks
Clinical remission as assessed by endoscopy, rectal bleeding and stool frequency.
次要结局
- Assess the Proportion of Participants with Clinical Remission (CD)(13 weeks)
- Assess the Proportion of Participants with Clinical Remission (UC)(12 weeks)
- Assess the Proportion of Participants with Symptomatic Remission (CD and UC)(Up to 13 weeks)
- Assess the Proportion of Participants with Clinical Response (CD)(13 weeks)
- Assess the Proportion of Participants with Clinical Response (UC)(12 weeks)
- Assess the Proportion of Participants with Endoscopic and Clinical Response (CD Only)(13 weeks)
- Assess the Proportion of Participants with Histologic Response (UC Only)(12 weeks)
- Assess the Proportion of Participants with Histologic Remission (UC only)(12 weeks)
- Assess the Proportion of Participants with Histologic-Endoscopic Mucosal Improvement (UC only)(12 weeks)
- Characterize the Change in Endoscopy Score (CD)(13 weeks)
- Characterize the Change in Endoscopy Score (UC)(12 weeks)
- Characterize the Change in Histology Score (CD)(13 weeks)
- Characterize the Change in Histology Score (UC)(12 weeks)
- Asses the Pharmacokinetics (PK) (e.g., Trough Concentration [Ctrough]) of Investigational Drug(Up to 13 weeks)
- Assess immunogenicity(13 weeks)