Phase Ib Escalating Dose, Open-Label, Signal-Finding Study to Evaluate the Safety, Tolerability, and Short-Term Efficacy of the Anti-Light Monoclonal Antibody MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis Who Previously Failed Treatment With an Anti-TNFα Agent
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 13
- 主要终点
- Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD)
研究概览
简要总结
This is a Phase 1b, open-label, dose-escalation, signal-finding, multi-center study. The study will evaluate the safety, tolerability, pharmacokinetics and short-term efficacy of MDGN-002 in adults with moderate to severe, active Crohn's disease or Ulcerative Colitis who have previously failed anti-tumor necrosis factor alpha (anti-TNFα) treatment.
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
- None
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
- •Subject is male or female, ≥ 18 to ≤ 75 years of age.
- •Subject has a documented diagnosis of CD via endoscopy/colonoscopy and histological confirmation, or subject has received a diagnosis of UC for 90 days or greater prior to Visit 1, confirmed by endoscopy during the Screening Period, with exclusion of current infection, dysplasia and/or malignancy.
- •Subject has moderate to severe, active CD as evidenced Simple Endoscopy Score for Crohn's Disease (SES-CD) score of ≥7, and histological confirmation, or subject has moderately to severely active UC, as defined by a Modified Mayo Score (excluding the PGA component) of 5 to 9 points at Visit
- •Subject has failed treatment with an approved therapeutic dose of an anti-TNFα monoclonal antibody treatment.
排除标准
- •Subject has a diagnosis of ulcerative colitis (UC) or indeterminate colitis or subject has a diagnosis of Crohn's disease or indeterminate colitis .
- •Subject with signs or symptoms of bowel obstruction.
- •Subject has short bowel syndrome.
- •Subject has a current functional colostomy or ileostomy.
- •Subject has had a surgical bowel resection within the past 6 months prior to screening or is planning any resection during the study period.
- •Subject is pregnant or a nursing mother.
- •Subject is sexually active and not using effective contraception as defined in the protocol.
研究组 & 干预措施
MDGN-002
MDGN-002 will be supplied in vials of 150 mg/mL. MDGN-002 will be administered by SQ injection in the abdomen every 14 days at 1 of 2 dose levels: 1.0 mg/kg or 3.0 mg/kg.
干预措施: MDGN-002 (Drug)
结局指标
主要结局
Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD)
时间窗: Baseline to Visit 10 (Day 56) or early termination
The SES-CD is assessed through endoscopic review of 5 predefined gastrointestinal (GI) segments (ileum; right colon; transverse colon; left colon; rectum). For each segment, 4 endoscopic variables are assessed (presence of ulcers, ulcerated surface, affected surface, and presence of narrowing). Each variable is scored from 0 to 3 with higher scores indicating more severe symptoms. For each variable, the total score is calculated as the sum across all segments of the GI tract. The SES-CD total score, ranging from 0-60, is calculated as the sum of all variable total scores with a higher score indicating more severe endoscopic activity
次要结局
- Change From Baseline in Total Number of Loose/Watery Stools Daily(Baseline to Visit 10 (Day 56) or Early Termination)
- Change From Baseline in Total Number of Stools Daily(Baseline to Visit 10 (Day 56) or Early Termination)
- Change From Baseline in Crohn's Disease Activity Index (CDAI)(Baseline to Visit 10 (Day 56) or early termination.)
- Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBD-Q).(Baseline to Visit 10 (Day 56) or Early Termination)
- Change From Baseline in Abdominal Pain(Baseline to Visit 10 (Day 56) or Early Termination)
- Change From Baseline in General Well-Being(Baseline to Visit 10 (Day 56) or Early Termination)