EUCTR2021-000092-37-CZ进行中（未招募）1 期
A Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects with Moderately to Severely Active Crohn’s Disease
Prometheus Biosciences, Inc. a subsidiary of Merck & Co., Inc.0 个研究点目标入组 50 人开始时间: 2021年6月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male or female = 18 years of age.
- •- A diagnosis of CD (confirmed by endoscopy + histology)
- •- Moderately to severely active CD as defined by CDAI of = 220 and = 450.
- •- SES-CD score = 6 if ileocolonic or colonic disease; or = 4 if isolated ileal disease only.
- •- Subjects must have had insufficient response and/or intolerance to conventional therapy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- WOCBP and men with WOCBP partner unwilling/ unable to use two highly effective methods of contraception
- •- Women who are pregnant or breastfeeding
- •- Women with a positive pregnancy test on enrollment or prior to Day 1
- •- Diagnosis of ulcerative colitis or indeterminate colitis
- •- CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement
- •- Suspected or diagnosed intra-abdominal or perianal abscess at Screening
- •- Known symptomatic stricture or stenosis not passable in endoscopy (including pediatric colonoscope)
- •- Current stoma or need for colostomy or ileostomy
- •- Previous small bowel resection with combined resected length of > 100 cm or previous colonic resection of > 2 segments
- •- Currently receiving total parenteral nutrition
- •- Surgical bowel resection within 3 months before screening
- •- Concomitant PSC
- •- Prior exposure to PRA023
- •- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness
- •- Legal or mental incapacitation, or inability to understand and comply with the requirements of the study
研究者
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