JPRN-jRCT2031220662招募中2 期
A Phase 2, multi-center, randomized, double-blind, placebo-controlled parallel-group study to evaluate the efficacy and safety of dupilumab therapy in patients with moderately to severely active ulcerative colitis with an eosinophilic phenotype
Tanaka Tomoyuki0 个研究点目标入组 100 人开始时间: 2023年2月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Participants must be >= 18 years of age at the time of signing the informed consent.
- •- Evidence of biomarker enrichment at time of screening
- •- Moderately to severely active UC, defined as a baseline modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopic subscore assigned during the concurrent local and central reading of the video endoscopy.
- •- Has a screening endoscopy with >= 2 endoscopic subscore in the Mayo score component assessment as determined by concurrent local and central reading of the video endoscopy.
- •- Has a baseline rectal bleeding subscore of >=1 and baseline a stool frequency score of >=1 as determined by the Mayo score component assessment.
- •- Participants with inadequate response/non-response, loss of response, or are intolerant of standard biologic therapy for their UC
- •Inadequate or non-responders, have shown loss of response, or are intolerant to at least 1 of the following treatments: oral corticosteroids (<=20 mg/day), 5-ASA compounds, immunomodulators, small molecules.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •- Severe extensive colitis as evidenced by:
- •- - Current hospitalization
- •- - Likely to require surgery for the treatment of UC within 12 weeks of Screening Visit
- •- UC limited to the rectum only or to <20 cm of the colon.
- •- Presence of an ileal pouch, ostomy, stoma or fistula or history of a fistula.
- •- Require, or required within the 2 months before screening, surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage, or other conditions possibly confounding the evaluation of benefit from study agent treatment.
- •- Has a prior medical history of eosinophilic colitis.
- •- Participants with abdominal abscess, fulminant disease, or toxic megacolon.
- •- Participants with intestinal failure or short bowel syndrome.
- •- Presence of symptomatic colonic or small bowel obstruction, confirmed by objective radiographic or endoscopic evidence of a stricture with resulting obstruction (dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy).
- •- History of extensive colonic resection (eg, less than 30 cm of colon remaining) that would prevent adequate evaluation of the effect of study agent on clinical disease activity.
- •- History of colonic mucosal dysplasia or presence of adenomatous colonic polyps not removed OR presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during colonoscopy at screening visit.
- •- If the participant has extensive colitis for >=8 years or disease limited to left side of colon (ie, distal to splenic flexure) for >10 years, regardless of age, a colonoscopy within 1 year of the screening visit is required to survey for dysplasia. Participants with dysplasia or cancer identified on biopsies will be excluded.
- •- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease.
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