EUCTR2018-004002-25-HU进行中（未招募）1 期
A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
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
- •1. Male or female, 18 years of age or older
- •2. Documented diagnosis of UC at least 3 months before screening
- •3. Moderately to severely active UC as defined by baseline modified Mayo score
- •4. History of inadequate response to or failure to tolerate conventional or advanced therapy as defined in the protocol
- •5. Screening laboratory test results within the study protocol defined parameters
- •Please see section 5.1 in the protocol for all inclusion criteria.
- •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 900
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Severe extensive colitis as defined in the study protocol
- •2. UC limited to the rectum only
- •3. Presence of a stoma
- •4. Presence or history of a fistula
- •5. Presence of symptomatic colonic or small bowel obstruction
- •6. History of extensive colonic resection
- •7. History of colonic mucosal dysplasia
- •8. Indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease.
- •Please see section 5.2 in the protocol for all exclusion criteria.
研究者
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