EUCTR2019-004469-41-DE进行中（未招募）1 期
A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 169
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 and female subjects age 18 (or the minimum country specific age of consent if >18) to 75 years.
- •2. Diagnosis of UC for = 8 weeks prior to screening supported by appropriate documentation of biopsy results consistent with UC.
- •3. Moderate to severe active UC
- •4. Demonstrated inadequate response, loss of response, or intolerance of at least 1 of oral aminosalicylates (5-ASAs), corticosteroids, immunomodulators, or a biological.
- •See protocol for further 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 152
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •1. Subject with a current diagnosis of Crohn's disease (CD), indeterminate colitis (IC), microscopic colitis.
- •2. History of colonic dysplasia (other than completely removed low-grade dysplastic lesion).
- •3. History of active bacterial, viral, fungal or mycobacterial infection requiring hospitalization or IV antibiotic/anti-infective treatment within 4 weeks of screening or oral antibiotics/antiinfectives within 2 weeks of screening.
- •4. Positive stool test for C. difficile.
- •5. Chronic recurrent or serious infection.
- •6. Known primary or secondary immunodeficiency.
- •7. Pregnant or lactating female or considering becoming pregnant during the study or within 30 days after the last dose of study medication.
- •See protocol for further exclusion criteria
研究者
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