EUCTR2018-003303-19-PL进行中（未招募）1 期
A Phase II randomized, placebo controlled, double-blind, 4 arms dose-ranging study to evaluate the efficacy and safety of SHR0302 compared to placebo in patients with moderate to severe active Crohn’s Disease.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 144
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 age = 18 and =75 years of age at randomization.
- •Subjects with a documented at least three-month history of diagnosed ileal, colonic, or ileocolonic Crohn’s Disease at the time of randomization.
- •Currently having Crohn’s Disease with Crohn’s Disease Activity Index (CDAI) score = 220 to =450.
- •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 137
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •Diagnosis of indeterminate colitis, or clinical findings suggestive of Ulcerative Colitis.
- •Subject with CD with stoma, gastric or ileoanal pouch, proto-colectomy or total colectomy, symptomatic stenosis or stricture, history of bowel perforation, suspected abscess; actively draining fistula.
- •Treatment naïve subjects diagnosed with Crohn’s disease (without previous exposure to any of the following therapies for CD treatment: 5-
- •ASA, corticosteroids, immune-suppressants, or biological treatment).
研究者
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