EUCTR2022-003365-38-BG招募中1 期
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VTX958 in Participants with Moderately to Severely Active Crohn’s Disease
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 132
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
- 性别
- All
入选标准
- •1. Men or women, 18 to 75 years of age, inclusive, at the time of consent.
- •2. Capable of giving signed informed consent.
- •3. Documented diagnosis of CD = 3 months prior to Day 1. The diagnosis of CD must be confirmed by clinical, endoscopic, and histologic evidence.
- •4. Moderately to severely active CD.
- •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 122
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, or infectious colitis.
- •2. Presence of a stoma or ileoanal pouch.
- •3. Presence of currently known complications of CD such as fulminant colitis, toxic megacolon or any other manifestation that may require surgery or hospitalization.
- •4. Known diagnosis of short gut or bowel syndrome.
- •5. Previous exposure to VTX958 or any other TYK2 inhibitor (eg, deucravacitinib) in any study.
研究者
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