EUCTR2017-003229-14-HU进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,160
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
- •Principal Inclusion Criteria are as follows:
- •1. Male or female patients =18 and =80 years of age at the time of initial screening
- •2. Diagnosis of UC for at least 3 months prior to baseline.
- •3. Confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS).
- •4. Demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC.
- •5. If female, must meet the contraception requirements.
- •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 1044
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 116
排除标准
- •Principal Exclusion Criteria are as follows:
- •1. Patients with a current diagnosis of Crohn’s disease or inflammatory bowel disease-unclassified (indeterminate colitis).
- •2. Patients with a previous colectomy.
- •3. Patients with current evidence of toxic megacolon.
- •4. Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).
研究者
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