EUCTR2017-003238-96-ES进行中（未招募）1 期
A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,044
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. Have completed Study AMAN, with at least 1 study drug administration, without early termination of study drug, and underwent a Visit 5 (Week 12) endoscopy.
- •2. Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.
- •3. 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 940
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 104
排除标准
- •1. Participants diagnosed with Crohn’s disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN.
- •2. Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN, or are likely to require surgery for the treatment of UC during study AMBG.
- •3. Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN.
- •4. Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN.
- •5. Participants who initiate a new prohibited medication during the induction study AMAN.
- •6. Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug.
研究者
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