NCT03519945进行中（未招募）3 期
A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis LUCENT 3
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,058
- 试验地点
- 623
- 主要终点
- Percentage of Participants in Clinical Remission
研究概览
简要总结
This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC). The study will last up to 3 years. Participants who complete the 3-year study may continue to receive mirikizumab until it is (outside of this study) in their country or until they meet other discontinuation criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria
- •Participants from Study AMAC (NCT02589665) or AMBG (NCT03524092) who have had at least one study drug administration and have not had early termination of study drug.
- •Female participants must agree to contraception requirements.
排除标准
- •Participants must not have developed a new condition, including cancer in the originator study.
- •Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study
- •Participants may not have received surgery for UC in the originator study or are likely to require surgery for treatment of UC during the study.
- •Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study.
研究组 & 干预措施
Mirikizumab
Experimental
Mirikizumab administered subcutaneously (SC).
干预措施: Mirikizumab (Drug)
结局指标
主要结局
Percentage of Participants in Clinical Remission
时间窗: Week 52
Clinical remission based on the modified Mayo Score (MMS).
次要结局
- Percentage of Participants in Endoscopic Remission(Week 52)
- Percentage of Participants in Corticosteroid-free Remission(Week 52)
- Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Score(Baseline to Week 52)
- Percentage of Participants with Histologic-Endoscopic Mucosal Remission at Week 52(Week 52)
- UC Symptoms: Numeric Rating Score(Week 160)
- Percentage of Participants Who are Hospitalized Due to UC(Baseline to Week 160)
- Percentage of Participants Who Undergo UC Surgeries Including Colectomy(Baseline to Week 160)
研究者
研究点 (623)
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