2022-502841-91-00招募中3 期
I6T-MC-AMAX; A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients With Crohn’s Disease
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 338
- 试验地点
- 81
- 主要终点
- Percentage of Participants Achieving Endoscopic Response (Endoscopic response based on Simple Endoscopic Score for Crohn’s Disease (SES-CD) total score) [Time Frame: Week 52]
研究概览
简要总结
To evaluate the long-term efficacy and safety of mirikizumab in participants with Crohn’s disease
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130)
- •If female, participant must meet the contraception requirements.
排除标准
- •Participants must not have developed a new condition, including cancer in the previous study (I6T-MC-AMAG or I6T-MC-AMAM) that would pose an unacceptable risk in the trial.
- •Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either previous study.
- •Participants must not have a known hypersensitivity to any component of mirikizumab or have experienced acute systemic hypersensitivity event with previous study drug administration in the originating study that precludes mirikizumab therapy.
- •Participation must not be pregnant, lactating, or planning to become pregnant while enrolled in the study or 16 weeks after receiving the last dose of study drug.
结局指标
主要结局
Percentage of Participants Achieving Endoscopic Response (Endoscopic response based on Simple Endoscopic Score for Crohn’s Disease (SES-CD) total score) [Time Frame: Week 52]
Percentage of Participants Achieving Endoscopic Response (Endoscopic response based on Simple Endoscopic Score for Crohn’s Disease (SES-CD) total score) [Time Frame: Week 52]
Percentage of Participants Achieving Clinical Remission (Clinical remission based on CDAI) [Time Frame: Week 52]
Percentage of Participants Achieving Clinical Remission (Clinical remission based on CDAI) [Time Frame: Week 52]
次要结局
未报告次要终点
研究者
Lilly Clinical Trials information desk
Scientific
Eli Lilly & Co.
研究点 (81)
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