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 - VIVID-2

Eli Lilly and Company0 个研究点目标入组 778 人开始时间: 2020年5月18日最近更新: 2022年1月17日

研究概览

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•1. Participants who have completed the Phase 2 Study I6T-MC-AMAG (EudraCT 2016- 002204-84), and in the opinion of the investigator, would derive clinical benefit from continued treatment with mirikizumab
•2. Participants who have completed the Phase 3 Study I6T-MC-AMAM (2018-004614-18) and in the opinion of the investigator would derive clinical benefit from treatment with mirikizumab
•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 708
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 70

•-Participants must not have developed a new condition, including cancer in the previous study (I6T-MC-AMAG or I6T-MC-AMAM)
•-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
•Note: Participants with a history of active TB with documentation of
•treatment by the CDC and/or WHO criteria prior to the originator study
•are not excluded from 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
•-Participants must not have a known hypersensitivity to any component of mirikizumab or have experienced an acute systemic hypersensitivity
•event with previous study drug administration in the originating study that precludes mirikizumab therapy.
•-Participants 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.

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