A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohns Disease

Eli Lilly and Company India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年7月22日

研究概览

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•1. Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130).
•2. If female, participant must meet the contraception requirements.

•1. 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.
•2. 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 Centers for Disease Control (CDC) and/or World Health Organization (WHO) criteria prior to the originator study are not excluded from the study.)
•3. Participants must not have developed adenomatous polyps during the originator study that have been removed prior to the start of this study.
•4. 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.
•5. 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.

发起方

Eli Lilly and Company India Pvt Ltd