A Long-term Extension Study of Mirikizumab (LY3074828) in

Primary Investigator

Administratively Closed

18 years or above

All

Phase 3

778 participants needed

2 Locations

Brief description of study

The reason for this study is to determine the long-term efficacy and safety of the study drugkizumab in participants with Crohn's disease.

You may be eligible for this study if you meet the following criteria:

Inclusion Criteria:

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

Exclusion Criteria:

Participants must not have developed a new condition, including cancer in the previousudy (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 eithervious 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.

- 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

Updated on 13 Dec 2024. Study ID: GI-LILLY-VIVID-2-AMAX, 16628, 2009694997