A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease (VIVID-2)
M
Monika Fischer, MD
Primary Investigator
Enrolling By Invitation
18 years and older
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Crohn's Disease
-
Age: 18 Years
-
Gender: All
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 theCenters for Disease Control (CDC) and/or World Health Organization (WHO) criteria prior tothe originator study are not excluded from the study.- Participants must not have a known hypersensitivity to any component of mirikizumab orhave experienced acute systemic hypersensitivity event with previous study drugadministration in the originating study that precludes mirikizumab therapy.- Participation must not be pregnant, lactating, or planning to become pregnant whileenrolled in the study or 16 weeks after receiving the last dose of study drug
Updated on
01 Aug 2024.
Study ID: GI-LILLY-VIVID-2-AMAX, 16628, 2009694997
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