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