A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
Phase 3 – large-scale trial before approval
Conditions:
Crohn's Disease
Sponsor: Eli Lilly and Company
trial.available_in:
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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.
Who can participate
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.
Locations
30
Argentina (1)
DOM Centro de Reumatología
Buenos Aires
Australia (1)
Concord Repatriation General Hospital
Concord , New South Wales
Belgium (1)
Imelda General Hospital
Bonheiden , Antwerpen
Brazil (1)
CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição
Salvador , Estado de Bahia
Canada (1)
Gastroenterology and internal medicine research institute