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A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

NCT04232553

Active Not RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Crohn's Disease

Interventions: Mirikizumab

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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 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 (322)
  • Dothan, Alabama, United States
  • Litchfield Park, Arizona, United States
  • Phoenix, Arizona, United States
  • Gilroy, California, United States
  • Huntington Beach, California, United States
  • Northridge, California, United States
  • Bristol, Connecticut, United States
  • Clearwater, Florida, United States
  • Clearwater, Florida, United States
  • Kissimmee, Florida, United States
  • Miami, Florida, United States
  • Orlando, Florida, United States
  • Pensacola, Florida, United States
  • Sunrise, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Marietta, Georgia, United States
  • Idaho Falls, Idaho, United States
  • Evansville, Indiana, United States
  • Indianapolis, Indiana, United States
  • Monroe, Louisiana, United States
  • Chevy Chase, Maryland, United States
  • Glen Burnie, Maryland, United States
  • Chesterfield, Michigan, United States
  • Farmington Hills, Michigan, United States
  • Plymouth, Minnesota, United States
  • St Louis, Missouri, United States
  • Las Vegas, Nevada, United States
  • Teaneck, New Jersey, United States
  • + 292 more on CT.gov