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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT04232553

Run by

Eli Lilly and Company

People needed

996

Starts

2020-06-22

Expected to finish

2027-04-01

Last updated by the study team

2025-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Research Solutions of Arizona — Litchfield Park, Arizona, United States
• Arizona Arthritis & Rheumatology Research, PLLC — Phoenix, Arizona, United States
• Care Access - Gilroy — Gilroy, California, United States
• Newport Huntington Medical Group — Huntington Beach, California, United States
• California Medical Research Associates — Northridge, California, United States
• Connecticut Clinical Research Institute — Bristol, Connecticut, United States
• Gastroenterology Consultants of Clearwater — Clearwater, Florida, United States
• Clinical Research of West Florida, Inc. (Clearwater) — Clearwater, Florida, United States
• IHS Health Research — Kissimmee, Florida, United States
• Ezy Medical Research — Miami, Florida, United States
• Care Access - Orlando — Orlando, Florida, United States
• Gastroenterology Associates of Pensacola, PA — Pensacola, Florida, United States
• Precision Clinical Research — Sunrise, Florida, United States
• USF Health — Tampa, Florida, United States
• Alliance Clinical Research of Tampa — Tampa, Florida, United States
• Digestive Healthcare of Georgia — Atlanta, Georgia, United States
• Gastrointestinal Specialists of Georgia — Marietta, Georgia, United States
• Grand Teton Research Group — Idaho Falls, Idaho, United States
• Qualmedica Research, LLC — Evansville, Indiana, United States
• Indiana University Health University Hospital — Indianapolis, Indiana, United States
• Delta Research Partners — Monroe, Louisiana, United States
• Capital Digestive Care - Chevy Chase — Chevy Chase, Maryland, United States
• Woodholme Gastroenterology Associates - Glen Burnie — Glen Burnie, Maryland, United States
• The Digestive Health Center of Michigan (DHCMI) — Chesterfield, Michigan, United States
• Digestive Health Specialists — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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