A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.

Key facts

Study ID

NCT03926130

Run by

Eli Lilly and Company

People needed

1158

Starts

2019-07-23

Expected to finish

2023-10-02

Last updated by the study team

2024-12-27

Who can join

Age: 15 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of CD for at least 3 months prior to baseline
• Confirmed diagnosis of moderate to severe CD as assessed by SF, AP score, and SES-CD
• Demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD
• If female, subject must meet the contraception recommendations

You may not qualify if…

• Have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (IBD-U) (formerly known as indeterminate colitis) or short bowel syndrome
• Currently have or are suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained, adequately treated and resolved at least 3 weeks prior to baseline or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
• Have a stoma, ileoanal pouch or ostomy
• Have had a bowel resection within 6 months, or any kind of intra-abdominal or extra abdominal surgery within 3 months of baseline
• Have ever received any monoclonal antibodies binding IL-23

Where it is running

• Digestive Health Specialists — Dothan, Alabama, United States
• Lakeview Clinical Research — Guntersville, Alabama, United States
• Care Access Research - Tuscaloosa — Tuscaloosa, Alabama, United States
• Research Solutions of Arizona — Litchfield Park, Arizona, United States
• Central Arizona Medical Associates, PC — Mesa, Arizona, United States
• Arizona Arthritis & Rheumatology Research, PLLC — Phoenix, Arizona, United States
• Reliance Research — Scottsdale, Arizona, United States
• Synexus Site Network — Tempe, Arizona, United States
• inSite Digestive Health Care — Arcadia, California, United States
• B G Clinical Research, Inc. — Encinitas, California, United States
• Care Access - Gilroy — Gilroy, California, United States
• Newport Huntington Med Grp — Huntington Beach, California, United States
• Om Research, LLC — Lancaster, California, United States
• GastroIntestinal Biosciences Clinical Trials — Los Angeles, California, United States
• California Medical Research Associates — Northridge, California, United States
• University of California Irvine — Orange, California, United States
• inSite Digestive Health Care — Pasadena, California, United States
• Care Access Research - San Jose — San Jose, California, United States
• Wolverine Clinical Trials, LLC — Santa Ana, California, United States
• Fomat Medical Research, Inc. — Thousand Oaks, California, United States
• Connecticut Gastroenterology — Manchester, Connecticut, United States
• IMR of South Florida — Aventura, Florida, United States
• Gastroenterology Consultants of Clearwater — Clearwater, Florida, United States
• West Central Gastroenterology d/b/a Gastro Florida — Clearwater, Florida, United States
• University of Alabama-The Kirklin Clinic — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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