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

Completed · Phase 2 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

The purpose of this study is to evaluate the safety and effectiveness of the study drug Mirikizumab in participants with active Crohn's Disease.

Key facts

Study ID

NCT02891226

Run by

Eli Lilly and Company

People needed

191

Starts

2016-12-14

Expected to finish

2021-02-05

Last updated by the study team

2022-08-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Active Crohn's Disease (CD) as determined by the SES-CD, and participant reported stool frequency and abdominal pain.
• Inadequate response or failure to tolerate at least one of the following: aminosalicylates; budesonide; systemic corticosteroids; immunosuppressants (eg, azathioprine, 6-mercaptopurine, or methotrexate); or prior exposure to biologics for the treatment of CD.

You may not qualify if…

• Have complications of CD such as strictures, stenoses, or any other manifestation for which surgery might be indicated, or that could confound the evaluation of efficacy.
• Diagnosis of conditions affecting the digestive tract, such as ulcerative colitis, indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome.
• Have had any kind of bowel resection, diversion, or placement of a stoma within 6 months or any other intra-abdominal surgery within 3 months prior to screening.
• Are unsuitable for inclusion in the study in the opinion of the investigator or sponsor for any reason that may compromise the subject's safety or confound data interpretation.

Where it is running

• Del Sol Research Management, LLC — Tucson, Arizona, United States
• Valley View Internal Medicine — Garden Grove, California, United States
• Ventura Clinical Trials — Ventura, California, United States
• Delta Waves Sleep Disorders and Research Center — Colorado Springs, Colorado, United States
• Medical Research Center of Connecticut — Hamden, Connecticut, United States
• Clinical Research of West Florida — Clearwater, Florida, United States
• Wellness Clinical Research — Hialeah Gardens, Florida, United States
• University of Miami — Miami, Florida, United States
• Vista Health Research — Miami, Florida, United States
• Clinical Neuroscience Solutions Inc — Orlando, Florida, United States
• Digestive Healthcare of Georgia — Atlanta, Georgia, United States
• Columbus Regional Research Institute — Columbus, Georgia, United States
• Indiana University Health — Indianapolis, Indiana, United States
• Robley Rex VAMC — Louisville, Kentucky, United States
• Health Quest Medical Care — Owensboro, Kentucky, United States
• Delta Research Partners LLC — Monroe, Louisiana, United States
• Louisiana Research Center — Shreveport, Louisiana, United States
• MedStar Health Research Institute — Rosedale, Maryland, United States
• University of Michigan Health Systems — Ann Arbor, Michigan, United States
• Huron Gastroenterology Associates — Ypsilanti, Michigan, United States
• Minnesota Gastroenterology, P.A. — Plymouth, Minnesota, United States
• Washington University Medical School — St Louis, Missouri, United States
• St. Louis Center for Clinical Research — St Louis, Missouri, United States
• Las Vegas Medical Research — Las Vegas, Nevada, United States
• Longwood Research — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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