A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)

Completed · Phase 2

Conditions studied: Ulcerative Colitis

In brief

This study was designed to evaluate how the body processes and removes mirikizumab. The study also evaluated safety and disease response in pediatric participants with UC taking mirikizumab. The study lasted about 52 weeks and included up to 18 visits.

Key facts

Study ID

NCT04004611

Run by

Eli Lilly and Company

People needed

26

Starts

2020-05-18

Expected to finish

2023-03-15

Last updated by the study team

2024-03-26

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants weighing >10 kg
• Participants must have a diagnosis of ulcerative colitis for at least 3 months before the planned start date for the study medications
• Participants must have moderately to severely active UC as defined by a Modified Mayo Score (MMS) within 14 days before the first dose of study treatment
• Participants must have evidence of UC extending proximal to the rectum
• Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to corticosteroids, immunomodulators, Janus kinase inhibitor (JAK-inhibitor) or to biologic therapies for UC

You may not qualify if…

• Participants must not have a current diagnosis of Crohn's disease, inflammatory bowel disease-unclassified (indeterminate colitis), ulcerative proctitis, or primary sclerosing cholangitis
• Participants must not have had surgery to remove part of their colon
• Participants must not have current evidence of toxic megacolon
• Participants must not have received any of the following for treatment of UC: cyclosporine or thalidomide within 30 days of screening; corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 1 week of screening endoscopy
• Participants must not have had an inadequate response to Interleukin-12 p40 subunit antibody (anti-IL12p40) (e.g. ustekinumab) or had prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab)

Where it is running

• Childrens Hospital of Orange County — Orange, California, United States
• UCSF Medical Center at Mission Bay — San Francisco, California, United States
• Children's Hospital of Colorado — Denver, Colorado, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Emory University — Atlanta, Georgia, United States
• Children's Center for Digestive Health Care, LLC — Atlanta, Georgia, United States
• University of Chicago Hospital — Chicago, Illinois, United States
• Riley Hospital for Children — Carmel, Indiana, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• MGH for Children - Waltham — Waltham, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Goryeb Children's Hospital / Atlantic Health System — Morristown, New Jersey, United States
• Icahn Sch of Med at Mt. Sinai — New York, New York, United States
• Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio, United States
• The Abbigail Wexner Research Institute at Nationwide Children's Hospital — Columbus, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Cook Children's Hospital — Fort Worth, Texas, United States
• Texas Childrens Hospital — Houston, Texas, United States
• Pediatrics Specialists of Virginia — Fairfax, Virginia, United States
• Children's Hospital of The King's Daughters Inc — Norfolk, Virginia, United States
• Seattle Children's Hospital Research Foundation — Seattle, Washington, United States
• University of Alberta Hospital — Edmonton, Alberta, Canada
• IWK Health Centre — Halifax, Nova Scotia, Canada
• The Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.