A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis

Completed · Phase 3

Conditions studied: Ulcerative Colitis

In brief

The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).

Key facts

Study ID

NCT05784246

Run by

Eli Lilly and Company

People needed

63

Starts

2023-11-22

Expected to finish

2026-05-01

Last updated by the study team

2026-06-03

Who can join

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

You may qualify if…

• Males or females weighing ≥10 kg and ≥2 and <18 years old at the time of consent for screening.
• Have moderate to severe UC.
• Have failed corticosteroids, biologics, (for example, anti-tumor necrosis factor (TNF) antibodies or anti-integrin antibodies), immunomodulators (for example, azathioprine, thiopurines or methotrexate) or Janus Kinase (JAK)-Inhibitor treatment.
• Have UC at least 3 months in duration before baseline, which includes endoscopic evidence of UC corroborated by a histopathology report.

You may not qualify if…

• Have Crohn's disease, Inflammatory Bowel Disease Unclassified, ulcerative proctitis or primary sclerosing cholangitis.
• Have immune deficiency syndrome.
• Previous bowel resection or intestinal surgery.
• Evidence of toxic megacolon.
• History or current evidence of cancer of the gastrointestinal tract.

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• Children's Center for Digestive Health Care, LLC — Atlanta, Georgia, United States
• Riley Childrens Hospital — Indianapolis, Indiana, United States
• Washington University — St Louis, Missouri, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• UZA — Edegem, Belgium
• UZ Leuven — Leuven, Belgium
• The Hospital for Sick Children — Toronto, Canada
• Hôpital Necker - Enfants Malades — Paris, France
• Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz — Mainz, Germany
• LMU-Campus Innenstadt — München, Germany
• Helios Klinikum Wuppertal — Wuppertal, Germany
• Shaare Zedek — Jerusalem, Israel
• Hadassah University Hospital, Ein Kerem — Jerusalem, Israel
• Schneider Children's Medical Center — Petah Tikva, Israel
• King Fahad Medical City — Rishon LeZiyyon, Israel
• Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer — Florence, Italy
• Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza — Roma, Italy
• Juntendo University Hospital — Bunkyō City, Japan
• Institute of Science Tokyo Hospital — Bunkyō City, Japan
• Kokikai Tsujinaka Hospital Kashiwanoha — Kashiwa-shi, Japan
• Saga University Hospital — Saga, Japan
• National Center for Child Health and Development — Setagaya-ku, Japan
• Yokohama City University Medical Center, Center of IBD — Yokohama, Japan

Full record on ClinicalTrials.gov

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