Investigating Mirikizumab for Children with Active Ulcerative Colitis

A Multicenter, Phase 3, Open-Label Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mirikizumab in Participants 2 Years to Less Than 18 Years of Age With Moderately to Severely Active Ulcerative Colitis

This study is testing a new medication called Mirikizumab to see if it can help children aged 2 to under 18 with active ulcerative colitis who haven't had success with other treatments.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 2 Years to 17 Years
• Sex: All
• Sponsor: Eli Lilly and Company (Industry-sponsored)
• Drugs / interventions: methotrexate
• Locations: 34 sites (San Francisco, California and 33 other locations)
• Trial ID: NCT05784246 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy, pharmacokinetics, and safety of Mirikizumab in pediatric patients aged 2 to under 18 years who have moderately to severely active ulcerative colitis. Participants must have previously failed other treatments, including corticosteroids and biologics. The study includes both intravenous and subcutaneous administration of the drug, and those who complete it may have the option to enter a long-term extension study. The goal is to provide a new treatment option for this challenging condition in children.

Who should consider this trial

Good fit: Ideal candidates are children aged 2 to under 18 years with a diagnosis of moderately to severely active ulcerative colitis who have not responded to previous treatments.

Not a fit: Patients with Crohn's disease, ulcerative proctitis, or those who have had previous bowel surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new effective treatment for children suffering from moderately to severely active ulcerative colitis.

How similar studies have performed: Other studies have shown promise with similar biologic treatments for ulcerative colitis, indicating potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 this trial is running

San Francisco, California and 33 other locations

• University of California, San Francisco — San Francisco, California, United States (Completed)
• Children's Center for Digestive Health Care, LLC — Atlanta, Georgia, United States (Completed)
• Riley Childrens Hospital — Indianapolis, Indiana, United States (Completed)
• Washington University — St Louis, Missouri, United States (Completed)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (Completed)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
• Uza — Edegem, Belgium (Completed)
• UZ Leuven — Leuven, Belgium (Completed)
• The Hospital for Sick Children — Toronto, Canada (Completed)
• Hôpital Necker - Enfants Malades — Paris, France (Completed)
• Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz — Mainz, Germany (Completed)
• LMU-Campus Innenstadt — München, Germany (Completed)
• Helios Klinikum Wuppertal — Wuppertal, Germany (Completed)
• Shaare Zedek — Jerusalem, Israel (Completed)
• Hadassah University Hospital, Ein Kerem — Jerusalem, Israel (Completed)
• Schneider Children's Medical Center — Petah Tikva, Israel (Completed)
• King Fahad Medical City — Rishon LeZiyyon, Israel (Completed)
• Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer — Florence, Italy (Completed)
• Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza — Roma, Italy (Completed)
• Juntendo University Hospital — Bunkyō City, Japan (Completed)
• Institute of Science Tokyo Hospital — Bunkyō City, Japan (Completed)
• Kokikai Tsujinaka Hospital Kashiwanoha — Kashiwa-shi, Japan (Completed)
• Saga University Hospital — Saga, Japan (Completed)
• National Center for Child Health and Development — Setagaya-ku, Japan (Completed)
• Yokohama City University Medical Center, Center of IBD — Yokohama, Japan (Completed)
• Gabinet Lekarski Bartosz Korczowski — Rzeszów, Poland (Completed)
• Twoja Przychodnia-Szczecińskie Centrum Medyczne — Szczecin, Poland (Completed)
• Medical Network Spółka z o. o., WIP Warsaw IBD Point Profesor Kierkus — Warsaw, Poland (Completed)
• Instytut 'Pomnik - Centrum Zdrowia Dziecka — Warsaw, Poland (Completed)
• Centrum Medyczne Oporow — Wroclaw, Poland (Completed)
• Kyungpook National University Chilgok Hospital — Daegu, South Korea (Completed)
• Severance Hospital, Yonsei University Health System — Seoul, South Korea (Completed)
• Samsung Medical Center — Seoul, South Korea (Completed)
• Sheffield Children's Hospital — Sheffield, United Kingdom (Completed)

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Conditions Ulcerative Colitis