NCT05784246CompletedPhase 3
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or 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
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 63 (actual)
- First submitted
- 13 Mar 2023
- Start date
- 22 Nov 2023
- Primary completion date
- 1 May 2026
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Ulcerative colitis
- NCT number
- NCT05784246
- EU CT number
- 2022-502183-20-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 63
- From 22 Nov 2023 to the primary completion date, 1 May 2026
- 41 sites in 13 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous bowel resection or intestinal surgery.
Other illness
- Have Crohn's disease, Inflammatory Bowel Disease Unclassified, ulcerative proctitis or primary sclerosing cholangitis.
- Have immune deficiency syndrome.
- History or current evidence of cancer of the gastrointestinal tract.
Other
- Evidence of toxic megacolon.
Who the study is looking for
- 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.
Age in the registry: 2 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (41)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz Koerperschaft Des Offentlichen Rechts Coordinator of this site? Confirm its status | Mainz | Germany | Completed |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Completed |
| Helios Universitaetsklinikum Wuppertal Coordinator of this site? Confirm its status | Wuppertal | Germany | Completed |
| Centre Hospitalier Universitaire Amiens Picardie Coordinator of this site? Confirm its status | Amiens Cedex 1 | France | Completed |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Completed |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Completed |
| Sheffield Children's Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| Hadassah University Hospital - Ein Kerem Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Shaare Zedek Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Schneider Children's Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| King Fahad Medical City Coordinator of this site? Confirm its status | Rishon LeZiyyon | Israel | Unknown status |
| Azienda Ospedaliera Universitaria Meyer IRCCS Coordinator of this site? Confirm its status | Florence | Italy | Completed |
| Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Juntendo University Hospital Coordinator of this site? Confirm its status | Bunkyō City | Japan | Unknown status |
| Institute of Science Tokyo Hospital Coordinator of this site? Confirm its status | Bunkyō City | Japan | Unknown status |
| Kokikai Tsujinaka Hospital Kashiwanoha Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Unknown status |
| Saga University Hospital Coordinator of this site? Confirm its status | Saga | Japan | Unknown status |
| National Center for Child Health and Development Coordinator of this site? Confirm its status | Setagaya-Ku | Japan | Unknown status |
| Yokohama City University Medical Center, Center of IBD Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Completed |
| Gabinet Lekarski Bartosz Korczowski Coordinator of this site? Confirm its status | Rzeszów | Poland | Completed |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o. Coordinator of this site? Confirm its status | Szczecin | Poland | Completed |
| Instytut Pomnik Centrum Zdrowia Dziecka Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Medical Network Sp z o o Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Centrum Medyczne Oporow Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| CCAB Centro Clinico Academico Braga Associacao Coordinator of this site? Confirm its status | Braga | Portugal | Completed |
| Centro Hospitalar Universitario Sao Joao E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Completed |
| Children's Center for Digestive Health Care, LLC Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Riley Childrens Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.