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A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
Sponsor: Eli Lilly and Company
Summary
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).
Official title: 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
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2023-11-22
Completion Date
2026-08
Last Updated
2026-03-03
Healthy Volunteers
No
Conditions
Interventions
Mirikizumab IV
Administered IV
Mirikizumab SC
Administered SC
Locations (34)
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
Gabinet Lekarski Bartosz Korczowski
Rzeszów, Poland
Twoja Przychodnia-Szczecińskie Centrum Medyczne
Szczecin, Poland
Medical Network Spółka z o. o., WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Poland
Instytut 'Pomnik - Centrum Zdrowia Dziecka
Warsaw, Poland
Centrum Medyczne Oporow
Wroclaw, Poland
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Sheffield Children's Hospital
Sheffield, United Kingdom