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
Status: Completed
Location: See all (34) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
University of California, San Francisco
San Francisco
Georgia
Children's Center for Digestive Health Care, LLC
Atlanta
Indiana
Riley Childrens Hospital
Indianapolis
Missouri
Washington University
St Louis
New York
Icahn School of Medicine at Mount Sinai
New York
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
Other Locations
Belgium
UZA
Edegem
UZ Leuven
Leuven
Canada
The Hospital for Sick Children
Toronto
France
Hôpital Necker - Enfants Malades
Paris
Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz
LMU-Campus Innenstadt
München
Helios Klinikum Wuppertal
Wuppertal
Israel
Hadassah University Hospital, Ein Kerem
Jerusalem
Shaare Zedek
Jerusalem
Schneider Children's Medical Center
Petah Tikva
King Fahad Medical City
Rishon Leziyyon
Italy
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
Florence
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Roma
Japan
Institute of Science Tokyo Hospital
Bunkyō City
Juntendo University Hospital
Bunkyō City
Kokikai Tsujinaka Hospital Kashiwanoha
Kashiwa-shi
Saga University Hospital
Saga
National Center for Child Health and Development
Setagaya-ku
Yokohama City University Medical Center, Center of IBD
Yokohama
Poland
Gabinet Lekarski Bartosz Korczowski
Rzeszów
Twoja Przychodnia-Szczecińskie Centrum Medyczne
Szczecin
Instytut 'Pomnik - Centrum Zdrowia Dziecka
Warsaw
Medical Network Spółka z o. o., WIP Warsaw IBD Point Profesor Kierkus
Warsaw
Centrum Medyczne Oporow
Wroclaw
Republic of Korea
Kyungpook National University Chilgok Hospital
Daegu
Samsung Medical Center
Seoul
Severance Hospital, Yonsei University Health System
Seoul
United Kingdom
Sheffield Children's Hospital
Sheffield
Time Frame
Start Date: 2023-11-22
Completion Date: 2026-05-01
Participants
Target number of participants: 63
Treatments
Experimental: Mirikizumab Weight-Based Group 1
Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC).
Experimental: Mirikizumab Weight-Based Group 2
Experimental: Participants will receive mirikizumab weight-based dosing IV or SC.
Experimental: Mirikizumab Weight-Based Group 3
Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company