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: Recruiting
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
COMPLETED
San Francisco
Georgia
Children's Center for Digestive Health Care, LLC
COMPLETED
Atlanta
Indiana
Riley Childrens Hospital
COMPLETED
Indianapolis
Missouri
Washington University
COMPLETED
St Louis
New York
Icahn School of Medicine at Mount Sinai
COMPLETED
New York
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Other Locations
Belgium
UZA
COMPLETED
Edegem
UZ Leuven
COMPLETED
Leuven
Canada
The Hospital for Sick Children
COMPLETED
Toronto
France
Hôpital Necker - Enfants Malades
COMPLETED
Paris
Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
COMPLETED
Mainz
LMU-Campus Innenstadt
COMPLETED
München
Helios Klinikum Wuppertal
COMPLETED
Wuppertal
Israel
Hadassah University Hospital, Ein Kerem
COMPLETED
Jerusalem
Shaare Zedek
COMPLETED
Jerusalem
Schneider Children's Medical Center
COMPLETED
Petah Tikva
King Fahad Medical City
COMPLETED
Rishon Leziyyon
Italy
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
COMPLETED
Florence
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
COMPLETED
Roma
Japan
Institute of Science Tokyo Hospital
COMPLETED
Bunkyō City
Juntendo University Hospital
COMPLETED
Bunkyō City
Kokikai Tsujinaka Hospital Kashiwanoha
COMPLETED
Kashiwa-shi
Saga University Hospital
COMPLETED
Saga
National Center for Child Health and Development
COMPLETED
Setagaya-ku
Yokohama City University Medical Center, Center of IBD
COMPLETED
Yokohama
Poland
Gabinet Lekarski Bartosz Korczowski
COMPLETED
Rzeszów
Twoja Przychodnia-Szczecińskie Centrum Medyczne
COMPLETED
Szczecin
Instytut 'Pomnik - Centrum Zdrowia Dziecka
COMPLETED
Warsaw
Medical Network Spółka z o. o., WIP Warsaw IBD Point Profesor Kierkus
COMPLETED
Warsaw
Centrum Medyczne Oporow
COMPLETED
Wroclaw
Republic of Korea
Kyungpook National University Chilgok Hospital
COMPLETED
Daegu
Samsung Medical Center
COMPLETED
Seoul
Severance Hospital, Yonsei University Health System
COMPLETED
Seoul
United Kingdom
Sheffield Children's Hospital
COMPLETED
Sheffield
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2023-11-22
Estimated Completion Date: 2026-08
Participants
Target number of participants: 60
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