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 (61) 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
Stanford University
NOT_YET_RECRUITING
Palo Alto
Rady Childrens Hospital
NOT_YET_RECRUITING
San Diego
University of California, San Francisco
COMPLETED
San Francisco
Colorado
Children's Hospital Colorado
NOT_YET_RECRUITING
Aurora
Connecticut
Connecticut Children's Medical Center
RECRUITING
Hartford
Georgia
Children's Center for Digestive Health Care, LLC
COMPLETED
Atlanta
Indiana
Riley Childrens Hospital
COMPLETED
Indianapolis
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Massachusetts General Hospital for Children
RECRUITING
Boston
Missouri
Washington University
ACTIVE_NOT_RECRUITING
St Louis
New Jersey
Morristown Medical Center
RECRUITING
Morristown
New York
Icahn School of Medicine at Mount Sinai
COMPLETED
New York
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
South Carolina
Prisma Health Upstate
RECRUITING
Greenville
Texas
Texas Children's Hospital -Research Resource Office
NOT_YET_RECRUITING
Houston
Other Locations
Belgium
UZA
COMPLETED
Edegem
UZ Leuven
ACTIVE_NOT_RECRUITING
Leuven
Canada
IWK Health Centre
RECRUITING
Halifax
London Health Sciences Centre (LHSC) - Victoria Hospital
RECRUITING
London
The Hospital for Sick Children
ACTIVE_NOT_RECRUITING
Toronto
France
CHU Amiens - Picardie Site Sud
RECRUITING
Amiens
CHU Lyon - Hôpital Femme-Mère-Enfant
RECRUITING
Bron
Hôpital Armand Trousseau
RECRUITING
Paris
Hôpital Necker - Enfants Malades
COMPLETED
Paris
Germany
Universitaetsklinikum Erlangen
NOT_YET_RECRUITING
Erlangen
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
ACTIVE_NOT_RECRUITING
Mainz
LMU-Campus Innenstadt
ACTIVE_NOT_RECRUITING
München
Helios Klinikum Wuppertal
COMPLETED
Wuppertal
Israel
Rambam Health Care Campus
RECRUITING
Haifa
Hadassah University Hospital, Ein Kerem
ACTIVE_NOT_RECRUITING
Jerusalem
Shaare Zedek
ACTIVE_NOT_RECRUITING
Jerusalem
Schneider Children's Medical Center
ACTIVE_NOT_RECRUITING
Petah Tikva
King Fahad Medical City
ACTIVE_NOT_RECRUITING
Rishon Leziyyon
Italy
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
COMPLETED
Florence
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
COMPLETED
Roma
Ospedale Pediatrico Bambino Gesù
RECRUITING
Roma
Japan
Institute of Science Tokyo Hospital
ACTIVE_NOT_RECRUITING
Bunkyō City
Juntendo University Hospital
ACTIVE_NOT_RECRUITING
Bunkyō City
Kokikai Tsujinaka Hospital Kashiwanoha
COMPLETED
Kashiwa-shi
Saga University Hospital
COMPLETED
Saga
National Center for Child Health and Development
COMPLETED
Setagaya-ku
Osaka Medical and Pharmaceutical University Hospital
NOT_YET_RECRUITING
Takatsuki-shi
Mie University Hospital
RECRUITING
Tsu
Yokohama City University Medical Center, Center of IBD
ACTIVE_NOT_RECRUITING
Yokohama
Netherlands
Amsterdam UMC, locatie VUmc
RECRUITING
Amsterdam
Erasmus Medisch Centrum
RECRUITING
Rotterdam
Poland
Gabinet Lekarski Bartosz Korczowski
ACTIVE_NOT_RECRUITING
Rzeszów
Twoja Przychodnia-Szczecińskie Centrum Medyczne
ACTIVE_NOT_RECRUITING
Szczecin
Instytut 'Pomnik - Centrum Zdrowia Dziecka
ACTIVE_NOT_RECRUITING
Warsaw
Medical Network Spółka z o. o., WIP Warsaw IBD Point Profesor Kierkus
ACTIVE_NOT_RECRUITING
Warsaw
Centrum Medyczne Oporow
ACTIVE_NOT_RECRUITING
Wroclaw
Portugal
Centro Clínico Académico - Braga, Associação (2CA-Braga)
RECRUITING
Braga
Centro Hospitalar Universitário de São João, E.P.E.
RECRUITING
Porto
Republic of Korea
Inje University Haeundae Paik Hospital
RECRUITING
Busan
Kyungpook National University Chilgok Hospital
ACTIVE_NOT_RECRUITING
Daegu
Samsung Medical Center
ACTIVE_NOT_RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
COMPLETED
Seoul
United Kingdom
King's College Hospital
RECRUITING
London
Royal London Hospital
RECRUITING
London
Sheffield Children's Hospital
ACTIVE_NOT_RECRUITING
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