A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease
Status: Recruiting
Location: See all (83) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease. Study periods for the intervention-specific appendix (ISA) will be as follows: * A 12-week induction period * A maintenance period from Week 12 to Week 52, and * A safety follow-up period up to 16 weeks. The study will last about 74 weeks and may include up to 19 visits.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:
• Participants must have a diagnosis of CD or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.
• Participants have moderately to severely active CD (as defined by a baseline PCDAI score ≥30).
• Participants must have endoscopy with evidence of active CD defined as SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease) within 1 month of receiving study intervention at Week 0.
• Participants must have a documented history of inadequate response, loss of response or intolerance to at least one medication used to treat CD, which may include immunomodulators, oral or IV corticosteroids, a biologic therapy or a JAK inhibitor.
Locations
United States
California
University of California San Diego
NOT_YET_RECRUITING
La Jolla
Cedars Sinai Medical Center
NOT_YET_RECRUITING
Los Angeles
Connecticut
Connecticut Children's Medical Center
RECRUITING
Hartford
Georgia
Children's Center for Digestive Health Care, LLC
RECRUITING
Atlanta
Emory University
RECRUITING
Atlanta
Indiana
Riley Childrens Hospital
RECRUITING
Indianapolis
Massachusetts
Boston Children's Hospital
NOT_YET_RECRUITING
Boston
New Jersey
Atlantic Children's Health--Pediatric Gastroenterology
NOT_YET_RECRUITING
Morristown
New York
Columbia University Medical Center/New York Presbyterian
RECRUITING
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
RECRUITING
New York
Ohio
Childrens Medical Center
RECRUITING
Dayton
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Texas
Cook Children's Medical Center
RECRUITING
Fort Worth
Vermont
University of Vermont Medical Center
RECRUITING
Burlington
Washington
Seattle Children's Hospital
NOT_YET_RECRUITING
Seattle
Other Locations
Austria
AKH - Medizinische Universtität Wien
RECRUITING
Vienna
Belgium
Cliniques universitaires Saint-Luc
RECRUITING
Brussels
Universitair Ziekenhuis Brussel
RECRUITING
Brussels
Universitair Ziekenhuis Gent
RECRUITING
Ghent
UZ Leuven
NOT_YET_RECRUITING
Leuven
Brazil
Hospital PUC-CAMPINAS
RECRUITING
Campinas
Hospital Pequeno Príncipe
RECRUITING
Curitiba-pr
Hospital das Clínicas - UFG (Universidade Federal de Goiás)
RECRUITING
Goiânia
Hospital de Clínicas de Porto Alegre
RECRUITING
Porto Alegre
Irmandade da Santa Casa de Misericórdia de Porto Alegre
RECRUITING
Porto Alegre
NDI - Nucleo de Doenças Infecciosas
RECRUITING
Santos Dumont
Integral Pesquisa e Ensino
RECRUITING
Votuporanga
Canada
IWK Health Centre
NOT_YET_RECRUITING
Halifax
London Health Sciences Centre (LHSC) - Victoria Hospital
NOT_YET_RECRUITING
London
The Hospital for Sick Children
NOT_YET_RECRUITING
Toronto
Children's & Women's Health Centre of British Columbia
NOT_YET_RECRUITING
Vancouver
France
URC CIC
TERMINATED
Paris
Israel
Soroka Medical Center
RECRUITING
Beersheba
Shamir Medical Center (Assaf Harofeh)
RECRUITING
Israel
Hadassah University Hospital, Ein Kerem,
RECRUITING
Jerusalem
Shaare Zedek
RECRUITING
Jerusalem
Schneider Children's Medical Center
RECRUITING
Petah Tikva
Kaplan Medical Center, Pediatric Gastroenterology Dept.
NOT_YET_RECRUITING
Rehovot
Italy
Asst Papa Giovanni Xxiii Bergamo
RECRUITING
Bergamo
Azienda USL di Bologna
RECRUITING
Bologna
SOC Gastroenterologia e Nutrizione - AOU Meyer (Primo Piano Ala OVEST, accettazione DH centralizzato)
RECRUITING
Florence
Ospedale dei Bambini Vittore Buzzi
RECRUITING
Milan
Gastroenterologia ed epatologia pediatrica (Piano terra della Clinica Pediatrica)
RECRUITING
Roma
Ospedale Pediatrico Bambino Gesù
NOT_YET_RECRUITING
Roma
Japan
Juntendo University Hospital
RECRUITING
Bunkyō City
Hirosaki University Hospital
RECRUITING
Hirosaki
Kokikai Tsujinaka Hospital Kashiwanoha
RECRUITING
Kashiwa-shi
Kobe University Hospital
NOT_YET_RECRUITING
Kobe
Saga University Hospital
RECRUITING
Saga
Miyagi Children's Hospital
RECRUITING
Sendai
National Center for Child Health and Development
RECRUITING
Setagaya-ku
Mie University Hospital
NOT_YET_RECRUITING
Tsu
Saiseikai Yokohamashi Tobu Hospital
NOT_YET_RECRUITING
Yokohama
Yokohama City University Medical Center, Center of IBD
RECRUITING
Yokohama
Netherlands
Erasmus Medisch Centrum
RECRUITING
Rotterdam
Norway
Akershus Universitetssykehus
RECRUITING
Nordbyagen
Oslo University Hospital
RECRUITING
Oslo
Universitetssykehuset Nord-Norge
RECRUITING
Tromsø
St-Olavs Hospital
RECRUITING
Trondheim
Poland
Uniwersytecki Szpital Dziecięcy w Krakowie
NOT_YET_RECRUITING
Krakow
Korczowski Bartosz, Gabinet Lekarski
RECRUITING
Rzeszów
Centrum Zdrowia MDM
NOT_YET_RECRUITING
Warsaw
Instytut Pomnik-Centrum Zdrowia Dziecka
RECRUITING
Warsaw
Warsaw IBD Point Profesor Kierkus
RECRUITING
Warsaw
Portugal
Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)
RECRUITING
Braga
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
RECRUITING
Lisbon
Centro Hospitalar de São João, E.P.E.
RECRUITING
Porto
Republic of Korea
Inje University Haeundae Paik Hospital
RECRUITING
Busan
Kyungpook National University Chilgok Hospital
RECRUITING
Daegu
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Spain
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
Hospital Sant Joan de Deu
NOT_YET_RECRUITING
Esplugues De Llobregat
Corporacio Sanitaria Parc Tauli
RECRUITING
Sabadell
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
United Kingdom
Royal Hospital for Children and Young People
RECRUITING
Edinburgh
Oxford University Hospitals NHS trust John Radcliffe hospital
RECRUITING
Headington
Great Ormond Street Hospital For Children NHS Foundation Trust
RECRUITING
London
Manchester University NHS Foundation Trust
RECRUITING
Manchester
Sheffield Children's Hospital
RECRUITING
Sheffield
Royal London Hospital
RECRUITING
Whitechapel
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: 2024-03-13
Estimated Completion Date: 2028-04
Participants
Target number of participants: 90
Treatments
Experimental: Mirikizumab Dose 1
Mirikizumab administered intravenously (IV) or subcutaneously (SC) in participants that weigh greater than (\>) 40 kilograms (kg).
Experimental: Mirikizumab Dose 2
Mirikizumab administered IV or SC in participants that weigh \>20 kg to less than or equal to (≤) 40 kg.~Dosing is based on assessments of the participant's weight and appropriate weight class.
Experimental: Mirikizumab Dose 3
Mirikizumab administered IV or SC in participants that weigh greater than or equal to (≥) 9 kg to less than or equal to ≤20 kg.~Dosing is based on assessments of the participant's weight and appropriate weight class.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company