A Master Protocol for a Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Efficacy and Safety of Mirikizumab in Children and Adolescents With Moderate-to-severe Ulcerative Colitis or Crohn's Disease
Who is this study for? Children and adolescents with moderate-to-severe ulcerative colitis or Crohn's disease
What treatments are being studied? Mirikizumab
Status: Recruiting
Location: See all (57) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continued Access Period.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 19
Healthy Volunteers: f
View:
• Participants from originating studies (I6T-MC-AMBA \[NCT05784246\], I6T-MC-AMBU \[NCT04004611\], I6T-MC-AMAM \[NCT03926130\]) , I6T-MC-AMAY \[NCT05509777\]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab
• Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment.
• Female participants must agree to contraception requirements.
Locations
United States
California
UCSF Medical Center at Mission Bay
RECRUITING
San Francisco
Connecticut
Connecticut Children's Medical Center
RECRUITING
Hartford
Georgia
Children's Center for Digestive Health Care, LLC
RECRUITING
Atlanta
Emory University School of Medicine
RECRUITING
Atlanta
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Waltham
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Texas
Cook Children's Medical Center
RECRUITING
Fort Worth
Virginia
Pediatric Specialists of Virginia
RECRUITING
Fairfax
Other Locations
Austria
Medizinische Universität Wien
NOT_YET_RECRUITING
Vienna
Belgium
Cliniques universitaires Saint-Luc
NOT_YET_RECRUITING
Brussels
UZ Brussel
NOT_YET_RECRUITING
Brussels
Antwerp University Hospital
NOT_YET_RECRUITING
Edegem
UZ Gent
NOT_YET_RECRUITING
Ghent
UZ Leuven
NOT_YET_RECRUITING
Leuven
Brazil
Centro de Pesquisa Sao Lucas
NOT_YET_RECRUITING
Campinas
Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância
NOT_YET_RECRUITING
Curitiba
Universidade Federal de Goias
NOT_YET_RECRUITING
Goiânia
Hospital de Clinicas de Porto Alegre
NOT_YET_RECRUITING
Porto Alegre
Irmandade da Santa Casa de Misericórdia de Porto Alegre
NOT_YET_RECRUITING
Porto Alegre
Hospital Universitario Cassiano Antonio de Moraes
NOT_YET_RECRUITING
Vitória
Integral Pesquisa e Ensino
NOT_YET_RECRUITING
Votuporanga
Canada
The Hospital for Sick Children
NOT_YET_RECRUITING
Toronto
Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz
RECRUITING
Mainz
Dr. von Haunersches Kinderspital
RECRUITING
Munich
Israel
Rambam Health Care Campus
NOT_YET_RECRUITING
Haifa
Hadassah Medical Center
RECRUITING
Jerusalem
Shaare Zedek Medical Center
NOT_YET_RECRUITING
Jerusalem
Schneider Children's Medical Center
RECRUITING
Petah Tikva
Yitzhak Shamir Medical Center
RECRUITING
Ẕerifin
Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
NOT_YET_RECRUITING
Bergamo
Ospedale Maggiore Azienda USL di Bologna
NOT_YET_RECRUITING
Bologna
Azienda Ospedaliera Universitaria Meyer IRCCS
RECRUITING
Florence
Ospedale dei Bambini Vittore Buzzi
NOT_YET_RECRUITING
Milan
AOU Policlinico Umberto I
RECRUITING
Roma
Ospedale Pediatrico Bambino Gesù IRCCS
NOT_YET_RECRUITING
Rome
Japan
Institute of Science Tokyo Hospital
RECRUITING
Bunkyō
Juntendo University Hospital
RECRUITING
Bunkyō City
Tsujinaka Hospital - Kashiwanoha
RECRUITING
Kashiwa
Netherlands
Erasmus Medisch Centrum
NOT_YET_RECRUITING
Rotterdam
Poland
Korczowski Bartosz, Gabinet Lekarski
RECRUITING
Rzeszów
Twoja Przychodnia SCM
RECRUITING
Szczecin
Centrum Zdrowia Dziecka w Warszawie
RECRUITING
Warsaw
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
RECRUITING
Warsaw
Centrum Medyczne Oporów
NOT_YET_RECRUITING
Wroclaw
Portugal
2Ca Braga
NOT_YET_RECRUITING
Braga
Centro Hospitalar de Sao Joao - Hospital de Sao Joao
NOT_YET_RECRUITING
Porto
Republic of Korea
Kyungpook National University Chilgok Hospital
RECRUITING
Deagu
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Spain
Hospital Universitario Reina Sofia
NOT_YET_RECRUITING
Córdoba
Hospital Sant Joan de Déu
NOT_YET_RECRUITING
Esplugues De Llobregat
Hospital Universitari Parc Tauli
NOT_YET_RECRUITING
Sabadell
Hospital Universitari i Politecnic La Fe
NOT_YET_RECRUITING
Valencia
United Kingdom
Royal London Hospital
NOT_YET_RECRUITING
London
The John Radcliffe Hospital
NOT_YET_RECRUITING
Oxford
Sheffield Children's Hospital
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: 2021-05-26
Estimated Completion Date: 2030-12
Participants
Target number of participants: 150
Treatments
Experimental: Mirikizumab Dose 1 for UC
Dose 1 of Mirikizumab is administered subcutaneously (SC)~Dosing is based on the participant's weight.
Experimental: Mirikizumab Dose 2 for UC
Dose 2 of Mirikizumab is administered SC~Dosing is based on the participant's weight.
Experimental: Mirikizumab Dose 3 for UC
Dose 3 of Mirikizumab is administered SC~Dosing is based on the participant's weight.
Experimental: Mirikizumab Dose 4 for CD
Dose 4 of Mirikizumab is administered SC~Dosing is based on the participant's weight.
Experimental: Mirikizumab Dose 5 for CD
Dose 5 of Mirikizumab is administered SC~Dosing is based on the participant's weight.
Experimental: Mirikizumab Dose 6 for CD
Dose 6 of Mirikizumab is administered SC~Dosing is based on the participant's weight.
Experimental: Mirikizumab Dose 7 for UC or CD
Intravenous (IV) rescue dosing, if response is lost.
Authors
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company