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Recruiting Phase 3 NCT04844606

A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)

Phase 3 – large-scale trial before approval
Conditions: Ulcerative Colitis Ulcerative Colitis Chronic Inflammatory Bowel Diseases Crohn's Disease

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * 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. Exclusion Criteria: * Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant. * Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ. * Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety. * Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data interpretation. * Participants must not have adenomatous polyps that have not been removed. * Participants must not be pregnant or breastfeeding.
Interventions
Mirikizumab
DRUG
Mirikizumab
DRUG
Locations 66
Austria (1)
Medizinische Universität Wien
Vienna
NOT_YET_RECRUITING
Belgium (5)
UZ Brussel
Brussels
NOT_YET_RECRUITING
Cliniques universitaires Saint-Luc
Brussels
NOT_YET_RECRUITING
Antwerp University Hospital
Edegem
NOT_YET_RECRUITING
UZ Gent
Ghent
NOT_YET_RECRUITING
UZ Leuven
Leuven
Brazil (7)
Centro de Pesquisa Sao Lucas
Campinas
NOT_YET_RECRUITING
Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância
Curitiba
NOT_YET_RECRUITING
Universidade Federal de Goias
Goiânia
NOT_YET_RECRUITING
Hospital de Clinicas de Porto Alegre
Porto Alegre
NOT_YET_RECRUITING
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre
NOT_YET_RECRUITING
Hospital Universitario Cassiano Antonio de Moraes
Vitória
NOT_YET_RECRUITING
Integral Pesquisa e Ensino
Votuporanga
NOT_YET_RECRUITING
Canada (2)
London Health Sciences Centre
London
NOT_YET_RECRUITING
The Hospital for Sick Children
Toronto
NOT_YET_RECRUITING
Germany (2)
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz
Dr. von Haunersches Kinderspital
Munich
Israel (5)
Rambam Health Care Campus
Haifa
NOT_YET_RECRUITING
Shaare Zedek Medical Center
Jerusalem
Hadassah Medical Center
Jerusalem
Schneider Children's Medical Center
Petah Tikva
Yitzhak Shamir Medical Center
Ẕerifin
Italy (6)
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo
NOT_YET_RECRUITING
Ospedale Maggiore Azienda USL di Bologna
Bologna
NOT_YET_RECRUITING
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence
Ospedale dei Bambini Vittore Buzzi
Milan
AOU Policlinico Umberto I
Roma
Ospedale Pediatrico Bambino Gesù IRCCS
Rome
NOT_YET_RECRUITING
Japan (6)
Institute of Science Tokyo Hospital
Bunkyō
Juntendo University Hospital
Bunkyō City
Tsujinaka Hospital - Kashiwanoha
Kashiwa
Kobe University Hospital
Kobe
NOT_YET_RECRUITING
National Center for Child Health and Development
Tokyo
NOT_YET_RECRUITING
Yokohama City University Medical Center
Yokohama
NOT_YET_RECRUITING
Netherlands (1)
Erasmus Medisch Centrum
Rotterdam
NOT_YET_RECRUITING
Norway (4)
Akershus Universitetssykehus
Lørenskog
NOT_YET_RECRUITING
Oslo Universitetssykehus Ullevål
Oslo
NOT_YET_RECRUITING
Universitetssykehuset Nord-Norge HF
Tromsø
NOT_YET_RECRUITING
St. Olavs Hospital
Trondheim
NOT_YET_RECRUITING
Poland (5)
Korczowski Bartosz, Gabinet Lekarski
Rzeszów
Twoja Przychodnia SCM
Szczecin
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw
Centrum Zdrowia Dziecka w Warszawie
Warsaw
Centrum Medyczne Oporów
Wroclaw
Portugal (2)
2Ca Braga
Braga
NOT_YET_RECRUITING
Centro Hospitalar de Sao Joao - Hospital de Sao Joao
Porto
South Korea (3)
Kyungpook National University Chilgok Hospital
Deagu
Seoul National University Hospital
Seoul
Samsung Medical Center
Seoul
Spain (4)
Hospital Universitario Reina Sofia
Córdoba
NOT_YET_RECRUITING
Hospital Sant Joan de Déu
Esplugues de Llobregat
NOT_YET_RECRUITING
Hospital Universitari Parc Tauli
Sabadell
NOT_YET_RECRUITING
Hospital Universitari i Politecnic La Fe
Valencia
NOT_YET_RECRUITING
United Kingdom (3)
Royal London Hospital
London
NOT_YET_RECRUITING
The John Radcliffe Hospital
Oxford
NOT_YET_RECRUITING
Sheffield Children's Hospital
Sheffield
United States (10)
Emory University School of Medicine
Atlanta , Georgia
Children's Center for Digestive Health Care, LLC
Atlanta , Georgia
Boston Children's Hospital
Boston , Massachusetts
Pediatric Specialists of Virginia
Fairfax , Virginia
NOT_YET_RECRUITING
Cook Children's Medical Center
Fort Worth , Texas
Connecticut Children's Medical Center
Hartford , Connecticut
Icahn School of Medicine at Mount Sinai
New York , New York
UCSF Medical Center at Mission Bay
San Francisco , California
Washington University School of Medicine
St Louis , Missouri
Massachusetts General Hospital
Waltham , Massachusetts
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
2 Years
Maximum age
19 Years
Healthy volunteers
No
Start date
26.05.2021
Completion date
01.12.2030
Registry ID
NCT04844606
Source
clinicaltrials.gov
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