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

NCT04844606 · Eli Lilly and Company
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Official title
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
About this study
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 criteria
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.
Study design
Enrollment target: 150 participants
Allocation: non_randomized
Masking: none
Age groups: child, adult
Timeline
Starts: 2021-05-26
Estimated completion: 2030-12
Last updated: 2026-04-17
Interventions
Drug: MirikizumabDrug: Mirikizumab
Primary outcomes
  • Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission (Week 52)
  • Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission (Week 52)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · study_director, Eli Lilly and Company
All locations (66)
UCSF Medical Center at Mission BayRecruiting
San Francisco, California, United States
Connecticut Children's Medical CenterRecruiting
Hartford, Connecticut, United States
Emory University School of MedicineRecruiting
Atlanta, Georgia, United States
Children's Center for Digestive Health Care, LLCRecruiting
Atlanta, Georgia, United States
Boston Children's HospitalRecruiting
Boston, Massachusetts, United States
Massachusetts General HospitalRecruiting
Waltham, Massachusetts, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Icahn School of Medicine at Mount SinaiRecruiting
New York, New York, United States
Cook Children's Medical CenterRecruiting
Fort Worth, Texas, United States
Pediatric Specialists of VirginiaNot Yet Recruiting
Fairfax, Virginia, United States
Medizinische Universität WienNot Yet Recruiting
Vienna, Austria
UZ BrusselNot Yet Recruiting
Brussels, Belgium
Cliniques universitaires Saint-LucNot Yet Recruiting
Brussels, Belgium
Antwerp University HospitalNot Yet Recruiting
Edegem, Belgium
UZ GentNot Yet Recruiting
Ghent, Belgium
UZ LeuvenRecruiting
Leuven, Belgium
Centro de Pesquisa Sao LucasNot Yet Recruiting
Campinas, Brazil
Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à InfânciaNot Yet Recruiting
Curitiba, Brazil
Universidade Federal de GoiasNot Yet Recruiting
Goiânia, Brazil
Hospital de Clinicas de Porto AlegreNot Yet Recruiting
Porto Alegre, Brazil
Irmandade da Santa Casa de Misericórdia de Porto AlegreNot Yet Recruiting
Porto Alegre, Brazil
Hospital Universitario Cassiano Antonio de MoraesNot Yet Recruiting
Vitória, Brazil
Integral Pesquisa e EnsinoNot Yet Recruiting
Votuporanga, Brazil
London Health Sciences CentreNot Yet Recruiting
London, Canada
The Hospital for Sick ChildrenNot Yet Recruiting
Toronto, Canada
Universitätsmedizin Johannes Gutenberg Universität MainzRecruiting
Mainz, Germany
Dr. von Haunersches KinderspitalRecruiting
Munich, Germany
Rambam Health Care CampusNot Yet Recruiting
Haifa, Israel
Shaare Zedek Medical CenterRecruiting
Jerusalem, Israel
Hadassah Medical CenterRecruiting
Jerusalem, Israel
Schneider Children's Medical CenterRecruiting
Petah Tikva, Israel
Yitzhak Shamir Medical CenterRecruiting
Ẕerifin, Israel
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIINot Yet Recruiting
Bergamo, Italy
Ospedale Maggiore Azienda USL di BolognaNot Yet Recruiting
Bologna, Italy
Azienda Ospedaliera Universitaria Meyer IRCCSRecruiting
Florence, Italy
Ospedale dei Bambini Vittore BuzziRecruiting
Milan, Italy
AOU Policlinico Umberto IRecruiting
Roma, Italy
Ospedale Pediatrico Bambino Gesù IRCCSNot Yet Recruiting
Rome, Italy
Institute of Science Tokyo HospitalRecruiting
Bunkyō, Japan
Juntendo University HospitalRecruiting
Bunkyō City, Japan
Tsujinaka Hospital - KashiwanohaRecruiting
Kashiwa, Japan
Kobe University HospitalNot Yet Recruiting
Kobe, Japan
National Center for Child Health and DevelopmentNot Yet Recruiting
Tokyo, Japan
Yokohama City University Medical CenterNot Yet Recruiting
Yokohama, Japan
Erasmus Medisch CentrumNot Yet Recruiting
Rotterdam, Netherlands
Akershus UniversitetssykehusNot Yet Recruiting
Lørenskog, Norway
Oslo Universitetssykehus UllevålNot Yet Recruiting
Oslo, Norway
Universitetssykehuset Nord-Norge HFNot Yet Recruiting
Tromsø, Norway
St. Olavs HospitalNot Yet Recruiting
Trondheim, Norway
Korczowski Bartosz, Gabinet LekarskiRecruiting
Rzeszów, Poland
Twoja Przychodnia SCMRecruiting
Szczecin, Poland
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor KierkuśRecruiting
Warsaw, Poland
Centrum Zdrowia Dziecka w WarszawieRecruiting
Warsaw, Poland
Centrum Medyczne OporówRecruiting
Wroclaw, Poland
2Ca BragaNot Yet Recruiting
Braga, Portugal
Centro Hospitalar de Sao Joao - Hospital de Sao JoaoRecruiting
Porto, Portugal
Kyungpook National University Chilgok HospitalRecruiting
Deagu, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Hospital Universitario Reina SofiaNot Yet Recruiting
Córdoba, Spain
Hospital Sant Joan de DéuNot Yet Recruiting
Esplugues de Llobregat, Spain
Hospital Universitari Parc TauliNot Yet Recruiting
Sabadell, Spain
Hospital Universitari i Politecnic La FeNot Yet Recruiting
Valencia, Spain
Royal London HospitalNot Yet Recruiting
London, United Kingdom
The John Radcliffe HospitalNot Yet Recruiting
Oxford, United Kingdom
Sheffield Children's HospitalRecruiting
Sheffield, United Kingdom
A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON) · TrialPath