RecruitingPhase 3NCT04844606

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

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

Sponsor

Eli Lilly and Company

Enrollment

150 participants

Start Date

May 26, 2021

Study Type

INTERVENTIONAL

Conditions

Inflammatory Bowel Diseases Crohn's Disease Ulcerative Colitis Ulcerative Colitis Chronic

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

Min Age: 2 YearsMax Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This is a long-term extension study for children with ulcerative colitis or Crohn's disease who have already been in a mirikizumab trial and continue to benefit from the treatment. This study allows continued access to mirikizumab beyond the original study period. **You may be eligible if:** - You are already enrolled in one of the specific originating mirikizumab pediatric studies - You are still benefiting from mirikizumab treatment - You have completed the final assessments in your original study while still receiving the drug **You may NOT be eligible if:** - You experienced a serious side effect in the original study that would make continuing risky - You stopped taking mirikizumab in the previous study in a way that would make restarting unsafe - You have an unstable or uncontrolled illness - You have unremoved polyps in your colon - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMirikizumab

Administered SC

DRUGMirikizumab

Administered IV

Locations(66)

UCSF Medical Center at Mission Bay

San Francisco, California, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Children's Center for Digestive Health Care, LLC

Atlanta, Georgia, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Massachusetts General Hospital

Waltham, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Cook Children's Medical Center

Fort Worth, Texas, United States

Pediatric Specialists of Virginia

Fairfax, Virginia, United States

Medizinische Universität Wien

Vienna, Austria

UZ Brussel

Brussels, Belgium

Cliniques universitaires Saint-Luc

Brussels, Belgium

Antwerp University Hospital

Edegem, Belgium

UZ Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Centro de Pesquisa Sao Lucas

Campinas, Brazil

Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância

Curitiba, Brazil

Universidade Federal de Goias

Goiânia, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Brazil

Hospital Universitario Cassiano Antonio de Moraes

Vitória, Brazil

Integral Pesquisa e Ensino

Votuporanga, Brazil

London Health Sciences Centre

London, Canada

The Hospital for Sick Children

Toronto, Canada

Universitätsmedizin Johannes Gutenberg Universität Mainz

Mainz, Germany

Dr. von Haunersches Kinderspital

Munich, Germany

Rambam Health Care Campus

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Hadassah Medical Center

Jerusalem, Israel

Schneider Children's Medical Center

Petah Tikva, Israel

Yitzhak Shamir Medical Center

Ẕerifin, Israel

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Bergamo, Italy

Ospedale Maggiore Azienda USL di Bologna

Bologna, Italy

Azienda Ospedaliera Universitaria Meyer IRCCS

Florence, Italy

Ospedale dei Bambini Vittore Buzzi

Milan, Italy

AOU Policlinico Umberto I

Roma, Italy

Ospedale Pediatrico Bambino Gesù IRCCS

Rome, Italy

Institute of Science Tokyo Hospital

Bunkyō, Japan

Juntendo University Hospital

Bunkyō City, Japan

Tsujinaka Hospital - Kashiwanoha

Kashiwa, Japan

Kobe University Hospital

Kobe, Japan

National Center for Child Health and Development

Tokyo, Japan

Yokohama City University Medical Center

Yokohama, Japan

Erasmus Medisch Centrum

Rotterdam, Netherlands

Akershus Universitetssykehus

Lørenskog, Norway

Oslo Universitetssykehus Ullevål

Oslo, Norway

Universitetssykehuset Nord-Norge HF

Tromsø, Norway

St. Olavs Hospital

Trondheim, Norway

Korczowski Bartosz, Gabinet Lekarski

Rzeszów, Poland

Twoja Przychodnia SCM

Szczecin, Poland

Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś

Warsaw, Poland

Centrum Zdrowia Dziecka w Warszawie

Warsaw, Poland

Centrum Medyczne Oporów

Wroclaw, Poland

2Ca Braga

Braga, Portugal

Centro Hospitalar de Sao Joao - Hospital de Sao Joao

Porto, Portugal

Kyungpook National University Chilgok Hospital

Deagu, South Korea

Seoul National University Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Hospital Universitario Reina Sofia

Córdoba, Spain

Hospital Sant Joan de Déu

Esplugues de Llobregat, Spain

Hospital Universitari Parc Tauli

Sabadell, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Royal London Hospital

London, United Kingdom

The John Radcliffe Hospital

Oxford, United Kingdom

Sheffield Children's Hospital

Sheffield, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04844606

Related Trials

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

NCT0718494412 locations

A Study of Filgotinib 200 mg in Korean Participants With Moderately to Severely Active Ulcerative Colitis Under Routine Clinical Practice

NCT0696411319 locations

FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis

NCT062867095 locations

A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)

NCT0544256798 locations

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

NCT0718500920 locations