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NCT04844606PHASE3Recruiting

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

Eli Lilly and Company

Start Date

5/26/2021

Completion Date

12/1/2030

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 Criteria

Age Range: 2 years to 19 years

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

DRUG

Mirikizumab

DRUG

Mirikizumab

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Conditions

Ulcerative ColitisUlcerative Colitis ChronicInflammatory Bowel DiseasesCrohn's Disease

Locations

UCSF Medical Center at Mission Bay

San Francisco, California 94158

United States

Connecticut Children's Medical Center

Hartford, Connecticut 06106

United States

Emory University School of Medicine

Atlanta, Georgia 30322

United States

Children's Center for Digestive Health Care, LLC

Atlanta, Georgia 30342

United States

Boston Children's Hospital

Boston, Massachusetts 02115

United States

Massachusetts General Hospital

Waltham, Massachusetts 02451

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Children's Hospital of Philadelphia (CHOP)

Philadelphia, Pennsylvania 19104

United States

Cook Children's Medical Center

Fort Worth, Texas 76104

United States

Pediatric Specialists of Virginia

Fairfax, Virginia 22031

United States

Medizinische Universität Wien

Vienna, 1090

Austria

UZ Brussel

Brussels, 1090

Belgium

Cliniques universitaires Saint-Luc

Brussels, 1200

Belgium

Antwerp University Hospital

Edegem, 2650

Belgium

UZ Gent

Ghent, 9000

Belgium

UZ Leuven

Leuven, 3000

Belgium

Centro de Pesquisa Sao Lucas

Campinas, 13060-803

Brazil

Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância

Curitiba, 80250-060

Brazil

Universidade Federal de Goias

Goiânia, 74605-020

Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, 90035-903

Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, 90050-170

Brazil

Hospital Universitario Cassiano Antonio de Moraes

Vitória, 29040-091

Brazil

Integral Pesquisa e Ensino

Votuporanga, 15500-269

Brazil

London Health Sciences Centre

London, N6A 5W9

Canada

The Hospital for Sick Children

Toronto, M5G 1X8

Canada

Universitätsmedizin Johannes Gutenberg Universität Mainz

Mainz, 55131

Germany

Dr. von Haunersches Kinderspital

Munich, 80337

Germany

Soroka Medical Center

Beersheba, 8410101

Israel

Rambam Health Care Campus

Haifa, 3109601

Israel

Shaare Zedek Medical Center

Jerusalem, 9013102

Israel

Hadassah Medical Center

Jerusalem, 9112001

Israel

Schneider Children's Medical Center

Petah Tikva, 49202

Israel

Yitzhak Shamir Medical Center

Ẕerifin, 70300

Israel

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Bergamo, 24127

Italy

Ospedale Maggiore Azienda USL di Bologna

Bologna, 40133

Italy

Azienda Ospedaliera Universitaria Meyer IRCCS

Florence, 50139

Italy

Ospedale dei Bambini Vittore Buzzi

Milan, 20154

Italy

AOU Policlinico Umberto I

Roma, 00161

Italy

Ospedale Pediatrico Bambino Gesù IRCCS

Rome, 00165

Italy

Institute of Science Tokyo Hospital

Bunkyō, 113-8519

Japan

Juntendo University Hospital

Bunkyō City, 113-8431

Japan

Tsujinaka Hospital - Kashiwanoha

Kashiwa, 273-0011

Japan

Kobe University Hospital

Kobe, 650-0017

Japan

National Center for Child Health and Development

Tokyo, 157-8535

Japan

Yokohama City University Medical Center

Yokohama, 232-0024

Japan

Erasmus Medisch Centrum

Rotterdam, 3015 GD

Netherlands

Akershus Universitetssykehus

Lørenskog, 1478

Norway

Oslo Universitetssykehus Ullevål

Oslo, 0450

Norway

Universitetssykehuset Nord-Norge HF

Tromsø, 9038

Norway

St. Olavs Hospital

Trondheim, 7030

Norway

Korczowski Bartosz, Gabinet Lekarski

Rzeszów, 35-302

Poland

Twoja Przychodnia SCM

Szczecin, 71-434

Poland

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

Warsaw, 04-501

Poland

Centrum Zdrowia Dziecka w Warszawie

Warsaw, 04-730

Poland

Centrum Medyczne Oporów

Wroclaw, 52-416

Poland

2Ca Braga

Braga, 4710-243

Portugal

Centro Hospitalar de Sao Joao - Hospital de Sao Joao

Porto, 4200-319

Portugal

Kyungpook National University Chilgok Hospital

Deagu, 41404

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Hospital Universitario Reina Sofia

Córdoba, 14004

Spain

Hospital Sant Joan de Déu

Esplugues de Llobregat, 08950

Spain

Hospital Universitari Parc Tauli

Sabadell, 08208

Spain

Hospital Universitari i Politecnic La Fe

Valencia, 46026

Spain

Royal London Hospital

London, E1 1BB

United Kingdom

The John Radcliffe Hospital

Oxford, OX3 9DU

United Kingdom

Sheffield Children's Hospital

Sheffield, S10 2TH

United Kingdom