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RECRUITING
NCT05509777
PHASE3

A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

Summary

Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease. Study periods for the intervention-specific appendix (ISA) will be as follows: * A 12-week induction period * A maintenance period from Week 12 to Week 52, and * A safety follow-up period up to 16 weeks. The study will last about 74 weeks and may include up to 19 visits.

Official title: A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease

Key Details

Gender

All

Age Range

2 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2024-03-13

Completion Date

2028-04

Last Updated

2026-03-27

Healthy Volunteers

No

Conditions

Interventions

DRUG

Mirikizumab

Administered IV or SC

Locations (81)

Cedars Sinai Medical Center

Los Angeles, California, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Emory University

Atlanta, Georgia, United States

Children's Center for Digestive Health Care, LLC

Atlanta, Georgia, United States

Riley Childrens Hospital

Indianapolis, Indiana, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Atlantic Children's Health--Pediatric Gastroenterology

Morristown, New Jersey, United States

Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Columbia University Medical Center/New York Presbyterian

New York, New York, United States

Childrens Medical Center

Dayton, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Cook Children's Medical Center

Fort Worth, Texas, United States

University of Vermont Medical Center

Burlington, Vermont, United States

Seattle Children's Hospital

Seattle, Washington, United States

AKH - Medizinische Universtität Wien

Vienna, Austria

Universitair Ziekenhuis Brussel

Brussels, Belgium

Cliniques universitaires Saint-Luc

Brussels, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Hospital PUC-CAMPINAS

Campinas, Brazil

Hospital Pequeno Príncipe

Curitiba-PR, Brazil

Hospital das Clínicas - UFG (Universidade Federal de Goiás)

Goiânia, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Brazil

NDI - Nucleo de Doenças Infecciosas

Santos Dumont, Brazil

Integral Pesquisa e Ensino

Votuporanga, Brazil

IWK Health Centre

Halifax, Canada

London Health Sciences Centre (LHSC) - Victoria Hospital

London, Canada

The Hospital for Sick Children

Toronto, Canada

Children's & Women's Health Centre of British Columbia

Vancouver, Canada

URC CIC

Paris, France

Soroka Medical Center

Beersheba, Israel

Shamir Medical Center (Assaf Harofeh)

Israel, Israel

Shaare Zedek

Jerusalem, Israel

Hadassah University Hospital, Ein Kerem,

Jerusalem, Israel

Schneider Children's Medical Center

Petah Tikva, Israel

Kaplan Medical Center, Pediatric Gastroenterology Dept.

Rehovot, Israel

Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e C. Arrigo

Alessandria, Italy

Asst Papa Giovanni Xxiii Bergamo

Bergamo, Italy

Azienda USL di Bologna

Bologna, Italy

SOC Gastroenterologia e Nutrizione - AOU Meyer (Primo Piano Ala OVEST, accettazione DH centralizzato)

Florence, Italy

Ospedale dei Bambini Vittore Buzzi

Milan, Italy

Gastroenterologia ed epatologia pediatrica (Piano terra della Clinica Pediatrica)

Roma, Italy

Juntendo University Hospital

Bunkyō City, Japan

Hirosaki University Hospital

Hirosaki, Japan

Kagoshima University Hospital

Kagoshima, Japan

Kokikai Tsujinaka Hospital Kashiwanoha

Kashiwa-shi, Japan

Kobe University Hospital

Kobe, Japan

Saga University Hospital

Saga, Japan

Miyagi Children's Hospital

Sendai, Japan

National Center for Child Health and Development

Setagaya-ku, Japan

Mie University Hospital

Tsu, Japan

Yamaguchi University Hospital

Ube, Japan

Saiseikai Yokohamashi Tobu Hospital

Yokohama, Japan

Yokohama City University Medical Center, Center of IBD

Yokohama, Japan

Erasmus Medisch Centrum

Rotterdam, Netherlands

Akershus Universitetssykehus

Nordbyagen, Norway

Oslo University Hospital

Oslo, Norway

Universitetssykehuset Nord-Norge

Tromsø, Norway

St-Olavs Hospital

Trondheim, Norway

Korczowski Bartosz, Gabinet Lekarski

Rzeszów, Poland

Warsaw IBD Point Profesor Kierkus

Warsaw, Poland

Instytut Pomnik-Centrum Zdrowia Dziecka

Warsaw, Poland

Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)

Braga, Portugal

Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria

Lisbon, Portugal

Centro Hospitalar de São João, E.P.E.

Porto, Portugal

Inje University Haeundae Paik Hospital

Busan, South Korea

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Hospital Universitario Reina Sofia

Córdoba, Spain

Corporacio Sanitaria Parc Tauli

Sabadell, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Royal Hospital for Children and Young People

Edinburgh, United Kingdom

Oxford University Hospitals NHS trust John Radcliffe hospital

Headington, United Kingdom

Great Ormond Street Hospital For Children NHS Foundation Trust

London, United Kingdom

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Sheffield Children's Hospital

Sheffield, United Kingdom

Royal London Hospital

Whitechapel, United Kingdom