RecruitingPhase 3NCT05509777

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

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

Sponsor

Eli Lilly and Company

Enrollment

90 participants

Start Date

Mar 13, 2024

Study Type

INTERVENTIONAL

Conditions

Crohn's Disease

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.

Eligibility

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study tests mirikizumab — an anti-inflammatory injection — in children and teenagers with Crohn's disease, a chronic condition that causes inflammation and pain in the digestive tract. It is part of a larger program that has already studied this drug in adults. **You may be eligible if...** - You are a child or teenager with a confirmed diagnosis of Crohn's disease, including fistulizing Crohn's disease (where abnormal tunnels form in the gut) - Your Crohn's disease is moderately to severely active based on a standard scoring system (PCDAI) - You have tried other treatments but your disease is still active - You and your parent or guardian are willing to participate and sign consent **You may NOT be eligible if...** - You have another serious intestinal condition such as short bowel syndrome - You have an active serious infection, including tuberculosis - You have taken certain biological medications recently that could interfere with the study - You have significant problems with your liver, kidneys, or immune system - 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.

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Interventions

DRUGMirikizumab

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

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