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NCT05509777PHASE3Recruiting

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

Eli Lilly and Company

Start Date

3/13/2024

Completion Date

4/1/2028

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.

Detailed Description

Participants screened in the MACARONI-23 Platform study could be randomized to mirikizumab to participate in this intervention specific arm of the study.

Eligibility Criteria

Age Range: 2 years to 17 years

Inclusion Criteria: * Participants must have a diagnosis of CD or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria. * Participants have moderately to severely active CD (as defined by a baseline PCDAI score ≥30). * Participants must have endoscopy with evidence of active CD defined as SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease) within 1 month of receiving study intervention at Week 0. * Participants must have a documented history of inadequate response, loss of response or intolerance to at least one medication used to treat CD, which may include immunomodulators, oral or IV corticosteroids, a biologic therapy or a JAK inhibitor. Exclusion Criteria: * Participants must not have complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestations that might be anticipated to require surgery. * Participants must not have an abscess. * Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.

Interventions

DRUG

Mirikizumab

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Conditions

Crohn's Disease

Locations

Cedars Sinai Medical Center

Los Angeles, California 90048

United States

Connecticut Children's Medical Center

Hartford, Connecticut 06032

United States

Emory University

Atlanta, Georgia 30322

United States

Children's Center for Digestive Health Care, LLC

Atlanta, Georgia 30342

United States

Riley Childrens Hospital

Indianapolis, Indiana 46202

United States

Boston Children's Hospital

Boston, Massachusetts 02115

United States

Atlantic Children's Health--Pediatric Gastroenterology

Morristown, New Jersey 07960

United States

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

New York, New York 10021-5663

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Columbia University Medical Center/New York Presbyterian

New York, New York 10032

United States

Childrens Medical Center

Dayton, Ohio 45404

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19146

United States

Cook Children's Medical Center

Fort Worth, Texas 76104

United States

University of Vermont Medical Center

Burlington, Vermont 05401

United States

Seattle Children's Hospital

Seattle, Washington 98105

United States

AKH - Medizinische Universtität Wien

Vienna, 1090

Austria

Universitair Ziekenhuis Brussel

Brussels, 1090

Belgium

Cliniques universitaires Saint-Luc

Brussels, 1200

Belgium

Universitair Ziekenhuis Gent

Ghent, 9000

Belgium

UZ Leuven

Leuven, 3000

Belgium

Hospital PUC-CAMPINAS

Campinas, 13060-904

Brazil

Hospital Pequeno Príncipe

Curitiba-PR, 80250-060

Brazil

Hospital das Clínicas - UFG (Universidade Federal de Goiás)

Goiânia, 74605-050

Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, 90035-903

Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, 90050-170

Brazil

NDI - Nucleo de Doenças Infecciosas

Santos Dumont, 29040-091

Brazil

Integral Pesquisa e Ensino

Votuporanga, 15501 405

Brazil

IWK Health Centre

Halifax, B3K 6R8

Canada

London Health Sciences Centre (LHSC) - Victoria Hospital

London, N6A 5W9

Canada

The Hospital for Sick Children

Toronto, M5G 1X8

Canada

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

Vancouver, V6H 3V4

Canada

URC CIC

Paris, 75015

France

Soroka Medical Center

Beersheba, 8410101

Israel

Shamir Medical Center (Assaf Harofeh)

Israel, 70300

Israel

Shaare Zedek

Jerusalem, 9103102

Israel

Hadassah University Hospital, Ein Kerem,

Jerusalem, 9112001

Israel

Schneider Children's Medical Center

Petah Tikva, 4920235

Israel

Kaplan Medical Center, Pediatric Gastroenterology Dept.

Rehovot, 7661041

Israel

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

Alessandria, 15121

Italy

Asst Papa Giovanni Xxiii Bergamo

Bergamo, 24127

Italy

Azienda USL di Bologna

Bologna, 40133

Italy

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

Florence, 50139

Italy

Ospedale dei Bambini Vittore Buzzi

Milan, 20154

Italy

Gastroenterologia ed epatologia pediatrica (Piano terra della Clinica Pediatrica)

Roma, CAP 00161

Italy

Juntendo University Hospital

Bunkyō City, 113-8431

Japan

Hirosaki University Hospital

Hirosaki, 036

Japan

Kagoshima University Hospital

Kagoshima, 890-8520

Japan

Kokikai Tsujinaka Hospital Kashiwanoha

Kashiwa-shi, 277-0871

Japan

Kobe University Hospital

Kobe, 650-0017

Japan

Saga University Hospital

Saga, 849-8501

Japan

Miyagi Children's Hospital

Sendai, 989 3126

Japan

National Center for Child Health and Development

Setagaya-ku, 157-8535

Japan

Mie University Hospital

Tsu, 514-8507

Japan

Yamaguchi University Hospital

Ube, 755-8505

Japan

Saiseikai Yokohamashi Tobu Hospital

Yokohama, 2308765

Japan

Yokohama City University Medical Center, Center of IBD

Yokohama, 232-0024

Japan

Erasmus Medisch Centrum

Rotterdam, 3015 CN

Netherlands

Akershus Universitetssykehus

Nordbyagen, 01474

Norway

Oslo University Hospital

Oslo, 0450

Norway

Universitetssykehuset Nord-Norge

Tromsø, 9038

Norway

St-Olavs Hospital

Trondheim, 7030

Norway

Korczowski Bartosz, Gabinet Lekarski

Rzeszów, 35-302

Poland

Warsaw IBD Point Profesor Kierkus

Warsaw, 00-728

Poland

Instytut Pomnik-Centrum Zdrowia Dziecka

Warsaw, 04-730

Poland

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

Braga, 4710-243

Portugal

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

Lisbon, 1649-035

Portugal

Centro Hospitalar de São João, E.P.E.

Porto, 4200 319

Portugal

Inje University Haeundae Paik Hospital

Busan, 48108

South Korea

Kyungpook National University Chilgok Hospital

Daegu, 41404

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 03722

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Seoul National University Hospital

Seoul, 3080

South Korea

Hospital Universitario Reina Sofia

Córdoba, 14004

Spain

Corporacio Sanitaria Parc Tauli

Sabadell, 08208

Spain

Hospital Universitari i Politecnic La Fe

Valencia, 46026

Spain

Royal Hospital for Children and Young People

Edinburgh, EH16 4TJ

United Kingdom

Oxford University Hospitals NHS trust John Radcliffe hospital

Headington, OX3 9DU

United Kingdom

Great Ormond Street Hospital For Children NHS Foundation Trust

London, WC1N 3JH

United Kingdom

Manchester University NHS Foundation Trust

Manchester, M139WL

United Kingdom

Sheffield Children's Hospital

Sheffield, S10 2RX

United Kingdom

Royal London Hospital

Whitechapel, E1 1FR

United Kingdom